Clinical trial NCT01268787: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Enterovirus Infection
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
First posted: 2010-12-31
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Primary endpoint
timeFrame: 210 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
state: Shihlin District
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Zhongshan Distric
Study officials:
affiliation: National Health Research Institutes, Taiwan
name: Pele Chong, Ph.D.
role: STUDY_CHAIR
affiliation: National Health Research Institutes, Taiwan
name: Chia-Chyi Liu, Ph.D.
role: STUDY_DIRECTOR
affiliation: Taipei Veterans General Hospital, Taiwan
name: C P Fung, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Taipei Meidcal College
name: S M Hsieh, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.