A Clinical Trial for Inactivated Vaccine(Vero Cell) Against EV71 in Chinese Healthy Young Adults and Children
A Clinical Trial for Inactivated Vaccine(Vero Cell) Against EV71 in Chinese Healthy Young Adults and Children
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.
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