Clinical Trial to Evaluate the Safety and Immunogenicity of the V2 Apex-Directed Immunogens DV201P-RNA and DV202B1-RNA in Adult Participants Without HIV
Eligible age
18–55 yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
Yes
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About this study
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.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
You may qualify if…
- ✓ 1. Demonstrates an understanding of the study and is able and willing to complete the informed consent process.
- ✓ 2. At least 18 years old at screening and up to 55 years old on day of enrollment.
- ✓ 3. Available for clinic follow-up through the last clinic visit.
- ✓ 4. Willing to undergo study procedures as outlined in the schedule of procedures (Appendix A).
- ✓ 5. Agrees not to enroll in another study of an investigational agent during participation in the trial. If a potential participant is already enrolled in another clinical trial, approvals from the other trial sponsor and the HVTN 322 PSRT are required prior to enrollment into HVTN 322.
- ✓ 6. In good general health according to the clinical judgment of the site investigator.
- ✓ 7. Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity in the clinical judgment of the site investigator.
- ✓ 8. Agrees to discuss their potential for HIV acquisition and agrees to HIV prevention counseling.
You may not qualify if…
- ✕ 1. Women who are breastfeeding or pregnant.
- ✕ 2. Body mass index (BMI) ≥40. Enrollment of individuals with BMI ≥40 who are in good health, as assessed by the site investigator, may be considered by PSRT approval.
- ✕ 3. Diabetes mellitus (DM). Type 2 DM controlled with diet alone (and confirmed by HgbA1c ≤8% within the last 6 months) or a history of isolated gestational diabetes are not exclusionary. Enrollment of individuals with type 2 DM that is well controlled on hypoglycemic agent(s) may be considered by the PSRT on a case-by-case basis, provided that the HgbA1c is ≤8% within the last 6 months (sites may draw these at screening).
- ✕ 4. Previous or current recipient of an investigational HIV vaccine (previous placebo/control recipients are not excluded).
- ✕ 5. Receipt of non-HIV investigational vaccine(s) received within the last 1 year. Exceptions include vaccines that have subsequently undergone licensure or Emergency Use Authorization (EUA) by the FDA or World Health Organization (WHO) Emergency Use Listing (EUL), or if outside the US, by the national Regulatory Authority (RA) authorizing this clinical trial.
- ✕ 6. Congenital or acquired immunodeficiency, including systemic medication use likely to impair immune response to vaccine in the opinion of the site investigator, such as glucocorticoid use or prednisone dose of ≥10 mg/day, within 3 months prior to enrollment.
- ✕ 7. Blood products or immunoglobulin within 16 weeks prior to enrollment; receipt of immunoglobulin within 16 weeks prior to enrollment requires PSRT approval.
- ✕ 8. Receipt of any of the following within 4 weeks prior to enrollment:
Where it's recruiting
Atlanta · Decatur
Boston
New York · Rochester
Philadelphia · Pittsburgh
Source: ClinicalTrials.gov · NCT07390474 · last updated 2026-08-06