Study of DV201P-RNA and DV202B1-RNA for HIV Prevention
This study is testing two new vaccines, DV201P-RNA and DV202B1-RNA, in healthy adults who do not have HIV. These vaccines are designed to help your body make special antibodies (proteins that fight infection) against HIV. Researchers want to see if the vaccines are safe and if they can create an immune response. The study will enroll 40 participants. Success in this study means the vaccines are well-tolerated and can trigger the desired immune response. The current status of this study is unclear.
- Study design
- This is a Phase 1, open-label study, meaning both you and the study team will know which vaccine you receive. It will involve about 40 participants.
- What's involved
- You would need to be available for clinic follow-up through the last visit and be willing to undergo study procedures as outlined.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for serious side effects, medically attended side effects, and side effects of special interest from informed consent through the end of the study. All other side effects will be collected for 30 days after receiving any study vaccination.
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NCT07390474
Clinical Trial to Evaluate the Safety and Immunogenicity of the V2 Apex-Directed Immunogens DV201P-RNA and DV202B1-RNA in Adult Participants Without HIV
Recruiting
PHASE1Ages 18–55InterventionalPreventionNational Institute of Allergy and Infectious Diseases (NIAID)Government-funded
~40 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:DV201P-RNADV202B1-RNA
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Local reactogenicity for a minimum of 14 days following receipt of any study vaccine
Measured over Day 0 (vaccination) through 14 days post-vaccination; at days 15, 99, 183, and 295
+10 more outcomes measured
Conditions
Where it's being run
7 sites across 4 statesGeorgia2
New York2
Pennsylvania2
Massachusetts1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
11.0 g/dL for women
13.0 g/dL for men 10. White blood cell (WBC) count of 2,500 to 12,000/mm3. WBC over 12,000/mm3 is not exclusionary if further evaluation shows general good health and if PSRT approval is granted. 11. Platelet count of 125,000 to 550,000/mm3. 12. Alanine aminotransferase (ALT) \<2.5× the upper limit of institutional reference range. 13. Serum creatinine ≤1.1× the upper limit of normal (ULN) based on the institutional normal range. 14. Total measured serum calcium level \>8.5 mg/dL. 15. Systolic blood pressure of 90 to \<140 mm Hg and diastolic blood pressure of 50 to \<90 mm Hg at screening visit. The average blood pressure between the screening visit and the enrollment visit must be below 140 mm Hg systolic and 90 mmHg diastolic. A single measurement of ≥160 mm Hg systolic or ≥100 mm Hg diastolic during the current study evaluation is exclusionary. 16. HIV test results by one of the following options:
What this trial measures
- Local reactogenicity for a minimum of 14 days following receipt of any study vaccineDay 0 (vaccination) through 14 days post-vaccination; at days 15, 99, 183, and 295
- Systemic reactogenicity for a minimum of 14 days following receipt of any study vaccineDay 0 (vaccination) through 14 days post-vaccination; at days 15, 99, 183, and 295
- Serious adverse events (SAEs), medically attended AEs (MAAEs), AEs of special interest (AESIs), and AEs leading to withdrawal/discontinuation collected throughout study; additionally, all AEs collected for 30 days after receipt of any study vaccinationFrom informed consent through end of study for SAEs, MAAEs, AESIs, and AEs leading to withdrawal/discontinuation; all AEs for 30 days after receipt of any study vaccination
- Response rate of V2 apex-specific IgG+ B cells as assessed by flow cytometry 2 weeks after second vaccination2 weeks after the second vaccination (Day 99)
- Frequency of V2 apex-specific IgG+ B cells as assessed by flow cytometry 2 weeks after second vaccination2 weeks after the second vaccination (Day 99)
- Response rate of differential serum Ab neutralization of precursor detection viruses and corresponding epitope knock-out mutant forms of the viruses, as measured by the TZM-bl assay at 2 weeks after second vaccination2 weeks after the second vaccination (Day 99)
- Magnitude of differential serum Ab neutralization of precursor detection viruses and corresponding epitope knock-out mutant forms of the viruses, as measured by the TZM-bl assay at 2 weeks after second vaccination2 weeks after the second vaccination (Day 99)
- Response rate of serum IgG binding antibodies to autologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA) at 2 weeks after second vaccination2 weeks after the second vaccination (Day 99)
- Magnitude of serum IgG binding antibodies to autologous HIV Env stabilized trimers, as assessed by BAMA at 2 weeks after second vaccination2 weeks after the second vaccination (Day 99)
- Response rate of differential serum Ab neutralization of precursor detection viruses and corresponding epitope knock-out mutant forms of the viruses as measured by TZM-bl pseudovirus assay 2 weeks after the third and fourth vaccinations (Groups 1-3)2 weeks after the third vaccination and 2 weeks after the fourth vaccination (Days 183 and 295)
- Magnitude of differential serum Ab neutralization of precursor detection viruses and corresponding epitope knock-out mutant forms of the viruses as measured by TZM-bl pseudovirus assay 2 weeks after third and fourth vaccinations (Groups 1-3)2 weeks after the third vaccination and 2 weeks after the fourth vaccination (Days 183 and 295)