NCT05349617

Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years

A Phase 3 Safety and Immunogenicity Trial of the VLP-Based Chikungunya Virus Vaccine PXVX0317 in Adults ≥65 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 413 (actual)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this phase 3, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity to PXVX0317 in adults ≥65 years of age.

Detailed description

Co-primary Objectives: * To compare the anti-CHIKV serum neutralizing antibody (SNA) response to PXVX0317 and placebo at Day 22, as measured by geometric mean titer (GMT) and clinically relevant difference in seroresponse rate (PXVX0317 minus placebo) in adults ≥65 years of age. * To evaluate the safety of PXVX0317 in adults ≥65 years of age Secondary Objectives: * To compare the anti-CHIKV SNA response to PXVX0317 and placebo at Day 15 and Day 183, as measured by GMT and seroresponse rate. * To compare the anti-CHIKV SNA response to PXVX0317 and placebo in participants ≥65 to \<75 and ≥75 years of age as measured by GMT and seroresponse rate.

Conditions

• Chikungunya Virus

Interventions

Type	Name	Description
BIOLOGICAL	CHIKV VLP/adjuvant	PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant
BIOLOGICAL	Placebo	Placebo is comprised of formulation buffer

Timeline

• Start date: 2022-05-12
• Primary completion: 2023-06-19
• Completion: 2023-08-08
• First posted: 2022-04-27
• Last updated: 2024-12-13
• Results posted: 2024-12-13

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study