NCT05065983

A Study to Assess the Safety and Immunogenicity of PXVX0317 Chikungunya Virus Virus-Like Particle Vaccine

A Phase 2 Open-Label Study to Assess the Safety and Immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV VLP], Aluminum Hydroxide Adjuvanted)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to assess the safety and immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine \[CHIKV VLP\], aluminum hydroxide adjuvanted).

Detailed description

Primary Objectives: 1. To assess the induction of anti-CHIKV neutralizing antibody responses following a single adjuvanted dose of PXVX0317 (40 µg CHIKV VLP, alum-adjuvanted) as measured 21 days (Day 22) after vaccination. 2. To assess the induction of anti-CHIKV neutralizing antibody responses following a single adjuvanted dose of PXVX0317 as measured 7 days (Day 8), 14 days (Day 15), and 56 days (Day 57) after vaccination. Secondary Objectives: 1\. To assess safety of a single adjuvanted dose of PXVX0317 in healthy adults.

Conditions

• Chikungunya Virus

Interventions

Type	Name	Description
BIOLOGICAL	CHIKV VLP, adjuvanted	Adjuvanted formulation includes aluminum hydroxide

Timeline

• Start date: 2021-10-11
• Primary completion: 2022-05-05
• Completion: 2022-05-05
• First posted: 2021-10-04
• Last updated: 2023-07-03
• Results posted: 2023-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study