Long-term Follow-up Study to Evaluate Safety and Immunogenicity of PXVX0317 Single or Booster Vaccination

Chikungunya Virus Infection Clinical Trial

Official title: A Long-term Follow-up Study to Evaluate Safety and Immunogenicity of a Chikungunya Virus Virus-like Particle Vaccine (PXVX0317) in Healthy Adults and Adolescents After Either a Single or Booster Vaccination Dosing Regimen

Status Recruiting

Clinical Trial Summary

The purpose of this phase 3 multicenter, randomized, double-blind, placebo-controlled rollover study is to evaluate the safety and long-term immunogenicity of PXVX0317 in adult and adolescent participants and to evaluate PXVX0317 booster vaccine induced serum neutralizing antibody (SNA) response at 3, 4, or 5 years post-initial PXVX0317 vaccination.

Clinical Trial Description

Primary Objectives:

• To evaluate the long-term immunogenicity of PXVX0317 vaccine in healthy adult and adolescent participants as measured by proportion of participants maintaining an anti-CHIKV serum neutralizing antibody (SNA) titer ≥100 (seroresponse rate, also considered the presumptive seroprotection rate) at yearly intervals up to 5 years postvaccination in feeder study EBSI-CV-317-004 (NCT05072080).

• To assess the vaccine-induced SNA titers by a booster dose of PXVX0317 vaccine at 3, 4, or 5 years post-initial vaccination in feeder study EBSI-CV- 317-004.

• To evaluate the safety and tolerability of PXVX0317 in all participants.

• To evaluate the safety and tolerability of a booster vaccination and compare with safety and tolerability reported post-initial vaccination of PXVX0317 under feeder study EBSI-CV-317-004 in healthy adults and adolescents.

Secondary Objectives:

• To evaluate the long-term immunogenicity of PXVX0317 vaccine in healthy adult and adolescent participants as measured by anti-CHIKV SNA geometric mean titers (GMTs) at yearly intervals up to 5 years post-initial vaccination in feeder study EBSI-CV-317-004.

• To evaluate the immune response to a booster vaccination and compare this response to that reported post-initial vaccination of PXVX0317 under feeder study EBSI-CV-317-004 in healthy adults and adolescents. ;

Related Conditions & MeSH terms

• Chikungunya Fever
• Chikungunya Virus Infection

• NCT number: NCT06007183
• Study type: Interventional
• Source: Bavarian Nordic
• Contact: Sufia Muhammad, MD
• Phone: 240-631-3573
• Email: SUMU@bavarian-nordic.com
• Status: Recruiting
• Phase: Phase 3
• Start date: August 30, 2023
• Completion date: August 2028