A Phase 3 Trial of the VLP-Based Chikungunya Vaccine PXVX0317 (CHIKV VLP Vaccine)

NCT05072080 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: EBSI-CV-317-004
• Study Type: interventional
• Target: 3,258
• Locations: 1 country
• Sites: 47

Brief Summary

The goal of this multi-center, randomized, double blind, placebo controlled study is to evaluate the safety and immunogenicity of PXVX0317 (CHIKV VLP vaccine) in healthy adult and adolescent subjects.

Conditions

Chikungunya Virus

Keywords

Chikungunya; VLP; PXVX0317; vaccine; immunogenicity; CHIKV

Outcome Measures

Primary Outcomes (11)

• Incidence of Solicited Adverse Events (AE)

  Incidence of solicited AEs through Day 8 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).

  7 days post-vaccination

• Incidence of Unsolicited AEs

  Incidence of unsolicited AEs through Day 29 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).

  28 days post-vaccination

• Incidence of Adverse Events of Special Interest (AESI)

  Incidence of AESIs, through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).

  182 days post-vaccination

• Incidence of Medically Attended Adverse Event (MAAE)

  Incidence of MAAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).

  182 days post-vaccination

• Incidence of Serious Adverse Event (SAE)

  Incidence of SAEs through Day 183 for PXVX0317 (CHIKV VLP vaccine) and placebo for all age strata combined (safety population).

  182 days post-vaccination

• Anti-CHIKV Serum Neutralizing Antibody (SNA) Seroresponse Rates at Day 22

  Anti-CHIKV SNA seroresponse rates for PXVX0317 (CHIKV VLP vaccine) and placebo, difference (PXVX0317 minus placebo), and associated 95% confidence interval (CI) at Day 22 for the immunogenicity evaluable population (IEP), all age strata combined.

  21 days post-vaccination

• Anti-CHIKV Serum Neutralizing Antibody (SNA) Seroresponse Rates at Day 22 (Data Reported Per Arm)

  Anti-CHIKV SNA seroresponse rates and associated 95% confidence interval for PXVX0317 (CHIKV VLP vaccine) and placebo at Day 22 for the immunogenicity evaluable population (IEP), all age strata combined.

  21 days post-vaccination

• Anti-CHIKV SNA Geometric Mean Titers (GMT) at Day 22

  Anti-CHIKV SNA GMTs and associated 95% CIs at Day 22 for PXVX0317 (CHIKV VLP vaccine) and placebo for the IEP, all age strata combined.

  21 days post-vaccination

• Anti-CHIKV SNA Geometric Mean Titers (GMT) at Day 22 (Data Reported Per Arm - All Age Strata)

  Anti-CHIKV SNA GMTs and associated 95% CIs at Day 22 for PXVX0317 (CHIKV VLP vaccine) and placebo for the IEP, all age strata combined.

  21 days post-vaccination

• Anti-CHIKV SNA Geometric Mean Titers (GMT) at Day 22 (for Lot Comparison)

  Anti-CHIKV SNA GMTs and associated 95% CIs between all three pairs of PXVX0317 (CHIKV VLP vaccine) lots (104:105, 104:106, 105:106) in adults 18 to \<46 years of age in the IEP at Day 22. Placebo group 4 is not relevant for this lot-to-lot consistency analysis. Reported GMT estimates and 95% CIs are derived from an ANOVA model that includes site and product lot as fixed effects assuming normality of log titers.

  21 days post-vaccination

• Anti-CHIKV SNA Geometric Mean Titers (GMT) at Day 22 (Data Reported Per Arm - Adults 18 to <46)

  Anti-CHIKV SNA GMTs and associated 95% CIs for PXVX0317 (CHIKV VLP vaccine) and placebo in adults 18 to \<46 years of age in the IEP at Day 22.

  21 days post-vaccination

Secondary Outcomes (8)

• Anti-CHIKV SNA Seroresponse Rates at Days 15, 183, and 8

  Day 15, 183, and 8 (14, 182, and 7 days post-vaccination, respectively)

• Anti-CHIKV SNA Seroresponse Rates at Days 15, 183, and 8 (Data Reported Per Arm)

  Day 15, 183, and 8 (14, 182, and 7 days post-vaccination, respectively)

• Anti-CHIKV SNA Geometric Mean Titers (GMTs) at Days 8, 15, and 183

  Day 8, 15, and 183 (7, 14, and 182 days post-vaccination, respectively)

• Anti-CHIKV SNA Geometric Mean Titers (GMTs) at Days 8, 15, and 183 (Data Reported Per Arm)

  Day 8, 15, and 183 (7, 14, and 182 days post-vaccination, respectively)

• Geometric Mean Fold Increase (GMFI) in Anti-CHIKV SNA Titers From Day 1 to Days 8, 15, 22, and 183

  Day 8, 15, 22, and 183 (7,14, 21, and 182 days post-vaccination, respectively)

Study Arms (4)

Group 1

EXPERIMENTAL

Group 1 - PXVX0317 lot A (Lot 104)

Biological: CHIKV VLP/adjuvant

Group 2

EXPERIMENTAL

Group 2 - PXVX0317 lot B (Lot 105)

Biological: CHIKV VLP/adjuvant

Group 3

EXPERIMENTAL

Group 3 - PXVX0317 lot C (Lot 106)

Biological: CHIKV VLP/adjuvant

Group 4

PLACEBO COMPARATOR

Group 4 - Placebo

Biological: Placebo

Interventions

CHIKV VLP/adjuvant BIOLOGICAL

CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant 2%

Group 1; Group 2; Group 3

Placebo BIOLOGICAL

Placebo is comprised of formulation buffer

Group 4

Eligibility Criteria

• Age: 12 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Able and willing to provide informed consent (and assent, as applicable) voluntarily signed by participant (and guardian, as applicable).
• 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.

