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.
Age range
18 Years – 55 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Local reactogenicity for a minimum of 14 days following receipt of any study vaccine
Timeframe: Day 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 vaccine
Timeframe: Day 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 vaccination
Timeframe: From 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 vaccination
Timeframe: 2 weeks after the second vaccination (Day 99)
Frequency of V2 apex-specific IgG+ B cells as assessed by flow cytometry 2 weeks after second vaccination
Timeframe: 2 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 vaccination
Timeframe: 2 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 vaccination
Timeframe: 2 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 vaccination
Timeframe: 2 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 vaccination
Timeframe: 2 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)
Timeframe: 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)
Timeframe: 2 weeks after the third vaccination and 2 weeks after the fourth vaccination (Days 183 and 295)