CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 445 enrolled
Drug / intervention
CHIKV VLP/unadjuvanted +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03483961
NCT03483961Phase 2Completed
CompareCT.gov

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)

Bavarian Nordic·interventional·Posted Mar 30, 2018·Updated Jul 3, 2023

In Brief

A Phase 2 clinical trial evaluating CHIKV VLP/unadjuvanted, CHIKV VLP/adjuvanted, and 1 other intervention for Chikungunya Virus Infection. Completed, enrolled 445 participants across 3 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChikungunya Virus Infection
CountriesUnited States
CollaboratorsEmergent BioSolutions

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMar 30, 2018
Enrollment StartApr 18, 2018
Primary CompletionSep 14, 2020
Study CompletionSep 21, 2020
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 8.3 years ago

Interventions

CHIKV VLP/unadjuvantedbiological

Vaccine consists of virus-like particles of chikungunya virus antigens

CHIKV VLP/adjuvantedbiological

Adjuvanted formulation includes Alhydrogel

Placebobiological

Placebo is vaccine diluent alone