Evaluating the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Alum Adjuvants in Healthy, HIV-uninfected Adults
A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Aalum Adjuvants and VRC HIV Env Trimer 4571 and 3M-052-AF With Alum in Healthy, HIV-uninfected Adults
2 other identifiers
interventional
127
1 country
10
Brief Summary
The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 BG505 SOSIP.664 gp140 with TLR agonist and/or alum adjuvants in healthy, HIV-uninfected adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
Started Jan 2020
Longer than P75 for phase_1 hiv-infections
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2019
CompletedFirst Posted
Study publicly available on registry
November 26, 2019
CompletedStudy Start
First participant enrolled
January 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 4, 2024
CompletedResults Posted
Study results publicly available
June 27, 2025
CompletedSeptember 2, 2025
May 1, 2025
4.8 years
November 22, 2019
May 5, 2025
August 28, 2025
Conditions
Outcome Measures
Primary Outcomes (7)
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 for 7 days after each injection in Parts A and B and 14 days after each injection in Part C, up to Month 6
Number of Participants Reporting Local Solicited 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 for 7 days after each injection in Parts A and B and 14 days after each injection in Part C, up to Month 6
Number of Participants Reporting Systemic Solicited Adverse Events 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 for 7 days after each injection in Parts A and B and 14 days after each injection in Part C, up to Month 6
Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above
For each local laboratory measure meeting Grade 1 AE criteria (Mild) or above as specified in the DAIDS AE Grading Table, counts of severity were presented by treatment group and timepoint for the overall population
Measured through Month 8 (Part A without second boost) or Month 12 (Part A with second boost, Part B, Part C)
Number of Participants Reporting Unsolicited Adverse Events (AEs)
The number (percentage) of Participants Reporting Unsolicited Adverse Events (AEs) was summarized by arm
Measured through Month 14 (Part A without second boost) or Month 18 (Part A with second boost, Part B, Part C)
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm
Measured through Month 2 (Part A without second boost) or Month 6 (Part A with second boost, Part B, Part C)
Number of Participants With Early Study Termination and Reason for Early Study Termination
The number (percentage) of participants with early study termination and reason for early study termination was summarized by arm
Measured through Month 8 (Part A without second boost) or Month 12 (Part A with second boost, Part B, Part C)
Study Arms (16)
Part A, Group 1 (T1): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum
EXPERIMENTALParticipants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 1 mcg of 3M-052-AF and 500 mcg of Aluminum Hydroxide Suspension (Alum), as one intramuscular (IM) injection at Months 0 and 2, with optional second boost at Month 6.
Part A, Group 1 (P1): Placebo
PLACEBO COMPARATORParticipants will receive placebo as one IM injection at Months 0 and 2, with optional second boost at Month 6.
Part A, Group 2 (T2): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum
EXPERIMENTALParticipants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 5 mcg of 3M-052-AF and 500 mcg of Alum, as one IM injection at Months 0 and 2, with optional second boost at Month 6.
Part A, Group 2 (P2): Placebo
PLACEBO COMPARATORParticipants will receive placebo as one IM injection at Months 0 and 2, with optional second boost at Month 6.
Part B, Group 3 (T3): BG505 SOSIP.664 gp140 + CpG 1018 + Alum
EXPERIMENTALParticipants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 300 mcg of CpG 1018 and 500 mcg of Alum, as one IM injection at Months 0, 2, and 6.
Part B, Group 3 (P3): Placebo
PLACEBO COMPARATORParticipants will receive placebo as one IM injection at Months 0, 2, and 6.
Part B, Group 4 (T4): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum
EXPERIMENTALParticipants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with either 1 mcg or 5 mcg of 3M-052-AF (the highest tolerated dose from Part A), and 500 mcg of Alum, as one IM injection at Months 0, 2, and 6.
Group 4 (P4): Placebo
PLACEBO COMPARATORParticipants will receive placebo as one IM injection at Months 0, 2, and 6.
Part B, Group 5 (T5): BG505 SOSIP.664 gp140 + GLA-LSQ
EXPERIMENTALParticipants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with GLA-LSQ (GLA 5 mcg, and QS-21 2 mcg), as one IM injection at Months 0, 2, and 6.
Part B, Group 5 (P5): Placebo
PLACEBO COMPARATORParticipants will receive placebo as one IM injection at Months 0, 2, and 6.
Part B, Group 6 (T6): BG505 SOSIP.664 gp140 + Alum
EXPERIMENTALParticipants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 500 mcg of Alum, administered as one IM injection at Months 0, 2, and 6.
Part B, Group 6 (P6): Placebo
PLACEBO COMPARATORParticipants will receive placebo as one IM injection at Months 0, 2, and 6.
Part C, Group 7 (T7): BG505 SOSIP.664 gp140 + Alum
EXPERIMENTALParticipants will receive BG505 SOSIP.664 gp140, 100 mcg admixed with 3M-052-AF, 3 mcg and Alum, 500 mcg to be administered as one 0.5-mL dose intramuscularly (IM) at months 0, 2, and 6.
