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| Name | Class |
|---|---|
| HIV Vaccine Trials Network | NETWORK |
| Bill and Melinda Gates Foundation | OTHER |
| Medical Research Council | OTHER_GOV |
| Sanofi Pasteur, a Sanofi Company |
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The HIV Vaccine Trials Network (HVTN) is doing a study to test a new HIV vaccine combination. HIV is the virus that causes AIDS.
252 people are taking part in this study at multiple sites. The US National Institutes of Health (NIH) is paying for the study.
The investigators are doing this study to answer several questions.
The HIV Vaccine Trials Network (HVTN) is doing a study to test a new HIV vaccine combination. HIV is the virus that causes AIDS. The investigators are doing this study to answer several questions:
The study uses 2 different vaccines: ALVAC-HIV (vCP2438) and bivalent gp120/MF59. These are experimental HIV vaccines -- the investigators do not know whether the vaccines will be safe to use in people, or whether they will work to prevent HIV infection. These vaccines are used only in research studies.
The ALVAC vaccine is made out of canarypox virus, which infects birds but cannot grow in human cells. This virus has small bits of man-made DNA inserted into it. DNA is a natural substance found in all living things, including people and some viruses. The canarypox virus helps get the DNA into the body's cells. The DNA then tells those cells to make small amounts of proteins that look like some of the ones found in HIV.
A study in South Africa, HVTN 097, gave a similar ALVAC vaccine to about 80 participants. So far, no one has had serious health problems.
The Protein vaccine has man-made pieces of a protein found on the outside of HIV. These protein pieces are mixed with an adjuvant called MF59. An adjuvant is something added to the vaccine to help the immune system respond better. MF59 has been included with other vaccines that have been given to over 50,000 people in clinical trials without causing any serious health problems.
This combination of study vaccines has not been given to people before. However, similar ALVAC and protein vaccines have been given to more than 10,000 people in clinical trials without causing any serious health problems. Also, over 300 people have received a similar combination of ALVAC and protein vaccines with the MF59 adjuvant in clinical trials without having any serious health problems.
The study is in 2 parts, Part A and Part B. Part B continues the study in order to learn how well boosting the study vaccines improves immune responses. 252 people took part in Part A of this study at multiple sites. Those who continue to meet eligibility requirements are invited to continue in Part B.
The US National Institutes of Health (NIH) is paying for the study. For people who continue to Part B, the study requires about 23 clinic visits in 4 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A, Group 1: Vaccine | Active Comparator | ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12 |
|
| Part A, Group 2: Placebo | Placebo Comparator | Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12 |
|
| Part B, Group 1a: Vaccine | Active Comparator | Participants originally in Part A Group 1 (Vaccine) receive ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30 |
|
| Part B, Group 1b: Vaccine + Placebo | Active Comparator | Participants originally in Part A Group 1 (Vaccine) receive placebo for ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30 |
|
| Part B, Group 2: Placebo | Placebo Comparator | Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALVAC-HIV | Biological | a lyophilized vaccine for injection at a viral titer ≥ 1 × 10E6 cell culture infectious dose (CCID)50 and < 1 × 10E8 CCID50 (nominal dose of 10E7 CCID50) and is reconstituted with 1mL of sterile sodium chloride solution (NaCl 0.4%) for intramuscular (IM) injection as a single dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017] The maximum grade observed for each symptom over the time frame is presented. | Measured through 3 days after participants' last vaccination at Month 0,1,3, and 6 |
| Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017] | Measured through 3 days after each vaccination at Month 0, 1, 3, and 6 |
| Part A: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm | Measured through Month 18 |
| Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | From the study product discontinuation form, study product administration reasons are tabulated by treatment arm | Measured through the Month 12 vaccination |
| Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown. | Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]. The maximum grade observed for each symptom over the time frame is presented. | Measured through 3 days after each vaccination at Month 0, 1, 3, 6, and 12 |
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Inclusion Criteria:
Age of 18 to 40 years
Access to a participating HVTN CRS and willingness to be followed for the planned duration of the study
Ability and willingness to provide informed consent
Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
Agrees not to enroll in another study of an investigational research agent
Good general health as shown by medical history, physical exam, and screening laboratory tests
Willingness to receive HIV test results
Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling
Assessed by the clinic staff as being at "low risk" for HIV infection (per Low Risk Guidelines for South African sites) and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit
Hemoglobin ≥ 11.0 g/dL for volunteers who were born female, ≥ 13.0 g/dL for volunteers who were born male
WBC = 3,300 to 12,000 cells/mm3
Total lymphocyte count ≥ 800 cells/mm3
Remaining differential either within institutional normal range or with site physician approval
Platelets = 125,000 to 550,000/mm3
Chemistry panel: ALT, AST, and ALP < 1.25 times the institutional upper limit of normal; creatinine ≤ institutional upper limit of normal.
