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Phase 2 Open-label Study of Alum-adjuvanted Chikungunya Virus-like Particle Vaccine (PXVX0317)

NCT03992872 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-16

Study results available
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Summary

This was a phase 2 parallel-group age- and gender-matched open label study in healthy adults 18-65 years of age to assess the safety and immunogenicity of an alum-adjuvanted chikungunya virus-like particle vaccine (PXVX0317; CHIKV VLP vaccine) in prior recipients of other alphavirus vaccines versus alphavirus naïve controls.

Conditions

  • Chikungunya

Interventions

BIOLOGICAL

Chikungunya

Virus Like Particle

Sponsors & Collaborators

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • Emergent BioSolutions

    collaborator INDUSTRY

  • Bavarian Nordic

    lead INDUSTRY

Principal Investigators

  • James McCarty, MD · Emergent BioSolutions

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-20
Primary Completion
2021-01-19
Completion
2021-01-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03992872 on ClinicalTrials.gov