RecruitingPhase 1NCT06694753

Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall Good Health in South Africa.

A Phase 1, Placebo-controlled, Blinded, Dose-escalation Study to Evaluate the Safety and Immunogenicity of mRNAs Encoding HIV Immunogens (eOD-GT8 60mer, Core-g28v2 60mer, N332-GT5 gp151) in Adult Participants Without HIV and in Overall Good Health in South Africa.

Sponsor

International AIDS Vaccine Initiative

Enrollment

96 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

HIV Infections

Summary

The purpose of this study is to evaluate the safety and immunogenicity of mRNAs encoding HIV immunogens (eOD-GT8 60mer, core-g28v2 60mer, N332-GT5 gp151) in adult participants without HIV and in overall good health in South Africa.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and immune response generated by three experimental mRNA vaccines designed to train the immune system to recognize HIV — similar to how COVID-19 mRNA vaccines work, but aimed at preventing HIV infection. This early-phase trial is being conducted in South Africa among HIV-negative adults. **You may be eligible if...** - You are between 18 and 55 years old and in good general health - You do not have HIV - You are considered at low risk of acquiring HIV, or you are stably taking PrEP (pre-exposure prophylaxis) as prescribed - You are available for all clinic follow-up visits - You are willing to undergo certain sample collection procedures (lymph node sampling and a blood cell collection procedure) **You may NOT be eligible if...** - You are HIV-positive - You have significant lab abnormalities or a condition that could affect the study's safety assessments - You are pregnant or breastfeeding - You have received another investigational vaccine or drug recently - You have received a live vaccine recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALmRNA-1645-eODGT8

eOD-GT8 60mer is a self-assembling nanoparticle composed of 60 subunits of the engineered HIV-1 gp120 outer domain germline targeting version 8 (eOD-GT8) fused to an engineered form of a bacterial enzyme, Lumazine Synthase, through a 15-amino acid Glycine-Serine linker. eOD-GT8 60mer will be delivered using an mRNA lipid nanoparticle (LNP) platform. To be administered by intramuscular (IM) injection at doses of 10 or 30 mcg.

BIOLOGICALmRNA-1645-CoreG28v2

core-g28v2 60mer is a nanoparticle composed of 60 protein subunits of an engineered core-gp120 fused to an engineered form of a bacterial enzyme, Lumazine Synthase, through a 21-amino acid Glycine-Serine linker. Core-g28v2 60mer will be delivered using an mRNA-LNP platform. To be administered by IM injection at doses of 10 or 30 mcg.

BIOLOGICALmRNA-1645-N332GT5

N332-GT5 gp151 is an HIV envelope glycoprotein gp151 trimer based on BG505 SOSIP MD39 (clade A) trimer with "germline-targeting" mutations added that confer the ability to bind germline precursors of BG18 class B cells. N332-GT5 gp151 will be delivered using an mRNA-LNP platform. To be administered by IM injection at doses of 10 or 30 mcg.

BIOLOGICALPlacebo

Saline