Actively Recruiting

Phase 1
Age: 18Years - 50Years
All Genders
Healthy Volunteers
ID06205056

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

Led by U.S. Army Medical Research and Development Command · Updated on 2025-10-07

78

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

U

U.S. Army Medical Research and Development Command

Lead Sponsor

J

Janssen Vaccines & Prevention B.V.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying a Phase I clinical trial to evaluate the safety and immune response of two different dosing schedules of the Ad26.Mos4.HIV and CH505 TF chTrimer vaccine combination in healthy adults aged 18 to 50 years who have a low risk of HIV infection. The trial is randomized, double-blind, and placebo-controlled, aiming to compare a rapid dose-escalating vaccination schedule with a dose-consistent schedule. This study is exploring how well these vaccination regimens mimic acute HIV viral replication and their effects on immune markers. Participants will be divided into four study groups receiving different combinations and dosing schedules of the vaccines and placebo. Some groups receive consistent doses of Ad26.Mos4.HIV and CH505 TF chTrimer+ALFQ on specific study days, while others receive lower initial doses followed by rapid dose escalations before consistent doses later. Injections are given intramuscularly into the same thigh muscle on scheduled days across a timeline up to 169 days. Optional lymph node biopsies may be performed on Day 71 for consenting participants. During the study, participants will attend multiple visits for injections and monitoring for up to 18 months. Researchers will assess the occurrence and severity of local and systemic side effects, serious adverse events, and specific adverse events of interest from Day 0 to Day 505. Immune responses will be measured by antibody levels targeting HIV envelope proteins at various visits throughout the study. Safety monitoring includes sentinel groups with early safety reviews before expanding enrollment. Participants are expected to comply with study requirements and follow-up visits throughout the trial.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, aged 18 to 50 years inclusive at enrollment
  • Willing and able to read, sign, and date the informed consent form
  • Understands the study with a passing score (90% or greater) on the test of understanding by the third attempt
  • Willing and able to comply with study requirements and attend all visits
  • Has means to be contacted by telephone during study participation
  • Agrees to have photo or fingerprint taken for identification
  • At low risk for HIV acquisition per investigator assessment
  • Agrees to refrain from donating blood or plasma during study participation
  • Healthy based on physician's clinical judgment and normal physical exam and vital signs
  • Meets specific laboratory criteria within 45 days prior to enrollment including hemoglobin, white blood cells, platelets, liver function, serum creatinine, urinalysis, negative HIV, hepatitis B and C tests
  • Biological males must agree to avoid sperm donation and use contraception from screening until 12 weeks after last injection
  • Biological females must not be pregnant or breastfeeding and agree to effective contraception from screening until 12 weeks after last injection
Not Eligible

You will not qualify if you...

  • Body mass index less than 18.0 or greater than 35.1 kg/m2
  • Conditions affecting immune function such as immunodeficiency, diabetes, thyroid disease, asplenia, or immune-mediated medical conditions
  • History of chronic or significant diseases that jeopardize safety or rights
  • History of cancer except certain skin cancers unless cured
  • Major surgery within 28 days before screening or planned during study
  • Personal or family history of bleeding or blood clotting disorders
  • Conditions increasing blood clot risk including autoimmune disease or recent infection
  • Positive hepatitis B surface antigen or untreated syphilis
  • Recent use of immune-modifying therapies or blood products
  • Recent or planned use of certain vaccines or investigational products
  • Known allergy or serious reaction to vaccines or vaccine components
  • Current or planned participation in another study with blood draws or investigational products
  • Tattoos or scars interfering with injection site assessment
  • Substance abuse within 12 months affecting participation
  • Inability to communicate reliably or adhere to study requirements
  • Any other medical condition risking safety or immune response
  • Study site employee

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessments including medical history, physical exam, and lab tests

Treatment

Duration - Approximately 6 months

Participants receive injections of study vaccines or placebo according to their assigned study arm on specific study days.

Multiple visits for injections on Study Days 1, 4, 8, 15, 57, and 169 depending on study arm

Follow-up

Duration - Up to 18 months from first injection

Participants are monitored for safety and immune response through periodic visits after treatment completion.

Follow-up visits on Study Days 29, 71, 85, 183, and 337 including optional lymph node biopsy on Day 71 for consenting participants

Trial Site Locations

Total: 1 location

1

Makerere University Walter Reed Project (MUWRP)

Kampala, Uganda

Actively Recruiting

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Research Team

G

Grace Mirembe, MBChB, MMed

H

Hannah Kibuuka, MBChB, MMed, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

4

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