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

NCT04838444 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: VLA1553-303
• Study Type: interventional
• Target: 363
• Locations: 1 country
• Sites: 10

Brief 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).

Conditions

Chikungunya Virus Infection

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with seroresponse levels post-vaccination. (defined as µPRNT50 ≥150)

  until Year 10

Secondary Outcomes (6)

• Frequency of any Serious Adverse Event (SAE)

  until Year 2

• Relatedness of any Serious Adverse Event (SAE)

  until Year 2

• Immune response as measured by CHIKV-specific neutralizing antibody titers post-vaccination

  until Year 10

• Proportion of participants with seroconversion

  until Year 10

• Fold increase of CHIKV-specific neutralizing antibody titers post-vaccination as compared to baseline (i.e. at start of trial VLA1553-301)

  until Year 10

Study Arms (1)

VLA1553

EXPERIMENTAL

Biological: VLA1553

Interventions

VLA1553 BIOLOGICAL

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

VLA1553

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Valneva Austria GmbH: lead

Study Sites (10)

Accelerated Enrollment Solutions (AES)

Phoenix, Arizona, 85020, United States

Location

Velocity Clinical Research

Hallandale, Florida, 33090, United States

Location

Accelerated Enrollment Solutions (AES)

Chicago, Illinois, 60602, United States

Location

Alliance for Multispecialty Research (AMR)

Lexington, Kentucky, 40509, United States

Location

Velocity Clinical Research

Grand Island, Nebraska, 68803, United States

Location

Velocity Clinical Research

Omaha, Nebraska, 68134, United States

Location

Alliance for Multispecialty Research (AMR)

Knoxville, Tennessee, 37920, United States

Location

Velocity Clinical Research

Austin, Texas, 78759, United States

Location

Velocity Clinical Research

West Jordan, Utah, 84088, United States

Location

Allliance for Multispecialty Research (AMR)

Norfolk, Virginia, 23502, United States

Location

Related Publications (1)

• 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.

  PMID: 39146946 DERIVED

MeSH Terms

Conditions

Chikungunya Fever

Condition Hierarchy (Ancestors)

Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Infections; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections

Study Officials

• Valneva Clinical Development

  Valneva Austria GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 9, 2021
• Study Start: April 2, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): May 1, 2031
• Last Updated: December 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (10)