Extension Study of Protocol EV-BR1701 Group B1
Long-Term Immunogenicity Study of an Adjuvanted, Inactivated Enterovirus 71 (EV71) Vaccine in Healthy Infants and Children: An Extension Study of Protocol EV-BR1701 Group B1
The main study was a randomized, multi-nation, multi-centered, double-blinded, phase III study on subjects aged 2 months to <6 years old (<72 months). Two parts were conducted in Taiwan (Group A) and Vietnam (Group B). This extended study involved the subjects enrolled in the EV-BR1701 Group B1 who received any IP injections. For Group B, out of 2727 subjects enrolled from June 2022 to Jul 2023, 241 subjects of Group B1 would be assigned to this extension study. The extension study aimed to evaluate the immunogenicity persistence after EnVAX-A71 vaccination.
The subjects of Group B1 would be recalled for phlebotomy and immunogenicity analysis. The subjects would not receive further study EV71 vaccines in the extension study.
The principal investigators (PIs) and study coordinators (SCs) of the original medical center would contact the subject's guardians/legal representative by phone to return to the medical center for phlebotomy.
Informed consent would be provided to the guardians/legal representative of the subjects, and the eligibility of subjects would be verified on the day of the recall visit.
After the subject was evaluated by the PI and meets the phlebotomy requirements, the subject's guardian/legal representative would be asked to sign the informed consent form, and the new subject's number would be given.
About 3-4 mL of blood would be collected from each subject, and the serum would be collected and sent to the designated central laboratory for testing. The validated neutralizing antibody (NTAb) analysis method would be used to determine the neutralizing antibody titer.
The NTAb titer results would be directly sent to the CRO Data Manager Team, and statistical analysis for immunogenicity would be performed and reported after the main study was complete.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Vinh Long Province
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Vĩnh Long, Vinh Long Province, Vietnam
- Centers for Disease Control and Prevention, Vinh Long Province, Vietnam
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
The main study is a randomized, multi-nation, multi-centered, double-blinded, phase III study on subjects aged 2 months to <6 years old (<72 months). Two parts are conducted in Taiwan (Group A) and Vietnam (Group B). This extended study involves the subjects enrolled in the EV-BR1701 Group B1 who received any IP injections. For Group B, out of 2727 subjects enrolled from June 2022 to Jul 2023, 241 subjects of Group B1 will be assigned to this extension study. The extension study aims to evaluate the immunogenicity persistence after EnVAX-A71 vaccination.
The subjects of Group B1 will be recalled for phlebotomy and immunogenicity analysis. The subjects will not receive further study EV71 vaccines in the extension study.
Description
Inclusion Criteria:
- Healthy children enrolled in group B1 of the EV-BR1701 study who received at least one dose of IP injection with the duration after the last vaccination from at least 2 years up to 2 years and 6 months.
- The subject's guardians are able and willing to comply with study procedures and provide signed informed consent.
Exclusion Criteria:
- Severe malnutrition or dysgenopathy at the screening visit.
- Bleeding disorder diagnosed by a doctor or significant bruising or hemostatic difficulties with IM injections or phlebotomy.
- Any condition in the investigator's opinion may interfere with evaluating study objectives.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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This extension study aims to assess the long-term immunogenicity of EnVAX-A71 vaccination in children aged two months to under six years old.
Time Frame: From Dec-2024 to Jan-2025
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To determine the serum EV71-specific neutralizing antibody (NTAb) titers by measuring the GMT, SCRa, and SPRb for those subjects from Part B1 upon recall.
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From Dec-2024 to Jan-2025
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Wendy Wu, Enimmune Corporation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EV-BR1701e
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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