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ACTIVE NOT RECRUITING
NCT06007183
PHASE3

Long-term Follow-up Study to Evaluate Safety and Immunogenicity of PXVX0317 Single or Booster Vaccination

Sponsor: Bavarian Nordic

View on ClinicalTrials.gov

Summary

The purpose of this phase 3 multicenter, randomized, double-blind, placebo-controlled rollover study is to evaluate the safety and long-term immunogenicity of CHIKV VLP vaccine in adult and adolescent participants and to evaluate CHIKV VLP booster vaccine induced serum neutralizing antibody (SNA) response at 3, 4, or 5 years post-initial CHIKV VLP vaccination.

Official title: A Long-term Follow-up Study to Evaluate Safety and Immunogenicity of a Chikungunya Virus Virus-like Particle Vaccine (PXVX0317) in Healthy Adults and Adolescents After Either a Single or Booster Vaccination Dosing Regimen

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

800

Start Date

2023-08-30

Completion Date

2028-08

Last Updated

2025-04-03

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

CHIKV VLP vaccine booster

CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP) 40mg, aluminum hydroxide 2% adjuvant, and formulation buffer supplied as a single dose of 0.8 mL in a pre-filled syringe, to be administered via intramuscular (IM) injection in the deltoid muscle.

BIOLOGICAL

Placebo booster

Placebo is comprised of formulation buffer supplied as a single dose of 0.8 mL in a pre-filled syringe administered via IM injection in the deltoid muscle.

Locations (24)

Alliance for Multispecialty Research, LLC

Mobile, Alabama, United States

Alliance for Multispecialty Research, LLC

Tempe, Arizona, United States

Optimal Research, LLC

Melbourne, Florida, United States

Suncoast Research Associates, LLC

Miami, Florida, United States

Synexus Clinical Research US, Inc.

Chicago, Illinois, United States

Optimal Research, LLC

Peoria, Illinois, United States

Alliance for Multispecialty Research, LLC

Newton, Kansas, United States

Alliance for Multispecialty Research, LLC

Wichita, Kansas, United States

Alliance for Multispecialty Research, LLC

Lexington, Kentucky, United States

Alliance for Multispecialty Research, LLC

Kansas City, Missouri, United States

Wr-Crcn, Llc

Las Vegas, Nevada, United States

Alliance for Multispecialty Research, LLC

Las Vegas, Nevada, United States

Rochester Clinical Research, LLC

Rochester, New York, United States

M3 Wake Research Inc.

Raleigh, North Carolina, United States

Velocity Clinical Research, Cleveland

Cleveland, Ohio, United States

Lynn Institute of Norman

Norman, Oklahoma, United States

Velocity Clinical Research, Medford

Medford, Oregon, United States

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, United States

Velocity Clinical Research, Austin

Cedar Park, Texas, United States

DM Clinical Research

Houston, Texas, United States

BFHC Research, LLC

San Antonio, Texas, United States

DM Clinical Research

Tomball, Texas, United States

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, United States

Alliance for Multispecialty Research, LLC

Norfolk, Virginia, United States