Negative HIV-1 and -2 blood test: Sites may use locally available assays that have been approved by HVTN Laboratory Operations.
Negative Hepatitis B surface antigen (HBsAg)
Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
Normal urine:
Volunteers who were born female: negative urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination or negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test within 24 hours prior to initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy with bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.
Reproductive status: A volunteer who was born female must:
PLUS 1 of the following methods:
Intrauterine device (IUD),
Hormonal contraception (in accordance with Republic of South Africa: National Contraception Clinical Guidelines),
Successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner has [1] documentation of azoospermia by microscopy, or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy); or
Any other contraceptive method approved by the HVTN 100 PSRT
Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation;
Or be sexually abstinent.
Exclusion Criteria:
Blood products received within 120 days before first vaccination
Investigational research agents received within 30 days before first vaccination
Body mass index (BMI) ≥ 40; or BMI ≥ 35 with 2 or more of the following: systolic blood pressure > 140 mm Hg, diastolic blood pressure > 90 mm Hg, current smoker, known hyperlipidemia
Intent to participate in another study of an investigational research agent or any study that includes HIV testing during the planned duration of the HVTN 100 study
Pregnant, breastfeeding, or lactating
HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 100 PSRT will determine eligibility on a case-by-case basis.
Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure by the South Africa Medicines Control Council (MCC). For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 100 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the HVTN 100 PSRT on a case-by-case basis.
Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection (eg, measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever)
Influenza vaccine or any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B)
Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination
Immunosuppressive medications received within 168 days before first vaccination. (Not excluded from participation: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatitis; or [4] a single course of oral/parenteral corticosteroids at doses < 2 mg/kg/day and length of therapy < 11 days with completion at least 30 days prior to enrollment.)
Serious adverse reactions to vaccines or to vaccine components such as eggs, egg products, or neomycin, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.)
Immunoglobulin received within 60 days before first vaccination
Autoimmune disease
Immunodeficiency
Untreated or incompletely treated syphilis infection
Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a volunteer's ability to give informed consent
Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.
Current anti-tuberculosis (TB) prophylaxis or therapy
Asthma other than mild or moderate, well-controlled asthma. (Symptoms of asthma severity as defined in the most recent National Asthma Education and Prevention Program (NAEPP) Expert Panel report). Exclude a volunteer who:
Diabetes mellitus type 1 or type 2, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes.)
Thyroidectomy, or thyroid disease requiring medication during the last 12 months
Hypertension:
Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
Malignancy (Not excluded: Volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure or who is unlikely to experience recurrence of malignancy during the period of the study)
Seizure disorder: History of seizure(s) within past three years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
Asplenia: any condition resulting in the absence of a functional spleen
History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
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| Name | Affiliation | Role |
|---|---|---|
| Linda-Gail Bekker, MBChB, DTMH, DCH, FCP(SA), PhD | HIV Vaccine Trials Network | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CAPRISA eThekwini CRS | Durban | KwaZulu-Natal | 4001 | South Africa | ||
| Isipingo CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40190112 | Derived | Moodie Z, Li SS, Giorgi EE, Williams LD, Dintwe O, Carpp LN, Chen S, Seaton KE, Sawant SS, Zhang L, Heptinstall J, Liu S, Grunenberg N, Tomaka F, Rerks-Ngarm S, Pitisuttithum P, Nitayaphan S, Ake JA, Vasan S, Pantaleo G, Frank I, Baden LR, Goepfert PA, Keefer M, Chirenje M, Hosseinipour MC, Mngadi K, Laher F, Garrett N, Bekker LG, De Rosa S, Andersen-Nissen E, Kublin JG, Lu S, Gilbert PB, Gray GE, Corey L, McElrath MJ, Tomaras GD. A polyvalent DNA prime with matched polyvalent protein/GLA-SE boost regimen elicited the most robust and broad IgG and IgG3 V1V2 binding antibody and CD4+ T cell responses among 13 HIV vaccine trials. Emerg Microbes Infect. 2025 Dec;14(1):2485317. doi: 10.1080/22221751.2025.2485317. Epub 2025 Apr 7. | |
