Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults
Condition: Chikungunya Virus Infection
MeSH terms: Chikungunya Fever
Intervention: CHIKV VLP/unadjuvanted; CHIKV VLP/adjuvanted; Placebo
Intervention description: Vaccine consists of virus-like particles of chikungunya virus antigens; Adjuvanted formulation includes Alhydrogel; Placebo is vaccine diluent alone
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 445.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

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
    

Eligibility 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)