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| ID | Type | Description | Link |
|---|---|---|---|
| 12035 | Registry Identifier | DAIDS-ES Registry Number |
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The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the AIDSVAX B/E vaccine and the MVA/HIV62B vaccine in healthy, HIV-1-uninfected adults who previously received MVA/HIV62B in DNA/MVA or MVA/MVA vaccine regimens in the HVTN 205 study.
This study will evaluate the safety, tolerability, and immunogenicity of the AIDSVAX B/E vaccine and the MVA/HIV62B vaccine in healthy, HIV-1-uninfected adults who previously received MVA/HIV62B in DNA/MVA or MVA/MVA vaccine regimens as part of the HVTN 205 study.
Participants in this study will be assigned to one of five groups based on their previous vaccine regimen received in HVTN 205. Depending on their group, participants will receive the MVA/HIV62B vaccine, the AIDSVAX B/E vaccine, or both the MVA/HIV62B vaccine and the AIDSVAX B/E vaccine. All participants will receive their assigned vaccines at study entry (Day 0) and Month 4. Participants will attend several study visits through Month 10. Visits will include physical examinations, blood collection, HIV testing and risk reduction counseling, and interviews and questionnaires. Optional procedures at some visits include collection of rectal fluids, cervical fluids, and semen. Study staff will contact participants 2 years following the initial study injection for follow-up health monitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: MVA/HIV62B + Placebo | Experimental | Participants who received 3 sequential administrations of MVA/HIV62B in HVTN 205 will receive the MVA/HIV62B vaccine in their left deltoid at Months 0 and 4. They will receive placebo in their right deltoid at Months 0 and 4. |
|
| Group 2: MVA/HIV62B + AIDSVAX B/E | Experimental | Participants who received 3 sequential administrations of MVA/HIV62B in HVTN 205 will receive the MVA/HIV62B vaccine in their left deltoid at Months 0 and 4. They will receive the AIDSVAX B/E vaccine in their right deltoid at Months 0 and 4. |
|
| Group 3: MVA/HIV62B + Placebo | Experimental | Participants who received 2 sequential priming administrations of JS7 DNA plasmid followed by 2 sequential boost administrations of MVA/HIV62B in HVTN 205 will receive the MVA/HIV62B vaccine in their left deltoid at Months 0 and 4. They will receive placebo in their right deltoid at Months 0 and 4. |
|
| Group 4: MVA/HIV62B + AIDSVAX B/E | Experimental | Participants who received 2 sequential priming administrations of JS7 DNA plasmid followed by 2 sequential boost administrations of MVA/HIV62B in HVTN 205 will receive the MVA/HIV62B vaccine in their left deltoid at Months 0 and 4. They will receive the AIDSVAX B/E vaccine in their right deltoid at Months 0 and 4. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MVA/HIV62B vaccine | Biological | 1×10^8 TCID50 dose to be administered as a 1 mL intramuscular (IM) injection in the deltoid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 [November 2014], The maximum grade observed for each symptom over the time frame is presented. | Measured through 3 days after the boost at Month 0 and Month 4 |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 [November 2014], The maximum grade observed for each symptom over the time frame is presented. | Measured through 3 days after the boost at Month 0 and Month 4 |
| Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 [November 2014], The maximum grade observed for each symptom over the time frame is presented. | Measured through Month Measured through 3 days after each boost at Month 0 and 4 |
| 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 10 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | 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. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p<=0.00001. The Fisher's exact test is not applied to compare between endpoints. 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. The responses at month 0.5 was not assayed. |
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Inclusion Criteria:
General and Demographic Criteria:
Age of 18 to 55 years
Prior participation in HVTN 205 with assignment to treatment (not placebo) arm:
Access to a participating HVTN clinical research site (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
Willing to be contacted 2 years following initial study injection.
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
HIV-Related Criteria:
Laboratory Inclusion Values:
Hemogram/Complete Blood Count (CBC)
Chemistry
Virology
Urine
Normal urine:
Reproductive Status
Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.
Reproductive status: A volunteer who was born female must:
Volunteers who were born female must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit
Exclusion Criteria:
General
Blood products received within 120 days before first vaccination
Investigational research agents received within 30 days before first vaccination
Body mass index (BMI) greater than or equal to 40
Volunteer has 2 or more of the following cardiac risk factors:
Pregnant or breastfeeding
Active duty and reserve U.S. military personnel
Vaccines and Other Injections
Immune System
Cardiac
Clinically Significant Medical Conditions
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, well-controlled asthma. (Symptoms of asthma severity as defined in the most recent National Asthma Education and Prevention Program (NAEPP) Expert Panel report).
