VLA1553 Vaccine for Chikungunya
Recruiting at 10 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Valneva Austria GmbH
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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).
Research Team
VC
Valneva Clinical Development
Principal Investigator
Valneva Austria GmbH
Eligibility Criteria
This trial is for individuals who previously participated in the VLA1553-301 study, testing a Chikungunya virus vaccine. Participants must have had no neutralizing antibodies at baseline and understand the study's procedures. Those with substance abuse issues, conditions preventing blood draws, recent immunosuppressive drugs or blood donations are excluded.Inclusion Criteria
Subject participated in the VLA1553-301 clinical study
Subject has an understanding of the study and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any study-related procedures
I provided blood samples for a study and tested negative for neutralizing antibodies initially.
Exclusion Criteria
You have a known or suspected issue with alcohol or drug abuse, as determined by the person in charge of the study.
Subject is a 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.
Subject is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities)
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Treatment Details
Interventions
- VLA1553 (Virus Therapy)
Trial OverviewThe trial is an open-label Phase 3b study focusing on long-term safety and persistence of antibodies from the Chikungunya virus vaccine candidate VLA1553. Up to 375 subjects from a prior study will be monitored to assess these outcomes.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: VLA1553Experimental Treatment1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Valneva Austria GmbH
Lead Sponsor
Trials
46
Recruited
59,100+