RecruitingPhase 1NCT06205056

Evaluation of Safety and Immunogenicity of Ad26.Mos4.HIV and CH505 TF chTrimer Combination in Healthy Adults

Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Ad26.Mos4.HIV and CH505 TF chTrimer (Env) Combination to Mimic Acute HIV Viral Replication Kinetics in Healthy Adults

Sponsor

U.S. Army Medical Research and Development Command

Enrollment

78 participants

Start Date

Jan 30, 2024

Study Type

INTERVENTIONAL

Conditions

Human Immunodeficiency Virus

Summary

This is a Phase I, randomized, double-blind, placebo-controlled clinical study to define the safety and immunogenicity resulting from a rapid dose-escalating vaccination schedule as compared to that of a co-administered, dose-consistent vaccination schedule. Participants randomized to receive vaccines will get either dose-consistent injections of CH505 TF chTrimer+ALFQ co-administered with Ad26.Mos4.HIV or rapid, dose-escalating injections of CH505 TF chTrimer+ALFQ with an Ad26.Mos4.HIV prime, followed by dose-consistent injection of CH505 TF chTrimer+ALFQ co-administered with Ad26.Mos4.HIV

Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new experimental HIV vaccine combination in healthy adults who are HIV-negative and at low risk of infection, to see if it is safe and triggers a strong immune response. **You may be eligible if...** - You are a healthy adult between 18 and 50 years old - You are at low risk for HIV infection - You are willing to follow study requirements, including regular visits and follow-up - You are willing to abstain from certain behaviors (such as unprotected sex with HIV-positive partners) during the study - You pass a study understanding test with 90% or higher **You may NOT be eligible if...** - You are currently HIV-positive or have a history of HIV infection - You have a weakened immune system or are taking immunosuppressive medications - You have received a prior HIV vaccine - You have a chronic illness that would put you at risk from vaccine administration - You are pregnant or planning to become pregnant 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

BIOLOGICALAd26.Mos4.HIV in CH505 TF chTrimer + ALFQ [Arm 1a]

Participants in Arm 1a will receive dose consistent injections (5x10\^10 vp/0.5 mL) of Ad26.Mos4.HIV in a 0.5 mL injection volume and dose consistent injections of CH505 TF chTrimer (300 µg)+ALFQ (200 µg MPLA/100 µg QS-21) in a 1.1 mL injection volume on Study Days 1 and 57

BIOLOGICALCH505 TF chTrimer + ALFQ [Arm 1a]

Participants in Arm 1a will receive a dose-consistent injection of CH505 TF chTrimer (300 µg)+ALFQ (200 µg MPLA/100 µg QS 21) in a 1.1 mL injection volume on Study Day 169.

BIOLOGICALPlacebo [Arm 1a]

Participants in Arm 1a will receive dose-consistent 0.5 mL injection and a 1.1 mL injection of Placebo on Study Days 1 and 57, followed by a 1.1 mL injection of Placebo on Study Day 169.

BIOLOGICALAd26.Mos4.HIV in CH505 TF chTrimer +ALFQ [Arm 2a]

Participants in Arm 2a will receive a lower dose of Ad26.Mos4.HIV (2.5x10\^10 vp/0.25 mL) in a 0.25 mL injection volume and a lower dose of CH505 TF chTrimer (30 µg)+ALFQ (50 µg MPLA/25 µg QS-21) in a 0.5 mL injection volume on Study Day 1. Participants in Arm 2a will receive an injection Ad26.Mos4.HIV (5x10\^10 vp/0.5 mL) in a 0.5 mL injection volume and CH505 TF chTrimer (300 µg)+ALFQ (200 µg MPLA/100 µg QS 21) in a 1.1 mL injection volume on Study Day 57.

BIOLOGICALCH505 TF chTrimer +ALFQ [Arm 2a]

Participants in Arm 2a will receive a rapid, dose escalating injections of CH505 TF chTrimer (100 µg, 150 µg, and 300 µg)+ALFQ (50 µg MPLA/ 25 µg QS-21) on Study Days 4 (0.5 mL injection volume), 8 (0.5 mL injection volume), and 15 (0.9 mL injection volume). Participants in Arm 2a will receive a injection of CH505 TF chTrimer (300 µg)+ALFQ (200 µg MPLA/100 µg QS 21) in a 1.1 mL injection volume on Study Day 169.

BIOLOGICALPlacebo [Arm 2a]

Participants in Arm 2a will receive a 0.25 mL injection and a 0.5 mL injection of Placebo on Study Day 1; followed by 0.5 mL, 0.5 mL, and 0.9 mL injections of Placebo on Study Days 4, 8, and 15, respectively; followed by a 0.5 mL injection and a 1.1 mL injection of Placebo on Study Day 57; followed by a 1.1 mL injection of Placebo on Study Day 169.

BIOLOGICALCH505 TF chTrimer + ALFQ [Arm 1b]

Participants in Arm 1b will receive dose consistent injections of CH505 TF chTrimer (300 µg)+ALFQ (200 µg MPLA/100 µg QS-21) in a 1.1 mL injection volume on Study Days 1, 57, and 169.

BIOLOGICALPlacebo [Arm 1b]

Participants in Arm 1b will receive a 1.1 mL injection of Placebo on Study Days 1, 57, and 169.

BIOLOGICALCH505 TF chTrimer + ALFQ [Arm 2b]

Participants in Arm 2b will receive a lower dose of CH505 TF chTrimer (30 µg)+ALFQ (50 µg MPLA/25 µg QS 21) in a 0.5 mL injection volume on Study Day 1. Participants in Arm 2b will receive a rapid, dose escalating injections of CH505 TF chTrimer (100 µg, 150 µg, and 300 µg)+ALFQ (50 µg MPLA/ 25 µg QS-21) on Study Days 4 (0.5 mL injection volume), 8 (0.5 mL injection volume), and 15 (0.9 mL injection volume). Participants in Arm 2b will receive a injections of CH505 TF chTrimer (300 µg)+ALFQ (200 µg MPLA/100 µg QS 21) in a 1.1 mL injection volume on Study Days 57 and 169.

BIOLOGICALPlacebo [Arm 2b]

Participants in Arm 2b will receive a 0.5 mL injection of Placebo on Study Days 1, 4, and 8; followed by a 0.9 mL injection of Placebo on Study Day 15; followed by a 1.1 mL injection of Placebo on Study Days 57 and 169.

Locations(1)

Makerere University Walter Reed Project (MUWRP)

Kampala, Uganda

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