A Clinical Trial to Evaluate the Safety and Immunogenicit... | NCT05217641 | Trialant
NCT05217641
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Status
Active, not recruiting
Last Update Posted
Oct 14, 2025Actual
Enrollment
108Actual
Phase
Phase 1
Conditions
HIV Infections
Interventions
BG505 MD39.3 mRNA
BG505 MD39.3 gp151 mRNA
BG505 MD39.3 gp151 CD4KO mRNA
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT05217641
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
HVTN 302
Secondary IDs
ID
Type
Description
Link
DAIDS-ES ID: 38791
Other Identifier
Division of AIDS
Brief Title
A Clinical Trial to Evaluate the Safety and Immunogenicity of BG505 MD39.3, BG505 MD39.3 gp151, and BG505 MD39.3 gp151 CD4KO HIV Trimer mRNA Vaccines in Healthy, HIV-uninfected Adult Participants
Official Title
A Phase 1, Randomized, Open-label Clinical Trial to Evaluate the Safety and Immunogenicity of BG505 MD39.3, BG505 MD39.3 gp151, and BG505 MD39.3 gp151 CD4KO HIV Trimer mRNA Vaccines in Healthy, HIV-uninfected Adult Participants
Acronym
Not provided
Organization
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Status Module
Record Verification Date
Sep 2025
Overall Recruitment Status or Expanded Access Status
Active, not recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 11, 2022Actual
Primary Completion Date
Jul 17, 2023Actual
Completion Date
Jun 24, 2027Estimated
First Submitted Date
Dec 30, 2021
First Submission Date that Met QC Criteria
Jan 20, 2022
First Posted Date
Feb 1, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Jul 18, 2024
Results First Submitted that Met QC Criteria
Oct 29, 2024
Results First Posted Date
Oct 31, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 25, 2025
Last Update Posted Date
Oct 14, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Collaborators
Name
Class
National Institutes of Health (NIH)
NIH
Department of Health and Human Services
FED
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This is an open-label, multicenter, randomized phase 1 study to evaluate the safety and immunogenicity of BG505 MD39.3, BG505 MD39.3 gp151, and BG505 MD39.3 gp151 CD4KO HIV trimer mRNA. These trimers are based on the BG505 MD39 native-like trimer reported in Steichen et al. Immunity 2016. The primary hypothesis is that the BG505 MD39.3 soluble and membrane-bound trimer mRNA vaccines will be safe and well-tolerated among HIV-uninfected individuals and will elicit autologous neutralizing antibodies.
Detailed Description
Participants will receive BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA or BG505 MD39.3 gp151 CD4KO mRNA, at doses of 100 mcg or 250mcg, administered via intramuscular (IM) injections into the deltoid muscle. Participants will be evaluated for safety and immune responses through blood and lymph node fine-needle aspiration collection at specified timepoints throughout the study.
A dose escalation plan will be implemented, whereby sentinel safety groups for each of the three low-dose groups in Part A would be enrolled and evaluated for safety 2 weeks after the first vaccination. If safety criteria are met, then enrollment of the Part B sentinel safety groups and the remainder of the Part A participants would commence. Safety for the sentinel groups in Part B will be assessed after the first vaccination prior to full enrollment of Part B. In addition, standard safety evaluations will occur routinely throughout the trial.
Conditions Module
Conditions
HIV Infections
Keywords
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
108Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A, Group 1: Low dose BG505 MD39.3 mRNA
Experimental
18 participants Dose: 100mcg of BG505 MD39.3 mRNA formulated administered at months 0, 2, and 6
Biological: BG505 MD39.3 mRNA
Part A, Group 2: Low dose BG505 MD39.3 gp151 mRNA
Experimental
18 participants Dose: 100mcg of BG505 MD39.3 gp151 mRNA administered at months 0, 2, and 6
Biological: BG505 MD39.3 gp151 mRNA
Part A, Group 3: Low dose BG505 MD39.3 gp151 CD4KO mRNA
Experimental
18 participants Dose: 100mcg of BG505 MD39.3 gp151 CD4KO mRNA administered at months 0, 2, and 6
Biological: BG505 MD39.3 gp151 CD4KO mRNA
Part B, Group 1: BG505 MD39.3 mRNA
Experimental
18 participants Dose: 250mcg of BG505 MD39.3 mRNA administered at months 0, 2, and 6
Biological: BG505 MD39.3 mRNA
Part B, Group 2: BG505 MD39.3 gp151 mRNA
Experimental
18 participants Dose: 250mcg of BG505 MD39.3 gp151 mRNA administered at months 0, 2, and 6
Biological: BG505 MD39.3 gp151 mRNA
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BG505 MD39.3 mRNA
Biological
Administered by IM injection
Part A, Group 1: Low dose BG505 MD39.3 mRNA
Part B, Group 1: BG505 MD39.3 mRNA
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Measured through 7 days after each vaccine dose
Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Measured through 7 days after each vaccine dose
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Measured through 7 days after each vaccine dose
Chemistry and Hematology Laboratory Measures - ALT in U/L
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Measured during Screening, Days 8, 64, 176 and 225
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Measured during Screening, Days 8, 64, 176 and 225
Secondary Outcomes
Measure
Description
Time Frame
Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
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 performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Able and willing to complete the informed consent process, including an 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.