You may not qualify if:

• Currently pregnant, breastfeeding, or planning to become pregnant during the study.
• 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).
• 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.

Sponsors & Collaborators

• Bavarian Nordic: lead
• Emergent BioSolutions: collaborator

Study Sites (47)

Optimal Research, LLC

Huntsville, Alabama, 35802, United States

Location

Alliance for Multispecialty Research - Mobile

Mobile, Alabama, 36608, United States

Location

Alliance for Multispecialty Research, LLC

Tempe, Arizona, 85281, United States

Location

Velocity Clinical Research, Banning

Banning, California, 92220, United States

Location

Optimal Research, LLC

San Diego, California, 92108, United States

Location

Lynn Institute of the Rockies

Colorado Springs, Colorado, 80918, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Accel Research Sites-DeLand Clinical Research Unit

Lake Mary, Florida, 32746, United States

Location

Optimal Research, LLC

Melbourne, Florida, 32934, United States

Location

Suncoast Research Associates, LLC

Miami, Florida, 33173, United States

Location

Synexus Clinical Research US, Inc.

Pinellas Park, Florida, 33781, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Velocity Clinical Research, Boise

Meridian, Idaho, 83642, United States

Location

Synexus Clinical Research US, Inc.

Chicago, Illinois, 60602, United States

Location

Optimal Research LLC

Peoria, Illinois, 61614, United States

Location

Johnson County ClinTrials

Lenexa, Kansas, 66219, United States

Location

Alliance for Multispecialty Research, LLC

Newton, Kansas, 67114, United States

Location

Alliance for Multispecialty Research - Wichita East

Wichita, Kansas, 67207, United States

Location

Alliance for Multispecialty Research, LLC

Lexington, Kentucky, 40509, United States

Location

Alliance for Multispecialty Research, LLC

New Orleans, Louisiana, 70119, United States

Location

Optimal Research, LLC

Rockville, Maryland, 20850, United States

Location

Alliance for Multispecialty Research - Kansas City

Kansas City, Missouri, 64114, United States

Location

Saint Louis University

St Louis, Missouri, 63104, United States

Location

Synexus Clinical Research US, Inc.

St Louis, Missouri, 63141, United States

Location

Wr-Crcn, Llc

Las Vegas, Nevada, 89106, United States

Location

Alliance for Multispecialty Research, LLC.

Las Vegas, Nevada, 89119, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

M3 Wake Research, Inc

Raleigh, North Carolina, 27612, United States

Location

Trial Management Associates, LLC

Wilmington, North Carolina, 28403, United States

Location

Cincinnati Children's Hospital Medical Center - The Gamble Vaccine Research Center

Cincinnati, Ohio, 45229, United States

Location

Velocity Clinical Rsearch, Inc.

Cleveland, Ohio, 44122, United States

Location

Aventiv Research Inc.

Columbus, Ohio, 43213, United States

Location

Lynn Institute of Norman

Norman, Oklahoma, 73072, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Velocity Clinical Research, Medford

Medford, Oregon, 97504, United States

Location

Velocity Clinical Research-Providence

East Greenwich, Rhode Island, 02818, United States

Location

Synexus Clinical Research US, Inc.

Anderson, South Carolina, 29621, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, 37920, United States

Location

Velocity Clinical Research, Austin

Cedar Park, Texas, 78613, United States

Location

Texas Center for Drug Development, Inc.

Houston, Texas, 77081, United States

Location

Research Your Health

Plano, Texas, 75093, United States

Location

BFHC Research

San Antonio, Texas, 78249, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

Alliance for Multispecialty Research, LLC

Norfolk, Virginia, 23502, United States

Location

Related Publications (3)

• 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.

  PMID: 40158526 DERIVED

• 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.

  PMID: 39004524 DERIVED

• 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.

  PMID: 35709798 DERIVED

MeSH Terms

Conditions

Chikungunya Fever

Condition Hierarchy (Ancestors)

Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Infections; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections

Results Point of Contact

• Title: Medical Information
• Organization: Bavarian Nordic

medical.information_na@bavarian-nordic.com

1-844-422-8274

Study Officials

• Patrick Ajiboye, MD

  Bavarian Nordic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 2:2:2:1 ratio within each age stratum (12 to \<18, 18 to \<46, and 46 to \<65). This study will be conducted in the US, using up to 50 sites.

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 8, 2021
• Study Start: September 29, 2021
• Primary Completion: April 3, 2023
• Study Completion: April 3, 2023
• Last Updated: August 30, 2024
• Results First Posted: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (47)