- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04786444
Study to Demonstrate Consistency of Three Lots of a Live-attenuated Chikungunya Virus Vaccine Candidate in Healthy Adults
September 27, 2023 updated by: Valneva Austria GmbH
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This was a prospective, randomized, double-blinded, multicenter Phase 3 clinical study investigating three Lots of VLA1553.
Overall 409 healthy subjects aged 18 to 45 years were randomized into the study, approximately136 subjects per VLA1553 Lot.
Subjects were block-randomized in a 1:1:1 ratio into the three study arms to receive one of three Lots of VLA1553 as a single i.m. vaccination.
The primary objective was to demonstrate Lot-to-Lot manufacturing consistency of VLA1553 28 days following the single vaccination.
Study Type
Interventional
Enrollment (Actual)
409
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Coral Gables, Florida, United States, 33134
- AMR Miami
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Fort Myers, Florida, United States, 33912
- AMR Fort Myers
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Ponte Vedra, Florida, United States, 32081
- St. Johns Center for Clinical Research
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Kansas
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Wichita, Kansas, United States, 67205
- AMR Wichita West
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Kentucky
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Lexington, Kentucky, United States, 40509
- AMR Lexington
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Maryland
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Silver Spring, Maryland, United States, 20910
- Walter Reed Amy Institute of Research
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Missouri
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Kansas City, Missouri, United States, 64114
- Alliance for Multispecialty Research (AMR)
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Nebraska
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Omaha, Nebraska, United States, 68134
- Meridian Clinical Research
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Nevada
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Las Vegas, Nevada, United States, 89104
- Wr-Crcn, Llc
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New York
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Rochester, New York, United States, 14609
- Rochester Clinical Research
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Tennessee
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Knoxville, Tennessee, United States, 37919
- AMR Knoxville
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Texas
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Tomball, Texas, United States, 77375
- Dynamed Clinical Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18 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.
Exclusion Criteria:
- 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
- Any condition that, in the opinion of the Investigator, could compromise the subjects well-being, could interfere with evaluation of study endpoints, or could limit the subject's ability to complete the study;
- Committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities)
- Participation in another clinical study involving an investigational medicinal product (IMP) or device within 30 days prior to study enrollment or is scheduled to participate in another clinical study involving an IMP, or device during the course of this study
- 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: VLA1553 Lot 1
|
Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
|
Active Comparator: VLA1553 Lot 2
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Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
|
Active Comparator: VLA1553 Lot 3
|
Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: On Day 29 after single vaccination
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On Day 29 after single vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers
Time Frame: on Day 8, 85 and Month 6
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on Day 8, 85 and Month 6
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Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects
Time Frame: on Day 8, 29, 85 and Month 6
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on Day 8, 29, 85 and Month 6
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Proportion of Subjects With Seroconversion
Time Frame: on Day 29, Day 85 and Month 6
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on Day 29, Day 85 and Month 6
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Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Time Frame: on Day 8, 29, 85 and Month 6
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on Day 8, 29, 85 and Month 6
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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: up to Month 6
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up to Month 6
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Frequency of Solicited Injection Site
Time Frame: 10 days post vaccination
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10 days post vaccination
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Frequency of Solicited Systemic Reactions
Time Frame: 10 days post vaccination
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10 days post vaccination
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Severity of Solicited Injection Site
Time Frame: 10 days post vaccination
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10 days post vaccination
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Severity of Solicited Systemic Reactions
Time Frame: 10 days post vaccination
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10 days post vaccination
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Severity of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination
Time Frame: up to Day 29
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up to Day 29
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Frequency of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination
Time Frame: up to Day 29
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up to Day 29
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Severity of Any Adverse Event During the Entire Study Period
Time Frame: up to Month 6
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up to Month 6
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Frequency of Any Adverse Event During the Entire Study Period
Time Frame: up to Month 6
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up to Month 6
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Frequency of Any Serious Adverse Event (SAE) During the Entire Study Period
Time Frame: up to Month 6
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up to Month 6
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Severity of Any Adverse Event of Special Interest (AESI)
Time Frame: within 2 to 21 days post-vaccination
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AESI Definition: The following cluster of symptoms suggestive of CHIKV infection with or without remissions or exacerbations received particular consideration:
Ongoing AESIs are monitored for entire study period |
within 2 to 21 days post-vaccination
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Frequency of Any Adverse Event of Special Interest (AESI)
Time Frame: Within 2 to 21 Days Post-vaccination
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Within 2 to 21 Days Post-vaccination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Valneva Clinical Development, Valneva Austria GmbH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 22, 2021
Primary Completion (Actual)
July 22, 2021
Study Completion (Actual)
January 26, 2022
Study Registration Dates
First Submitted
February 22, 2021
First Submitted That Met QC Criteria
March 5, 2021
First Posted (Actual)
March 8, 2021
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 27, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VLA1553-302
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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