18-55 years old, inclusive, on day of enrollment.
Agrees to comply with planned study procedures and be available for clinic follow-up through the last clinic visit.
Agrees not to enroll in another study of an investigational agent during participation in the trial.
In good general health according to the clinical judgement of the site investigator.
Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity in the clinical judgement of the site investigator.
Assessed as low risk for HIV acquisition per low risk guidelines, agrees to discuss HIV infection risks, agrees to risk reduction counseling, and agrees to avoid behavior associated with high risk of HIV exposure through the final study visit. Low risk may include persons stably taking pre-exposure prophylaxis (PrEP) as prescribed for 6 months or longer.
Hemoglobin
Greater than or equal to 11.0 g/dL for volunteers who were assigned female sex at birth
Greater than or equal to 13.0 g/dL for volunteers who were assigned male sex at birth and transgender males who have been on hormone therapy for more than 6 consecutive months
Greater than or equal to 12.0 g/dL for transgender females who have been on hormone therapy for more than 6 consecutive months
For transgender participants who have been on hormone therapy for less than 6 consecutive months, determine hemoglobin eligibility based on the sex assigned at birth
White blood cell (WBC) count > 3,500/mm3
Platelets ≥125,000 /mm3
Alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) based on the institutional normal range
Serum creatinine ≤1.1 x ULN based on the institutional normal range
Negative results for HIV infection by an (US) Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA).
Negative for anti-Hepatitis C antibodies (anti-HCV) or negative HCV nucleic acid test (NAT) if anti-HCV antibodies are detected.
Negative for Hepatitis B surface antigen.
For a volunteer capable of becoming pregnant:
Volunteers who were assigned female sex at birth and are of reproductive potential must agree to use effective means of birth control from at least 21 days prior to enrollment through 3 months after their third vaccination timepoint
Has negative β-HCG (beta human chorionic gonadotropin) pregnancy test (urine or serum) at screening and prior to study product administration on day of enrollment.
Exclusion Criteria:
Volunteer who is breast-feeding or pregnant.
Hypertension that is not well controlled. If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. Well-controlled blood pressure is defined in this protocol as consistently < 140 mm Hg systolic and < 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤ 150 mm Hg systolic and ≤ 100 mm Hg diastolic. For these volunteers, blood pressure must be < 140 mm Hg systolic and < 90 mm Hg diastolic at enrollment. If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure ≥ 150 mm Hg at enrollment or diastolic blood pressure ≥ 100 mm Hg at enrollment.
Diabetes mellitus type 1 or type 2. (Not exclusionary: type 2 cases controlled with diet alone or a history of isolated gestational diabetes).
Previous or current recipient of an investigational HIV vaccine (previous placebo recipients are not excluded).
Acutely ill or febrile (temperature ≥ 38.0°C/100.4°F) on the day of the first vaccination. Participants meeting this criterion may be rescheduled within the enrollment window period. Afebrile participants with minor illnesses can be enrolled at the discretion of the Investigator.
Immunosuppressive medications received within 168 days before first vaccination (Not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatologic condition; or [4] a single course of oral/parenteral prednisone or equivalent at doses < 60 mg/day and length of therapy < 11 days with completion at least 30 days prior to enrollment).
Blood products or immunoglobulin within 16 weeks prior to enrollment; receipt of immunoglobulin within 16 weeks prior to enrollment requires PSRT approval.
Receipt of any of the following:
Within 4 weeks prior to enrollment:
Any licensed live, attenuated vaccine
Any emergency use authorized (EUA) or licensed mRNA-based SARS-CoV-2 vaccine
Within 2 weeks prior to enrollment:
Any licensed killed/subunit/inactivated vaccine
Any EUA or licensed adenoviral-vectored or protein SARS-CoV-2 vaccines Receipt of any SARS-CoV-2 vaccination series should be completed 4 weeks prior to enrollment when possible; however, exceptions may be made by approval of the HVTN 302 PSRT.
Initiation of antigen-based immunotherapy for allergies within the previous year (stable immunotherapy is not exclusionary); inclusion of participants who initiated immunotherapy within the previous year requires PSRT approval.
