Antibody Persistence And Long Term Safety Of A Chikungunya Virus Vaccine (VLA1553)
Running, not enrolling · Phase 3
Conditions studied: Chikungunya Virus Infection
In brief
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).
Key facts
- Study ID
- NCT04838444
- Run by
- Valneva Austria GmbH
- People needed
- 363
- Starts
- 2021-04-02
- Expected to finish
- 2031-05-01
- Last updated by the study team
- 2026-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the Investigator or site personnel conducting the trial.
Where it is running
- Accelerated Enrollment Solutions (AES) — Phoenix, Arizona, United States
- Velocity Clinical Research — Hallandale, Florida, United States
- Accelerated Enrollment Solutions (AES) — Chicago, Illinois, United States
- Alliance for Multispecialty Research (AMR) — Lexington, Kentucky, United States
- Velocity Clinical Research — Grand Island, Nebraska, United States
- Velocity Clinical Research — Omaha, Nebraska, United States
- Alliance for Multispecialty Research (AMR) — Knoxville, Tennessee, United States
- Velocity Clinical Research — Austin, Texas, United States
- Velocity Clinical Research — West Jordan, Utah, United States
- Allliance for Multispecialty Research (AMR) — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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