Phase 1
Completed N=127
Evaluating the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Alum Adjuvants in Healthy, HIV-uninfected Adults
HIV Infections
Source: ClinicalTrials.gov NCT04177355 ↗
Enrolled (actual)
127
Serious AEs
2.4%
Results posted
Jun 2025
Primary outcomePrimary: Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness — 0; 0; 1; 5 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness |
0; 0; 1; 5; 0; 4 | — |
| PRIMARY Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration |
5; 8; 2; 19; 19; 20 | — |
| PRIMARY Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms |
0; 0; 2; 6; 1; 5 | — |
| PRIMARY Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Number of Participants Reporting Unsolicited Adverse Events (AEs) |
1; 4; 1; 4; 6; 5 | — |
| PRIMARY Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation |
0; 1; 0; 1; 1; 0 | — |
| PRIMARY Number of Participants With Early Study Termination and Reason for Early Study Termination |
0; 0; 0; 1; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
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)
Laboratory Inclusion Values
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
- ≥ 12.0 g/dL for transgender females who have been on hormone therapy for more than 6 consecutive months
- For transgender volunteers 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 count = 2, 500 to 12,000 cells/mm^3 with normal differential, or differential approved by Investigator of Record (IoR) or designee as not clinically significant
- Total lymphocyte count ≥ 650 cells/mm^3 with normal differential, or differential approved by IoR or designee as not clinically significant
- Remaining differential either within institutional normal range or with IoR or designee approval
- Platelets = 125,000 to 550,000 cells/mm^3
Chemistry
- Alanine aminotransferase (ALT) 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
Data sourced from ClinicalTrials.gov (NCT04177355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.