Antibody Persistence And Long Term Safety Of A Chikungunya Virus Vaccine (VLA1553)
NCT ID: NCT04838444
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
363 participants
INTERVENTIONAL
2021-04-02
2031-05-31
Brief Summary
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Detailed Description
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These participants will have annual follow-up visits at Months 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 after immunization. The primary objective of this trial will be to evaluate persistence of antibodies annually from 1 to 10 years after the single immunization with VLA1553. The secondary objective is to evaluate long-term safety 6 months to 2 years after the single immunization with VLA1553.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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VLA1553
VLA1553
Trial participants previously vaccinated with VLA1553 in trial VLA1553-301 will be followed up for safety and immunogenicity.
Interventions
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VLA1553
Trial participants previously vaccinated with VLA1553 in trial VLA1553-301 will be followed up for safety and immunogenicity.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
Yes
Sponsors
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Valneva Austria GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Valneva Clinical Development
Role: STUDY_CHAIR
Valneva Austria GmbH
Locations
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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
Countries
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References
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McMahon R, Toepfer S, Sattler N, Schneider M, Narciso-Abraham M, Hadl S, Hochreiter R, Kosulin K, Mader R, Zoihsl O, Wressnigg N, Dubischar K, Buerger V, Eder-Lingelbach S, Jaramillo JC. Antibody persistence and safety of a live-attenuated chikungunya virus vaccine up to 2 years after single-dose administration in adults in the USA: a single-arm, multicentre, phase 3b study. Lancet Infect Dis. 2024 Dec;24(12):1383-1392. doi: 10.1016/S1473-3099(24)00357-8. Epub 2024 Aug 12.
Other Identifiers
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VLA1553-303
Identifier Type: -
Identifier Source: org_study_id