search
Back to results

A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine

Primary Purpose

Enterovirus Infection

Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
EV71 vaccine
Sponsored by
National Health Research Institutes, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Enterovirus Infection

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subject who is free of obvious health problems
  • Able and willing to comply with the study procedure adn give written informed consent

Exclusion Criteria:

  • Female who is pregnant/lactating or planning to be pregnant
  • Body mass index(BMI) > 35
  • Oral temperature > 37.5 Celsius at the time of planned vaccination
  • Subject with any abnormal laboratory results at screening
  • With a history of herpangina, hand-foot-mouth disease, acute hemorrhagic conjunctivitis or acute gastrointestinal illness associated with enterovirus infection in the past 3 months
  • Has been diagnosed with neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder
  • With a history of hypersensitivity to vaccine or allergic disease
  • Use of any investigational/non-registered product within 30 days prior to vaccination
  • Use of immunoglobulins or any blood products within 3 months prior to vaccination
  • Chronic administration of immunosuppressants or other immunomodulators within 5 months prior to vaccination

Sites / Locations

  • Taipei Veterans General Hospital
  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

EV 71 vaccine 5ug

EV 71 vaccine 10ug

Arm Description

EV71 Vaccine 5ug

EV71 vaccine 10ug

Outcomes

Primary Outcome Measures

Primary endpoint
The percentage, intensity and relationship to vaccination of local and systemic signs and symptoms at a 0.25ml and 0.5ml dose

Secondary Outcome Measures

Full Information

First Posted
December 30, 2010
Last Updated
April 15, 2015
Sponsor
National Health Research Institutes, Taiwan
search

1. Study Identification

Unique Protocol Identification Number
NCT01268787
Brief Title
A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine
Official Title
A Phase I, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine Administrated With Adjuvant AlPO4 in Health Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Health Research Institutes, Taiwan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine at a 0.25ml or 0.5ml dose in health volunteers
Detailed Description
This is a phase I, prospective, randomized, open-label, two-center study. A total 60 healthy volunteers will be screened for baseline characteristic inclusion/exclusion criteria after providing a written informed consent. Eligible subjects will be recruited and equally randomized to either receive 2 doses of EV71 vaccine 0.25ml or 0.5ml. All subjects should be followed till Day 210.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enterovirus Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EV 71 vaccine 5ug
Arm Type
Active Comparator
Arm Description
EV71 Vaccine 5ug
Arm Title
EV 71 vaccine 10ug
Arm Type
Experimental
Arm Description
EV71 vaccine 10ug
Intervention Type
Biological
Intervention Name(s)
EV71 vaccine
Other Intervention Name(s)
EV71 vac
Intervention Description
Two-vaccination 0.25ml or 0.5ml dose assigned to two groups.
Primary Outcome Measure Information:
Title
Primary endpoint
Description
The percentage, intensity and relationship to vaccination of local and systemic signs and symptoms at a 0.25ml and 0.5ml dose
Time Frame
210 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject who is free of obvious health problems Able and willing to comply with the study procedure adn give written informed consent Exclusion Criteria: Female who is pregnant/lactating or planning to be pregnant Body mass index(BMI) > 35 Oral temperature > 37.5 Celsius at the time of planned vaccination Subject with any abnormal laboratory results at screening With a history of herpangina, hand-foot-mouth disease, acute hemorrhagic conjunctivitis or acute gastrointestinal illness associated with enterovirus infection in the past 3 months Has been diagnosed with neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder With a history of hypersensitivity to vaccine or allergic disease Use of any investigational/non-registered product within 30 days prior to vaccination Use of immunoglobulins or any blood products within 3 months prior to vaccination Chronic administration of immunosuppressants or other immunomodulators within 5 months prior to vaccination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pele Chong, Ph.D.
Organizational Affiliation
National Health Research Institutes, Taiwan
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chia-Chyi Liu, Ph.D.
Organizational Affiliation
National Health Research Institutes, Taiwan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
C P Fung, M.D.
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
S M Hsieh, M.D
Organizational Affiliation
Taipei Meidcal College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
State/Province
Shihlin District
ZIP/Postal Code
112
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
State/Province
Zhongshan Distric
ZIP/Postal Code
104
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24278177
Citation
Chou AH, Liu CC, Chang JY, Jiang R, Hsieh YC, Tsao A, Wu CL, Huang JL, Fung CP, Hsieh SM, Wang YF, Wang JR, Hu MH, Chiang JR, Su IJ, Chong PC. Formalin-inactivated EV71 vaccine candidate induced cross-neutralizing antibody against subgenotypes B1, B4, B5 and C4A in adult volunteers. PLoS One. 2013 Nov 21;8(11):e79783. doi: 10.1371/journal.pone.0079783. eCollection 2013.
Results Reference
derived
PubMed Identifier
23541623
Citation
Cheng A, Fung CP, Liu CC, Lin YT, Tsai HY, Chang SC, Chou AH, Chang JY, Jiang RH, Hsieh YC, Su IJ, Chong PC, Hsieh SM. A Phase I, randomized, open-label study to evaluate the safety and immunogenicity of an enterovirus 71 vaccine. Vaccine. 2013 May 7;31(20):2471-6. doi: 10.1016/j.vaccine.2013.03.015. Epub 2013 Mar 27.
Results Reference
derived

Learn more about this trial

A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine

We'll reach out to this number within 24 hrs