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Clinical Trials in the USA / NCT04838444
Active, not recruiting Phase 3

Antibody Persistence And Long Term Safety Of A Chikungunya Virus Vaccine (VLA1553)

NCT04838444 · tracked via the Priya Life Science USA tracker
Sponsor
Valneva Austria GmbH
Phase
Phase 3
Started
2021-04-02
Last updated
2026-07-09

Condition(s) studied

Chikungunya Virus Infection

Investigational drug(s) / intervention(s)

VLA1553

VLA1553: Trial participants previously vaccinated with VLA1553 in trial VLA1553-301 will be followed up for safety and immunogenicity.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
Accepted
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 close relatives (i.e., children, partner/spouse, siblings, parents) as well as employees of the Investigator or site personnel conducting the trial.

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
Accelerated Enrollment Solutions (AES) Phoenix Arizona
Velocity Clinical Research Hallandale Florida
Accelerated Enrollment Solutions (AES) Chicago Illinois
Alliance for Multispecialty Research (AMR) Lexington Kentucky
Velocity Clinical Research Grand Island Nebraska
Velocity Clinical Research Omaha Nebraska
Alliance for Multispecialty Research (AMR) Knoxville Tennessee
Velocity Clinical Research Austin Texas
Velocity Clinical Research West Jordan Utah
Allliance for Multispecialty Research (AMR) Norfolk Virginia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04838444 on ClinicalTrials.gov ↗ ← All trials in the USA