Clinical trial NCT04838444: Antibody Persistence And Long Term Safety Of A Chikungunya Virus Vaccine (VLA1553)
Official title: An Open-Label, Single Arm Trial To Evaluate Antibody Persistence And Long Term Safety Of A Live-Attenuated Chikungunya Virus Vaccine (VLA1553) In Adults Aged 18 Years and Above
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Chikungunya Virus Infection
Lead sponsor: Valneva Austria GmbH
Sponsor class: INDUSTRY
First posted: 2021-04-09
Enrollment: 363
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In this open-label Phase 3b, single arm trial, persistence of antibodies and long term safety will be evaluated in up to 375 participants rolled over from trial VLA1553-301 (NCT number: NCT04546724).

Detailed description: In this open-label Phase 3b, single arm trial, persistence of antibodies and long term safety in up to 375 participants rolled over from trial VLA1553-301 (NCT number: NCT04546724)

These participants will have annual follow-up visits at Months 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120 after immunization. The primary objective of this trial will be to evaluate persistence of antibodies annually from 1 to 10 years after the single immunization with VLA1553. The secondary objective is to evaluate long-term safety 6 months to 2 years after the single immunization with VLA1553.

Eligibility criteria: Inclusion Criteria:

* Individual participated in the VLA1553-301 clinical trial;
* Participant has an understanding of the trial and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any trial-related procedures;
* Participant had immunogenicity blood samples taken at baseline (Visit 1) and either Day 29 (Visit 3), Day 85 (Visit 4) or Day 180 (Visit 5) in Trial VLA1553-301 and was negative for neutralizing antibodies at baseline

Exclusion Criteria:

* Participant presents with clinical conditions representing a contraindication to blood draws;
* Participant has donated blood or use of blood products prior 30 days of immunogenicity sampling;
* Participant has received an active drug with potential immunosuppressive action or investigational drug or device within a period of 30 days prior a trial visit;
* Participant has a known or suspected problem with alcohol or drug abuse as determined by the Investigator;
* Participant has any condition that, in the opinion of the Investigator, may compromise the participant's well-being, might interfere with evaluation of trial endpoints, or would limit the participant's ability to complete the trial;
* Participant is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities);
* Participant is a member of the team conducting the trial or in a dependent relationship with one of the trial 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 trial.

Primary outcomes:
measure: Proportion of participants with seroresponse levels post-vaccination. (defined as µPRNT50 ≥150)
timeFrame: until Year 10
Secondary outcomes:
measure: Frequency of any Serious Adverse Event (SAE)
timeFrame: until Year 2
measure: Relatedness of any Serious Adverse Event (SAE)
timeFrame: until Year 2
measure: Immune response as measured by CHIKV-specific neutralizing antibody titers post-vaccination
timeFrame: until Year 10
measure: Proportion of participants with seroconversion
timeFrame: until Year 10
measure: Fold increase of CHIKV-specific neutralizing antibody titers post-vaccination as compared to baseline (i.e. at start of trial VLA1553-301)
timeFrame: until Year 10
measure: Proportion of participants reaching an at least 4-fold, 8-fold, 16-fold or 64-fold increase in CHIKV-specific neutralizing antibody titer compared to baseline
timeFrame: until Year 10
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Accelerated Enrollment Solutions (AES)
state: Arizona
city: Hallandale Beach
country: United States
facility: ELITE Research Network
state: Florida
city: Chicago
country: United States
facility: Accelerated Enrollment Solutions (AES)
state: Illinois
city: Lexington
country: United States
facility: Alliance for Multispecialty Research (AMR)
state: Kentucky
city: Grand Island
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: Platinum Research Network
state: Nebraska
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research (AMR)
state: Tennessee
city: Cedar Park
country: United States
facility: ELITE Research Network
state: Texas
city: West Jordan
country: United States
facility: ELITE Research Network
state: Utah
city: Norfolk
country: United States
facility: Allliance for Multispecialty Research (AMR)
state: Virginia
Study officials:
affiliation: Valneva Austria GmbH
name: Valneva Clinical Development
role: STUDY_CHAIR
References: