Study to Demonstrate Consistency of Three Lots of a Live-attenuated Chikungunya Virus Vaccine Candidate in Healthy Adults
A Randomized, Double-Blinded Phase 3 Study to Demonstrate Lot-to-Lot Consistency of Three Lots of a Live-Attenuated Chikungunya Virus Vaccine Candidate (VLA1553) in Healthy Adults Aged 18 to 45 Years
1 other identifier
interventional
409
1 country
12
Brief Summary
This was a prospective, randomized, double-blinded, multicenter Phase 3 clinical study investigating three Lots of VLA1553 at the final dose. Overall 409 healthy subjects aged 18 to 45 years were randomized into the study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2021
Shorter than P25 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2021
CompletedStudy Start
First participant enrolled
February 22, 2021
CompletedFirst Posted
Study publicly available on registry
March 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2022
CompletedResults Posted
Study results publicly available
September 28, 2023
CompletedSeptember 28, 2023
September 1, 2023
5 months
February 22, 2021
July 21, 2022
September 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Geometric Mean Titer (GMT) of CHIKV-specific Neutralizing Antibodies as Determined by Microneutralization (μPRNT) Assay in Subjects Who Tested Negative for CHIKV Antibodies at Baseline
On Day 29 after single vaccination
Secondary Outcomes (16)
Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers
on Day 8, 85 and Month 6
Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects
on Day 8, 29, 85 and Month 6
Proportion of Subjects With Seroconversion
on Day 29, Day 85 and Month 6
Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
on Day 8, 29, 85 and Month 6
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
up to Month 6
- +11 more secondary outcomes
Study Arms (3)
VLA1553 Lot 1
ACTIVE COMPARATORVLA1553 Lot 2
ACTIVE COMPARATORVLA1553 Lot 3
ACTIVE COMPARATORInterventions
Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
Eligibility Criteria
You may qualify if:
- to 45 years of age on the Day of screening
- Able to provide informed consent
- Generally healthy as determined by the Investigator's clinical judgement based on medical history, physical examination and screening laboratory tests
- For women of childbearing potential:
- practiced an adequate method of contraception during 30 days before screening
- negative serum or urine pregnancy test at screening or vaccination, respectively
- agreed to employ adequate birth control measures for the first three months post-vaccination.
You may not qualify if:
- CHIKV infection in the past (self-reported), including suspected CHIKV infection; was taking medication or other treatment for unresolved symptoms attributed to a previous CHIKV infection; or had participated in a clinical study involving an investigational CHIKV vaccine
- Acute or recent infection (and not symptom-free in the week prior to screening)
- Tested positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV);
- Received another live virus vaccine within 28 days or inactivated vaccine within 14 days prior to vaccination in this study or plans to receive a vaccine within 28 days or 14 days after vaccination, respectively
- Abnormal findings in any required study investigations (including medical history, physical examination, and clinical laboratory) considered clinically relevant by the Investigator which pose a risk for participation in the study
- Medical history of or currently had acute or progressive, unstable or uncontrolled clinical conditions that posed a risk for participation in the study
- History of immune-mediated or clinically relevant arthritis / arthralgia
- History of malignancy in the past 5 years other than squamous cell or basal cell skin cancer. If there had been surgical excision or treatment more than 5 years ago that was considered to have achieved a cure, the subject could be enrolled.
- Known or suspected defect of the immune system, such as subjects with congenital or acquired immunodeficiency, including infection with HIV, status post organ transplantation or immuno-suppressive therapy within 4 weeks prior to vaccination.
- History of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to components of the candidate vaccine, other known contraindications)
- Clinical conditions representing a contraindication to intramuscular vaccination and blood draws
- Pregnant, had plans to become pregnant during the first three months post-vaccination or lactating at the time of enrollment
- Donation of blood, blood fractions or plasma within 30 days or received blood-derived products (e.g. plasma) within 90 days prior to vaccination in this study or planned to donate blood or use blood products until Day 180 of the study
- Rash, dermatological condition or tattoos that would, in the opinion of the Investigator, interfere with injection site reaction rating
- Known or suspected problem with alcohol or drug abuse as determined by the Investigator
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
AMR Miami
Coral Gables, Florida, 33134, United States
AMR Fort Myers
Fort Myers, Florida, 33912, United States
St. Johns Center for Clinical Research
Ponte Vedra, Florida, 32081, United States
AMR Wichita West
Wichita, Kansas, 67205, United States
AMR Lexington
Lexington, Kentucky, 40509, United States
Walter Reed Amy Institute of Research
Silver Spring, Maryland, 20910, United States
Alliance for Multispecialty Research (AMR)
Kansas City, Missouri, 64114, United States
Meridian Clinical Research
Omaha, Nebraska, 68134, United States
Wr-Crcn, Llc
Las Vegas, Nevada, 89104, United States
Rochester Clinical Research
Rochester, New York, 14609, United States
AMR Knoxville
Knoxville, Tennessee, 37919, United States
Dynamed Clinical Research
Tomball, Texas, 77375, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Strategy Manager
- Organization
- Valneva Austria GmbH
Study Officials
- STUDY CHAIR
Valneva Clinical Development
Valneva Austria GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2021
First Posted
March 8, 2021
Study Start
February 22, 2021
Primary Completion
July 22, 2021
Study Completion
January 26, 2022
Last Updated
September 28, 2023
Results First Posted
September 28, 2023
Record last verified: 2023-09