Phase 2 Open-label Study of Alum-adjuvanted Chikungunya Virus-like Particle Vaccine (PXVX0317)

NCT03992872 | Completed Phase 2 Results FDA Drug

• 1 other identifier: EBSI-CV-317-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This was a phase 2 parallel-group age- and gender-matched open label study in healthy adults 18-65 years of age to assess the safety and immunogenicity of an alum-adjuvanted chikungunya virus-like particle vaccine (PXVX0317; CHIKV VLP vaccine) in prior recipients of other alphavirus vaccines versus alphavirus naïve controls.

Conditions

Chikungunya

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With 4-fold Rise in Anti-CHIKV Neutralizing Antibody Response

  Seroconversion, defined as a 4-fold or greater rise in neutralizing antibody against chikungunya virus, as determined by luciferase-based assay (NT80), induced by PXVX0317. PXVX0317 was administered to prior alphavirus vaccine recipients versus gender- and age-matched controls.

  Day 22 (21 days after vaccination)

Secondary Outcomes (12)

• Geometric Mean Titer of Anti-CHIKV Neutralizing Antibody Response

  Day 1, 8, 22, 29, 57, 182

• Percentage of Participants With 4-fold Rise in Anti-CHIKV Neutralizing Antibody Response

  Day 8, 29, 57, 182

• Percentage of Participants With Anti-CHIKV Neutralizing Antibody at or Above Selected Thresholds

  Day 1, 8, 22, 29, 57, 182

• Geometric Mean Titer of Anti-CHIKV Total Antibody Response

  Day 1, 22, 29

• Percentage of Participants With 4-fold Rise in Anti-CHIKV Total Antibody Response

  Day 22, 29

Study Arms (2)

Prior Alpha

EXPERIMENTAL

All study participants received the same Investigational Product according to the same schedule. Participants were prior recipients of experimental alphavirus vaccines.

Biological: Chikungunya

Control: Naïve Alpha

ACTIVE COMPARATOR

All study participants received the same Investigational Product according to the same schedule. The alphavirus vaccine naïve participants will serve as controls for determining the effect of pre-existing alphavirus immunity on vaccine safety and immunogenicity.

Biological: Chikungunya

Interventions

Chikungunya BIOLOGICAL

Virus Like Particle

Control: Naïve Alpha; Prior Alpha

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 65 years old (inclusive)
• For women of childbearing potential, a negative pregnancy test at screening and on vaccination day, practicing highly effective contraception for at least 30 days prior to vaccination, and willing to use a highly effective method of contraception through study completion.
• Able and willing to provide informed consent for study participation prior to screening procedures.
• Free of obvious health problems as established by medical history and clinical examination at screening and enrollment.
• Available to participate for the duration of the study (approximately 8 months).
• For the cohort of prior alphavirus vaccine recipients, a documented history of prior alphavirus vaccination.

You may not qualify if:

• Acute disease or febrile illness at the time of screening or enrollment.
• Clinically significant cardiac, respiratory, rheumatologic or other medical or psychiatric condition that, in the opinion of the Investigator, places the subject at increased risk or affects their ability to understand and comply with study procedures.
• Abnormal screening lab test result that, in the opinion of the investigator, obscures interpretation of the safety data or suggests a clinically significant cardiac, respiratory, rheumatologic or other medical condition that places the subject at increased risk.
• Pregnant, lactating or planning to become pregnant during the study period.
• Laboratory evidence of infection with Hepatitis B, C or HIV.
• History of naturally (non-laboratory) acquired chikungunya or other alphavirus infection or travel to a WHO-designated chikungunya-endemic region within 30 days prior to Day 1.
• History of acute allergic reaction to any component of CHIKV VLP vaccine or Alhydrogel®.
• Current (30 days prior to Day 1) or anticipated use of systemic immunomodulatory or immunosuppressive medications.
• History of splenectomy, immunosuppressive condition, autoimmune disease, or immunodeficient condition.
• Family history of congenital or hereditary immunodeficiency.
• Suspected or known current alcohol abuse that, in the opinion of the Investigator, would interfere with the subject's ability to understand and comply with study procedures.
• Current intravenous drug use.
• Prior receipt of an investigational chikungunya vaccine.
• Receipt or planned receipt of any licensed vaccine from 30 days prior to Day 1 through Day 29 study visit.
• Participation in another clinical trial during the study period in which an investigational product is administered.

Sponsors & Collaborators

• Bavarian Nordic: lead
• Walter Reed Army Institute of Research (WRAIR): collaborator
• Emergent BioSolutions: collaborator

Study Sites (2)

United States Army Medical Research Institute of Infectious Diseases

Fort Deterick, Maryland, 21702, United States

Location

Walter Reed Army Institute of Research

Silver Spring, Maryland, 20910, United States

Location

Related Publications (1)

• Hamer MJ, McCarty JM, Pierson BC, Regules JA, Mendy J, Sanborn AD, Gardner CL, Haller JM, Gregory MK, Liggett DL, Glass PJ, Ghosh N, Royalty Tredo S, Warfield KL, Burke CW, Lee C, Saunders D, Bedell L, Richardson JS. Safety and immunogenicity of an adjuvanted chikungunya virus virus-like particle (CHIKV VLP) vaccine in previous recipients of other alphavirus vaccines versus alphavirus vaccine-naive controls: an open-label, parallel-group, age-matched, sex-matched, phase 2 randomised controlled study. Lancet Microbe. 2025 Apr;6(4):101000. doi: 10.1016/j.lanmic.2024.101000. Epub 2025 Feb 12.

  PMID: 39954701 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

• James McCarty, MD

  Emergent BioSolutions

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open Label Safety and Immunogenicity

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 20, 2019
• Study Start: November 20, 2019
• Primary Completion: January 19, 2021
• Study Completion: January 19, 2021
• Last Updated: October 16, 2024
• Results First Posted: October 16, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)