Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults
- Conditions
- Chikungunya Virus Infection
- Interventions
- Biological: CHIKV VLP/unadjuvantedBiological: CHIKV VLP/adjuvantedBiological: Placebo
- Registration Number
- NCT03483961
- Lead Sponsor
- Bavarian Nordic
- 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 445
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 3: 10 mcg/adjuvanted (Day 1 & 29) Placebo 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) Group 6: 10 mcg/adjuvanted (Day 15 & 29) Placebo Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) Group 2: 6 mcg/adjuvanted (Day 1 & 29) Placebo 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) Group 5: 6 mcg/adjuvanted (Day 15 & 29) Placebo Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) Group 1: 20 mcg/unadjuvanted (Day 1 & 29) CHIKV VLP/unadjuvanted 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) Group 5: 6 mcg/adjuvanted (Day 15 & 29) CHIKV VLP/adjuvanted Placebo (Day 1) // 6 mcg CHIKV VLP/adjuvanted (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) Group 1: 20 mcg/unadjuvanted (Day 1 & 29) Placebo 20 mcg CHIKV VLP/unadjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/unadjuvanted (Day 29) Group 2: 6 mcg/adjuvanted (Day 1 & 29) CHIKV VLP/adjuvanted 6 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 6 mcg CHIKV VLP/adjuvanted (Day 29) Group 4: 20mcg/adjuvanted (Day 1 & 29);40mcg/adjuvant (Day 547) CHIKV VLP/adjuvanted 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) Group 4: 20mcg/adjuvanted (Day 1 & 29);40mcg/adjuvant (Day 547) Placebo 20 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) // 40 mcg CHIKV (Day 547) Group 6: 10 mcg/adjuvanted (Day 15 & 29) CHIKV VLP/adjuvanted Placebo (Day 1) // 10 mcg CHIKV VLP/adjuvanted (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) Group 7: 20 mcg/adjuvanted (Day 15 & 29) Placebo Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) Group 3: 10 mcg/adjuvanted (Day 1 & 29) CHIKV VLP/adjuvanted 10 mcg CHIKV VLP/adjuvanted (Day 1) // Placebo (Day 15) // 10 mcg CHIKV VLP/adjuvanted (Day 29) Group 8: 40 mcg/adjuvanted (Day 29) Placebo Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) Group 9: 20 mcg/adjuvanted (Day 1 & 29) CHIKV VLP/adjuvanted 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 Group 7: 20 mcg/adjuvanted (Day 15 & 29) CHIKV VLP/adjuvanted Placebo (Day 1) // 20 mcg CHIKV VLP/adjuvanted (Day 15) // 20 mcg CHIKV VLP/adjuvanted (Day 29) Group 8: 40 mcg/adjuvanted (Day 29) CHIKV VLP/adjuvanted Placebo (Day 1) // Placebo (Day 15) // 40 mcg CHIKV VLP/adjuvanted (Day 29) Group 10: 40 mcg/adjuvanted (Day 1) CHIKV VLP/adjuvanted 40 mcg CHIKV VLP/adjuvanted (Day 1). This group will also have plasmapheresis performed on Day 22.
- Primary Outcome Measures
Name Time Method Anti-CHIKV Neutralizing Antibody Geometric Mean Titer 28 Days After the Last Injection for Groups 2-8. 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
Name Time Method Kinetics of Anti-chikungunya Virus (CHIKV) Neutralizing Antibody Geometric Mean Titer for Groups 2-8. 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.
Differences in Persistence of Neutralizing Antibody Geometric Mean Titer for Groups 2-8. 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.
Boosting of Vaccine-induced Neutralizing Antibody Geometric Mean Titer by a Booster Dose of PXVX0317 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. 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.
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. 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.
Trial Locations
- Locations (3)
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