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Virus Therapy
VLA1553 Vaccine for Chikungunya
Phase 3
Waitlist Available
Research Sponsored by Valneva Austria GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject 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 Study VLA1553-301 and was negative for neutralizing antibodies at baseline
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until 5 year 5
Awards & highlights
Study Summary
This trial will study the long-term safety and effectiveness of an experimental drug in people who have already taken it for a different condition.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be observed for any long-term safety concerns related to the VLA1553 vaccine which could include typical vaccine-related reactions such as soreness at injection site, fever, fatigue or allergic responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I provided blood samples for a study and tested negative for neutralizing antibodies initially.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until 5 year 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until 5 year 5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects with a seroprotective CHIKV antibody level post-vaccination.
Secondary outcome measures
Fold increase of CHIKV-specific neutralizing antibody titers post-vaccination as compared to baseline (i.e. at start of study VLA1553-301)
Frequency of any Serious Adverse Event (SAE)
Antibodies, Blocking
+3 moreSide effects data
From 2021 Phase 3 trial • 4128 Patients • NCT0454672432%
Headache
29%
Fatigue
24%
Myalgia
18%
Arthralgia
14%
Pyrexia
13%
Injection site pain
12%
Nausea
3%
Rash
2%
COVID-19
2%
Vomiting
2%
Chills
2%
Injection site erythema
1%
Back pain
1%
Urinary tract infection
1%
Diarrhoea
1%
Injection site induration
1%
Back Pain
1%
Neutropenia
1%
Induration
100%
80%
60%
40%
20%
0%
Study treatment Arm
VLA1553
Placebo
Trial Design
1Treatment groups
Experimental Treatment
Group I: VLA1553Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VLA1553
2018
Completed Phase 3
~4250
Find a Location
Who is running the clinical trial?
Valneva Austria GmbHLead Sponsor
45 Previous Clinical Trials
54,556 Total Patients Enrolled
2 Trials studying Chikungunya
870 Patients Enrolled for Chikungunya
Valneva Clinical DevelopmentStudy ChairValneva Austria GmbH
8 Previous Clinical Trials
9,902 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a known or suspected issue with alcohol or drug abuse, as determined by the person in charge of the study.You have a medical condition that makes it unsafe to take blood samples.I haven't taken any experimental drugs or those that weaken the immune system in the last 30 days.I provided blood samples for a study and tested negative for neutralizing antibodies initially.I have not donated blood or used blood products in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: VLA1553
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
If I am interested, how can I sign up for this research project?
"According to the latest information on clinicaltrials.gov, this particular study is not looking for more participants at the moment. The trial was originally announced on April 2nd, 2021 but was last updated on October 21st, 2021. There are, however, 8 other ongoing trials that are actively recruiting patients."
Answered by AI
What is the status of VLA1553's FDA application?
"VLA1553 is considered safe and it received a score of 3."
Answered by AI
Is this study being conducted extensively throughout the US in different hospitals?
"There are 11 different locations across the United States of America that are actively recruiting patients for this trial. A few of these sites include AMR in Knoxville, Tennessee, ELITE Research Network in West Jordan, Utah, and AMR in Cedar Park, Texas."
Answered by AI
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