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Chikungunya Virus InfectionPhase 3NCT04546724

Pivotal Study to Evaluate Safety and Immunogenicity of a Live-Attenuated Chikungunya Virus Vaccine Candidate in Adults

A Phase 3 study testing VLA1553 in people with Chikungunya Virus Infection, run by Valneva Austria GmbH at 44 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

This was a prospective, randomized, double-blinded, multicenter, pivotal clinical study evaluating the final dose of VLA1553 (1 x10E4 TCID50 per dose) in comparison to a placebo control. The final dose of VLA1553 or control was administered as single immunization on Day 1. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Chikungunya Virus Infection
What is being tested?
VLA1553
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4,128 participants
Where
44 sitesUnited States
Study dates
17 Sep 2020to 15 Oct 2021
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 years of age or above 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
Show all 27Show fewer
  • agreed to employ adequate birth control measures for the first three months post-vaccination.
  • Main Exclusion Criteria:
  • CHIKV infection in the past, 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
  • Subject tested positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV);
  • live virus vaccine within 28 days or inactivated vaccine within 14 days prior to vaccination in this study or planned 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)
  • with clinical conditions representing a contraindication to intramuscular vaccination and blood draws
  • pregnant 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 used 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, interfere with evaluation of study endpoints, or would 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.

Who cannot join

None listed.

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

United States44 sites

  • Synexus - Anderson

    Anderson, South Carolina, 29621

  • Vitalink Research - Anderson

    Anderson, South Carolina, 29621

  • Tekton Research - Beaumont

    Beaumont, Texas, 77706

  • PanAmerican Clinical Research - US Headquarter

    Brownsville, Texas, 78521

  • Velocity Clinical Research - Austin

    Cedar Park, Texas, 78613

  • Accelerated Enrollment Solutions (AES)

    Chandler, Arizona, 85224

  • Accelerated Enrollment Solutions (AES)

    Chicago, Illinois, 60602

  • Velocity Clinical Research, Chula Vista

    Chula Vista, California, 91911

  • Accelerated Enrollment Solutions (AES)

    Cincinnati, Ohio, 45236

  • Accel Research Sites - DeLand

    DeLand, Florida, 32720

  • Alliance for Multispecialty Research (AMR)

    El Dorado, Kansas, 67042

  • Meridian Clinical Research

    Endwell, New York, 13760

  • Meridian Clinical Research - Grand Island

    Grand Island, Nebraska, 68803

  • ELITE Research Network (ELITE)

    Hallandale, Florida, 33009

  • Alliance for Multispecialty Research (AMR)

    Kansas City, Missouri, 64114

  • Alliance for Multispecialty Research (AMR)

    Knoxville, Tennessee, 37920

  • Alliance for Multispecialty Research (AMR)

    Las Vegas, Nevada, 89119

  • Alliance for Multispecialty Research (AMR)

    Lexington, Kentucky, 40509

  • ELITE Research Network (ELITE)

    Little Rock, Arkansas, 72204

  • Meridien Research - Maitland

    Maitland, Florida, 32751

  • Velocity Clinical Research - Medford

    Medford, Oregon, 97504

  • Accelerated Enrollment Solutions (AES)

    Melbourne, Florida, 32934

  • ELITE Research Network (ELITE)

    Meridian, Idaho, 83642

  • Suncoast Research Group, LLC

    Miami, Florida, 33135

  • Lucas Research

    Morehead City, North Carolina, 28557

  • AMR - New Orleans - Center for Clinical Research

    New Orleans, Louisiana, 70119

  • Alliance for Multispecialty Research (AMR)

    Newton, Kansas, 67114

  • Alliance for Multispecialty Research (AMR)

    Norfolk, Virginia, 23507

  • ELITE Research Network (ELITE)

    North Miami Beach, Florida, 33135

  • ELITE Research Network (ELITE)

    Oklahoma City, Oklahoma, 73112

  • Platinum Research Network (Platinum)

