A Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants
Condition: Hand, Foot, and Mouth Disease; Enterovirus Infections
MeSH terms: Enterovirus Infections; Hand, Foot and Mouth Disease; Mouth Diseases
Study type: Interventional
Phase: Phase 1

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.

      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.
    

Detailed description: 
      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.
    

Intervention name(s): 160U /0.5ml; 320U /0.5ml; 640U /0.5ml; 0/0.5ml placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Safety; Immunogenicity; inactivated EV71 vaccine