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 from participation: 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 3 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 |
|---|---|---|
| Paul Goepfert | University of Alabama at Birmingham | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama CRS | Birmingham | Alabama | 35294 | United States | ||
| Bridge HIV CRS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34229888 | Background | Huang Y, Seaton KE, Casapia M, Polakowski L, De Rosa SC, Cohen K, Yu C, Elizaga M, Paez C, Miner MD, Kelley CF, Maenza J, Keefer M, Lama JR, Sobieszczyk M, Buchbinder S, Baden LR, Lee C, Gulati V, Sinangil F, Montefiori D, McElrath MJ, Tomaras GD, Robinson HL, Goepfert P; NIAID-funded HIV Vaccine Trials Network (HVTN) 114 Study Team. AIDSVAX protein boost improves breadth and magnitude of vaccine-induced HIV-1 envelope-specific responses after a 7-year rest period. Vaccine. 2021 Jul 30;39(33):4641-4650. doi: 10.1016/j.vaccine.2021.06.066. Epub 2021 Jul 3. | |
| 34843602 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Boost | MVA/HIV62B mo(0,4) post HVTN 205 MMM |
| FG001 | Group 2: Boost | MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Jun 20, 2016 |
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|
| Group 5: Placebo + AIDSVAX B/E | Experimental | Participants who received 2 sequential priming administrations of JS7 DNA plasmid followed by 2 sequential boost administrations of MVA/HIV62B in HVTN 205 will receive placebo in their left deltoid at Months 0 and 4. They will receive the AIDSVAX B/E vaccine in their right deltoid at Months 0 and 4. |
|
| AIDSVAX B/E vaccine | Biological | 600 mcg/mL dose to be administered as a 1 mL IM injection in the deltoid |
|
| Placebo | Biological | Sodium Chloride for Injection USP, 0.9% to be administered as a 1 mL IM injection in the deltoid |
|
| Measured through the Month 4 boost |
| Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. | Measured during screening, and 2 weeks after each boost at Month 0 and 4 |
| Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population. | Measured during screening, and 2 weeks after each boost at Month 0 and 4 |
| Chemistry and Hematology Laboratory Measures, for Each Boost: 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, and 2 weeks after each boost at Month 0 and 4 |
| Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | 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. The responses to the IDR of gp41 was not assayed. | Measured at Month 0.5 and 4.5 |
| Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | 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. The responses to the IDR of gp41 was not assayed. | Measured at Month 0.5 and 4.5 |
| Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Serum HIV-1-specific IgG3 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. The responses to the IDR of gp41 was not assayed. | Measured at Month 0.5 and 4.5 |
| Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Serum HIV-1-specific IgG3 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. The responses to the IDR of gp41 was not assayed. | Measured at Month 0.5 and 4.5 |
| Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Serum HIV-1-specific IgA 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. IgA responses to V1V2 and the IDR of gp41 were not assayed. | Measured at Month 0.5 and 4.5 |
| Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Serum HIV-1-specific IgA 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. IgA responses to V1V2 and the IDR of gp41 were not assayed. | Measured at Month 0.5 and 4.5 |
| Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay measured neutralization titers against a panel of autologous and heterologous Env-pseudotyped viruses. | Measured at Month 0.5 and 4.5 |
| Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay measured neutralization titers against a panel of autologous and heterologous Env-pseudotyped viruses. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% (ID50) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). Titer < 10 is truncated at 5. | Measured at Month 0.5 and 4.5 |
| Measured at Month 4.5 |
| Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | 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. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p<=0.00001. The Fisher's exact test is not applied to compare between endpoints. 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. The responses at month 0.5 was not assayed. | Measured at Month 4.5 |
| Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | 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. The responses at month 0.5 was not assayed. | Measured at Month 4.5 |
| Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | 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. The responses at month 0.5 was not assayed. | Measured at Month 4.5 |
| Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | 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. The responses to the IDR of gp41 was not assayed. | Measured at Month 10 |
| Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | 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. The responses to the IDR of gp41 was not assayed. | Measured at Month 10 |
| San Francisco |
| California |
| 94143 |
| United States |
| The Hope Clinic of the Emory Vaccine Center CRS | Decatur | Georgia | 30030 | United States |
| Brigham and Women's Hospital Vaccine CRS (BWH VCRS) | Boston | Massachusetts | 02115-6110 | United States |
| Columbia P&S CRS | New York | New York | 10032-3732 | United States |
| University of Rochester Vaccines to Prevent HIV Infection CRS | Rochester | New York | 14642 | United States |
| Seattle Vaccine and Prevention CRS | Seattle | Washington | 98109-1024 | United States |
| ACSA CRS | Iquitos | Maynas | 1 | Peru |
| Barranco CRS | Lima | 04 - 15063 | Peru |
| Derived |
| Fischinger S, Cizmeci D, Deng D, Grant SP, Frahm N, McElrath J, Fuchs J, Bart PA, Pantaleo G, Keefer M, O Hahn W, Rouphael N, Churchyard G, Moodie Z, Donastorg Y, Streeck H, Alter G. Sequence and vector shapes vaccine induced antibody effector functions in HIV vaccine trials. PLoS Pathog. 2021 Nov 29;17(11):e1010016. doi: 10.1371/journal.ppat.1010016. eCollection 2021 Nov. |
