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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)