The goal of this Phase 2 trial is to evaluate the immune response to and safety profile of various doses/formulations/and schedules of administration of PXVX0317 in 445 healthy adults.
Primary Objective: To assess the immune response to the vaccine
Secondary Objectives: To assess the kinetics of the immune response to different doses/formulations/schedules To assess the persistence of immune responses to different doses/formulations/schedules To assess the effect of a booster dose of the vaccine
Safety Objective: To assess local and systemic reactions to the vaccine and to describe the safety profile of the vaccine
Emergent BioSolutions Inc. announced two-year persistence data from this Phase 2 clinical study evaluating the safety and immunogenicity of the company’s investigational chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate in 415 healthy adults.
Emergent’s CHIKV VLP vaccine, the only single-dose VLP-based vaccine currently in clinical development for active immunization against chikungunya disease, continued to demonstrate a favorable safety profile and had generated a dose-related increase in neutralizing antibody response against the chikungunya virus as previously reported.
Two years post-vaccination, SNA responses were 19 times higher than pre-vaccination titers following a single adjuvanted 40 µg dose of the CHIKV VLP vaccine, supporting the persistence of the immune response.
All subjects in the single-dose regimen remained seropositive at their one-year and two-year visits. The vaccine candidate was well-tolerated and no significant vaccine-related safety concerns were identified.
The majority of solicited adverse events were mild or moderate in severity and the most frequent was local injection site pain.