Actively Recruiting
Clinical Trial to Evaluate the Safety and Immunogenicity of a Priming Regimen of 426c.Mod.Core-C4b Followed by HxB2.WT.Core-C4b Boosts, Both Adjuvanted With 3M-052 AF + Alum, in Adult Participants Without HIV and in Overall Good Health
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2025-09-25
42
Participants Needed
6
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a partially randomized, open-label phase 1 study to evaluate the safety and immunogenicity of a priming regimen of 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum followed by boosts with HxB2.WT.Core-C4b adjuvanted with 3M-052 AF + Alum. The primary hypothesis is that the boosting with HxB2.WT.Core-C4b adjuvanted with 3M-052 AF + Alum will further mature broadly neutralizing antibody (bnAb)-precursor B-cell lineages elicited by 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum. 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum has been tested in HVTN 301 previously, whereas the HxB2.WT.Core-C4b will be first-in-human (FIH).
CONDITIONS
Official Title
Clinical Trial to Evaluate the Safety and Immunogenicity of a Priming Regimen of 426c.Mod.Core-C4b Followed by HxB2.WT.Core-C4b Boosts, Both Adjuvanted With 3M-052 AF + Alum, in Adult Participants Without HIV and in Overall Good Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understands and agrees to the study and consent process
- Aged 18 to 55 years on enrollment day
- Available for clinic follow-up through last visit and willing to undergo leukapheresis
- Agrees not to enroll in another investigational study during this trial without approvals
- In good general health per investigator
- Physical exam and labs without significant findings affecting safety assessment
- Agrees to HIV prevention counseling
- Hemoglobin level meets specified thresholds 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 upper institutional limit
- Serum creatinine at or below 1.1 times upper institutional limit
- Corrected serum calcium level at or above 8.5 mg/dL
- Blood pressure within defined systolic and diastolic ranges
- Negative HIV test by approved methods
- Negative for hepatitis C antibodies or nucleic acid if antibodies detected
- Negative hepatitis B surface antigen
- For persons who can become pregnant: agree to contraception and have negative pregnancy test
- Agree not to seek pregnancy through assisted methods during study period
You will not qualify if you...
- Currently pregnant or breastfeeding
- Body mass index (BMI) of 40 or higher unless approved
- Diabetes mellitus except well-controlled cases with diet or medication and approval
- Previous or current receipt of investigational HIV vaccine (placebo recipients allowed)
- Receipt of non-HIV investigational vaccines within last year except approved ones
- Congenital or acquired immunodeficiency or immune-suppressing medications
- Recent blood products or immunoglobulin without approval
- Previous receipt of certain monoclonal antibodies
- Recent receipt of live vaccines or specific mRNA vaccines
- Recent receipt of other vaccines within 14 days
- Recent antigen-based immunotherapy initiation without approval
- Recent investigational agents with short half-life or longer with approval
- History of serious vaccine reactions
- Specific types of angioedema or urticaria
- Bleeding disorders contraindicating procedures
- History of seizures within past 3 years or treatment for seizures
- Asplenia or functional asplenia
- Active duty or reserve US military
- Other serious conditions affecting safety or participation
- Asthma with recent exacerbations or certain medication use
- History of specific medical conditions like Bell's palsy, psoriasis only if mild
- Allergy to local anesthetics
- Difficulty with venous access based on history or exam
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Bridge HIV, San Francisco Department of Public Health
San Francisco, California, United States, 94102
Not Yet Recruiting
2
Ponce de Leon Center CRS
Atlanta, Georgia, United States, 30308
Not Yet Recruiting
3
The Hope Clinic of the Emory Vaccine Research Center; Emory University
Decatur, Georgia, United States, 30030
Actively Recruiting
4
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, United States, 02115
Actively Recruiting
5
Columbia Physicians & Surgeons
New York, New York, United States, 10032
Not Yet Recruiting
6
NY Blood Center CRS
New York, New York, United States, 10065
Withdrawn
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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