Receipt of investigational research agents with a half-life of 7 or fewer days within 4 weeks prior to enrollment. If a potential participant has received investigational agents with a half-life greater than 7 days (or unknown half-life) within the past year, PSRT approval is required for enrollment.
History of serious reaction (eg, hypersensitivity, anaphylaxis) to any vaccine or any component of the study vaccine.
History of myocarditis and/or pericarditis.
Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.
Idiopathic urticaria within the past year.
Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions).
Seizure disorder; febrile seizures as a child or seizures secondary to alcohol withdrawal more than 5 years ago are not exclusionary.
Asplenia or functional asplenia.
Active duty and reserve US military personnel.
Any other chronic or clinically significant condition that in the clinical judgement of the investigator would jeopardize the safety or rights of the study participant, including, but not limited to: clinically significant forms of drug or alcohol abuse, serious psychiatric disorders, or cancer that, in the clinical judgement of the site investigator, has a potential for recurrence (excluding basal cell carcinoma).
Asthma is excluded if the participant has ANY of the following:
Required either oral or parenteral corticosteroids for an exacerbation two or more times within the past year; OR
Needed emergency care, urgent care, hospitalization, or intubation for an acute asthma exacerbation within the past year (eg, would NOT exclude individuals with asthma who meet all other criteria but sought urgent/emergent care solely for asthma medication refills or co-existing conditions unrelated to asthma); OR
Uses a short-acting rescue inhaler more than 2 days/week for acute asthma symptoms (ie, not for preventive treatment prior to athletic activity); OR
Uses medium-to-high-dose inhaled corticosteroids (greater than 250 mcg fluticasone or therapeutic equivalent per day), whether in single-therapy or dual-therapy inhalers (ie, with a long-acting beta agonist [LABA]); OR
Uses more than one medication for maintenance therapy daily. Inclusion of anyone on a stable dose of more than one medication for maintenance therapy daily for greater than two years requires PSRT approval.
A participant with a history of an immune-mediated disease, either active or remote. Not exclusionary: 1) remote history of Bell's palsy (>2 years ago) not associated with other neurologic symptoms, 2) mild psoriasis that does not require ongoing systemic treatment.
Riddler SA, Moodie Z, Clark J, Yen C, Allen M, Furch BD, Lu H, Grant S, Mondal K, Anderson M, Maenza J, Lemos MP, Woodward Davis AS, Walsh SR, Sobieszczyk ME, Frank I, Goepfert P, Stephenson KE, Baden LR, Tieu HV, Keefer MC, McElrath MJ, Kublin JG, Corey L. High Frequency of Chronic Urticaria Following an Investigational HIV-1 BG505 MD39.3 Trimer mRNA Vaccine in a Phase 1, Randomized, Open-Label Clinical Trial (HVTN 302). Ann Intern Med. 2025 Jul;178(7):963-974. doi: 10.7326/ANNALS-24-02701. Epub 2025 Apr 29.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
FG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jul 7, 2023
Jul 2, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Single
Masking Description
Not provided
Who Masked
Participant
Part B, Group 3: BG505 MD39.3 gp151 CD4KO mRNA
Experimental
18 participants Dose: 250mcg of BG505 MD39.3 gp151 CD4KO mRNA administered at months 0, 2, and 6
Biological: BG505 MD39.3 gp151 CD4KO mRNA
BG505 MD39.3 gp151 mRNA
Biological
Administered by IM injection
Part A, Group 2: Low dose BG505 MD39.3 gp151 mRNA
Part B, Group 2: BG505 MD39.3 gp151 mRNA
BG505 MD39.3 gp151 CD4KO mRNA
Biological
Administered by IM injection
Part A, Group 3: Low dose BG505 MD39.3 gp151 CD4KO mRNA
Part B, Group 3: BG505 MD39.3 gp151 CD4KO mRNA
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Measured during Screening, Days 8, 64, 176 and 225
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Measured during Screening, Days 8, 64, 176 and 225
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Measured during Screening, Days 8, 64, 176 and 225
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
The number (percentage) of participants with lab grade > 1 for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC), basophils, eosinophils was summarized by arm
Measured during Screening, Days 8, 64, 176 and 225
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
30 days following each injection
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply).
30 days following each injection
Number of Participants Reporting Serious Adverse Events (SAEs)
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Measured through Month 12
Number of Participants Reporting Medically Attended Adverse Events (MAAEs)
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Measured through Month 12
Number of Participants Reporting Adverse Events of Special Interest (AESIs)
There were no adverse events of special interest reported by any participant.
Measured through Month 12.
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Measured through Month 12
Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
There were no early study terminations associated with an AE or reactogenicity reported by any participant.
Measured through Month 12.
Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
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 performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.
2 weeks after the 3rd vaccination timepoint (M6.5)
Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
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 performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.
