A Multicenter Study to Evaluate Safety and Immunogenicity of a Live-attenuated Chikungunya Vaccin… (NCT04650399) | Clinical Trial Compass
CompletedPhase 3
A Multicenter Study to Evaluate Safety and Immunogenicity of a Live-attenuated Chikungunya Vaccine in Adolescents
Brazil754 participantsStarted 2022-02-14
Plain-language summary
This was a prospective, randomized, double-blinded, multicenter, pivotal study evaluating the full dose of VLA1553 (1 x10E4 TCID50 per dose) in comparison to a placebo control. The dose of VLA1553 or control was administered as single vaccination on Day 1. Overall, approximately 750 male and female participants aged 12 years to \<18 years were enrolled into the study. After completion of the trial, a Post Trial Access program was performed to offer the VLA1553 vaccine to all placebo recipients.
Who can participate
Age range
12 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. male or female adolescents from the 12th birthday to the last day before the 18th birthday at the time of vaccination;
. written informed consent by the subject's legal representative(s), and written informed assent of the subject;
. generally healthy as determined by the Investigator's clinical judgement based on medical history, physical examination and screening laboratory tests;
. seropositive for previous CHIKV exposure (i.e. IgM+/IgG+ or IgM-/IgG+) or seronegative (i.e. IgM-/IgG-) as screened by CHIKV-specific ELISA.
. for women of childbearing potential:
. negative serum or urine pregnancy test at screening and on Day 1.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Seroprotection
Timeframe: On study Day 29,which is 28 days after single vaccination
. practiced an adequate method of contraception during 30 days before screening
. agreed to employ adequate birth control measures for the first three months post-vaccination (i.e. until Day 85).
Exclusion criteria
. 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;
. 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 which was considered to have achieved a cure, the subject could be enrolled;