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

NCT04546724 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: VLA1553-301
• Study Type: interventional
• Target: 4,128
• Locations: 1 country
• Sites: 44

Brief 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. Overall, 4.128 male and female subjects aged 18 years and above were randomized into the study.

Conditions

Chikungunya Virus Infection

Keywords

VLA1553; Chikungunya Virus Infection; CHIKV; Live-attenuated Chikungunya virus vaccine

Outcome Measures

Primary Outcomes (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.

  on Day 29 after single vaccination

Secondary Outcomes (14)

• CHIKV-specific Neutralizing Antibody Titers

  Until Day 180

• Number of Participants With Seroprotective CHIKV Antibody Level

  Until Day 180

• Number of Participants With Seroconversion

  Until Day 180

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

  until Day 180

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

  until Day 180

Study Arms (2)

VLA1553

ACTIVE COMPARATOR

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

Biological: VLA1553

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

VLA1553 BIOLOGICAL

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

VLA1553

Placebo BIOLOGICAL

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• agreed to employ adequate birth control measures for the first three months post-vaccination.

You may not qualify if:

• 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

Sponsors & Collaborators

• Valneva Austria GmbH: lead

Study Sites (44)

Accelerated Enrollment Solutions (AES)

Chandler, Arizona, 85224, United States

Location

Accelerated Enrollment Solutions (AES)

Phoenix, Arizona, 85020, United States

Location

Alliance for Multispecialty Research (AMR)

Tempe, Arizona, 85283, United States

Location

ELITE Research Network (ELITE)

Little Rock, Arkansas, 72204, United States

Location

Velocity Clinical Research, Chula Vista

Chula Vista, California, 91911, United States

Location

Accelerated Enrollment Solutions (AES)

San Diego, California, 92108, United States

Location

Accel Research Sites - DeLand

DeLand, Florida, 32720, United States

Location

ELITE Research Network (ELITE)

Hallandale, Florida, 33009, United States

Location

Meridien Research - Maitland

Maitland, Florida, 32751, United States

Location

Accelerated Enrollment Solutions (AES)

Melbourne, Florida, 32934, United States

Location

Suncoast Research Group, LLC

Miami, Florida, 33135, United States

Location

ELITE Research Network (ELITE)

North Miami Beach, Florida, 33135, United States

Location

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

Ponte Vedra, Florida, 32081, United States

Location

Synexus - The Villages

The Villages, Florida, 32162, United States

Location

ELITE Research Network (ELITE)

Meridian, Idaho, 83642, United States

Location

Accelerated Enrollment Solutions (AES)

Chicago, Illinois, 60602, United States

Location

Accelerated Enrollment Solutions (AES)

Peoria, Illinois, 61614, United States

Location

Alliance for Multispecialty Research (AMR)

El Dorado, Kansas, 67042, United States

Location

Alliance for Multispecialty Research (AMR)

Newton, Kansas, 67114, United States

Location

Alliance for Multispecialty Research (AMR)

Wichita, Kansas, 67207, United States

Location

Alliance for Multispecialty Research (AMR)

Lexington, Kentucky, 40509, United States

Location

AMR - New Orleans - Center for Clinical Research

New Orleans, Louisiana, 70119, United States

Location

Alliance for Multispecialty Research (AMR)

Kansas City, Missouri, 64114, United States

Location

Meridian Clinical Research - Grand Island

Grand Island, Nebraska, 68803, United States

Location

Platinum Research Network (Platinum)

Omaha, Nebraska, 68134, United States

Location

Accelerated Enrollment Solutions (AES)

Omaha, Nebraska, 68144, United States

Location

Alliance for Multispecialty Research (AMR)

Las Vegas, Nevada, 89119, United States

Location

Meridian Clinical Research

Endwell, New York, 13760, United States

Location

Rochester Clinical Research

Rochester, New York, 14609, United States

Location

Lucas Research

Morehead City, North Carolina, 28557, United States

Location

ELITE Research Network (ELITE)

Wilmington, North Carolina, 28403, United States

Location

Accelerated Enrollment Solutions (AES)

Cincinnati, Ohio, 45236, United States

Location

ELITE Research Network (ELITE)

Oklahoma City, Oklahoma, 73112, United States

Location

Velocity Clinical Research - Medford

Medford, Oregon, 97504, United States

Location

Synexus - Anderson

Anderson, South Carolina, 29621, United States

Location

Vitalink Research - Anderson

Anderson, South Carolina, 29621, United States

Location

Alliance for Multispecialty Research (AMR)

Knoxville, Tennessee, 37920, United States

Location

Tekton Research - Beaumont

Beaumont, Texas, 77706, United States

Location

PanAmerican Clinical Research - US Headquarter

Brownsville, Texas, 78521, United States

Location

Velocity Clinical Research - Austin

Cedar Park, Texas, 78613, United States

Location

Research Your Health, LLC

Plano, Texas, 75093, United States

Location

ELITE Research Network (ELITE)

Tomball, Texas, 77375, United States

Location

ELITE Research Network (ELITE)

West Jordan, Utah, 84088, United States

Location

Alliance for Multispecialty Research (AMR)

Norfolk, Virginia, 23507, United States

Location

Related Publications (2)

• 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.

  PMID: 39998495 DERIVED

• 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.

  PMID: 37321235 DERIVED

MeSH Terms

Conditions

Chikungunya Fever

Condition Hierarchy (Ancestors)

Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Infections; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections

Results Point of Contact

• Title: Clinical Strategy Manager
• Organization: Valn

office@valneva.com

+43 1 206 20

Study Officials

• Valneva Clinical Development

  Valneva Austria GmbH

  STUDY CHAIR

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: September 4, 2020
• First Posted: September 14, 2020
• Study Start: September 17, 2020
• Primary Completion: May 19, 2021
• Study Completion: October 15, 2021
• Last Updated: June 28, 2023
• Results First Posted: July 25, 2022

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (44)