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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
409

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Florida
      • Coral Gables, Florida, United States, 33134
        • AMR Miami
      • Fort Myers, Florida, United States, 33912
        • AMR Fort Myers
      • Ponte Vedra, Florida, United States, 32081
        • St. Johns Center for Clinical Research
    • Kansas
      • Wichita, Kansas, United States, 67205
        • AMR Wichita West
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • AMR Lexington
    • Maryland
      • Silver Spring, Maryland, United States, 20910
        • Walter Reed Amy Institute of Research
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Alliance for Multispecialty Research (AMR)
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Meridian Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89104
        • Wr-Crcn, Llc
    • New York
      • Rochester, New York, United States, 14609
        • Rochester Clinical Research
    • Tennessee
      • Knoxville, Tennessee, United States, 37919
        • AMR Knoxville
    • Texas
      • Tomball, Texas, United States, 77375
        • Dynamed Clinical Research

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 18 to 45 years of age on the Day of screening
  2. Able to provide informed consent
  3. Generally healthy as determined by the Investigator's clinical judgement based on medical history, physical examination and screening laboratory tests

  4. For women of childbearing potential:

    1. practiced an adequate method of contraception during 30 days before screening
    2. negative serum or urine pregnancy test at screening or vaccination, respectively
    3. agreed to employ adequate birth control measures for the first three months post-vaccination.

Exclusion Criteria:

  1. 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
  2. Acute or recent infection (and not symptom-free in the week prior to screening)
  3. Tested positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV);
  4. 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
  5. 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
  6. Medical history of or currently had acute or progressive, unstable or uncontrolled clinical conditions that posed a risk for participation in the study
  7. History of immune-mediated or clinically relevant arthritis / arthralgia
  8. 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.
  9. 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.
  10. History of any vaccine related contraindicating event (e.g., anaphylaxis, allergy to components of the candidate vaccine, other known contraindications)
  11. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws
  12. Pregnant, had plans to become pregnant during the first three months post-vaccination or lactating at the time of enrollment
  13. 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
  14. Rash, dermatological condition or tattoos that would, in the opinion of the Investigator, interfere with injection site reaction rating
  15. Known or suspected problem with alcohol or drug abuse as determined by the Investigator
  16. 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;
  17. Committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities)
  18. 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
  19. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: VLA1553 Lot 1
Biological: Biological Vaccine VLA1553
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
Biological: Biological Vaccine VLA1553
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
Biological: Biological Vaccine VLA1553
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
On Day 29 after single vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
on Day 8, 85 and Month 6
Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects
Time Frame: on Day 8, 29, 85 and Month 6
on Day 8, 29, 85 and Month 6
Proportion of Subjects With Seroconversion
Time Frame: on Day 29, Day 85 and Month 6
on Day 29, Day 85 and Month 6
Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline
Time Frame: on Day 8, 29, 85 and Month 6
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
Time Frame: up to Month 6
up to Month 6
Frequency of Solicited Injection Site
Time Frame: 10 days post vaccination
10 days post vaccination
Frequency of Solicited Systemic Reactions
Time Frame: 10 days post vaccination
10 days post vaccination
Severity of Solicited Injection Site
Time Frame: 10 days post vaccination
10 days post vaccination
Severity of Solicited Systemic Reactions
Time Frame: 10 days post vaccination
10 days post vaccination
Severity of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination
Time Frame: up to Day 29
up to Day 29
Frequency of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination
Time Frame: up to Day 29
up to Day 29
Severity of Any Adverse Event During the Entire Study Period
Time Frame: up to Month 6
up to Month 6
Frequency of Any Adverse Event During the Entire Study Period
Time Frame: up to Month 6
up to Month 6
Frequency of Any Serious Adverse Event (SAE) During the Entire Study Period
Time Frame: up to Month 6
up to Month 6
Severity of Any Adverse Event of Special Interest (AESI)
Time Frame: within 2 to 21 days post-vaccination

AESI Definition:

The following cluster of symptoms suggestive of CHIKV infection with or without remissions or exacerbations received particular consideration:

  1. Fever (≥38.0°C [100.4°F] measured orally) and
  2. Acute (poly)arthralgia/arthritis most frequently in the extremities (wrists, ankles, and phalanges, often symmetric), back pain and/or neurological symptoms (e.g. confusion, optic neuritis, meningoencephalitis, or polyneuropathy) and/or cardiac symptoms (e.g. myocarditis) or One or more of the following signs and symptoms: macular to maculopapular rash (sometimes with cutaneous pruritus [foot plant] and edema of the face and extremities), polyadenopathies; and
  3. Onset of symptoms 2 to 21 days after vaccination and
  4. Duration of event ≥3 days.

Ongoing AESIs are monitored for entire study period
within 2 to 21 days post-vaccination
Frequency of Any Adverse Event of Special Interest (AESI)
Time Frame: Within 2 to 21 Days Post-vaccination
Within 2 to 21 Days Post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Valneva Austria GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 22, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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