2 weeks after the 3rd vaccination timepoint (M6.5)
2 weeks after the 2nd vaccination (M2.5), 6 months after the 3rd vaccination (M12)
Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
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 performed in TZM-bl cells measured neutralization titers against a panel of autologous and Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.
2 weeks after the 2nd vaccination (M2.5), 6 months after the 3rd vaccination (M12)
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
Serum HIV-1 specific IgG responses against BG505 MD39.3 trimer and BG505 MD39.3 CD4KO trimer were measured on a BioPlex instrument using a standardized custom HIV-1 Luminex assay. The readout was background subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. Serum samples from post enrollment visits were declared to have positive direct binding responses if they met three conditions: 1) MFI* ≥antigen specific positivity threshold (based on the 95th percentile of baseline samples and at least 100 MFI*), 2) MFI* > 3x(Visit 2 MFI* ), and 3) MFI > 3x(Visit 2 MFI). MFI = Mean Fluorescent Intensity minus a plate specific background measure, MFI* = MFI Blank, where 'Blank' is a sample specific background measure. Results from samples with high sample background (Blank>5000 MFI), high baseline (Baseline>6500 MFI*) are excluded. MFI* above 22,000 were truncated at 22,000, the upper limit of the linear range of the assay.
2 weeks after the 2nd vaccination (M2.5), 2 weeks after the 3rd vaccination (M6.5), 6 months after the 3rd vaccination (M12)
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
Serum HIV-1 specific IgG responses against BG505 MD39.3 trimer and BG505 MD39.3 CD4KO trimer were measured on a BioPlex instrument using a standardized custom HIV-1 Luminex assay. The readout was background subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. Serum samples from post enrollment visits were declared to have positive direct binding responses if they met three conditions: 1) MFI* ≥antigen specific positivity threshold (based on the 95th percentile of baseline samples and at least 100 MFI*), 2) MFI* > 3x(Visit 2 MFI* ), and 3) MFI > 3x(Visit 2 MFI). MFI = Mean Fluorescent Intensity minus a plate specific background measure, MFI* = MFI Blank, where 'Blank' is a sample specific background measure. Results from samples with high sample background (Blank>5000 MFI), high baseline (Baseline>6500 MFI*) are excluded. MFI* above 22,000 were truncated at 22,000, the upper limit of the linear range of the assay.
2 weeks after the 2nd vaccination (M2.5), 2 weeks after the 3rd vaccination (M6.5), 6 months after the 3rd vaccination (M12)
Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
Flow cytometry was used to examine HIV-1-specific CD4+ T-cell responses using a validated the 27-color COVID v2 staining panel. Response magnitudes were defined as the negative control- or background adjusted percent of CD4+ T cells expressing the cytokines or cytokine combinations. Total Env is the sum of gp120 and gp41 peptide pools. One-sided Fisher's exact test was applied to test whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. A multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. Records are excluded if the number of CD4+ T-cell subsets is less than ten thousands
2 weeks after the 3rd vaccination (M6.5)
Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
Flow cytometry was used to examine HIV-1-specific CD4+ T-cell responses using a validated the 27-color COVID v2 staining panel. Response magnitudes were defined as the negative control- or background adjusted percent of CD4+ T cells expressing the cytokines or cytokine combinations. Total Env is the sum of gp120 and gp41 peptide pools. One-sided Fisher's exact test was applied to test whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. A multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. Records are excluded if the number of CD4+ T-cell subsets is less than ten thousands
2 weeks after the 3rd vaccination (M6.5)
Los Angeles
California
90038
United States
Bidmc Vcrs [32077]
Boston
Massachusetts
02115
United States
Brigham and Women's Hospital Vaccine CRS [30007]
Boston
Massachusetts
02115
United States
New York Blood Center CRS [31801]
New York
New York
10065
United States
Columbia P&S CRS [30329]
New York
New York
30329
United States
University of Rochester Vaccines to Prevent HIV Infection CRS [31467]
Rochester
New York
14642
United States
Penn Prevention CRS [30310]
Philadelphia
Pennsylvania
19104
United States
University of Pittsburgh CRS [1001]
Pittsburgh
Pennsylvania
15213
United States
Seattle Vaccine and Prevention CRS [30331]
Seattle
Washington
98104
United States
FG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
FG003
Part B, Group 4: Treatment
250 mcg of BG505 MD39.3 mRNA
FG004
Part B, Group 5: Treatment
250 mcg of BG505 MD39.3 gp151 mRNA
FG005
Part B, Group 6: Treatment
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
FG00018 subjects
FG00119 subjects
FG00217 subjects
FG00318 subjects
FG00418 subjects
FG00518 subjects
COMPLETED
FG00016 subjects
FG00117 subjects
FG00217 subjects
FG00314 subjects
FG00414 subjects
FG00518 subjects
NOT COMPLETED
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG0034 subjects
FG0044 subjects
FG0050 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG004
Other: participant did not specify reason
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Extended Follow up
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
BG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
BG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
BG003
Part B, Group 4: Treatment
250 mcg of BG505 MD39.3 mRNA
BG004
Part B, Group 5: Treatment
250 mcg of BG505 MD39.3 gp151 mRNA
BG005
Part B, Group 6: Treatment
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00018
BG00119
BG00217
