Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-24 @ 12:19 PM
NCT ID:
NCT03483961
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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03483961
Study Brief:
Protocol Section:
NCT03483961