- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03483961
Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults
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)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Kansas
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Lenexa, Kansas, United States, 66219
- Johnson County Clin-Trials
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Missouri
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Kansas City, Missouri, United States, 64114
- The Center for Pharmaceutical Research
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Utah
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West Jordan, Utah, United States, 84088
- Advanced Clinical Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female
- Age 18 to 45 years old (inclusive)
- Using an acceptable method of contraception (if female of childbearing potential).
- Able and willing to provide informed consent for study participation.
Exclusion Criteria:
- Current acute febrile illness.
- Clinically significant cardiac, respiratory, or rheumatologic disease, in the opinion of the Investigator.
- Pregnant or breast-feeding.
- Laboratory evidence of infection with Hepatitis B/C or HIV.
- History of chikungunya virus infection.
- Travel to a World Health Organization-designated chikungunya-endemic region within 30 days prior to Day 1.
- History of allergic reaction to any component of CHIKV-VLP vaccine, Diluent, or Alhydrogel®.
- Inability to discontinue systemic immunomodulatory or immunosuppressive medications 30 days prior to Day 1.
- Received or plans to receive any licensed vaccine from 30 days prior to Day 1 through Day 57.
- Received or plans to receive an investigational agent from 30 days prior to Day 1 through the duration of study participation.
- Any other condition that, in the opinion of the Investigator, creates an unacceptable risk to the subject.
- Any other condition that, in the opinion of the Investigator, may interfere with the conduct of the study or the validity of the data.
- Any other condition that, in the opinion of the Investigator, creates an unacceptable safety risk for apheresis (Group 9 & 10 only).
- Restricted venous access that would prevent the collection of PBMCs, plasma, and lymphocytes necessary for participation (Group 9 & 10 only).
- Weight < 110 pounds (Group 9 & 10 only)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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)
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Vaccine consists of virus-like particles of chikungunya virus antigens
Placebo is vaccine diluent alone
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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)
|
Placebo is vaccine diluent alone
Adjuvanted formulation includes Alhydrogel
|
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)
|
Placebo is vaccine diluent alone
Adjuvanted formulation includes Alhydrogel
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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)
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Placebo is vaccine diluent alone
Adjuvanted formulation includes Alhydrogel
|
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)
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Placebo is vaccine diluent alone
Adjuvanted formulation includes Alhydrogel
|
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)
|
Placebo is vaccine diluent alone
Adjuvanted formulation includes Alhydrogel
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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)
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Placebo is vaccine diluent alone
Adjuvanted formulation includes Alhydrogel
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Experimental: Group 8: 40 mcg/adjuvanted (Day 29)
Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29)
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Placebo is vaccine diluent alone
Adjuvanted formulation includes Alhydrogel
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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
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Adjuvanted formulation includes Alhydrogel
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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.
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Adjuvanted formulation includes Alhydrogel
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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.
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Day 57 (from Day 1 vaccination), 28 days after the last injection.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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To describe the kinetics of induction of anti-CHIKV neutralizing antibody geometric mean titers by different formulations and schedules for Groups 2-8.
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At Days 8, 15, 22, 29, 36, and 57.
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Differences in Persistence of Neutralizing Antibody Geometric Mean Titer for Groups 2-8.
Time Frame: At Days 182, 365, 547, and 760.
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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.
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At Days 182, 365, 547, and 760.
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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.
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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.
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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.
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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.
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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.
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Day 57 (from Day 1 vaccination), 28 days after the last injection.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: James McCarty, MD, Emergent BioSolutions
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PXVX-CV-317-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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