BG00318
BG00418
BG00518
BG006108
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00025.5(19 to 41)
BG00135(19 to 54)
BG00231(18 to 55)
BG003
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
18 - 20 years
Title
Measurements
BG0003
BG0012
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00012
BG00110
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0008
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
US
Title
Measurements
BG00018
BG00119
BG002
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 Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Posted
Count of Participants
Participants
Measured through 7 days after each vaccine dose
ID
Title
Description
OG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
OG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
OG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
OG003
Part B, Group 4: Treatment
250 mcg of BG505 MD39.3 mRNA
OG004
Part B, Group 5: Treatment
250 mcg of BG505 MD39.3 gp151 mRNA
OG005
Part B, Group 6: Treatment
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
Units
Counts
Participants
OG00018
OG00119
OG00217
OG003
Title
Denominators
Categories
Title
Measurements
None
OG0000
OG0011
OG0021
OG003
Primary
Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Posted
Count of Participants
Participants
Measured through 7 days after each vaccine dose
ID
Title
Description
OG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
OG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
OG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
OG003
Part B, Group 4: Treatment
250 mcg of BG505 MD39.3 mRNA
OG004
Part B, Group 5: Treatment
Primary
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Posted
Count of Participants
Participants
Measured through 7 days after each vaccine dose
ID
Title
Description
OG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
OG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
OG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
OG003
Part B, Group 4: Treatment
250 mcg of BG505 MD39.3 mRNA
OG004
Part B, Group 5: Treatment
250 mcg of BG505 MD39.3 gp151 mRNA
Primary
Chemistry and Hematology Laboratory Measures - ALT in U/L
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
'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, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
Posted
Median
Inter-Quartile Range
U/L
Measured during Screening, Days 8, 64, 176 and 225
ID
Title
Description
OG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
OG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
OG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
OG003
Part B, Group 4: Treatment
250 mcg of BG505 MD39.3 mRNA
Primary
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
'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, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
Posted
Median
Inter-Quartile Range
mg/dL
Measured during Screening, Days 8, 64, 176 and 225
ID
Title
Description
OG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
OG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
OG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
OG003
Part B, Group 4: Treatment
250 mcg of BG505 MD39.3 mRNA
Primary
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
'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, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
Posted
Median
Inter-Quartile Range
g/dL
Measured during Screening, Days 8, 64, 176 and 225
ID
Title
Description
OG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
OG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
OG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
OG003
Part B, Group 4: Treatment
250 mcg of BG505 MD39.3 mRNA
Primary
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
'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, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
Posted
Median
Inter-Quartile Range
1000 cells/Cubic mm
Measured during Screening, Days 8, 64, 176 and 225
ID
Title
Description
OG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
OG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
OG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
OG003
Part B, Group 4: Treatment
Primary
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
'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, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
Posted
Median
Inter-Quartile Range
1000 cells/Cubic mm
Measured during Screening, Days 8, 64, 176 and 225
ID
Title
Description
OG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
OG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
OG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
OG003
Part B, Group 4: Treatment
250 mcg of BG505 MD39.3 mRNA
Primary
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
The number (percentage) of participants with lab grade > 1 for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC), basophils, eosinophils was summarized by arm
'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, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
Posted
Count of Participants
Participants
Measured during Screening, Days 8, 64, 176 and 225
ID
Title
Description
OG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
OG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
OG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
OG003
Primary
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Safety population
Posted
Count of Participants
Participants
30 days following each injection
ID
Title
Description
OG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
OG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
OG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
OG003
Part B, Group 4: Treatment
250 mcg of BG505 MD39.3 mRNA
OG004
Part B, Group 5: Treatment
250 mcg of BG505 MD39.3 gp151 mRNA
Primary
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply).
