A new peer-reviewed publication in Open Forum Infectious Diseases reports results from an extended follow-up of the first-in-human Phase 1 PROVENT trial of PRV-101, a pentavalent vaccine candidate targeting coxsackieviruses B (CVB1–5), being developed by Vactech. The follow-up evaluated participants approximately two years after immunization to assess long-term immune response and safety.
The results demonstrate that PRV-101 maintained a favorable safety profile, with no late-appearing adverse effects and no emergence of autoantibodies associated with type 1 diabetes (IAA, GADA, IA-2A, ZnT8A) or celiac disease (anti-transglutaminase IgA/IgG). Importantly, PRV-101 induced durable neutralizing antibody responses that remained elevated at follow-up, with a clear dose-dependent effect. In the high-dose group, antibody levels against all CVB types reached presumably protective levels, with only limited waning observed, most notably for CVB2 in a small number of participants.
These findings support Vactech’s strategy to develop PRV-101 as a vaccine providing long-lasting protection against CVB infections and their associated disease burden. The demonstration of sustained neutralizing antibodies for at least two years strengthens the case for PRV-101 as a potential preventive intervention for both acute CVB infections and CVB-associated chronic diseases, including type 1 diabetes and celiac disease.
The results further reinforce Vactech’s ongoing clinical development program, supporting the advancement of PRV-101 into the next phases of evaluation, including planned studies in young children – the key target population for preventing early-life CVB infections.
Read the publication: https://academic.oup.com/ofid/advance-article/doi/10.1093/ofid/ofag277/8672777