Status:
COMPLETED
Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults
Lead Sponsor:
Bavarian Nordic
Collaborating Sponsors:
Emergent BioSolutions
Conditions:
Chikungunya Virus Infection
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
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:...
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 D...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2020
Estimated Enrollment :
445 Patients enrolled
Trial Details
Trial ID
NCT03483961
Start Date
April 18 2018
End Date
September 21 2020
Last Update
July 3 2023
Active Locations (3)
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1
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
2
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
3
Advanced Clinical Research
West Jordan, Utah, United States, 84088