Clinical trial NCT01267903: A Clinical Trial for Inactivated Vaccine(Vero Cell) Against EV71 in Chinese Healthy Young Adults and Children
Official title: A Phase Ia Clinical Trial for Inactivated Vaccine(Vero Cell) Against EV71 in Chinese Healthy Young Adults and Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hand, Foot and Mouth Disease
Keywords: Vaccines Adverse Reaction
Lead sponsor: Jiangsu Province Centers for Disease Control and Prevention
Sponsor class: NETWORK
Collaborators: name: Bejing Vigoo Biological Co., LTD
First posted: 2010-12-29
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused by viruses that belong to the enterovirus genus of the picornavirus family. Although most HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71 (EV71) can present with a high rate of neurological complications, including meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by EV71 has become a major emerging infectious disease in Asia and the highly pathogenic potential of EV71 clearly requires the attention of world medical community.

The development of vaccine against EV71 is active and ongoing in Asian countries now. Several studies have examined the effectiveness of inactivated viral vaccines against EV71 in animal model. A wide range of experimental EV71 vaccine approaches have been studied including heat-inactivated or formaldehyde-inactivated virion, EV71 virus-like particles (VLP) , VP1 recombinant protein ,VP1 DNA vaccine , VP1 peptide-based vaccine targeting the neutralizing domain, bacterial or viral vector expressing VP1, and a Vero cell-adapted live attenuated virus. Furthermore, neutralizing antibodies against EV71 have been suggested as one of the most important factors in prevention of the severe EV71 infection. Recently, an inactivated vaccine(vero cell) against EV71 has been licensed by SFDA in China, this clinical trial phase Ia is armed to evaluate safety and tolerance in Chinese healthy adults and children.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects aged from 5 to 22 years old as established by medical history and clinical examination
* The subjects or their guardians are able to understand and sign the informed consent
* Had never received the vaccine against EV71
* Subjects who can and will comply with the requirements of the protocol

Exclusion Criteria:

* Subject that has a medical history of HFMD
* subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
* Family history of seizures or progressive neurological disease
* Family history of congenital or hereditary immunodeficiency
* Women of pregnancy, lactation or about to be pregnant in 60 days
* Autoimmune disease or immunodeficiency
* Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
* Any prior administration of administration of immunoglobulins

Primary outcomes:
measure: to evaluate the safety of EV71 vaccine in Chinese healthy adults and children
timeFrame: 28 days after the first vaccination
measure: to evaluate the safety of EV71 vaccine in Chinese healthy adults and children
timeFrame: 28 days after the second vaccination
Secondary outcomes:
measure: to evaluate the seroconversion rate of Antinuclear antibodies in serum after first vaccination
timeFrame: 28 days after the first vaccination
measure: to evaluate the seroconversion rate of Antinuclear antibodies in serum after second vaccination
timeFrame: 28 days after second vaccination
measure: to evaluate the abnormity change of live and kidney function indexes in serum after first vaccination
timeFrame: 3 days after first vaccination
measure: to evaluate the abnormity change of live and kidney function indexes in serum after second vaccination
timeFrame: 3 days after second vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Jiangsu Provincial Center for Diseases Control and Prevention
name: Fengcai Zhu, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meng FY, Li JX, Li XL, Chu K, Zhang YT, Ji H, Li L, Liang ZL, Zhu FC. Tolerability and immunogenicity of an inactivated enterovirus 71 vaccine in Chinese healthy adults and children: an open label, phase 1 clinical trial. Hum Vaccin Immunother. 2012 May;8(5):668-74. doi: 10.4161/hv.19521. Epub 2012 May 1.