Safety and Immunogenicity of a Universal Influenza Vaccine Candidate

摘要

An in-development vaccine is safe and immunogenic in humans, but efficacy data are needed. The constant shift in circulating human influenza strains lowers the effectiveness of seasonal influenza vaccines and poses vaccine manufacturing challenges. A vaccine that provides protection against influenza, regardless of strain variation, would be a major advance for public health. FLU-v, a vaccine candidate (not FDA approved) that is a mix of peptides based on the conserved regions of three different influenza proteins, has been shown to attenuate disease marginally in a controlled human influenza infection. Investigators have now randomized 175 volunteers (97% white; 44% men; mean age, 40 years) in a 2:2:1:1 ratio to receive two doses of adju-vanted FLU-v, FLU-v (nonadjuvanted), placebo, or adjuvant alone, in a partially manufacturer-supported study. The investigators tracked safety, immunogenicity, and reverse-transcriptase polymerase chain reaction-confirmed influenza illness in participants. The candidate vaccine was well tolerated. Vaccine-specific interferon-gamma (IFN-γ) responses in peripheral blood mononuclear cells were significantly higher in the adjuvanted FLU-v group than in the adjuvant-alone group. IFN-y responses did not differ significantly between the FLU-v and placebo groups. Serologic responses to the vaccine were higher in the adjuvanted FLU-V group on day 42 (93%) than in the FLU-v group (72.4%) and placebo groups (0%). The overall vaccine efficacy was 37%, which was not statistically significant.