A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317 (CHIKV VLP Vaccine)
NCT ID: NCT05072080
Last Updated: 2024-08-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
3258 participants
INTERVENTIONAL
2021-09-29
2023-04-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years
NCT05349617
Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults
NCT03483961
A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children.
NCT07003984
Pivotal Study to Evaluate Safety and Immunogenicity of a Live-Attenuated Chikungunya Virus Vaccine Candidate in Adults
NCT04546724
Chikungunya Virus Vaccine Trial in Healthy Adults
NCT01489358
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. To evaluate the safety of PXVX0317 (CHIKV VLP vaccine) in healthy adult and adolescent participants 12 to \<65 years of age.
2. To compare the anti-CHIKV serum neutralizing antibody (SNA) response to PXVX0317 (CHIKV VLP vaccine) and placebo at Day 22, as measured by geometric mean titer (GMT) and clinically relevant difference in seroresponse rate (PXVX0317 minus placebo).
3. To demonstrate the consistency of the anti-CHIKV SNA response across three consecutively manufactured lots of PXVX0317 (CHIKV VLP vaccine) at Day 22 as measured by GMT.
Secondary Objectives:
1. To compare the anti-CHIKV SNA response to PXVX0317 (CHIKV VLP vaccine) and placebo at Day 15, Day 183, and Day 8 as measured by GMT and seroresponse rate.
2. To compare the GMT fold increase in anti-CHIKV SNA response and number and percentage of participants with an anti-CHIKV SNA titer ≥15 and 4-fold rise over baseline, both at Day 8, 15, 22, and 183.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
Group 1 - PXVX0317 lot A (Lot 104)
CHIKV VLP/adjuvant
CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
Group 2
Group 2 - PXVX0317 lot B (Lot 105)
CHIKV VLP/adjuvant
CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
Group 3
Group 3 - PXVX0317 lot C (Lot 106)
CHIKV VLP/adjuvant
CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
Group 4
Group 4 - Placebo
Placebo
Placebo is comprised of formulation buffer
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CHIKV VLP/adjuvant
CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%
Placebo
Placebo is comprised of formulation buffer
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Males or females, 12 to \<65 years of age.
* Generally healthy, in the opinion of the investigator, based on medical history, physical examination, and screening laboratory assessments.
* Women who are either: (i) Not of childbearing potential (CBP): pre-menarche, surgically sterile (at least six weeks post bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or postmenopausal (defined as a history of ≥12 consecutive months without menses prior to randomization in the absence of other pathologic or physiologic causes, following cessation of exogenous sex-hormonal treatment) or (ii) Meeting all the below criteria: Negative serum pregnancy test at screening visit, Negative urine pregnancy test immediately prior to dosing at Day 1, Using an acceptable method of contraception (if women of CBP) for the duration of participation, such as hormonal contraceptives (eg, implants, pills, patches) initiated ≥30 days prior to dosing, intrauterine device (IUD) inserted ≥30 days prior to dosing, double barrier type of birth control (male condom with female diaphragm, male condom with cervical cap), Abstinence is acceptable only for adolescents (12 to \<18 years old) who are not sexually active.
Exclusion Criteria
* Body Mass Index (BMI) ≥35 kg/m2.
* Positive laboratory evidence of current infection with human immunodeficiency virus (HIV-1, HIV-2), hepatitis C virus (HCV) or hepatitis B virus (HBV).
* History of severe allergic reaction or anaphylaxis to any component of the vaccine.
* History of any known congenital or acquired immunodeficiency that could impact response to vaccination (eg, leukemia, lymphoma, generalized malignancy, functional or anatomic asplenia, alcoholic cirrhosis).
* Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications from six months prior to screening through Day 22. Note: For systemic corticosteroids, use at a dose or equivalent dose of 20 mg of prednisone daily for 14 days or more within three months of screening through Day 22 is exclusionary. The use of inhaled, intranasal, topical, ocular, or intraocular steroids is allowed.
* Receipt or anticipated receipt of blood or blood-derived products from 90 days prior to screening through Day 22.
* Acute disease within the last 14 days (participants with an acute mild febrile illness can be considered for a deferral of vaccination two weeks after the illness has resolved and treatment has been completed).
* Clinically significant cardiac, pulmonary, rheumatologic, or other chronic disease, in the opinion of the investigator. This may include chronic illness requiring hospitalization in the last 30 days prior to screening.
* Enrollment in an interventional study and/or receipt of another investigational product from 30 days prior to screening through the duration of study participation.
* Receipt or anticipated receipt of any vaccine from 30 days prior to Day 1 through Day 22.