Safety population
Posted
Count of Participants
Participants
30 days following each injection
ID
Title
Description
OG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
OG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
OG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
OG003
Part B, Group 4: Treatment
250 mcg of BG505 MD39.3 mRNA
OG004
Part B, Group 5: Treatment
Primary
Number of Participants Reporting Serious Adverse Events (SAEs)
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Safety population
Posted
Count of Participants
Participants
Measured through Month 12
ID
Title
Description
OG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
OG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
OG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
OG003
Part B, Group 4: Treatment
250 mcg of BG505 MD39.3 mRNA
OG004
Part B, Group 5: Treatment
250 mcg of BG505 MD39.3 gp151 mRNA
Primary
Number of Participants Reporting Medically Attended Adverse Events (MAAEs)
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Safety population
Posted
Count of Participants
Participants
Measured through Month 12
ID
Title
Description
OG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
OG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
OG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
OG003
Part B, Group 4: Treatment
250 mcg of BG505 MD39.3 mRNA
OG004
Part B, Group 5: Treatment
250 mcg of BG505 MD39.3 gp151 mRNA
Primary
Number of Participants Reporting Adverse Events of Special Interest (AESIs)
There were no adverse events of special interest reported by any participant.
Safety population
Posted
Count of Participants
Participants
Measured through Month 12.
ID
Title
Description
OG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
OG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
OG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
OG003
Part B, Group 4: Treatment
250 mcg of BG505 MD39.3 mRNA
OG004
Part B, Group 5: Treatment
250 mcg of BG505 MD39.3 gp151 mRNA
Primary
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Safety population
Posted
Count of Participants
Participants
Measured through Month 12
ID
Title
Description
OG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
OG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
OG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
OG003
Part B, Group 4: Treatment
250 mcg of BG505 MD39.3 mRNA
OG004
Part B, Group 5: Treatment
Primary
Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
There were no early study terminations associated with an AE or reactogenicity reported by any participant.
Safety population
Posted
Count of Participants
Participants
Measured through Month 12.
ID
Title
Description
OG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
OG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
OG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
OG003
Part B, Group 4: Treatment
250 mcg of BG505 MD39.3 mRNA
OG004
Part B, Group 5: Treatment
250 mcg of BG505 MD39.3 gp151 mRNA
Primary
Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
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 performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.
In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available NAb data after filtering for assay specific quality control criteria.
Posted
Median
Inter-Quartile Range
log10(titer)
2 weeks after the 3rd vaccination timepoint (M6.5)
ID
Title
Description
OG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
OG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
OG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
OG003
Primary
Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
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 performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.
In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available NAb data after filtering for assay specific quality control criteria.
Posted
Count of Participants
Participants
2 weeks after the 3rd vaccination timepoint (M6.5)
ID
Title
Description
OG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
OG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
OG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
OG003
Secondary
Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
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 performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.
In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 2nd vaccination and 6 months after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available NAb data after filtering for assay specific quality control criteria.
Posted
Median
Inter-Quartile Range
log10(titer)
2 weeks after the 2nd vaccination (M2.5), 6 months after the 3rd vaccination (M12)
ID
Title
Description
OG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
OG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
OG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
Secondary
Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
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 performed in TZM-bl cells measured neutralization titers against a panel of autologous and Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.
In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 2nd vaccination and 6 months after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available NAb data after filtering for assay specific quality control criteria.
Posted
Count of Participants
Participants
2 weeks after the 2nd vaccination (M2.5), 6 months after the 3rd vaccination (M12)
ID
Title
Description
OG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
OG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
OG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
Secondary
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
Serum HIV-1 specific IgG responses against BG505 MD39.3 trimer and BG505 MD39.3 CD4KO trimer were measured on a BioPlex instrument using a standardized custom HIV-1 Luminex assay. The readout was background subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. Serum samples from post enrollment visits were declared to have positive direct binding responses if they met three conditions: 1) MFI* ≥antigen specific positivity threshold (based on the 95th percentile of baseline samples and at least 100 MFI*), 2) MFI* > 3x(Visit 2 MFI* ), and 3) MFI > 3x(Visit 2 MFI). MFI = Mean Fluorescent Intensity minus a plate specific background measure, MFI* = MFI Blank, where 'Blank' is a sample specific background measure. Results from samples with high sample background (Blank>5000 MFI), high baseline (Baseline>6500 MFI*) are excluded. MFI* above 22,000 were truncated at 22,000, the upper limit of the linear range of the assay.
In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 2nd vaccination, 2 weeks after the 3rd vaccination, and 6 months after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available BAMA data after filtering for assay specific quality control criteria.
Posted
Median
Inter-Quartile Range
Relative fluorescence units
2 weeks after the 2nd vaccination (M2.5), 2 weeks after the 3rd vaccination (M6.5), 6 months after the 3rd vaccination (M12)
ID
Title
Description
OG000
Part A, Group 1: Treatment
Secondary
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
Serum HIV-1 specific IgG responses against BG505 MD39.3 trimer and BG505 MD39.3 CD4KO trimer were measured on a BioPlex instrument using a standardized custom HIV-1 Luminex assay. The readout was background subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. Serum samples from post enrollment visits were declared to have positive direct binding responses if they met three conditions: 1) MFI* ≥antigen specific positivity threshold (based on the 95th percentile of baseline samples and at least 100 MFI*), 2) MFI* > 3x(Visit 2 MFI* ), and 3) MFI > 3x(Visit 2 MFI). MFI = Mean Fluorescent Intensity minus a plate specific background measure, MFI* = MFI Blank, where 'Blank' is a sample specific background measure. Results from samples with high sample background (Blank>5000 MFI), high baseline (Baseline>6500 MFI*) are excluded. MFI* above 22,000 were truncated at 22,000, the upper limit of the linear range of the assay.
