HIV Trimer mRNA Vaccines for HIV Prevention

Recruiting at 9 trial locations

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sharon Riddler, MD

Principal Investigator

University of Pittsburgh

Jesse Clark, MD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

Healthy adults aged 18-55 who are HIV-negative, not pregnant or breastfeeding, and at low risk for HIV infection. They must be willing to use birth control if applicable, have normal blood counts and organ function tests, understand the study requirements, and commit to follow-up visits. Exclusions include poorly controlled hypertension, diabetes (except diet-controlled type 2), previous investigational HIV vaccine recipients (unless placebo), acute illness on vaccination day, recent immunosuppressants or blood products usage.

Inclusion Criteria

- 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

Serum creatinine ≤1.1 x ULN based on the institutional normal range

Negative for Hepatitis B surface antigen.

Exclusion Criteria

I have completed my COVID-19 vaccination series at least 4 weeks ago, or have approval for an exception.

I have a weakened immune system.

History of serious reaction (eg, hypersensitivity, anaphylaxis) to any vaccine or any component of the study vaccine.

Treatment Details

Interventions

• BG505 MD39.3 gp151 CD4KO mRNA (Cancer Vaccine)
• BG505 MD39.3 gp151 mRNA (Cancer Vaccine)
• BG505 MD39.3 mRNA (Cancer Vaccine)

Trial Overview The trial is testing three different mRNA vaccines based on the BG505 MD39 HIV trimer: BG505 MD39.3 alone; with gp151; and with gp151 CD4KO. It's an early-phase study assessing safety and whether these vaccines can stimulate the body's immune system to produce antibodies against HIV in people without the virus.

Participant Groups

Group I: Part B, Group 3: BG505 MD39.3 gp151 CD4KO mRNA Experimental Treatment 1 Intervention

18 participants Dose: 250mcg of BG505 MD39.3 gp151 CD4KO mRNA administered at months 0, 2, and 6

Group II: Part B, Group 2: BG505 MD39.3 gp151 mRNA Experimental Treatment 1 Intervention

18 participants Dose: 250mcg of BG505 MD39.3 gp151 mRNA administered at months 0, 2, and 6

Group III: Part B, Group 1: BG505 MD39.3 mRNA Experimental Treatment 1 Intervention

18 participants Dose: 250mcg of BG505 MD39.3 mRNA administered at months 0, 2, and 6

Group IV: Part A, Group 3: Low dose BG505 MD39.3 gp151 CD4KO mRNA Experimental Treatment 1 Intervention

18 participants Dose: 100mcg of BG505 MD39.3 gp151 CD4KO mRNA administered at months 0, 2, and 6

Group V: Part A, Group 2: Low dose BG505 MD39.3 gp151 mRNA Experimental Treatment 1 Intervention

18 participants Dose: 100mcg of BG505 MD39.3 gp151 mRNA administered at months 0, 2, and 6

Group VI: Part A, Group 1: Low dose BG505 MD39.3 mRNA Experimental Treatment 1 Intervention

18 participants Dose: 100mcg of BG505 MD39.3 mRNA formulated administered at months 0, 2, and 6

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+