    Omaha, Nebraska, 68134

  • Accelerated Enrollment Solutions (AES)

    Omaha, Nebraska, 68144

  • Accelerated Enrollment Solutions (AES)

    Peoria, Illinois, 61614

  • Accelerated Enrollment Solutions (AES)

    Phoenix, Arizona, 85020

  • Research Your Health, LLC

    Plano, Texas, 75093

  • Jacksonville Center for Clinical Research, LTD dba St. Johns Center for Clinical Research

    Ponte Vedra, Florida, 32081

  • Rochester Clinical Research

    Rochester, New York, 14609

  • Accelerated Enrollment Solutions (AES)

    San Diego, California, 92108

  • Alliance for Multispecialty Research (AMR)

    Tempe, Arizona, 85283

  • Synexus - The Villages

    The Villages, Florida, 32162

  • ELITE Research Network (ELITE)

    Tomball, Texas, 77375

  • ELITE Research Network (ELITE)

    West Jordan, Utah, 84088

  • Alliance for Multispecialty Research (AMR)

    Wichita, Kansas, 67207

  • ELITE Research Network (ELITE)

    Wilmington, North Carolina, 28403

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Pivotal Study To Evaluate Safety And Immunogenicity Of A Live-Attenuated Chikungunya Virus Vaccine Candidate In Adults Aged 18 Years And Above

This was a prospective, randomized, double-blinded, multicenter, pivotal clinical study evaluating the final dose of VLA1553 (1 x10E4 TCID50 per dose) in comparison to a placebo control. The final dose of VLA1553 or control was administered as single immunization on Day 1. Overall, 4.128 male and female subjects aged 18 years and above were randomized into the study.

Read the detailed description

This was a prospective, double-blinded, multicenter, randomized, pivotal Phase 3 study and 4.128 participants aged 18 years or above were randomized in a 3:1 ratio to the live-attenuated CHIKV vaccine candidate (VLA1553) or placebo. The final dose of lyophilized VLA1553 or placebo was administered as a single intramuscular immunization. Subjects in this study were stratified into two age strata of 18 to 64 years and 65 years of age or above. The primary objective of the study was to evaluate the immunogenicity and safety of the final dose of VLA1553 28 days following the single immunization. Immunogenicity evaluations in the immunogenicity subset included the proportion of subjects with seroprotective neutralizing CHIKV antibody titers above a surrogate threshold indicative of protection. The surrogate of protection reasonably likely to predict clinical benefit has been established in non-human primate passive transfer studies using human sera from the Phase 1 study and was supported by sero-epidemiological studies. Safety data collection and immunogenicity were assessed until Month 6.

The first enrolled and randomized 501 subjects comprised the immunogenicity subset.

Being tested
VLA1553, Placebo
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.

  • VLA1553Biological

    Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose

  • PlaceboBiological

    Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo

Study groups in NCT04546724
Study groupRoleWhat they receive
VLA1553Active comparatorSingle intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
Receives: Biological: VLA1553
PlaceboPlacebo comparatorSingle intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
Receives: Biological: Placebo

What is being measured

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

  1. Number of Participants With a Seroprotective CHIKV Antibody Level for Baseline Negative Subjects 28 Days Post-vaccination

    Seroprotection rate, based on a surrogate of protection agreed with FDA

    Assay used for analysis was based on µPRNT (Micro Plaque Reduction Neutralization Test). Participants at pre-selected sites were included, if they had available Day 1 and Day 29 samples and without major protocol deviations that could impact the immune response.

