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

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.

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)