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

Phase 3

Active, not recruiting

• Conditions: Chikungunya Virus Infection
• Interventions: Biological: VLA1553

• Registration Number: NCT04838444
• Lead Sponsor: Valneva Austria GmbH

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).

Detailed Description

In this open-label Phase 3b, single arm trial, persistence of antibodies and long term safety in up to 375 participants rolled over from trial VLA1553-301 (NCT number: NCT04546724)

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.

Study Timeline

• Study Start: 2021-04-02
• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-08
• Study First Posted: 2021-04-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-12
• Study Completion: 2031-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 363

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VLA1553	VLA1553	-

Primary Outcome Measures

Name	Time	Method
Proportion of participants with seroresponse levels post-vaccination. (defined as µPRNT50 ≥150)	until Year 10

Secondary Outcome Measures

Name	Time	Method
Frequency 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
Relatedness of any Serious Adverse Event (SAE)	until Year 2
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
Proportion of participants reaching an at least 4-fold, 8-fold, 16-fold or 64-fold increase in CHIKV-specific neutralizing antibody titer compared to baseline	until Year 10

Trial Locations

Locations (6)

Meridian Clinical Research; 🇺🇸 Grand Island, Nebraska, United States

Platinum Research Network; 🇺🇸 Omaha, Nebraska, United States

Accelerated Enrollment Solutions (AES); 🇺🇸 Chicago, Illinois, United States

ELITE Research Network; 🇺🇸 West Jordan, Utah, United States

Allliance for Multispecialty Research (AMR); 🇺🇸 Norfolk, Virginia, United States

Alliance for Multispecialty Research (AMR); 🇺🇸 Knoxville, Tennessee, United States