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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Chikungunya Virus Infection
• Intervention / Treatment: Biological: VLA1553

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 363
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Accelerated Enrollment Solutions (AES)
  • California
    • San Diego, California, United States, 92108
      • Accelerated Enrollment Soutions (AES)
  • Florida
    • Hallandale Beach, Florida, United States, 33090
      • Elite Research Network
  • Illinois
    • Chicago, Illinois, United States, 60602
      • Accelerated Enrollment Solutions (AES)
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Alliance for Multispecialty Research (AMR)
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Meridian Clinical Research
    • Omaha, Nebraska, United States, 68134
      • Platinum Research Network
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Alliance for Multispecialty Research (AMR)
  • Texas
    • Cedar Park, Texas, United States, 78613
      • Elite Research Network
  • Utah
    • West Jordan, Utah, United States, 84088
      • Elite Research Network
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Allliance for Multispecialty Research (AMR)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VLA1553	Biological: VLA1553; Study participants previously vaccinated with VLA1553 in study VLA1553-301 will be followed up for safety and immunogenicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects with a seroprotective CHIKV antibody level post-vaccination.	until Year 5

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency of any Serious Adverse Event (SAE)	until Year 2
Relatedness of any Serious Adverse Event (SAE)	until Year 2
Immune r esponse as measured by CHIKV-specific neutralizing antibody titers post-vaccination	until Year 5
Proportion of subjects with seroconversion	until Year 5
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
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

Collaborators and Investigators

• Sponsor: Valneva Austria GmbH

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2021
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Actual): February 15, 2023
• Last Update Submitted That Met QC Criteria: February 14, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Alphavirus Infections; Togaviridae Infections; Chikungunya Fever
• Other Study ID Numbers: VLA1553-303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No