Study on the Persistence of Immunity Following EV71 Vaccination
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hand, Foot, and Mouth Disease, Hand, Foot, and Mouth Disease (HFMD). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study on the Immunity Persistence Following Immunization With Enterovirus Type 71 Vaccine, Inactivated (Human Diploid Cell)
Overview
This is a thirteen-year follow-up study conducted as an extension of a Phase III clinical trial. In this study, a sub-cohort of volunteers who was eligible for enrollment and randomly administrated either 2 dose EV71 vaccine or placebo in the phase III clinical trial was selected to evaluate the EV71 immune levels 13 years after the primary vaccination.
Detailed description
The initial study was a randomized, double-blind, placebo-controlled phase III clinical trial conducted in children aged 6-71 months from Guilin region of Guangxi Province in 2012. A total of 12000 participants (with 1100 in the immunogenicity group) were randomized in a 1:1 ratio to receive two doses EV71 vaccine or placebo on a 0-, 28-day schedule. Besides, an extended one-year and two year follow-up of this study was completed in 2013.
In this study, immunogenicity group participants from the phase III clinical trial was chosen as the studied subjects. A retrospective survey for the enrolled subjects involved with the history of HFMD and the extra vaccination of EV71 vaccine was conducted before blood collection. 3 ml venous blood were collected from each available subject for EV71 neutralizing antibody (NAb) testing. Since the unblinding was performed after the initial study completed, this study was an open-labelled detection for the persistence of the vaccine-induced EV71 NAb.
Primary outcome measures
- Immunogenicity index-seropositive rates of neutralizing antibody [Time frame: Year 13 after the second vaccination]
- Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody [Time frame: Year 13 after the second vaccination]
Eligibility criteria
Inclusion criteria
- Included in the immunogenicity group of initial studyand randomly into either vaccine (fulfilled the two doses vaccination following the protocol) or placebo group.
- Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
- Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the study's requirements.
Exclusion criteria
- Had history of extra EV71 vaccination.
- Previous history of hand-foot-mouth disease.
- Participating in other research.
- Subjects with a hereditary bleeding tendency or coagulopathy, or a history of bleeding disorders.
- Investigators' Discretion: The final exclusion criterion is the discretion of investigators to determine whether a subject is suitable for participation in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 4 centers
- Lingchuan Center for Disease Control and Prevention — Guilin
- Lipu Center for Disease Control and Prevention — Guilin
- Xing'an Center for Disease Control and Prevention — Guilin
- Yongfu Center for Disease Control and Prevention — Guilin
Identifiers
NCT: NCT07144202 · EV71-402