Antibody Persistence And Long Term Safety Of A Chikungunya Virus Vaccine (VLA1553) (NCT04838444) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Antibody Persistence And Long Term Safety Of A Chikungunya Virus Vaccine (VLA1553)
United States363 participantsStarted 2021-04-02
Plain-language summary
In this open-label Phase 3b, single arm trial, persistence of antibodies and long term safety will be evaluated in up to 375 participants rolled over from trial VLA1553-301 (NCT number: NCT04546724).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Individual participated in the VLA1553-301 clinical trial;
* Participant has an understanding of the trial and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any trial-related procedures;
* Participant had immunogenicity blood samples taken at baseline (Visit 1) and either Day 29 (Visit 3), Day 85 (Visit 4) or Day 180 (Visit 5) in Trial VLA1553-301 and was negative for neutralizing antibodies at baseline
Exclusion Criteria:
* Participant presents with clinical conditions representing a contraindication to blood draws;
* Participant has donated blood or use of blood products prior 30 days of immunogenicity sampling;
* Participant has received an active drug with potential immunosuppressive action or investigational drug or device within a period of 30 days prior a trial visit;
* Participant has a known or suspected problem with alcohol or drug abuse as determined by the Investigator;
* Participant has any condition that, in the opinion of the Investigator, may compromise the participant's well-being, might interfere with evaluation of trial endpoints, or would limit the participant's ability to complete the trial;
* Participant is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities);
* Participant is a member of the team conducting the trial or in a dependent relationship with one of the trial team members. Dependent relationships include c…
What they're measuring
1
Proportion of participants with seroresponse levels post-vaccination. (defined as µPRNT50 ≥150)