Actively Recruiting
Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall Good Health in South Africa.
Led by International AIDS Vaccine Initiative · Updated on 2026-05-07
96
Participants Needed
6
Research Sites
67 weeks
Total Duration
On this page
Sponsors
I
International AIDS Vaccine Initiative
Lead Sponsor
M
ModernaTX, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall Good Health in South Africa.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understands the study and can give informed consent
- Aged 18 to 55 years on day of enrollment
- Available for follow-up visits through last clinic visit
- Willing to undergo fine needle aspiration and leukapheresis procedures
- Agrees not to join another investigational study during this trial without approval
- In good general health as judged by the Investigator
- Physical exam and lab results show no significant health issues
- Assessed as having low risk of acquiring HIV and agrees to prevention counseling
- Hemoglobin levels meet specified limits based on sex and hormone therapy status
- White blood cell count between 2,500 and 12,000/mm3
- Platelet count between 125,000 and 550,000/mm3
- Alanine aminotransferase (ALT) less than 2.5 times institutional upper limit
- Serum creatinine within normal institutional limits
- Blood pressure between 90/50 mmHg and less than 140/90 mmHg
- Negative HIV test by approved methods
- Negative Hepatitis C antibody or nucleic acid test if antibody positive
- Negative Hepatitis B surface antigen test
- For persons of pregnancy potential, agree to effective contraception and negative pregnancy test
- Agree not to pursue pregnancy through assisted methods during study
You will not qualify if you...
- Currently pregnant or nursing
- Body mass index 40 kg/m2 or higher unless approved
- Diabetes mellitus except well-controlled type 2 diabetes in some cases
- Previous or current receipt of investigational HIV vaccine (except placebo recipients)
- Received non-HIV investigational vaccines within the past year except licensed vaccines
- Immunodeficiency or use of immune-impairing medications
- Received blood products or immunoglobulin within 16 weeks unless approved
- Receipt of certain monoclonal antibodies
- Received any vaccine within 4 weeks before enrollment or planned within 4 weeks after
- History of myocarditis or pericarditis
- History of immune-mediated diseases including autoimmune disorders
- History or active severe skin conditions
- Conditions with urticaria manifestations
- Receipt of antigen-based immunotherapy
- Receipt of investigational agents with short half-life within 4 weeks
- History of serious vaccine reactions
- History of angioedema or urticaria
- History of atopy
- Diagnosed bleeding disorders contraindicating study procedures
- Seizure history within past 3 years or recent seizure medications
- Asplenia or functional asplenia
- Other chronic or significant conditions risking safety or rights
- Asthma diagnosis
- Allergy to local anesthetics
- Difficult venous access
- Recent or planned blood donation within restricted timeframes
- Working or related to study personnel or sponsor staff
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Setshaba Research Centre CRS
Soshanguve, Gauteng, South Africa, 0152
Actively Recruiting
2
Perinatal HIV Research Unit (PHRU)
Soweto, Gauteng, South Africa, 1862
Actively Recruiting
3
CAPRISA eThekwini CRS
Durban, KwaZulu-Natal, South Africa, 4001
Actively Recruiting
4
Isipingo CRS
Isipingo, KwaZulu-Natal, South Africa, 4110
Actively Recruiting
5
Desmond Tutu Health Foundation Emavundleni CRS
Cape Town, Western Cape, South Africa, 7750
Actively Recruiting
6
Desmond Tutu Health Foundation- Groote Schuur Hospital/J52
Cape Town, Western Cape, South Africa, 7925
Actively Recruiting
Research Team
B
Babalwa Jongihlati, MBChB
CONTACT
V
Vincent Muturi-Kioi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
8
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