NCT03483961

Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults

A Phase 2 Parallel-Group, Randomized, Double-Blind Study to Assess the Safety and Immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV-VLP], Unadjuvanted or Alum-adjuvanted)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 445 (actual)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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 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

Detailed description

The trial will explore 8 formulation/schedule combinations of CHIKV VLP vaccine with or without Alhydrogel adjuvant, and will also explore different dose schedules of Day 1 and 15 or Day 1 and 29 or Day 29 only.

Conditions

• Chikungunya Virus Infection

Interventions

Type	Name	Description
BIOLOGICAL	CHIKV VLP/unadjuvanted	Vaccine consists of virus-like particles of chikungunya virus antigens
BIOLOGICAL	CHIKV VLP/adjuvanted	Adjuvanted formulation includes Alhydrogel
BIOLOGICAL	Placebo	Placebo is vaccine diluent alone

Timeline

• Start date: 2018-04-18
• Primary completion: 2020-09-14
• Completion: 2020-09-21
• First posted: 2018-03-30
• Last updated: 2023-07-03
• Results posted: 2021-11-09

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study