Actively Recruiting
Evaluation of Safety and Immunogenicity of Ad26.Mos4.HIV and CH505 TF chTrimer Combination in Healthy Adults
Led by U.S. Army Medical Research and Development Command · Updated on 2025-10-07
78
Participants Needed
1
Research Sites
121 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
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
CONDITIONS
Official Title
Evaluation of Safety and Immunogenicity of Ad26.Mos4.HIV and CH505 TF chTrimer Combination in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 50 years at enrollment
- Willing and able to read, sign, and date informed consent
- Understands the study with a passing score of 90% or higher on the test of understanding
- Willing and able to follow study requirements and attend all visits
- Has a way to be contacted by phone during the study
- Agrees to have photo or fingerprint taken for ID
- At low risk for HIV infection as judged by the investigator
- Agrees not to donate blood or plasma during the study
- Healthy based on medical history, vital signs, physical exam, and lab results
- Hemoglobin, white blood cells, platelets, liver and kidney function tests within normal limits
- Negative HIV test
- Negative hepatitis B surface antigen
- Negative hepatitis C test or viral load if antibodies found
- Biological males agree to avoid sperm donation and use contraception from screening until 12 weeks after last injection
- Biological females not pregnant or breastfeeding and agree to use effective contraception from 45 days before enrollment until 12 weeks after last injection
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 diseases
- History of chronic or significant diseases that may risk safety or study results like sickle cell anemia, chronic hepatitis, severe asthma, or renal failure
- 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 clotting disorders
- Conditions increasing risk of blood clotting
- Positive hepatitis B surface antigen anytime in past
- Untreated syphilis infection
- Recent use of immune-modifying therapies, blood products, immunoglobulins, tuberculosis therapy, certain vaccines, or investigational products
- Allergy or serious reaction to vaccines or latex
- Participation in other studies involving blood draws or vaccines during this study
- Tattoos or marks interfering with injection site assessments
- Substance abuse within 12 months that may affect participation
- Unreliable communication or inability to complete study
- Other significant medical conditions risking safety or study integrity
- Employment at study site
AI-Screening
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Trial Site Locations
Total: 1 location
1
Makerere University Walter Reed Project (MUWRP)
Kampala, Uganda
Actively Recruiting
Research Team
G
Grace Mirembe, MBChB, MMed
CONTACT
H
Hannah Kibuuka, MBChB, MMed, MPH
CONTACT
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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