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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase Ia Clinical Trial for Inactivated Vaccine(Vero Cell) Against EV71 in Chinese Healthy Young Adults and Children

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.

Detailed Summary:
Sponsor: Jiangsu Province Centers for Disease Control and Prevention

Current Primary Outcome:

• to evaluate the safety of EV71 vaccine in Chinese healthy adults and children [ Time Frame: 28 days after the first vaccination ]
  to evaluate the Adverse reactions of EV71 vaccine in Chinese healthy adults and children
• to evaluate the safety of EV71 vaccine in Chinese healthy adults and children [ Time Frame: 28 days after the second vaccination ]
  to evaluate the Adverse reactions of EV71 vaccine in Chinese healthy adults and children

Original Primary Outcome: Same as current

Current Secondary Outcome:

• to evaluate the seroconversion rate of Antinuclear antibodies in serum after first vaccination [ Time Frame: 28 days after the first vaccination ]
  to evaluate the seroconversion rate of Antinuclear antibodies in serum 28 days after first vaccination
• to evaluate the seroconversion rate of Antinuclear antibodies in serum after second vaccination [ Time Frame: 28 days after second vaccination ]
  to evaluate the seroconversion rate of Antinuclear antibodies in serum 28 days after second vaccination
• to evaluate the abnormity change of live and kidney function indexes in serum after first vaccination [ Time Frame: 3 days after first vaccination ]
  to evaluate the abnormity change of live and kidney function indexes in serum 3 days after first vaccination
• to evaluate the abnormity change of live and kidney function indexes in serum after second vaccination [ Time Frame: 3 days after second vaccination ]
  to evaluate the abnormity change of live and kidney function indexes in serum 3 days after second vaccination

Original Secondary Outcome: Same as current

Information By: Jiangsu Province Centers for Disease Control and Prevention

Dates:
Date Received: December 28, 2010
Date Started: January 2011
Date Completion:
Last Updated: June 9, 2011
Last Verified: January 2011