| FG002 | Group 3: Boost | MVA/HIV62B mo(0,4) post HVTN 205 DDMM |
| FG003 | Group 4: Boost | MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| FG004 | Group 5: Boost | AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| Month 0.5 |
|
| Month 4.5 |
|
| Month 10 |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Boost | MVA/HIV62B mo(0,4) post HVTN 205 MMM |
| BG001 | Group 2: Boost | MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM |
| BG002 | Group 3: Boost | MVA/HIV62B mo(0,4) post HVTN 205 DDMM |
| BG003 | Group 4: Boost | MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| BG004 | Group 5: Boost | AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| 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 |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| 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 | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo) | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 [November 2014], The maximum grade observed for each symptom over the time frame is presented. | The "overall number of participants analyzed" represents participants enrolled and received MVA/HIV62B or placebo. However, one participant in T5 received MVA/HIV62B placebo in the right arm. Hence no left arm reactogenicity data was collected for the participant. | Posted | Count of Participants | Participants | Measured through 3 days after the boost at Month 0 and Month 4 |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo) | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 [November 2014], The maximum grade observed for each symptom over the time frame is presented. | Posted | Count of Participants | Participants | Measured through 3 days after the boost at Month 0 and Month 4 |
| |||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 [November 2014], The maximum grade observed for each symptom over the time frame is presented. | Posted | Count of Participants | Participants | Measured through Month Measured through 3 days after each boost at Month 0 and 4 |
| |||||||||||||||||||||||||||||||||||||||||
| Primary | 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 10 |
| |||||||||||||||||||||||||||||||||||||||||
| Primary | 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 4 boost |
| |||||||||||||||||||||||||||||||||||||||||
| Primary | Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L | 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, and 2 weeks after each boost at Month 0 and 4 |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL | 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, and 2 weeks after each boost at Month 0 and 4 |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Chemistry and Hematology Laboratory Measures, for Each Boost: 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, and 2 weeks after each boost at Month 0 and 4 |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | 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. The responses to the IDR of gp41 was not assayed. | "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. "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 0.5 and 4.5 |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | 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. The responses to the IDR of gp41 was not assayed. | "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. "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 0.5 and 4.5 |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Serum HIV-1-specific IgG3 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. The responses to the IDR of gp41 was not assayed. | "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. "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 0.5 and 4.5 |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost | Serum HIV-1-specific IgG3 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. The responses to the IDR of gp41 was not assayed. | "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. "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 0.5 and 4.5 |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Serum HIV-1-specific IgA 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. IgA responses to V1V2 and the IDR of gp41 were not assayed. | "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. "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 0.5 and 4.5 |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost | Serum HIV-1-specific IgA 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. IgA responses to V1V2 and the IDR of gp41 were not assayed. | "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. "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 0.5 and 4.5 |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay measured neutralization titers against a panel of autologous and heterologous Env-pseudotyped viruses. | "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. "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 0.5 and 4.5 |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost | Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay measured neutralization titers against a panel of autologous and heterologous Env-pseudotyped viruses. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% (ID50) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). Titer < 10 is truncated at 5. | "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria. | Posted | Median | Inter-Quartile Range | Dilution factor | Measured at Month 0.5 and 4.5 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | 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. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p<=0.00001. The Fisher's exact test is not applied to compare between endpoints. 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. The responses at month 0.5 was not assayed. | "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "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 4.5 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | 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. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p<=0.00001. The Fisher's exact test is not applied to compare between endpoints. 