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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants with seroresponse levels post-vaccination. (defined as µPRNT50 ≥150)