| 39302924 |
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Participants who received all vaccinations in Part A and completed Part A as scheduled were eligible for the Part B extension study. N=63 vaccination recipients in Part A (Group 1) were re-randomized to Part B Group 1a or 1b with a 1:1 ratio, while N=7 placebo recipients from Part A (Group 2) re-enrolled to receive placebo injections in Part B.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A, Group 1: Vaccine | Participants receive ALVAC-HIV (vCP2438) injections at months 0 and 1, and ALVAC-HIV (vCP2438) + bivalent subtype C gp120/MF59® injections at months 3, 6, and 12. |
| FG001 | Part A, Group 2: Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A: Month 0-18 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 23, 2017 |
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| INDUSTRY |
| GlaxoSmithKline | INDUSTRY |
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|
|
| Bivalent Subtype C gp120/MF59® | Biological | 2 recombinant monomeric proteins, each at a dose of 100 mcg, mixed with MF59® adjuvant (an oil-in-water emulsion) delivered as a 0.5 mL IM injection |
|
| ALVAC-HIV (vCP2438) Placebo | Biological | a sterile, lyophilized product that consists of a mixture of virus stabilizer, and freeze drying medium and is reconstituted with 1mL of sterile sodium chloride solution (NaCl 0.4%) for injection as a single dose IM |
|
| Bivalent gp120/MF59® Placebo | Biological | Sodium chloride for injection, 0,9% delivered as a 0.5 mL IM injection |
|
| Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT |
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. |
| Time Frame: Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12 |
| Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. | Time Frame: Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12 |
| Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. | Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12 |
| Part A: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. | Measured at Month 6.5 |
| Part A: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. | Measured at Month 6.5 |
| Part A: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen | Measured by HIV-1 multiplex Ab assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by antigen. | Measured at Month 6.5 |
| Part A: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. | Measured at Month 6.5 |
| Part A: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. Measured by Flow Cytometry. | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. | Measured at Month 6.5 |
| Part A: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. | Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. Percentage of T-cells expressing cytokines are summarized for positive responders only. | Measured at Month 6.5 |
| Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]. For each participant, the maximum grade observed for each symptom over the time frame is presented. | Measured through 3 days after the Month 30 vaccination |
| Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]. For each participant, the maximum grade observed for each symptom over the time frame is presented. | Measured through 3 days after the Month 30 vaccination |
| Part B: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | From the study termination form, early termination reasons associated with an AE are tabulated by treatment arm | Measured through Month 36 |
| Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown. | Time Frame: Measured during screening for part B, and 2 weeks after vaccination at Month 30 |
| Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. | Measured during screening for part B, and 2 weeks after vaccination at Month 30 |
| Part B Chemistry Laboratory Measures: Hemoglobin, Creatinine | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. | Measured during screening for part B, and 2 weeks after vaccination at Month 30 |
| Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. | Measured during screening for part B, and 2 weeks after vaccination at Month 30 |
| Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | Measured by HIV-1 multiplex Ab assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by antigen. | Measured at Month 30.5 |
| Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. | Measured at Month 30.5 |
| Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | Measured by HIV-1 multiplex Ab assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by antigen. | Measured at Month 30.5 |
| Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. | Measured at Month 30.5 |
| Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by peptide pool. | Measured at Month 30.5 |
| Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. Percentage of T-cells expressing cytokines are summarized for positive responders only. | Measured at Month 30.5 |
| Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]. The maximum grade observed for each symptom over the time frame is presented. | Measured through 3 days after each vaccination at Month 0, 1, 3, 6, and 12 |
| Part A: Compare the Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. | Measured at Month 6.5 and 12.5 |
| Part A: Compare the Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. Comparisons were performed among positive responders only (positivity criteria is described in Outcome 30). | Measured at Month 6.5 and 12.5 |
| Part A: Compare the Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. | Measured at Month 6.5 and 12.5 |
| Part A: Compare the Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. Comparisons were performed among positive responders only (positivity criteria is described in Outcome 32). | Measured at Month 6.5 and 12.5 |
| Part A: Compare the Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. | Measured at Month 6.5 and 12.5 |
| Part A: Compare the Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. Comparisons were performed among positive responders only. | Measured at Month 6.5 and 12.5 |
| Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. | Measured at Month 30 and 36 |
| Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. | Measured at Month 30 and 36 |
| Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. | Measured at Month 30 and 36 |
| Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. | Measured at Month 30 and 36 |
| Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. | Measured at Month 30 and 36 |
| Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. | Measured at Month 30 and 36 |
| Durban |
| KwaZulu-Natal |
| 4133 |
| South Africa |
| Emavundleni Desmond Tutu HIV Centre CRS | Cape Town | Western Cape | 7750 | South Africa |
| Aurum Institute for Health Research | Klerksdorp | 2570 | South Africa |
| Perinatal HIV Research Unit | Soweto | 2013 | South Africa |
| Derived |
| Naicker V, Laher F, Bekker LG, Seaton KE, Allen M, De Rosa S, Yates NL, Mkhize NN, Saunders K, Heptinstall J, Malahleha M, Mngadi K, Daniels B, Innes C, Yu C, Modise T, Bekker V, Grunenberg N, Furch B, Miner MD, Phogat S, Diazgranados CA, Gurunathan S, Koutsoukos M, Van Der Meeren O, Roxby AC, Ferrari G, Morris L, Montefiori D, McElrath MJ, Tomaras GD, Moodie Z. Safety and immunogenicity after a 30-month boost of a subtype C ALVAC-HIV (vCP2438) vaccine prime plus bivalent subtype C gp120/MF59 vaccine boost (HVTN 100): A phase 1-2 randomized double-blind placebo-controlled trial. PLOS Glob Public Health. 2024 Sep 20;4(9):e0003319. doi: 10.1371/journal.pgph.0003319. eCollection 2024. |
| 34895272 | Derived | Hanass-Hancock J, Carpenter B, Reddy T, Nzuza A, Gaffoor Z, Goga A, Andrasik M. Participants' characteristics and motivations to screen for HIV vaccine and monoclonal antibody trials in KwaZulu-Natal, South Africa. Trials. 2021 Dec 11;22(1):897. doi: 10.1186/s13063-021-05792-7. |
| 32092060 | Derived | Laher F, Moodie Z, Cohen KW, Grunenberg N, Bekker LG, Allen M, Frahm N, Yates NL, Morris L, Malahleha M, Mngadi K, Daniels B, Innes C, Saunders K, Grant S, Yu C, Gilbert PB, Phogat S, DiazGranados CA, Koutsoukos M, Van Der Meeren O, Bentley C, Mkhize NN, Pensiero MN, Mehra VL, Kublin JG, Corey L, Montefiori DC, Gray GE, McElrath MJ, Tomaras GD. Safety and immune responses after a 12-month booster in healthy HIV-uninfected adults in HVTN 100 in South Africa: A randomized double-blind placebo-controlled trial of ALVAC-HIV (vCP2438) and bivalent subtype C gp120/MF59 vaccines. PLoS Med. 2020 Feb 24;17(2):e1003038. doi: 10.1371/journal.pmed.1003038. eCollection 2020 Feb. |
| 31999736 | Derived | Zhao LP, Fiore-Gartland A, Carpp LN, Cohen KW, Rouphael N, Fleurs L, Dintwe O, Zhao M, Moodie Z, Fong Y, Garrett N, Huang Y, Innes C, Janes HE, Lazarus E, Michael NL, Nitayaphan S, Pitisuttithum P, Rerks-Ngarm S, Robb ML, De Rosa SC, Corey L, Gray GE, Seaton KE, Yates NL, McElrath MJ, Frahm N, Tomaras GD, Gilbert PB. Landscapes of binding antibody and T-cell responses to pox-protein HIV vaccines in Thais and South Africans. PLoS One. 2020 Jan 30;15(1):e0226803. doi: 10.1371/journal.pone.0226803. eCollection 2020. |
| 29898870 | Derived | Bekker LG, Moodie Z, Grunenberg N, Laher F, Tomaras GD, Cohen KW, Allen M, Malahleha M, Mngadi K, Daniels B, Innes C, Bentley C, Frahm N, Morris DE, Morris L, Mkhize NN, Montefiori DC, Sarzotti-Kelsoe M, Grant S, Yu C, Mehra VL, Pensiero MN, Phogat S, DiazGranados CA, Barnett SW, Kanesa-Thasan N, Koutsoukos M, Michael NL, Robb ML, Kublin JG, Gilbert PB, Corey L, Gray GE, McElrath MJ; HVTN 100 Protocol Team. Subtype C ALVAC-HIV and bivalent subtype C gp120/MF59 HIV-1 vaccine in low-risk, HIV-uninfected, South African adults: a phase 1/2 trial. Lancet HIV. 2018 Jul;5(7):e366-e378. doi: 10.1016/S2352-3018(18)30071-7. Epub 2018 Jun 18. |
Participants receive placebo for ALVAC-HIV (vCP2438) at months 0 and 1, and placebo for ALVAC-HIV (vCP2438) + placebo for bivalent subtype C gp120/MF59® injections at months 3, 6, and 12.
| FG002 | Part B, Group 1a: Vaccine | Participants originally in Part A Group 1 receive ALVAC-HIV (vCP2438) + bivalent subtype C gp120/MF59® (vCP2438) injections at month 30. |
| FG003 | Part B, Group 1b: Vaccine + Placebo | Participants originally in Part A Group 1 receive placebo for ALVAC-HIV (vCP2438) + active bivalent subtype C gp120/MF59® at month 30. |
| FG004 | Part B, Group 2: Placebo | Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV (vCP2438) + placebo for bivalent subtype C gp120/MF59® at month 30. |
| Per Protocol |
|
| Month 6.5 Immunogenicity Timepoint |
|
| Month 12.5 Immunogenicity Timepoint |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part B: Month 30-36 |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Part A Only: Group 1 (Vaccine) | Participants did not go on to Part B. In Part A, participants received ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12 |
| BG001 | Part A Only: Group 2 (Placebo) | Participants did not go on to Part B. In Part A, participants received Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12 |
| BG002 | Part A, Group 1 (Vaccine) + Part B, Group 1a (Vaccine) | Participants completed Part A in Group 1 (Vaccine), joined Part B and were randomized to Group 1a (Vaccine): ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30 |
| BG003 | Part A, Group 1 (Vaccine) + Part B, Group 1b: Vaccine/Placeb | Participants completed Part A in Group 1 (Vaccine), joined Part B and were randomized to Group 1b (Vaccine/Placebo ): placebo for ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30 |
| BG004 | Part A, Group 2 (Placebo) + Part B, Group 2 (Placebo) | Participants completed Part A in Group 2 (Placebo), joined Part B and received placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30 |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part A: Number of Participants Reporting Local Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017] The maximum grade observed for each symptom over the time frame is presented. | Posted | Count of Participants | Participants | Measured through 3 days after participants' last vaccination at Month 0,1,3, and 6 |
|
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| Primary | Part A: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Primary Vaccine Regimen | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017] | Posted | Count of Participants | Participants | Measured through 3 days after each vaccination at Month 0, 1, 3, and 6 |
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| Primary | Part A: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm | Posted | Count of Participants | Participants | Measured through Month 18 |
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| Primary | Part A: Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity | From the study product discontinuation form, study product administration reasons are tabulated by treatment arm | Posted | Count of Participants | Participants | Measured through the Month 12 vaccination |
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| Primary | Part A: Chemistry and Hematology Laboratory Results With Grade 1 or Higher | Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown. | The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit. | Posted | Count of Participants | Participants | Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12 |
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| Primary | Part A Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. | The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit. | Posted | Median | Inter-Quartile Range | U/L | Time Frame: Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12 |
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| Primary | Part A Chemistry Laboratory Measures: Hemoglobin, Creatinine | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. | The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit. | Posted | Median | Inter-Quartile Range | g/dL | Time Frame: Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12 |
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| Primary | Part A Hematology Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. | The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit. | Posted | Median | Inter-Quartile Range | thousand cells/cubic mm | Measured during screening for part A, and 2 weeks after each vaccination at Month 0, 1, 3, 6, and 12 |
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| Primary | Part A: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. | "Overall Number of Participants Analyzed" includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected and received the first 4 vaccinations. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria. | Posted | Count of Participants | Participants | Measured at Month 6.5 |
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| Primary | Part A: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Primary Vaccine Regimen, Measured by HIV-1 Multiplex Antibody Assay | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. | "Overall Number of Participants Analyzed" includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected and received the first 4 vaccinations. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria. | Posted | Median | Inter-Quartile Range | fluorescence unit relative to background | Measured at Month 6.5 |
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| Primary | Part A: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen | Measured by HIV-1 multiplex Ab assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by antigen. | "Overall Number of Participants Analyzed" includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected and received the first 4 vaccinations. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria. | Posted | Count of Participants | Participants | Measured at Month 6.5 |
|
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| Primary | Part A: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Primary Vaccine Regimen | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. | "Overall Number of Participants Analyzed" includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected and received the first 4 vaccinations. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria. | Posted | Median | Inter-Quartile Range | fluorescence unit relative to background | Measured at Month 6.5 |
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| Primary | Part A: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. Measured by Flow Cytometry. | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. | "Overall Number of Participants Analyzed" includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected and received the first 4 vaccinations. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria. | Posted | Count of Participants | Participants | Measured at Month 6.5 |
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| Primary | Part A: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Primary Vaccine Regimen. | Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. Percentage of T-cells expressing cytokines are summarized for positive responders only. | "Overall Number of Participants Analyzed" includes those with samples collected at the month 6.5 immunogenicity timepoint, who were HIV-uninfected and received the first 4 vaccinations. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria. | Posted | Median | Inter-Quartile Range | % CD4+ T-cells | Measured at Month 6.5 |
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| Primary | Part B: Number of Participants Reporting Local Reactogenicity Signs and Symptoms in the Extension Study | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]. For each participant, the maximum grade observed for each symptom over the time frame is presented. | Posted | Count of Participants | Participants | Measured through 3 days after the Month 30 vaccination |
|
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| Primary | Part B: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms in the Extension Study | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]. For each participant, the maximum grade observed for each symptom over the time frame is presented. | Posted | Count of Participants | Participants | Measured through 3 days after the Month 30 vaccination |
|
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| Primary | Part B: Number of Participants With Early Study Termination Associated With an AE or Reactogenicity | From the study termination form, early termination reasons associated with an AE are tabulated by treatment arm | Posted | Count of Participants | Participants | Measured through Month 36 |
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| Primary | Part B: Chemistry and Hematology Laboratory Results of Grade 1 or Higher | Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown. | The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit. | Posted | Count of Participants | Participants | Time Frame: Measured during screening for part B, and 2 weeks after vaccination at Month 30 |
| |||||||||||||||||||||||||||||||||
| Primary | Part B Chemistry Laboratory Measures: Alkaline Phosphatase, AST, and ALT | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. | The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit. | Posted | Median | Inter-Quartile Range | U/L | Measured during screening for part B, and 2 weeks after vaccination at Month 30 |
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| Primary | Part B Chemistry Laboratory Measures: Hemoglobin, Creatinine | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. | The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit. | Posted | Median | Inter-Quartile Range | g/dL | Measured during screening for part B, and 2 weeks after vaccination at Month 30 |
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| Primary | Part B Chemistry Laboratory Measures: WBC, Platelets, Lymphocytes, Neutrophils | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. | The "overall number of participants analyzed" represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit. | Posted | Median | Inter-Quartile Range | thousand cells/cubic mm | Measured during screening for part B, and 2 weeks after vaccination at Month 30 |
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| Primary | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | Measured by HIV-1 multiplex Ab assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by antigen. | "Overall Number of Participants Analyzed" includes those with samples collected at month 30.5, who were HIV-uninfected and received the all vaccinations. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. | Posted | Count of Participants | Participants | Measured at Month 30.5 |
| |||||||||||||||||||||||||||||||||
| Primary | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. | "Overall Number of Participants Analyzed" includes those with samples collected at month 30.5, who were HIV-uninfected and received the all vaccinations. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. | Posted | Median | Inter-Quartile Range | fluorescence unit relative to background | Measured at Month 30.5 |
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| Primary | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | Measured by HIV-1 multiplex Ab assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by antigen. | "Overall Number of Participants Analyzed" includes those with samples collected at month 30.5, who were HIV-uninfected and received the all vaccinations. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. | Posted | Count of Participants | Participants | Measured at Month 30.5 |
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| Primary | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. | "Overall Number of Participants Analyzed" includes those with samples collected at month 30.5, who were HIV-uninfected and received the all vaccinations. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. | Posted | Median | Inter-Quartile Range | fluorescence unit relative to background | Measured at Month 30.5 |
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| Primary | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. The number and percentage of participants with positive responses are summarized by peptide pool. | "Overall Number of Participants Analyzed" includes those with samples collected at month 30.5, who were HIV-uninfected and received the all vaccinations. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. | Posted | Count of Participants | Participants | Measured at Month 30.5 |
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| Primary | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study | Measured by flow cytometry ICS assay: refer to earlier description for assay methods and analysis variable derivation. Percentage of T-cells expressing cytokines are summarized for positive responders only. | "Overall Number of Participants Analyzed" includes those with samples collected at month 30.5, who were HIV-uninfected and received the all vaccinations. "Number Analyzed" counts participants with available data after filtering for assay-specific quality control criteria. | Posted | Median | Inter-Quartile Range | % of CD4+ T-cells | Measured at Month 30.5 |
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| Secondary | Part A: Frequency of Severe Local Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]. The maximum grade observed for each symptom over the time frame is presented. | Posted | Count of Participants | Participants | Measured through 3 days after each vaccination at Month 0, 1, 3, 6, and 12 |
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| Secondary | Part A: Frequency of Severe Systemic Reactogenicity Signs and Symptoms, Through the Fifth Vaccination | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [March 2017]. The maximum grade observed for each symptom over the time frame is presented. | Posted | Count of Participants | Participants | Measured through 3 days after each vaccination at Month 0, 1, 3, 6, and 12 |
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| Secondary | Part A: Compare the Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. | The durability cohort was randomly selected from those in the month 6.5 cohort with samples collected at month 12.5. Selection was stratified by gender to match the overall protocol. "Overall Number of Participants Analyzed" represents the durability cohort. "Number Analyzed" counts participants with data meeting assay-specific quality criteria. | Posted | Count of Participants | Participants | Measured at Month 6.5 and 12.5 |
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| Secondary | Part A: Compare the Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) After the Fourth Versus the Fifth Vaccination | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. Comparisons were performed among positive responders only (positivity criteria is described in Outcome 30). | The durability cohort was randomly selected from those in the month 6.5 cohort with samples collected at month 12.5. Selection was stratified by gender to match the overall protocol. "Overall Number of Participants Analyzed" represents the durability cohort. "Number Analyzed" counts participants with data meeting assay-specific quality criteria. | Posted | Median | Inter-Quartile Range | fluorescence unit relative to background | Measured at Month 6.5 and 12.5 |
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| Secondary | Part A: Compare the Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. | The durability cohort was randomly selected from those in the month 6.5 cohort with samples collected at month 12.5. Selection was stratified by gender to match the overall protocol. "Overall Number of Participants Analyzed" represents the durability cohort. "Number Analyzed" counts participants with data meeting assay-specific quality criteria. | Posted | Count of Participants | Participants | Measured at Month 6.5 and 12.5 |
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| Secondary | Part A: Compare the Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins After the Fourth Versus the Fifth Vaccination | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. Comparisons were performed among positive responders only (positivity criteria is described in Outcome 32). | The durability cohort was randomly selected from those in the month 6.5 cohort with samples collected at month 12.5. Selection was stratified by gender to match the overall protocol. "Overall Number of Participants Analyzed" represents the durability cohort. "Number Analyzed" counts participants with data meeting assay-specific quality criteria. | Posted | Median | Inter-Quartile Range | fluorescence unit relative to background | Measured at Month 6.5 and 12.5 |
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| Secondary | Part A: Compare the Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. | Posted | Count of Participants | Participants | Measured at Month 6.5 and 12.5 |
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| Secondary | Part A: Compare the Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine After the Fourth Versus the Fifth Vaccinations | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. Comparisons were performed among positive responders only. | Posted | Median | Inter-Quartile Range | % CD4+ T-cells | Measured at Month 6.5 and 12.5 |
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| Secondary | Part B: Occurrence of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. | "Overall Number of Participants Analyzed" represents Part B participants. "Number Analyzed" counts participants with data meeting assay-specific quality criteria. | Posted | Count of Participants | Participants | Measured at Month 30 and 36 |
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| Secondary | Part B: Level of IgG Ab Binding to gp120 Env Proteins Contained in the Vaccine (ZM96, TV1.C, 1086.C) in the Extension Study, at 6 Months After the Month 30 Vaccination | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. | "Overall Number of Participants Analyzed" represents Part B participants. "Number Analyzed" counts participants with data meeting assay-specific quality criteria. | Posted | Median | Inter-Quartile Range | fluorescence unit relative to background | Measured at Month 30 and 36 |
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| Secondary | Part B: Occurrence of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. Samples from post-enrollment visits have positive responses if they meet three conditions: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of pre-vaccination net MFI), (2) net MFI values are greater than 3 times pre-vaccination net MFI, and (3) experimental antigen MFI values are greater than 3 times pre-vaccination MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 5000 MFI. | "Overall Number of Participants Analyzed" represents Part B participants. "Number Analyzed" counts participants with data meeting assay-specific quality criteria. | Posted | Count of Participants | Participants | Measured at Month 30 and 36 |
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| Secondary | Part B: Level of IgG Binding Antibodies to 3 V1V2-scaffolded Env Proteins in the Extension Study, at 6 Months After the Month 30 Vaccination | Serum HIV-1-specific IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. | "Overall Number of Participants Analyzed" represents Part B participants. "Number Analyzed" counts participants with data meeting assay-specific quality criteria. | Posted | Median | Inter-Quartile Range | fluorescence unit relative to background | Measured at Month 30 and 36 |
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| Secondary | Part B: Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. | "Overall Number of Participants Analyzed" represents Part B participants. "Number Analyzed" counts participants with data meeting assay-specific quality criteria. | Posted | Count of Participants | Participants | Measured at Month 30 and 36 |
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| Secondary | Part B: Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine in the Extension Study, at 6 Months After the Month 30 Vaccination | PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if p<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. | "Overall Number of Participants Analyzed" represents Part B participants. "Number Analyzed" counts participants with data meeting assay-specific quality criteria. | Posted | Median | Inter-Quartile Range | % CD4+ T-cells | Measured at Month 30 and 36 |
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Serious adverse events are collected throughout the study (months 0-18 for Part A, and months 30-36 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0, 1, 3, 6, and 12 for Part A, and month 30 for Part B).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A, Group 1: Vaccine | ALVAC-HIV at months 0 and 1, and ALVAC-HIV + bivalent subtype C gp120/MF59 at months 3, 6, and 12 | 2 | 210 | 7 | 210 | 147 | 210 |
| EG001 | Part A, Group 2: Placebo | Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12 | 0 | 42 | 0 | 42 | 34 | 42 |
| EG002 | Part B, Group 1a: Vaccine | Participants originally in Part A Group 1 (Vaccine) receive ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30 | 0 | 32 | 0 | 32 | 15 | 32 |
| EG003 | Part B, Group 1b: Vaccine/Placebo | Participants originally in Part A Group 1 (Vaccine) receive placebo for ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30 | 0 | 31 | 0 | 31 | 18 | 31 |
| EG004 | Part B, Group 2: Placebo | Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30 | 0 | 7 | 0 | 7 | 1 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Event in SOC | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Injury, poisoning and procedural complications | MEDRA 21.1 | Non-systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MEDRA 21.1 | Non-systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MEDRA 21.1 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MEDRA 21.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Musculoskeletal and connective tissue disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Rheumatic fever | Musculoskeletal and connective tissue disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Nervous system disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Psychiatric disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MEDRA 21.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Event in SOC | Blood and lymphatic system disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Cardiac disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Ear and labyrinth disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Eye disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Eye pruritus | Eye disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Gastrointestinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Any Event in SOC | General disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Injection site nodule | General disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Suprapubic pain | General disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Vessel puncture site bruise | General disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Vessel puncture site pain | General disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Vessel puncture site swelling | General disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Blister infected | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Body tinea | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Chlamydial infection | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Dysentery | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Genitourinary chlamydia infection | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Genitourinary tract gonococcal infection | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Nasal herpes | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Pelvic inflammatory disease | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Respiratory tract infection bacterial | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Urethritis | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Urogenital trichomoniasis | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Varicella | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Vulvovaginitis trichomonal | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Injury, poisoning and procedural complications | MEDRA 21.1 | Non-systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MEDRA 21.1 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MEDRA 21.1 | Non-systematic Assessment |
| |
| Buttock injury | Injury, poisoning and procedural complications | MEDRA 21.1 | Non-systematic Assessment |
| |
| Ear canal abrasion | Injury, poisoning and procedural complications | MEDRA 21.1 | Non-systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MEDRA 21.1 | Non-systematic Assessment |
| |
| Foreign body in eye | Injury, poisoning and procedural complications | MEDRA 21.1 | Non-systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MEDRA 21.1 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MEDRA 21.1 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MEDRA 21.1 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MEDRA 21.1 | Non-systematic Assessment |
| |
| Post procedural contusion | Injury, poisoning and procedural complications | MEDRA 21.1 | Non-systematic Assessment |
| |
| Procedural dizziness | Injury, poisoning and procedural complications | MEDRA 21.1 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MEDRA 21.1 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MEDRA 21.1 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MEDRA 21.1 | Non-systematic Assessment |
| |
| Stab wound | Injury, poisoning and procedural complications | MEDRA 21.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Investigations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Urobilinogen urine increased | Investigations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MEDRA 21.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MEDRA 21.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Musculoskeletal and connective tissue disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Nervous system disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Tension headache | Nervous system disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Psychiatric disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Premature ejaculation | Psychiatric disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Stress | Psychiatric disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Substance abuse | Psychiatric disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Substance-induced psychotic disorder | Psychiatric disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Renal and urinary disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Glycosuria | Renal and urinary disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Reproductive system and breast disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Abnormal withdrawal bleeding | Reproductive system and breast disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Amenorrhoea | Reproductive system and breast disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Dyspareunia | Reproductive system and breast disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Respiratory, thoracic and mediastinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Nasal septum ulceration | Respiratory, thoracic and mediastinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Skin and subcutaneous tissue disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Vascular disorders | MEDRA 21.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MEDRA 21.1 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations | Fred Hutchinson Cancer Research Center | 206-667-5812 | jandries@fredhutch.org |
| Sep 18, 2020 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C112734 | AIDSVAX |
Not provided
Not provided
Not provided
| 18 - 20 years |
|
| 21 - 30 years |
|
| 31 - 40 years |
|
| 41 - 50 years |
|
| Above 50 years |
|
| Unknown or Not Reported |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Moderate |
|
| Severe |
|
| Life Threatening |
|
| Tenderness |
|
| Pain and/or Tenderness |
|
| Erythema |
|
| Induration |
|
| Erythema and/or Induration |
|
|
|
|
|
|
|
|
|
| OG001 | Part A, Group 2: Placebo | Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12 |
|
|
|
|
|
|
|
Placebo for ALVAC-HIV at months 0 and 1, and placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at months 3, 6, and 12 |
|
|
|
| Participants |
|
|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
| OG002 | Part B, Group 2: Placebo | Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30 |
|
|
|
|
| OG002 | Part B, Group 2: Placebo | Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30 |
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
Participants originally in Part A Group 1 (Vaccine) receive placebo for ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30 |
| OG002 | Part B, Group 2: Placebo | Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30 |
|
|
| OG002 | Part B, Group 2: Placebo | Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30 |
|
|
Participants originally in Part A Group 1 (Vaccine) receive placebo for ALVAC-HIV + bivalent subtype C gp120/MF59 at month 30 |
| OG002 | Part B, Group 2: Placebo | Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30 |
|
|
| OG002 | Part B, Group 2: Placebo | Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30 |
|
|
| OG002 | Part B, Group 2: Placebo | Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30 |
|
|
| OG002 | Part B, Group 2: Placebo | Participants originally in Part A Group 2 (Placebo) receive placebo for ALVAC-HIV + placebo for bivalent subtype C gp120/MF59 at month 30 |
|
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Life Threatening |
|
| Moderate |
|
| Severe |
|
| Life Threatening |
|
| Moderate |
|
| Severe |
|
| Life Threatening |
|
| Moderate |
|
| Severe |
|
| Life Threatening |
|
| Moderate |
|
| Severe |
|
| Life Threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Life Threatening |
|
| Moderate |
|
| Severe |
|
| Life Threatening |
|
| Moderate |
|
| Severe |
|
| Life Threatening |
|
| Moderate |
|
| Severe |
|
| Life Threatening |
|
| Moderate |
|
| Severe |
|
| Life Threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|