Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults
NCT ID: NCT03483961
Last Updated: 2023-07-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
445 participants
INTERVENTIONAL
2018-04-18
2020-09-21
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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)
CHIKV VLP/unadjuvanted
Vaccine consists of virus-like particles of chikungunya virus antigens
Placebo
Placebo is vaccine diluent alone
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)
CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel
Placebo
Placebo is vaccine diluent alone
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)
CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel
Placebo
Placebo is vaccine diluent alone
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)
CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel
Placebo
Placebo is vaccine diluent alone
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)
CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel
Placebo
Placebo is vaccine diluent alone
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)
CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel
Placebo
Placebo is vaccine diluent alone
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)
CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel
Placebo
Placebo is vaccine diluent alone
Group 8: 40 mcg/adjuvanted (Day 29)
Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29)
CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel
Placebo
Placebo is vaccine diluent alone
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
CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel
Group 10: 40 mcg/adjuvanted (Day 1)
40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22.
CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel
Interventions
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CHIKV VLP/unadjuvanted
Vaccine consists of virus-like particles of chikungunya virus antigens
CHIKV VLP/adjuvanted
Adjuvanted formulation includes Alhydrogel
Placebo
Placebo is vaccine diluent alone
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
45 Years
ALL
Yes
Sponsors
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Emergent BioSolutions
INDUSTRY
Bavarian Nordic
INDUSTRY
Responsible Party
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Principal Investigators
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James McCarty, MD
Role: STUDY_DIRECTOR
Emergent BioSolutions
Locations
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Johnson County Clin-Trials
Lenexa, Kansas, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, United States
Advanced Clinical Research
West Jordan, Utah, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol: Protocol Cover Page
Document Type: Study Protocol: Protocol Cover Page
Document Type: Statistical Analysis Plan: Statistical Analysis Plan Cover Page
Document Type: Statistical Analysis Plan: Statistical Analysis Plan Cover Page
Document Type: Informed Consent Form: Informed Consent Form Cover page
Document Type: Informed Consent Form: Informed Consent Form Cover page
Other Identifiers
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PXVX-CV-317-001
Identifier Type: -
Identifier Source: org_study_id
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