Actively Recruiting
Clinical Trial to Evaluate the Safety and Immunogenicity of the V2 Apex-Directed Immunogens DV201P-RNA and DV202B1-RNA in Adult Participants Without HIV
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-08
40
Participants Needed
7
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase 1, multicenter, open-label, dose escalation, first-in-human (FIH) trial to evaluate the safety and immunogenicity of DV201P-RNA and DV202B1-RNA, immunogens designed to induce HIV-1 envelope (Env) V2 apex-specific broadly neutralizing antibodies (V2 apex bnAbs). Both vaccines consist of a modified mRNA encapsulated in lipid nanoparticles (LNP) that when translated in cells produces HIV-1 Env gp150 transmembrane trimers. The trial will enroll adult volunteers without HIV and in overall good health.
CONDITIONS
Official Title
Clinical Trial to Evaluate the Safety and Immunogenicity of the V2 Apex-Directed Immunogens DV201P-RNA and DV202B1-RNA in Adult Participants Without HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understands the study and can provide informed consent
- Aged 18 to 55 years at enrollment
- Available for all study follow-up visits
- Willing to complete all study 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 labs show no significant health issues affecting safety assessment
- Willing to discuss HIV risk and receive prevention counseling
- Hemoglobin at least 11.0 g/dL for women, 13.0 g/dL for men
- White blood cell count between 2,500 and 12,000/mm3 (higher counts require approval)
- Platelet count between 125,000 and 550,000/mm3
- Alanine aminotransferase (ALT) less than 2.5 times upper normal limit
- Serum creatinine within normal limits
- Serum calcium level above 8.5 mg/dL
- Blood pressure systolic 90 to under 140 mm Hg and diastolic 50 to under 90 mm Hg
- Negative HIV test by FDA-approved methods
- Negative for Hepatitis C and Hepatitis B infections
- Women of childbearing potential must use effective contraception from 21 days before enrollment through 8 weeks after last vaccination
- Women of childbearing potential must have a negative pregnancy test on enrollment day
- Women of childbearing potential agree not to use assisted reproductive methods from 21 days before enrollment through 8 weeks after last vaccination
- Women who have had hysterectomy, oophorectomy, salpingectomy, or menopause are exempt from pregnancy testing
You will not qualify if you...
- Pregnant or breastfeeding women
- Body mass index (BMI) of 40 or higher unless approved
- Diabetes mellitus (except well-controlled type 2 diabetes with diet or medication and HbA1c ≤8%)
- Previous or current receipt of investigational HIV vaccine (placebo recipients allowed)
- Receipt of non-HIV investigational vaccine within last year unless licensed or authorized
- Immunodeficiency or use of immune suppressing medication recently
- Blood products or immunoglobulin in last 16 weeks unless approved
- Recent live or mRNA-based vaccines within specified time frames
- History of myocarditis or pericarditis
- Recent start of allergy immunotherapy unless approved
- Use of investigational agents with certain half-lives within last 4 weeks unless approved
- History of serious allergic reactions to mRNA vaccines or related drugs
- Certain types of angioedema or urticaria
- Bleeding disorders contraindicating study procedures
- Recent seizures or seizure treatment
- Asplenia or functional asplenia
- Active duty or reserve military personnel
- Any other significant health condition that may risk safety or rights
- Asthma with recent severe exacerbations or high medication use unless approved
- History of some specific medical conditions as detailed in Appendix E
- Allergy to local anesthetics
- Difficult venous access as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
The Ponce de Leon Center CRS
Atlanta, Georgia, United States, 30308
Not Yet Recruiting
2
The Hope Clinic of the Emory Vaccine Research Center; Emory University
Decatur, Georgia, United States, 30030
Actively Recruiting
3
Beth Israel Deaconess Medical Center VCRS (BIDMC VCRS Site # 32077)
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
4
Columbia P&S CRS
New York, New York, United States, 10032
Not Yet Recruiting
5
University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester, New York, United States, 14642
Not Yet Recruiting
6
Penn Prevention CRS
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
7
University of Pittsburgh CRS
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
4
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