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Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults

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: NCT03483961
Recruitment Status : Completed
First Posted : March 30, 2018
Results First Posted : November 9, 2021
Last Update Posted : November 9, 2021
Sponsor:
Information provided by (Responsible Party):
Emergent BioSolutions

Study Description
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Brief Summary:

The goal of this Phase 2 trial is to evaluate the immune response to and safety profile of various doses/formulations/and schedules of administration of PXVX0317 in healthy adults.

Primary Objective:

To assess the immune response to the vaccine

Secondary Objectives:

To assess the kinetics of the immune response to different doses/formulations/schedules To assess the persistence of immune responses to different doses/formulations/schedules To assess the effect of a booster dose of the vaccine

Safety Objective:

To assess local and systemic reactions to the vaccine and to describe the safety profile of the vaccine


Condition or disease Intervention/treatment Phase
Chikungunya Virus Infection Biological: CHIKV VLP/unadjuvanted Biological: CHIKV VLP/adjuvanted Biological: Placebo Phase 2

Detailed Description:
The trial will explore 8 formulation/schedule combinations of CHIKV VLP vaccine with or without Alhydrogel adjuvant, and will also explore different dose schedules of Day 1 and 15 or Day 1 and 29 or Day 29 only.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 445 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2 Parallel-Group, Randomized, Double-Blind Study to Assess the Safety and Immunogenicity of PXVX0317 (Chikungunya Virus Virus-Like Particle Vaccine [CHIKV-VLP], Unadjuvanted or Alum-adjuvanted)
Actual Study Start Date : April 18, 2018
Actual Primary Completion Date : September 14, 2020
Actual Study Completion Date : September 21, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1: 20 mcg/unadjuvanted (Day 1 & 29)
20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29)
 Biological: CHIKV VLP/unadjuvanted
Vaccine consists of virus-like particles of chikungunya virus antigens

Biological: Placebo
Placebo is vaccine diluent alone
Experimental: Group 2: 6 mcg/adjuvanted (Day 1 & 29)
6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)
 Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel

Biological: Placebo
Placebo is vaccine diluent alone
Experimental: Group 3: 10 mcg/adjuvanted (Day 1 & 29)
10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)
 Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel

Biological: Placebo
Placebo is vaccine diluent alone
Experimental: Group 4: 20mcg/adjuvanted (Day 1 & 29);40mcg/adjuvant (Day 547)
20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547)
 Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel

Biological: Placebo
Placebo is vaccine diluent alone
Experimental: Group 5: 6 mcg/adjuvanted (Day 15 & 29)
Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29)
 Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel

Biological: Placebo
Placebo is vaccine diluent alone
Experimental: Group 6: 10 mcg/adjuvanted (Day 15 & 29)
Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29)
 Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel

Biological: Placebo
Placebo is vaccine diluent alone
Experimental: Group 7: 20 mcg/adjuvanted (Day 15 & 29)
Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29)
 Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel

Biological: Placebo
Placebo is vaccine diluent alone
Experimental: Group 8: 40 mcg/adjuvanted (Day 29)
Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29)
 Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel

Biological: Placebo
Placebo is vaccine diluent alone
Experimental: Group 9: 20 mcg/adjuvanted (Day 1 & 29)
20 mcg CHIKV VLP/adjuvanted (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 29). This group will also have plasmapheresis performed on Day 57 and Leukapheresis on Day 182
 Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel
Experimental: Group 10: 40 mcg/adjuvanted (Day 1)
40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22.
 Biological: CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel


Outcome Measures
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Primary Outcome Measures :
  1. Anti-CHIKV Neutralizing Antibody Geometric Mean Titer 28 Days After the Last Injection for Groups 2-8. [ Time Frame: Day 57 (from Day 1 vaccination), 28 days after the last injection. ]
    To assess the induction of anti-chikungunya virus (CHIKV) neutralizing antibody geometric mean titers by different formulations and schedules, as measured at 28 days after the last injection (Day 57) for Groups 2-8.


Secondary Outcome Measures :
  1. Kinetics of Anti-chikungunya Virus (CHIKV) Neutralizing Antibody Geometric Mean Titer for Groups 2-8. [ Time Frame: At Days 8, 15, 22, 29, 36, and 57. ]
    To describe the kinetics of induction of anti-CHIKV neutralizing antibody geometric mean titers by different formulations and schedules for Groups 2-8.

  2. Differences in Persistence of Neutralizing Antibody Geometric Mean Titer for Groups 2-8. [ Time Frame: At Days 182, 365, 547, and 760. ]
    To assess differences in persistence of neutralizing antibody geometric mean titers induced by different formulations and schedules, as measured up to 731 days after the last injection (Day 760) relative to earlier time points for Groups 2-8.

  3. Boosting of Vaccine-induced Neutralizing Antibody Geometric Mean Titer by a Booster Dose of PXVX0317 for Group 4 Only. [ Time Frame: Antibody levels will be measured at Day 547 prior to the booster dose and again 28 days later on Day 575 and then at Day 760. ]
    To assess the effect of a booster dose of PXVX0317 on neutralizing antibody geometric mean titers when given at Day 547 for Group 4 only. Antibody levels will be measured at Day 547 prior to the booster dose and again 28 days later on Day 575 and then at Day 760.

  4. Percentage of Participants With an Anti-CHIKV Neutralizing Antibody Titer Exceeding the Following Cutoff Values: ≥15, 40, 160, 640, and 4-fold Rise Over Baseline. [ Time Frame: Day 57 (from Day 1 vaccination), 28 days after the last injection. ]
    Percentage of participants with an anti-CHIKV neutralizing antibody titer exceeding the following cutoff values: ≥15, 40, 160, 640, and 4-fold rise over baseline.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female
  2. Age 18 to 45 years old (inclusive)
  3. Using an acceptable method of contraception (if female of childbearing potential).
  4. Able and willing to provide informed consent for study participation.

Exclusion Criteria:

  1. Current acute febrile illness.
  2. Clinically significant cardiac, respiratory, or rheumatologic disease, in the opinion of the Investigator.
  3. Pregnant or breast-feeding.
  4. Laboratory evidence of infection with Hepatitis B/C or HIV.
  5. History of chikungunya virus infection.
  6. Travel to a World Health Organization-designated chikungunya-endemic region within 30 days prior to Day 1.
  7. History of allergic reaction to any component of CHIKV-VLP vaccine, Diluent, or Alhydrogel®.
  8. Inability to discontinue systemic immunomodulatory or immunosuppressive medications 30 days prior to Day 1.
  9. Received or plans to receive any licensed vaccine from 30 days prior to Day 1 through Day 57.
  10. Received or plans to receive an investigational agent from 30 days prior to Day 1 through the duration of study participation.
  11. Any other condition that, in the opinion of the Investigator, creates an unacceptable risk to the subject.
  12. Any other condition that, in the opinion of the Investigator, may interfere with the conduct of the study or the validity of the data.
  13. Any other condition that, in the opinion of the Investigator, creates an unacceptable safety risk for apheresis (Group 9 & 10 only).
  14. Restricted venous access that would prevent the collection of PBMCs, plasma, and lymphocytes necessary for participation (Group 9 & 10 only).
  15. Weight < 110 pounds (Group 9 & 10 only)
Contacts and Locations
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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): NCT03483961


Locations
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United States, Kansas
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
United States, Missouri
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
United States, Utah
Advanced Clinical Research
West Jordan, Utah, United States, 84088
Sponsors and Collaborators
Emergent BioSolutions
Investigators
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Study Director: James McCarty, MD Emergent BioSolutions
  Study Documents (Full-Text)

Documents provided by Emergent BioSolutions:
Study Protocol: Protocol Cover Page  [PDF] May 22, 2020
Study Protocol: Protocol Cover Page  [PDF] May 22, 2020
Statistical Analysis Plan: Statistical Analysis Plan Cover Page  [PDF] July 14, 2020
Statistical Analysis Plan: Statistical Analysis Plan Cover Page  [PDF] July 14, 2020
Informed Consent Form: Informed Consent Form Cover page  [PDF] June 6, 2019
Informed Consent Form: Informed Consent Form Cover page  [PDF] June 6, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Emergent BioSolutions
ClinicalTrials.gov Identifier: NCT03483961    
Other Study ID Numbers: PXVX-CV-317-001
First Posted: March 30, 2018    Key Record Dates
Results First Posted: November 9, 2021
Last Update Posted: November 9, 2021
Last Verified: October 2021
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
Virus Diseases
Infections
Alphavirus Infections
 Arbovirus Infections
Vector Borne Diseases
Togaviridae Infections
RNA Virus Infections