* Evidence of substance abuse that, in the opinion of the investigator, could adversely impact the participant's participation or the conduct of the study.
* Prior receipt of an investigational CHIKV vaccine/product.
* Any other medical condition that, in the opinion of the investigator, could adversely impact the participant's participation or the conduct of the study.
12 Years
64 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Emergent BioSolutions
INDUSTRY
Bavarian Nordic
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Patrick Ajiboye, MD
Role: STUDY_DIRECTOR
Bavarian Nordic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Optimal Research, LLC
Huntsville, Alabama, United States
Alliance for Multispecialty Research - Mobile
Mobile, Alabama, United States
Alliance for Multispecialty Research, LLC
Tempe, Arizona, United States
Velocity Clinical Research, Banning
Banning, California, United States
Optimal Research, LLC
San Diego, California, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Accel Research Sites-DeLand Clinical Research Unit
Lake Mary, Florida, United States
Optimal Research, LLC
Melbourne, Florida, United States
Suncoast Research Associates, LLC
Miami, Florida, United States
Synexus Clinical Research US, Inc.
Pinellas Park, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Velocity Clinical Research, Boise
Meridian, Idaho, United States
Synexus Clinical Research US, Inc.
Chicago, Illinois, United States
Optimal Research LLC
Peoria, Illinois, United States
Johnson County ClinTrials
Lenexa, Kansas, United States
Alliance for Multispecialty Research, LLC
Newton, Kansas, United States
Alliance for Multispecialty Research - Wichita East
Wichita, Kansas, United States
Alliance for Multispecialty Research, LLC
Lexington, Kentucky, United States
Alliance for Multispecialty Research, LLC
New Orleans, Louisiana, United States
Optimal Research, LLC
Rockville, Maryland, United States
Alliance for Multispecialty Research - Kansas City
Kansas City, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
Synexus Clinical Research US, Inc.
St Louis, Missouri, United States
Wr-Crcn, Llc
Las Vegas, Nevada, United States
Alliance for Multispecialty Research, LLC.
Las Vegas, Nevada, United States
Rochester Clinical Research, Inc.
Rochester, New York, United States
M3 Wake Research, Inc
Raleigh, North Carolina, United States
Trial Management Associates, LLC
Wilmington, North Carolina, United States
Cincinnati Children's Hospital Medical Center - The Gamble Vaccine Research Center
Cincinnati, Ohio, United States
Velocity Clinical Rsearch, Inc.
Cleveland, Ohio, United States
Aventiv Research Inc.
Columbus, Ohio, United States
Lynn Institute of Norman
Norman, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Velocity Clinical Research, Medford
Medford, Oregon, United States
Velocity Clinical Research-Providence
East Greenwich, Rhode Island, United States
Synexus Clinical Research US, Inc.
Anderson, South Carolina, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, United States
Velocity Clinical Research, Austin
Cedar Park, Texas, United States
Texas Center for Drug Development, Inc.
Houston, Texas, United States
Research Your Health
Plano, Texas, United States
BFHC Research
San Antonio, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Advanced Clinical Research
West Jordan, Utah, United States
Alliance for Multispecialty Research, LLC
Norfolk, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Richardson JS, Anderson DM, Mendy J, Tindale LC, Muhammad S, Loreth T, Tredo SR, Warfield KL, Ramanathan R, Caso JT, Jenkins VA, Ajiboye P, Bedell L; EBSI-CV-317-004 Study Group. Chikungunya virus virus-like particle vaccine safety and immunogenicity in adolescents and adults in the USA: a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2025 Apr 19;405(10487):1343-1352. doi: 10.1016/S0140-6736(25)00345-9. Epub 2025 Mar 27.
Miao Q, Nguyen W, Zhu J, Liu G, van Oers MM, Tang B, Yan K, Larcher T, Suhrbier A, Pijlman GP. A getah virus-like-particle vaccine provides complete protection from viremia and arthritis in wild-type mice. Vaccine. 2024 Nov 14;42(25):126136. doi: 10.1016/j.vaccine.2024.07.037. Epub 2024 Jul 14.
Bennett SR, McCarty JM, Ramanathan R, Mendy J, Richardson JS, Smith J, Alexander J, Ledgerwood JE, de Lame PA, Royalty Tredo S, Warfield KL, Bedell L. Safety and immunogenicity of PXVX0317, an aluminium hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial. Lancet Infect Dis. 2022 Sep;22(9):1343-1355. doi: 10.1016/S1473-3099(22)00226-2. Epub 2022 Jun 13.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EBSI-CV-317-004
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.