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Chikungunya Virus InfectionPhase 3NCT04786444

Study to Demonstrate Consistency of Three Lots of a Live-attenuated Chikungunya Virus Vaccine Candidate in Healthy Adults

A Phase 3 study testing Biological Vaccine VLA1553 in people with Chikungunya Virus Infection, run by Valneva Austria GmbH at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Chikungunya Virus Infection
What is being tested?
Biological Vaccine VLA1553
Could I receive a placebo?
No, everyone receives an active treatment
How many people
409 participants
Where
12 sitesUnited States
Study dates
22 Feb 2021to 26 Jan 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 19Show fewer
  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • AMR Miami

    Coral Gables, Florida, 33134

  • AMR Fort Myers

    Fort Myers, Florida, 33912

  • Alliance for Multispecialty Research (AMR)

    Kansas City, Missouri, 64114

  • AMR Knoxville

    Knoxville, Tennessee, 37919

  • Wr-Crcn, Llc

    Las Vegas, Nevada, 89104

  • AMR Lexington

    Lexington, Kentucky, 40509

  • Meridian Clinical Research

    Omaha, Nebraska, 68134

  • St. Johns Center for Clinical Research

    Ponte Vedra, Florida, 32081

  • Rochester Clinical Research

    Rochester, New York, 14609

  • Walter Reed Amy Institute of Research

    Silver Spring, Maryland, 20910

  • Dynamed Clinical Research

    Tomball, Texas, 77375

  • AMR Wichita West

    Wichita, Kansas, 67205

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Biological Vaccine VLA1553
Keywords
VLA1553, Chikungunya Virus Infection, CHIKV, Live-attenuated Chikungunya virus vaccine
Medical subject headings
Chikungunya Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biological Vaccine VLA1553Biological

    Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate

Study groups in NCT04786444
Study groupRoleWhat they receive
VLA1553 Lot 1Active comparatorNot described
Receives: Biological: Biological Vaccine VLA1553
VLA1553 Lot 2Active comparatorNot described
Receives: Biological: Biological Vaccine VLA1553
VLA1553 Lot 3Active comparatorNot described
Receives: Biological: Biological Vaccine VLA1553

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: On Day 29 after single vaccination

Secondary outcomes (16)

  1. Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers

    Measured: on Day 8, 85 and Month 6

  2. Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects

    Measured: on Day 8, 29, 85 and Month 6

  3. Proportion of Subjects With Seroconversion

    Measured: on Day 29, Day 85 and Month 6

  4. Fold Increase of CHIKV-specific Neutralizing Antibody Titers Compared to Baseline

    Measured: on Day 8, 29, 85 and Month 6

  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

    Measured: up to Month 6

  6. Frequency of Solicited Injection Site

    Measured: 10 days post vaccination

  7. Frequency of Solicited Systemic Reactions

    Measured: 10 days post vaccination

  8. Severity of Solicited Injection Site

    Measured: 10 days post vaccination

  9. Severity of Solicited Systemic Reactions

    Measured: 10 days post vaccination

  10. Severity of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination

    Measured: up to Day 29

  11. Frequency of Unsolicited Adverse Events (AEs) Within 28 Days Post-vaccination

    Measured: up to Day 29

  12. Severity of Any Adverse Event During the Entire Study Period

    Measured: up to Month 6

  13. Frequency of Any Adverse Event During the Entire Study Period

    Measured: up to Month 6

  14. Frequency of Any Serious Adverse Event (SAE) During the Entire Study Period

    Measured: up to Month 6

  15. Severity of Any Adverse Event of Special Interest (AESI)

    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

    Measured: within 2 to 21 days post-vaccination

  16. Frequency of Any Adverse Event of Special Interest (AESI)

    Measured: Within 2 to 21 Days Post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2021
  2. Study start22 Feb 2021
  3. Primary completion22 Jul 2021
  4. Study completion26 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
409 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04786444
Sponsor's protocol ID
VLA1553-302
Status last verified
Sep 2023
First submitted
22 Feb 2021
Last updated
28 Sep 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Biological Vaccine VLA1553 in people with Chikungunya Virus Infection, run by Valneva Austria GmbH at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04786444.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.

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