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

Chikungunya Virus Infection Clinical Trial

Official title:

An Open-Label, Single Arm Study To Evaluate Antibody Persistence And Long Term Safety Of A Live-Attenuated Chikungunya Virus Vaccine Candidate (VLA1553) In Adults Aged 18 Years and Above

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04838444
• Other study ID #: VLA1553-303
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 2, 2021
• Est. completion date: December 2025

Study information

• Verified date: February 2023
• Source: Valneva Austria GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

In this open-label Phase 3b, single arm study, persistence of antibodies and long term safety in up to 375 subjects rolled over from study VLA1553-301 (NCT number: NCT04546724) These subjects will have annual follow-up visits at Months 12, 24, 36, 48 and 60 after immunization. The primary objective of this study will be to evaluate persistence of antibodies annually from 1 to 5 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 363
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject participated in the VLA1553-301 clinical study;
• Subject has an understanding of the study and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any study-related procedures;
• Subject 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 Study VLA1553-301 and was negative for neutralizing antibodies at baseline

Exclusion Criteria:

• Subject presents with clinical conditions representing a contraindication to blood draws;
• Subject has donated blood or use of blood products prior 30 days of immunogenicity sampling;
• Subject has received an active drug with potential immunosuppressive action or investigational drug or device within a period of 30 days prior a study visit;
• Subject has a known or suspected problem with alcohol or drug abuse as determined by the Investigator;
• Subject has any condition that, in the opinion of the Investigator, may compromise the subject's well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study;
• Subject is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities);
• Subject is a member of the team conducting the study or in a dependent relationship with one of the study 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 study.

Related Conditions & MeSH terms

• Chikungunya Fever
• Chikungunya Virus Infection

Intervention

Biological:
• VLA1553
Study participants previously vaccinated with VLA1553 in study VLA1553-301 will be followed up for safety and immunogenicity.

Locations

Country	Name	City	State
United States	ELITE Research Network	Cedar Park	Texas
United States	Accelerated Enrollment Solutions (AES)	Chicago	Illinois
United States	Meridian Clinical Research	Grand Island	Nebraska
United States	ELITE Research Network	Hallandale Beach	Florida
United States	Alliance for Multispecialty Research (AMR)	Knoxville	Tennessee
United States	Alliance for Multispecialty Research (AMR)	Lexington	Kentucky
United States	Allliance for Multispecialty Research (AMR)	Norfolk	Virginia
United States	Platinum Research Network	Omaha	Nebraska
United States	Accelerated Enrollment Solutions (AES)	Phoenix	Arizona
United States	Accelerated Enrollment Soutions (AES)	San Diego	California
United States	ELITE Research Network	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Valneva Austria GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with a seroprotective CHIKV antibody level post-vaccination.		until Year 5
Secondary	Frequency of any Serious Adverse Event (SAE)		until Year 2
Secondary	Relatedness of any Serious Adverse Event (SAE)		until Year 2
Secondary	Immune r esponse as measured by CHIKV-specific neutralizing antibody titers post-vaccination		until Year 5
Secondary	Proportion of subjects with seroconversion		until Year 5
Secondary	Fold increase of CHIKV-specific neutralizing antibody titers post-vaccination as compared to baseline (i.e. at start of study VLA1553-301)		until Year 5
Secondary	Proportion of subjects reaching an at least 4-fold, 8-fold, 16-fold or 64-fold increase in CHIKV-specific neutralizing antibody titer compared to baseline		until 5 Year 5