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

NCT03483961 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 445

Last updated 2023-07-03

Study results available
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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

Conditions

  • Chikungunya Virus Infection

Interventions

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

Sponsors & Collaborators

  • Emergent BioSolutions

    collaborator INDUSTRY

  • Bavarian Nordic

    lead INDUSTRY

Principal Investigators

  • James McCarty, MD · Emergent BioSolutions

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-04-18
Primary Completion
2020-09-14
Completion
2020-09-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03483961 on ClinicalTrials.gov