Back to resultsAntibody Persistence And Long Term Safety Of A Chikungunya Virus Vaccine Candidate (VLA1553)
Primary Purpose
Chikungunya Virus Infection
Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
VLA1553
Sponsored by
About this trial
This is an interventional prevention trial for Chikungunya Virus Infection
Eligibility Criteria
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.
Sites / Locations
- Accelerated Enrollment Solutions (AES)
- Accelerated Enrollment Soutions (AES)
- ELITE Research Network
- Accelerated Enrollment Solutions (AES)
- Alliance for Multispecialty Research (AMR)
- Meridian Clinical Research
- Platinum Research Network
- Alliance for Multispecialty Research (AMR)
- ELITE Research Network
- ELITE Research Network
- Allliance for Multispecialty Research (AMR)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VLA1553
Arm Description
Outcomes
Primary Outcome Measures
Proportion of subjects with a seroprotective CHIKV antibody level post-vaccination.
Secondary Outcome Measures
Frequency of any Serious Adverse Event (SAE)
Relatedness of any Serious Adverse Event (SAE)
Immune r esponse as measured by CHIKV-specific neutralizing antibody titers post-vaccination
Proportion of subjects with seroconversion
Fold increase of CHIKV-specific neutralizing antibody titers post-vaccination as compared to baseline (i.e. at start of study VLA1553-301)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04838444
Brief Title
Antibody Persistence And Long Term Safety Of A Chikungunya Virus Vaccine Candidate (VLA1553)
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2, 2021 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valneva Austria GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chikungunya Virus Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
363 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VLA1553
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
VLA1553
Intervention Description
Study participants previously vaccinated with VLA1553 in study VLA1553-301 will be followed up for safety and immunogenicity.
Primary Outcome Measure Information:
Title
Proportion of subjects with a seroprotective CHIKV antibody level post-vaccination.
Time Frame
until Year 5
Secondary Outcome Measure Information:
Title
Frequency of any Serious Adverse Event (SAE)
Time Frame
until Year 2
Title
Relatedness of any Serious Adverse Event (SAE)
Time Frame
until Year 2
Title
Immune r esponse as measured by CHIKV-specific neutralizing antibody titers post-vaccination
Time Frame
until Year 5
Title
Proportion of subjects with seroconversion
Time Frame
until Year 5
Title
Fold increase of CHIKV-specific neutralizing antibody titers post-vaccination as compared to baseline (i.e. at start of study VLA1553-301)
Time Frame
until Year 5
Title
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
Time Frame
until 5 Year 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valneva Clinical Development
Organizational Affiliation
Valneva Austria GmbH
Official's Role
Study Chair
Facility Information:
Facility Name
Accelerated Enrollment Solutions (AES)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Accelerated Enrollment Soutions (AES)
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
ELITE Research Network
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33090
Country
United States
Facility Name
Accelerated Enrollment Solutions (AES)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Alliance for Multispecialty Research (AMR)
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Meridian Clinical Research
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Platinum Research Network
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Alliance for Multispecialty Research (AMR)
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
ELITE Research Network
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
ELITE Research Network
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Allliance for Multispecialty Research (AMR)
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Antibody Persistence And Long Term Safety Of A Chikungunya Virus Vaccine Candidate (VLA1553)
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