BioNTech has registered a randomized Phase I/II trial of its therapeutic mRNA HIV vaccine BNT168, which will test whether vaccine-induced immune responses can maintain viral suppression after treatment interruption in people living with HIV. The trial, expected to begin in July 2026, will enroll 126 participants and evaluate whether the vaccine can enable viral control during treatment interruption. The program representsone of the first randomized Phase I/II evaluations of an mRNA therapeutic HIV vaccine.
The BioNTech clinical trial (NCT07698600) is structured in two arms: three cohorts of HIV-negative participants will receive three injections of BNT168, while two cohorts of people living with HIV on stable antiretroviral therapy for at least 12 months will receive four injections. Enrollment will span participants aged 18 to 50 years; those with HIV must have plasma viral load below 50 copies per milliliter for at least six months and CD4 counts of at least 500 cells per microliter at screening. The study is expected to complete by January 2028, with approximately nine months of follow-up for HIV-negative participants and up to 13 months for those with HIV.
BNT168 targets a distinct unmet need: enabling HIV-positive individuals to maintain viral suppression without continuous antiretroviral therapy through vaccine-induced cellular immunity. The immunogen is designed to generate HIV-specific CD8+ T cell responses against key viral antigens, offering a complement to existing treatment rather than a replacement. The therapeutic goal—viral control during analytical treatment interruption (ATI)—depends on establishing robust T cell-mediated defense. Analytical treatment interruption is widely regarded as the clinical benchmark for evaluating HIV cure strategies because it directly tests whether immune interventions can control viral rebound after antiretroviral therapy is stopped.
The therapeutic HIV vaccine space remains sparse and early-stage. Genetic Immunity, a Hungarian clinical-stage company, is advancing DermaVir, a plasmid DNA therapeutic vaccine, toward Phase III, supported by manufacturing partnerships with VectorBuilder. The International AIDS Vaccine Initiative (IAVI) is simultaneously running the IAVI C114 trial of GRAdHIVNE1, a Gorilla adenovirus-vectored candidate enrolling 120 healthy adults and virally suppressed people with HIV across South African and Zimbabwean sites, with results expected over 19 months. Neither competing program uses mRNA technology, positioning BNT168's approach as potentially differentiated in mechanism.