Curevo Vaccine (Curevo), a privately held clinical-stage biotechnology company dedicated to reducing the burden of infectious disease by developing safe and highly-effective vaccines, today announced completion of enrollment in a Phase 2b trial of their CRV-101 subunit vaccine to prevent the reactivation of the varicella zoster virus (shingles) in older adults. CRV-101 is in development to be a potentially well-tolerated, highly effective shingles vaccine with high-yield manufacturing. The Phase 2b trial enrolled 678 participants across eleven U.S. sites, randomized to a high- or low-dose CRV-101 arm or Shingrix. Participants received two doses, two months apart as per current practice for a shingles vaccine. Eligibility criteria included adults over 50 with no prior varicella zoster virus vaccination or history of shingles and were broadly representative of the potential non-immunosuppressed patient population for a shingles vaccine. The primary endpoints focus on safety and immunologic outcomes, including the occurrence of local and systemic side effects, antibody levels at month three, comparison of the reactogenicity of CRV-101 to Shingrix, and the occurrence of serious adverse events. Patient enrollment started in February 2022 and topline data from this Phase 2b trial are expected in January 2023.
