Enterovirus Infections Clinical Trial
Official title:
A Phase Ib Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants
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.
Recently, an inactivated vaccine(vero cell) against EV71 has been licensed by SFDA in China,
this clinical trial phase Ib is armed to evaluate safety in Chinese healthy children (from
13 to 60 months old) and infants (from 6 to 12 months old) and also provide the evidences
for the EV71 vaccine immunogenicity and the probable immunizing dose.
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 Ib is armed to evaluate safety in Chinese healthy children and
infants and also provide the evidences for the EV71 vaccine immunogenicity and the probable
immunizing dose.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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