In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 2nd vaccination, 2 weeks after the 3rd vaccination and 6 months after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available BAMA data after filtering for assay specific quality control criteria.
Posted
Count of Participants
Participants
2 weeks after the 2nd vaccination (M2.5), 2 weeks after the 3rd vaccination (M6.5), 6 months after the 3rd vaccination (M12)
ID
Title
Description
OG000
Part A, Group 1: Treatment
Secondary
Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
Flow cytometry was used to examine HIV-1-specific CD4+ T-cell responses using a validated the 27-color COVID v2 staining panel. Response magnitudes were defined as the negative control- or background adjusted percent of CD4+ T cells expressing the cytokines or cytokine combinations. Total Env is the sum of gp120 and gp41 peptide pools. One-sided Fisher's exact test was applied to test whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. A multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. Records are excluded if the number of CD4+ T-cell subsets is less than ten thousands
In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria.
Posted
Median
Inter-Quartile Range
Percent T-cells expressing cytokines
2 weeks after the 3rd vaccination (M6.5)
ID
Title
Description
OG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
OG001
Part A, Group 2: Treatment
Secondary
Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
Flow cytometry was used to examine HIV-1-specific CD4+ T-cell responses using a validated the 27-color COVID v2 staining panel. Response magnitudes were defined as the negative control- or background adjusted percent of CD4+ T cells expressing the cytokines or cytokine combinations. Total Env is the sum of gp120 and gp41 peptide pools. One-sided Fisher's exact test was applied to test whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. A multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. Records are excluded if the number of CD4+ T-cell subsets is less than ten thousands
In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria.
Posted
Count of Participants
Participants
2 weeks after the 3rd vaccination (M6.5)
ID
Title
Description
OG000
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
OG001
Part A, Group 2: Treatment
Time Frame
Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
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: Treatment
100 mcg of BG505 MD39.3 mRNA
0
18
1
18
18
18
EG001
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
0
19
1
19
19
19
EG002
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
0
17
1
17
17
17
EG003
Part B, Group 4: Treatment
250 mcg of BG505 MD39.3 mRNA
0
18
0
18
18
18
EG004
Part B, Group 5: Treatment
250 mcg of BG505 MD39.3 gp151 mRNA
0
18
0
18
18
18
EG005
Part B, Group 6: Treatment
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
0
18
0
18
18
18
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Hypersensitivity
Immune system disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG0030 events0 affected18 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected18 at risk
Cellulitis
Infections and infestations
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG0030 events0 affected18 at risk
EG0040 events0 affected18 at risk
EG0050 events0 affected18 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MEDRA 23
Non-systematic Assessment
EG0003 events2 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Arrhythmia
Cardiac disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Palpitations
Cardiac disorders
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Ear pain
Ear and labyrinth disorders
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Inner ear inflammation
Ear and labyrinth disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Constipation
Gastrointestinal disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
Dry mouth
Gastrointestinal disorders
MEDRA 23
Non-systematic Assessment
EG0002 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0022 events1 affected17 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Nausea
Gastrointestinal disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
Nausea (Solicited)
Gastrointestinal disorders
MEDRA 27
Systematic Assessment
EG0007 events4 affected18 at risk
EG0016 events3 affected19 at risk
EG00213 events8 affected17 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Vomiting
Gastrointestinal disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Axillary pain
General disorders
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Chest discomfort
General disorders
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Chills (Solicited)
General disorders
MEDRA 27
Systematic Assessment
EG00016 events11 affected18 at risk
EG00111 events6 affected19 at risk
EG00217 events11 affected17 at risk
EG003
Fatigue
General disorders
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Fatigue (Solicited)
General disorders
MEDRA 27
Systematic Assessment
EG00034 events16 affected18 at risk
EG00126 events12 affected19 at risk
EG00238 events15 affected17 at risk
EG003
Injection site erythema (Solicited)
General disorders
MEDRA 27
Systematic Assessment
EG0001 events1 affected18 at risk
EG00110 events6 affected19 at risk
EG0022 events1 affected17 at risk
EG003
Injection site pain (Solicited)
General disorders
MEDRA 27
Systematic Assessment
EG00049 events18 affected18 at risk
EG00147 events18 affected19 at risk
EG00246 events16 affected17 at risk
EG003
Injection site pruritus
General disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Injection site swelling (Solicited)
General disorders
MEDRA 27
Systematic Assessment
EG0003 events2 affected18 at risk
EG0015 events4 affected19 at risk
EG0029 events5 affected17 at risk
EG003
Injury associated with device
General disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Nodule
General disorders
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Non-cardiac chest pain
General disorders
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Pyrexia
General disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
Swelling
General disorders
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Hypersensitivity
Immune system disorders
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Anal chlamydia infection
Infections and infestations
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
COVID-19
Infections and infestations
MEDRA 23
Non-systematic Assessment
EG0007 events7 affected18 at risk
EG0014 events4 affected19 at risk
EG0022 events2 affected17 at risk
EG003
Cellulitis
Infections and infestations
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Diverticulitis
Infections and infestations
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Gastroenteritis Escherichia coli
Infections and infestations
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Hordeolum
Infections and infestations
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Influenza
Infections and infestations
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Pharyngitis streptococcal
Infections and infestations
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Pneumonia
Infections and infestations
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Postoperative wound infection
Infections and infestations
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
Sinusitis
Infections and infestations
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Skin candida
Infections and infestations
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Spirochaetal infection
Infections and infestations
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Syphilis
Infections and infestations
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Tinea versicolour
Infections and infestations
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MEDRA 23
Non-systematic Assessment
EG0002 events2 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Urinary tract infection
Infections and infestations
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Viral infection
Infections and infestations
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Exposure to communicable disease
Injury, poisoning and procedural complications
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Soft tissue injury
Injury, poisoning and procedural complications
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
Alanine aminotransferase increased
Investigations
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Aspartate aminotransferase increased
Investigations
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Blood creatinine increased
Investigations
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0012 events2 affected19 at risk
EG0021 events1 affected17 at risk
EG003
Blood pressure increased
Investigations
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0012 events2 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Body temperature increased (Solicited)
Investigations
MEDRA 27
Systematic Assessment
EG0004 events4 affected18 at risk
EG0018 events6 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Creatinine renal clearance decreased
Investigations
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Haemoglobin decreased
Investigations
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0011 events1 affected19 at risk
EG0023 events2 affected17 at risk
EG003
Neutrophil count decreased
Investigations
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Vitamin D deficiency
Metabolism and nutrition disorders
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Arthralgia (Solicited)
Musculoskeletal and connective tissue disorders
MEDRA 27
Systematic Assessment
EG00013 events8 affected18 at risk
EG00112 events9 affected19 at risk
EG00218 events12 affected17 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Myalgia (Solicited)
Musculoskeletal and connective tissue disorders
MEDRA 27
Systematic Assessment
EG00022 events13 affected18 at risk
EG00115 events8 affected19 at risk
EG00223 events12 affected17 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0014 events2 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Dizziness
Nervous system disorders
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0023 events3 affected17 at risk
EG003
Headache
Nervous system disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Headache (Solicited)
Nervous system disorders
MEDRA 27
Systematic Assessment
EG00021 events14 affected18 at risk
EG00127 events13 affected19 at risk
EG00229 events14 affected17 at risk
EG003
Hypoaesthesia
Nervous system disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Presyncope
Nervous system disorders
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Seizure
Nervous system disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Syncope
Nervous system disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Anxiety
Psychiatric disorders
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Attention deficit hyperactivity disorder
Psychiatric disorders
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Depression
Psychiatric disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Insomnia
Psychiatric disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Substance use disorder
Psychiatric disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Suicidal ideation
Psychiatric disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Uterine malposition
Reproductive system and breast disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Asthma exercise induced
Respiratory, thoracic and mediastinal disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Bronchial irritation
Respiratory, thoracic and mediastinal disorders
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Obstructive sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Respiratory symptom
Respiratory, thoracic and mediastinal disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Tonsillar hypertrophy
Respiratory, thoracic and mediastinal disorders
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0022 events1 affected17 at risk
EG003
Angioedema
Skin and subcutaneous tissue disorders
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected17 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0011 events1 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MEDRA 23
Non-systematic Assessment
EG0000 events0 affected18 at risk
EG0010 events0 affected19 at risk
EG0021 events1 affected17 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MEDRA 23
Non-systematic Assessment
EG0003 events3 affected18 at risk
EG0011 events1 affected19 at risk
EG0021 events1 affected17 at risk
EG003
Hypertension
Vascular disorders
MEDRA 23
Non-systematic Assessment
EG0001 events1 affected18 at risk
EG0010 events0 affected19 at risk
EG0020 events0 affected17 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations