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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03992872
Recruitment Status : Active, not recruiting
First Posted : June 20, 2019
Last Update Posted : December 10, 2020
Sponsor:
Collaborator:
Walter Reed Army Institute of Research (WRAIR)
Information provided by (Responsible Party):
Emergent BioSolutions

Brief Summary:
This is 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) in prior recipients of other alphavirus vaccines versus alphavirus naïve controls.

Condition or disease Intervention/treatment Phase
Chikungunya Biological: Chikungunya Phase 2

Detailed Description:
It is currently unknown whether prior exposure to heterologous alphaviruses will enhance or interfere with immune responses to chikungunya virus (CHIKV) exposure or vaccination. The objective of this study is to evaluate the safety and immunogenicity of the chikungunya vaccine candidate PXVX0317 when administered to prior recipients of experimental alphavirus vaccines versus alphavirus naïve gender and age-matched controls.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open Label Safety and immunogencity
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 2 Open-label Study to Assess the Safety and Immunogenicity of an Alum-adjuvanted Chikungunya Virus-like Particle Vaccine (PXVX0317) in Prior Recipients of Other Alphavirus Vaccines Versus Alphavirus naïve Controls.
Actual Study Start Date : November 20, 2019
Estimated Primary Completion Date : February 3, 2021
Estimated Study Completion Date : September 3, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chikungunya

Arm Intervention/treatment
Experimental: PXVX0317, a purified CHIKV VLP vaccine in Alhydrogel adjuvant
All study participants will receive the same Investigational Product according to the same schedule. The alphavirus vaccine naïve subjects will serve as controls for determining the effect of pre-existing alphavirus immunity on vaccine safety and immunogenicity.
Biological: Chikungunya
Virus Like Particle




Primary Outcome Measures :
  1. Neutralizing Antibody Response [ Time Frame: 182 days ]
    Evaluate the neutralizing antibody response to chikungunya virus induced by PXVX0317 when administered to prior alphavirus vaccine recipients versus gender- and age-matched controls



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 or drug 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.
  • Participation in another clinical trial during the study period in which an investigational product is administered.
  • For the cohort of alphavirus naïve vaccine recipients, history of prior alphavirus vaccination is exclusionary.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03992872


Locations
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United States, Maryland
United States Army Medical Research Institute of Infectious Diseases
Fort Deterick, Maryland, United States, 21702
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States, 20910
Sponsors and Collaborators
Emergent BioSolutions
Walter Reed Army Institute of Research (WRAIR)
Investigators
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Study Director: James McCarty, MD Emergent BioSolutions
  Study Documents (Full-Text)

Documents provided by Emergent BioSolutions:
Informed Consent Form  [PDF] October 10, 2019

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Responsible Party: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT03992872    
Other Study ID Numbers: EBSI-CV-317-002
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chikungunya Fever
Alphavirus Infections
Togaviridae Infections
RNA Virus Infections
Virus Diseases