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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chikungunya Virus Infection

In brief

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.

Key facts

Study ID: NCT04546724
Run by: Valneva Austria GmbH
People needed: 4128
Starts: 2020-09-17
Expected to finish: 2021-10-15
Last updated by the study team: 2023-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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
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)

Where it is running

Accelerated Enrollment Solutions (AES) — Chandler, Arizona, United States
Accelerated Enrollment Solutions (AES) — Phoenix, Arizona, United States
Alliance for Multispecialty Research (AMR) — Tempe, Arizona, United States
ELITE Research Network (ELITE) — Little Rock, Arkansas, United States
Velocity Clinical Research, Chula Vista — Chula Vista, California, United States
Accelerated Enrollment Solutions (AES) — San Diego, California, United States
Accel Research Sites - DeLand — DeLand, Florida, United States
ELITE Research Network (ELITE) — Hallandale, Florida, United States
Meridien Research - Maitland — Maitland, Florida, United States
Accelerated Enrollment Solutions (AES) — Melbourne, Florida, United States
Suncoast Research Group, LLC — Miami, Florida, United States
ELITE Research Network (ELITE) — North Miami Beach, Florida, United States
Jacksonville Center for Clinical Research, LTD dba St. Johns Center for Clinical Research — Ponte Vedra, Florida, United States
Synexus - The Villages — The Villages, Florida, United States
ELITE Research Network (ELITE) — Meridian, Idaho, United States
Accelerated Enrollment Solutions (AES) — Chicago, Illinois, United States
Accelerated Enrollment Solutions (AES) — Peoria, Illinois, United States
Alliance for Multispecialty Research (AMR) — El Dorado, Kansas, United States
Alliance for Multispecialty Research (AMR) — Newton, Kansas, United States
Alliance for Multispecialty Research (AMR) — Wichita, Kansas, United States
Alliance for Multispecialty Research (AMR) — Lexington, Kentucky, United States
AMR - New Orleans - Center for Clinical Research — New Orleans, Louisiana, United States
Alliance for Multispecialty Research (AMR) — Kansas City, Missouri, United States
Meridian Clinical Research - Grand Island — Grand Island, Nebraska, United States
Platinum Research Network (Platinum) — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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