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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
360
inactivated vaccine(vero cell) against EV71 of 160U /0.5ml, two doses, one month interval
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, one month interval
inactivated vaccine(vero cell) against EV71 of 640U /0.5ml, two doses, one month interval
0/0.5ml placebo, two doses, one month interval
Donghai Center for Diseases Control and Prevention
Lianyungang, Jiangsu, China
Number of participants with adverse events after first vaccination
To evaluate the adverse events of EV71 vaccine in healthy children and infants after first vaccination
Time frame: 28 days after the first vaccination
Number of participants with adverse events after second vaccination
To evaluate the adverse events of EV71 vaccine in healthy children and infants after second vaccination
Time frame: 28 days after the second vaccination
The seroconversion rate of anti-EV71 antibodies in serum after first vaccination
To evaluate the seroconversion rate of anti-EV71 antibodies in serum 28 days after first vaccination
Time frame: 28 days after the first vaccination
The seroconversion rate of anti-EV71 antibodies in serum after second vaccination
To evaluate the seroconversion rate of anti-EV71 antibodies in serum 28 days after second vaccination
Time frame: 28 days after second vaccination
The abnormity change of liver and kidney function indexes in serum after first vaccination in children
To evaluate the abnormity change of liver and kidney function indexes in serum 3 days after first vaccination in children
Time frame: 3 days after first vaccination
The abnormity change of liver and kidney function indexes in serum after second vaccination in children
To evaluate the abnormity change of liver and kidney function indexes in serum 3 days after second vaccination in children
Time frame: 3 days after second vaccination
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