Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years

NCT05349617 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: EBSI-CV-317-005
• Study Type: interventional
• Target: 413
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this phase 3, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity to PXVX0317 in adults ≥65 years of age.

Conditions

Chikungunya Virus

Keywords

chikungunya; virus like particle (VLP); PXVX0317; vaccine; immunogenicity

Outcome Measures

Primary Outcomes (7)

• Anti-CHIKV SNA Titer (NT80) Seroresponse Rates at Day 22 in Baseline Seronegative Participants

  Difference in anti-CHIKV SNA titer (NT80) seroresponse rate (PXVX0317 minus placebo) and associated 95 percent confidence interval (CI) at Day 22.

  21 days postvaccination

• Anti-CHIKV SNA Titer (NT80) Geometric Mean Titers (GMT) at Day 22

  Anti-CHIKV SNA titer (NT80) GMT and associated 95 percent CIs at Day 22 for PXVX0317 and placebo.

  21 days postvaccination

• 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 postvaccination

• 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 postvaccination

• Incidence of Serious Adverse Events (SAE)

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

  182 days postvaccination

• Incidence of Medically Attended Adverse Events (MAAE)

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

  182 days postvaccination

• 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 postvaccination

Secondary Outcomes (4)

• Anti-CHIKV SNA Titer (NT80) Seroresponse Rates at Days 15 and 183

  Day 15 and 183 (14 and 182 days postvaccination, respectively)

• Anti-CHIKV SNA GMTs at Days 15 and 183

  Day 15, and 183 (14 and 182 days postvaccination, respectively)

• Anti-CHIKV SNA Geometric Mean Fold Increase (GMFI)

  Day 15, 22, and 183 (14, 21 and 182 days postvaccination, respectively)

• Subjects With Anti-CHIKV SNA Titer ≥15 and 4-fold Rise Over Baseline

  Day 15, 22 and 183 (14, 21 and 182 days postvaccination, respectively)

Study Arms (2)

Group 1 - PXVX0317

EXPERIMENTAL

PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant.

Biological: CHIKV VLP/adjuvant

Group 2 - Placebo

PLACEBO COMPARATOR

Placebo is comprised of formulation buffer.

Biological: Placebo

Interventions

CHIKV VLP/adjuvant BIOLOGICAL

PXVX0317 vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide adjuvant

Group 1 - PXVX0317

Placebo BIOLOGICAL

Placebo is comprised of formulation buffer

Group 2 - Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Able and willing to provide informed consent voluntarily signed by participant. Must verbalize understanding of the general procedures of, and reason for the study.
• Males or females, ≥65 years of age.
• Able to complete all scheduled visits and comply with all study procedures.
• Women who are not of childbearing potential (CBP): 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 post menopausal sex-hormonal treatment).
• Participants must be in stable health in the opinion of the investigator for at least 30 days prior to screening (eg, no hospital admission for acute illness in the last 30 days prior to screening).

You may not qualify if:

• Participation or planned participation in an investigational clinical trial (eg, vaccine, drug, medical device, or medical procedure) within 30 days of Day 1 and for the duration of the study. Note: Participation in an observational trial or follow-up phase of a trial may be allowed; however, these instances should be discussed with the sponsor's medical monitor (MM) prior to enrollment.
• Prior receipt of any CHIKV vaccine.
• Positive laboratory evidence of current infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV).
• Body mass index (BMI) ≥35 kg/m\^2
• History of any known or suspected allergy or history of anaphylaxis to any component of the investigational product (IP).
• Bleeding disorder or receipt of anticoagulants in the 21 days prior to screening, contraindicating intramuscular (IM) vaccination, as judged by the investigator.
• Moderate or severe acute illness with or without fever (oral temperature ≥100.4°F or 38.0°C).
• Receipt or anticipated receipt of immunoglobulin from 180 days prior to screening through Day 22.
• Medical condition (such as dementia) that, in the opinion of the investigator, could adversely impact the participant's participation in or conduct of the study.
• Evidence of substance abuse that, in the opinion of the investigator, could adversely impact the participant's participation in or conduct of the study.
• Identified as an investigator or employee of an Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse) of the investigator or employee with direct involvement in the proposed study.
• Receipt or anticipated receipt of any vaccine from 30 days prior to Day 1 through Day 22.
• Receipt or anticipated receipt of blood or blood-derived products from 90 days prior to screening through Day 22.
• Any planned elective surgery that may interfere with study participation or conduct.
• Any other medical condition that, in the opinion of the investigator, could adversely impact the participant's participation in or conduct of the study.

Sponsors & Collaborators

• Bavarian Nordic: lead
• Emergent BioSolutions: collaborator

Study Sites (10)

Suncoast Research Associates, LLC

Miami, Florida, 33173, United States

Location

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

Location

Global Clinical Research Professionals (GCP)

St. Petersburg, Florida, 33705, United States

Location

AMR Kansas City

Kansas City, Missouri, 64114, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

DM Clinical Research CyFair

Houston, Texas, 77065, United States

Location

BHFC Research

San Antonio, Texas, 78249, United States

Location

DM Clinical Research Tomball

Tomball, Texas, 77375, United States

Location

Spaulding Clinical

West Bend, Wisconsin, 53095, United States

Location

Related Publications (2)

• Tindale LC, Richardson JS, Anderson DM, Mendy J, Muhammad S, Loreth T, Tredo SR, Ramanathan R, Jenkins VA, Bedell L, Ajiboye P; EBSI-CV-317-005 Study Group. Chikungunya virus virus-like particle vaccine safety and immunogenicity in adults older than 65 years: a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2025 Apr 19;405(10487):1353-1361. doi: 10.1016/S0140-6736(25)00372-1. Epub 2025 Mar 27.

  PMID: 40158524 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 A/S

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, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to receive PXVX0317 or placebo within each age stratum. Participants will be stratified in two age subgroups (≥65 to \<75 and ≥75 years of age). This study will be conducted in the US, using up to 10 sites.

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 27, 2022
• Study Start: May 12, 2022
• Primary Completion: June 19, 2023
• Study Completion: August 8, 2023
• Last Updated: December 13, 2024
• Results First Posted: December 13, 2024

Record last verified: 2024-12

Locations

US (10)