    Measured: on Day 29 after single vaccination

Secondary outcomes (14)

  1. CHIKV-specific Neutralizing Antibody Titers

    CHIKV-specific Neutralizing Antibody Titers on Day 8, and Day 29 Postvaccination as Determined by μPRNT ( (Micro Plaque Reduction Neutralization Test) Assay

    Measured: Until Day 180

  2. Number of Participants With Seroprotective CHIKV Antibody Level

    Seroprotection rate, based on a surrogate of protection agreed with FDA Seroprotective CHIKV Antibody Level Defined as μPRNT (Micro Plaque Reduction Neutralization Test) for Baseline Negative Subjects

    Measured: Until Day 180

  3. Number of Participants With Seroconversion

    Seroconversion was defined as CHIKV-specific neutralizing antibody titer of ≥ 20 based on µPRNT (Micro Plaque Reduction Neutralization Test) for baseline negative subjects

    Measured: Until Day 180

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

    Fold Change of CHIKV-specific Neutralizing Antibody Titers Determined by μPRNT ( (Micro Plaque Reduction Neutralization Test) as compared to baseline

    Measured: until Day 180

  5. Number of Participants Reaching an X-fold Change in CHICKV-specific Neutralizing Antibody Titer Compared to Baseline

    Number of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold change of CHIKV-specific Neutralizing Antibody Titers Determined by μPRNT ( (Micro Plaque Reduction Neutralization Test) as compared to baseline

    Measured: until Day 180

  6. Unsolicited AEs

    Number of Participants with Unsolicited Adverse Events

    Measured: Until Day 29

  7. Solicited Injection Site AEs

    Number of Participants with solicited injection site reactions

    Measured: within 10 days post-vaccination

  8. Solicited Systemic AEs

    Number of Participants with solicited systemic reactions

    Measured: within 10 days post-vaccination

  9. Adverse Events

    Number of Participants with any Adverse Events

    Measured: until Day 180

  10. Related Adverse Events

    Number of Participants with any related Adverse Events

    Measured: until Day 180

  11. Serious Adverse Event

    Number of Participants with any Serious Adverse Events

    Measured: until Day 180

  12. Related Serious Adverse Event

    Number of Participants with any Related Serious Adverse Events

    Measured: until Day 180

  13. Adverse Event of Special Interest

    Number of Participants with any Adverse Event of Special Interest

    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.

    Measured: within 21 days post-vaccination

  14. Related Adverse Event of Special Interest

    Number of Participants with any Related Adverse Event of Special Interest

    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.

    Measured: within 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 posted14 Sep 2020
  2. Study start17 Sep 2020
  3. Primary completion19 May 2021
  4. Study completion15 Oct 2021

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
4,128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04546724
Sponsor's protocol ID
VLA1553-301
Status last verified
Jun 2023
First submitted
4 Sep 2020
Last updated
28 Jun 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kosulin K, Brasel TL, Smith J, Torres M, Bitzer A, Dubischar K, Buerger V, Mader R, Weaver SC, Beasley DWC, Hochreiter R. Cross-neutralizing activity of the chikungunya vaccine VLA1553 against three prevalent chikungunya lineages. Emerg Microbes Infect. 2025 Dec;14(1):2469653. doi: 10.1080/22221751.2025.2469653. Epub 2025 Mar 10.

    PubMed 39998495

  • Schneider M, Narciso-Abraham M, Hadl S, McMahon R, Toepfer S, Fuchs U, Hochreiter R, Bitzer A, Kosulin K, Larcher-Senn J, Mader R, Dubischar K, Zoihsl O, Jaramillo JC, Eder-Lingelbach S, Buerger V, Wressnigg N. Safety and immunogenicity of a single-shot live-attenuated chikungunya vaccine: a double-blind, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2023 Jun 24;401(10394):2138-2147. doi: 10.1016/S0140-6736(23)00641-4. Epub 2023 Jun 12.

    PubMed 37321235

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VLA1553 in people with Chikungunya Virus Infection, run by Valneva Austria GmbH at 44 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 27 inclusion and 0 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 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 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. Some participants in this study may receive a placebo. 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 25 Jul 2022). 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?

Number of Participants With a Seroprotective CHIKV Antibody Level for Baseline Negative Subjects 28 Days Post-vaccination (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 NCT04546724, which also lists 2 linked publications.

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 Jun 2023.

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