Study on the Persistence of Immunity Following EV71 Vacci... | NCT07144202

Studies
Study on the Persistence of Immunity Following EV71 Vaccination

NCT07144202

Sponsor

Institute of Medical Biology, Chinese Academy of Medical Sciences

Status

Enrolling by invitation

Last Update Posted

Aug 27, 2025Actual

Enrollment

270Estimated

Phase

Not provided

Conditions

Hand, Foot, and Mouth Disease
Hand, Foot, and Mouth Disease (HFMD)

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 10, 2025Actual

Primary Completion Date

Aug 25, 2025Estimated

Completion Date

Mar 10, 2026Estimated

First Submitted Date

Aug 20, 2025

First Submission Date that Met QC Criteria

Aug 20, 2025

First Posted Date

Aug 27, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2025

Last Update Posted Date

Aug 27, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

270Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo		Two doses of placebo at the vaccination schedule of Day 0, 28
Vaccine		EV71 vaccine on Day 0, 28

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Immunogenicity index-seropositive rates of neutralizing antibody	Neutralizing antibody assay will be performed using the neutralization and Microneutralization test method. Seropositive will be defined as the positive results with ties≥1:8	Year 13 after the second vaccination
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody	Neutralizing antibody assay will be performed using the neutralization and Microneutralization test method	Year 13 after the second vaccination

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Immunogenicity group participants from the phase III clinical trial

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Teng Huang	Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lingchuan Center for Disease Control and Prevention		Guilin	Guangxi		China
Lipu Center for Disease Control and Prevention

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006232	Hand, Foot and Mouth Disease

Ancestor Terms

ID	Term
D003384	Coxsackievirus Infections
D004769	Enterovirus Infections
D010850	Picornaviridae Infections
D012327	RNA Virus Infections

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Browse Branches

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