Part C, Group 7 (P7): Placebo
PLACEBO COMPARATORParticipants will receive placebo as one IM injection at Months 0, 2, and 6.
Part C, Group 8 (T8): Trimer 4571 + Alum
EXPERIMENTALParticipants will receive Trimer 4571, 100 mcg admixed with 3M-052-AF, 5 mcg and Alum, 500 mcg to be administered as one 0.5-mL dose IM at months 0, 2, and 6.
Part C, Group 8 (P8): Placebo
PLACEBO COMPARATORParticipants will receive placebo as one IM injection at Months 0, 2, and 6.
Interventions
Administered by IM injection
Administered by IM injection
Administered by IM injection
Administered by IM injection
Administered by IM injection
Eligibility Criteria
You may qualify if:
- General and Demographic Criteria
- Age of 18 through 50 years, inclusive
- Access to a participating HIV Vaccine Trials Network (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; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
- Agrees not to enroll in another study of an investigational research agent until after the final study contact.
- Good general health as shown by medical history, physical exam, and screening laboratory tests
- HIV-Related Criteria:
- Willingness to receive HIV test results
- Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling
- Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit (see study protocol for more information)
- Hemogram/Complete blood count (CBC)
- Hemoglobin
- ≥ 11.0 g/dL for volunteers who were assigned female sex at birth
- ≥ 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
- +31 more criteria
You may not qualify if:
- General
- Blood products received within 120 days before first vaccination
- Investigational research agents received within 30 days before first vaccination
- Body mass index (BMI) ≥ 40; or BMI ≥ 35 with 2 or more of the following: age \> 45, systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg, current smoker, known hyperlipidemia
- Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 137 study
- Pregnant or breastfeeding
- Active duty and reserve US military personnel
- Vaccines and other Injections
- HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 137 PSRT will determine eligibility on a case-by-case basis.
- Previous receipt of monoclonal antibodies (mAbs), whether licensed or investigational; the HVTN 137 PSRT will determine eligibility on a case-by-case basis
- Non-HIV experimental vaccine(s) received within the last 1 year in a prior vaccine trial. Exceptions may be made by the HVTN 137 PSRT for vaccines that have subsequently undergone licensure by the FDA. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 137 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 1 year ago, eligibility for enrollment will be determined by the HVTN 137 PSRT on a case-by-case basis.
- Live attenuated vaccines received within 30 days before first vaccination or scheduled within 30 days after injection (eg, measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever; live attenuated influenza vaccine)
- Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination or scheduled for 14 days after injection (eg, tetanus, pneumococcal, hepatitis virus A or B)
- Previous receipt of HEPLISAV, Shingrix, or RTS,S/AS01B/Mosquirix vaccine received within 30 days prior to first vaccination or scheduled for 30 days after injection.
- Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination
- +30 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)lead
- HIV Vaccine Trials Networkcollaborator
- International AIDS Vaccine Initiativecollaborator
- Access to Advanced Health Institute (AAHI)collaborator
- Dynavax Technologies Corporationcollaborator
- Fred Hutchinson Cancer Centercollaborator
Study Sites (10)
Alabama CRS
Birmingham, Alabama, 35294, United States
The Ponce de Leon Center CRS
Atlanta, Georgia, 30308-2012, 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, United States
New York Blood Center CRS (Site 31801)
New York, New York, 10065, United States
University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester, New York, 14642, United States
Penn Prevention CRS
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh CRS
Pittsburgh, Pennsylvania, 15213, United States
Seattle Vaccine and Prevention CRS
Seattle, Washington, 98109-1024, United States
Related Publications (1)
Hahn WO, Parks KR, Shen M, Ozorowski G, Janes H, Ballweber-Fleming L, Woodward Davis AS, Duplessis C, Tomai M, Dey AK, Sagawa ZK, De Rosa SC, Seese A, Kallur Siddaramaiah L, Stamatatos L, Lee WH, Sewall LM, Karlinsey D, Turner HL, Rubin V, Furth S, MacPhee K, Duff M, Corey L, Keefer MC, Edupuganti S, Frank I, Maenza J, Baden LR, Hyrien O, Sanders RW, Moore JP, Ward AB, Tomaras GD, Montefiori DC, Rouphael N, McElrath MJ. Use of 3M-052-AF with Alum adjuvant in HIV trimer vaccine induces human autologous neutralizing antibodies. J Exp Med. 2024 Oct 7;221(10):e20240604. doi: 10.1084/jem.20240604. Epub 2024 Sep 5.
PMID: 39235529BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
- Organization
- Fred Hutchinson Cancer Center
Study Officials
- STUDY CHAIR
M. Juliana McElrath
Seattle Vaccine Trials Unit
- STUDY CHAIR
Nadine Rouphael
Emory University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2019
First Posted
November 26, 2019
Study Start
January 13, 2020
Primary Completion
November 4, 2024
Study Completion
November 4, 2024
Last Updated
September 2, 2025
Results First Posted
June 27, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share