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. The responses at month 0.5 was not assayed. | "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "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 4.5 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | 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. The responses at month 0.5 was not assayed. | "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "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 4.5 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost | 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. The responses at month 0.5 was not assayed. | "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria. | Posted | Median | Inter-Quartile Range | % CD8+ T-cells | Measured at Month 4.5 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | 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. The responses to the IDR of gp41 was not assayed. | "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 10 immunogenicity timepoint. "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 10 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost | 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. The responses to the IDR of gp41 was not assayed. | "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 10 immunogenicity timepoint. "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 10 |
|
Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
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 | Group 1: Boost | MVA/HIV62B mo(0,4) post HVTN 205 MMM | 0 | 4 | 0 | 4 | 2 | 4 |
| EG001 | Group 2: Boost | MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM | 0 | 4 | 0 | 4 | 4 | 4 |
| EG002 | Group 3: Boost | MVA/HIV62B mo(0,4) post HVTN 205 DDMM | 0 | 6 | 0 | 6 | 3 | 6 |
| EG003 | Group 4: Boost | MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM | 0 | 6 | 0 | 6 | 2 | 6 |
| EG004 | Group 5: Boost | AIDSVAX B/E mo(0,4) post HVTN 205 DDMM | 0 | 7 | 0 | 7 | 7 | 7 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Event in SOC | Eye disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Photophobia | Eye disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Gastrointestinal disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Duodenogastric reflux | Gastrointestinal disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Any Event in SOC | General disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Immune system disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Infections and infestations | MEDRA 22.1 | Non-systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MEDRA 22.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MEDRA 22.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MEDRA 22.1 | Non-systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MEDRA 22.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MEDRA 22.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Injury, poisoning and procedural complications | MEDRA 22.1 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MEDRA 22.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Investigations | MEDRA 22.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MEDRA 22.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MEDRA 22.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MEDRA 22.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Musculoskeletal and connective tissue disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Nervous system disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Psychiatric disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Renal and urinary disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Reproductive system and breast disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Any Event in SOC | Skin and subcutaneous tissue disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MEDRA 22.1 | Non-systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MEDRA 22.1 | 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 |
| Dec 15, 2020 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| 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 |
Not provided
Not provided
| 18 - 20 |
|
| 21 - 30 |
|
| 31 - 40 |
|
| 41 - 50 |
|
| Over 50 |
|
| 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 |
|
| Peru |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Potentially Life-threatening |
|
| Tenderness |
|
| Pain and/or Tenderness |
|
| Erythema |
|
| Induration |
|
| Erythema and/or Induration |
|
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
|
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG004 | Group 5: Boost | AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
|
|
| OG004 | Group 5: Boost | AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
|
|
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
| OG004 | Group 5: Boost | AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
|
|
| Group 3: Boost |
MVA/HIV62B mo(0,4) post HVTN 205 DDMM |
| OG003 | Group 4: Boost | MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG004 | Group 5: Boost | AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG005 | Group 6: Boost | MVA/HIV62B at mo(0,4) |
| OG006 | Group 7: Boost | MVA/HIV62B + AIDSVAX B/E at mo(0,4) |
|
|
| Group 3: Boost |
MVA/HIV62B mo(0,4) post HVTN 205 DDMM |
| OG003 | Group 4: Boost | MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG004 | Group 5: Boost | AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG005 | Group 6: Boost | MVA/HIV62B at mo(0,4) |
| OG006 | Group 7: Boost | MVA/HIV62B + AIDSVAX B/E at mo(0,4) |
|
|
| Group 3: Boost |
MVA/HIV62B mo(0,4) post HVTN 205 DDMM |
| OG003 | Group 4: Boost | MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG004 | Group 5: Boost | AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG005 | Group 6: Boost | MVA/HIV62B at mo(0,4) |
| OG006 | Group 7: Boost | MVA/HIV62B + AIDSVAX B/E at mo(0,4) |
|
|
| OG002 |
| Group 3: Boost |
MVA/HIV62B mo(0,4) post HVTN 205 DDMM |
| OG003 | Group 4: Boost | MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG004 | Group 5: Boost | AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG005 | Group 6: Boost | MVA/HIV62B at mo(0,4) |
| OG006 | Group 7: Boost | MVA/HIV62B + AIDSVAX B/E at mo(0,4) |
|
|
| Group 3: Boost |
MVA/HIV62B mo(0,4) post HVTN 205 DDMM |
| OG003 | Group 4: Boost | MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG004 | Group 5: Boost | AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG005 | Group 6: Boost | MVA/HIV62B at mo(0,4) |
| OG006 | Group 7: Boost | MVA/HIV62B + AIDSVAX B/E at mo(0,4) |
|
|
| OG002 |
| Group 3: Boost |
MVA/HIV62B mo(0,4) post HVTN 205 DDMM |
| OG003 | Group 4: Boost | MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG004 | Group 5: Boost | AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG005 | Group 6: Boost | MVA/HIV62B at mo(0,4) |
| OG006 | Group 7: Boost | MVA/HIV62B + AIDSVAX B/E at mo(0,4) |
|
|
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG004 | Group 5: Boost | AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG005 | Group 6: Boost | MVA/HIV62B at mo(0,4) |
| OG006 | Group 7: Boost | MVA/HIV62B + AIDSVAX B/E at mo(0,4) |
|
|
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
| OG003 | Group 4: Boost | MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG004 | Group 5: Boost | AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG005 | Group 6: Boost | MVA/HIV62B at mo(0,4) |
| OG006 | Group 7: Boost | MVA/HIV62B + AIDSVAX B/E at mo(0,4) |
|
|
| OG002 | Group 3: Boost | MVA/HIV62B mo(0,4) post HVTN 205 DDMM |
| OG003 | Group 4: Boost | MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG004 | Group 5: Boost | AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG005 | Group 6: Boost | MVA/HIV62B at mo(0,4) |
| OG006 | Group 7: Boost | MVA/HIV62B + AIDSVAX B/E at mo(0,4) |
|
|
| OG002 | Group 3: Boost | MVA/HIV62B mo(0,4) post HVTN 205 DDMM |
| OG003 | Group 4: Boost | MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG004 | Group 5: Boost | AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG005 | Group 6: Boost | MVA/HIV62B at mo(0,4) |
| OG006 | Group 7: Boost | MVA/HIV62B + AIDSVAX B/E at mo(0,4) |
|
|
| OG002 | Group 3: Boost | MVA/HIV62B mo(0,4) post HVTN 205 DDMM |
| OG003 | Group 4: Boost | MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG004 | Group 5: Boost | AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG005 | Group 6: Boost | MVA/HIV62B at mo(0,4) |
| OG006 | Group 7: Boost | MVA/HIV62B + AIDSVAX B/E at mo(0,4) |
|
|
| OG002 | Group 3: Boost | MVA/HIV62B mo(0,4) post HVTN 205 DDMM |
| OG003 | Group 4: Boost | MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG004 | Group 5: Boost | AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG005 | Group 6: Boost | MVA/HIV62B at mo(0,4) |
| OG006 | Group 7: Boost | MVA/HIV62B + AIDSVAX B/E at mo(0,4) |
|
|
| Group 3: Boost |
MVA/HIV62B mo(0,4) post HVTN 205 DDMM |
| OG003 | Group 4: Boost | MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG004 | Group 5: Boost | AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG005 | Group 6: Boost | MVA/HIV62B at mo(0,4) |
| OG006 | Group 7: Boost | MVA/HIV62B + AIDSVAX B/E at mo(0,4) |
|
|
| Group 3: Boost |
MVA/HIV62B mo(0,4) post HVTN 205 DDMM |
| OG003 | Group 4: Boost | MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG004 | Group 5: Boost | AIDSVAX B/E mo(0,4) post HVTN 205 DDMM |
| OG005 | Group 6: Boost | MVA/HIV62B at mo(0,4) |
| OG006 | Group 7: Boost | MVA/HIV62B + AIDSVAX B/E at mo(0,4) |
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| Mild |
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| Moderate |
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| Severe |
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| Potentially Life-threatening |
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| Mild |
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| Moderate |
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| Severe |
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| Potentially Life-threatening |
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| Mild |
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| Moderate |
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| Severe |
|
| Potentially Life-threatening |
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| Mild |
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| Moderate |
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| Severe |
|
| Potentially Life-threatening |
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| Mild |
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| Moderate |
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| Severe |
|
| Potentially Life-threatening |
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| Mild |
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| Moderate |
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| Severe |
|
| Potentially Life-threatening |
|
| Mild |
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| Moderate |
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| Severe |
|
| Potentially Life-threatening |
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| Mild |
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| Moderate |
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| Severe |
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| Potentially Life-threatening |
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| Mild |
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| Moderate |
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| Severe |
|
| Potentially Life-threatening |
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| Mild |
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| Moderate |
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| Severe |
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| Potentially Life-threatening |
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| Mild |
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| Moderate |
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| Severe |
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| Potentially Life-threatening |
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| Mild |
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| Moderate |
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| Severe |
|
| Potentially Life-threatening |
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| Mild |
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| Moderate |
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| Severe |
|
| Potentially Life-threatening |
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