Study on Dynamic Changes of the Maternal Anti-EV71 and Anti-CVA16 Antibody Levels in Infants and Young Children
Condition: Hand, Foot and Mouth Disease; Anti-EV71; Anti-CVA16
MeSH terms: Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Mouth Diseases
Study type: Observational

Summary: 
      Hand, Foot and Mouth Disease（HFMD）is an infectious disease in infants and young children
      caused by enterovirus. There was a great outbreak of HFMD in China, 2008, which brought not
      only panic to the people, but also huge economic loss. Since 2008, HFMD has become one of the
      category c infectious diseases in China. Studies showed that Human Enterovirus 71 (EV71) and
      coxsackievirus A 16 (CVA16) are the most common reasons for this disease. And the
      investigators are going to develop the vaccines for this disease. There is an urgent need to
      know the dynamic changes of the maternal anti-EV71 and ant-CVA16 level in infants and young
      children. In April 2007, the investigators started a clinical trial named 'The Safety and
      Immunogenicity of Recombinant Hepatitis B Vaccines in the Health Neonates'
      (ClinicalTrials.gov ID: NCT01183611). In that study the investigators already built a cohort
      of Health Neonates, followed them and obtained the blood serum on the day 0, 30, 210 and 360
      after born. So, based on the cohort and blood serum the investigators got, the investigators
      plan this study to retrospectively investigate their HFMD histories from birth and follow-up
      for another year to get the information about the incidence of HFMD. The investigators also
      plan to assay the maternal anti-EV71 and anti-CVA16 antibodies on the day0 and the dynamic
      changes of antibodies on 1st month, 7th month (day 210), 1st year (day 360) and on October,
      2010.
    

Detailed description: 
      Hand, Foot and Mouth Disease（HFMD）is a common infectious disease in infants and young
      children which is caused by enterovirus. HFMD is one of the category c infectious diseases in
      China. However a group of picornavirus of enterovirus can caused HFMD, including
      coxsackievirus A (CVA), coxsackievirus B(CVB), Human Enterovirus 71(EV71), Echovirus(ECHO)
      and so on, EV71 and CVA16 are the most common reason for this disease. This study is carried
      out to discover dynamic changes of the maternal anti-EV71 and anti-CVA16 antibody in infants
      and young children from this study.

      Infections of Hand, Foot and Month Disease in infants and young children may lead to a
      certain proportion of serious cases with various complications or death. The primary aim of
      this study is to find dynamic changes of the maternal anti-EV71 antibody in infants and young
      children and to provide basic data for the future application of EV71 vaccines. The second
      aim of this study is to find dynamic changes of the maternal anti- CVA16 antibody levels in
      infants and young children The third aim of this study is to discover the risk factors of
      Hand, Foot and Month Disease and to estimate the burden of disease.Hand, Foot and Mouth
      Disease（HFMD）is a common infectious disease in infants and young children caused by
      enterovirus. Since 2008, HFMD has become one of the category c infectious diseases in China.
      However a group of picornavirus of enterovirus can caused HFMD, including coxsackievirus A
      (CVA), coxsackievirus B(CVB), Human Enterovirus 71(EV71), Echovirus(ECHO) and so on, EV71 and
      CVA16 are the most common reason for this disease. This study is carried out to discover
      dynamic changes of the maternal anti-EV71 and ant-CVA16 in infants and young children from
      this study.

      Infections of Hand, Foot and Month Disease in infants and young children may lead to a
      certain proportion of serious cases with various complications or death. The primary aim of
      this study is to find dynamic changes of the maternal anti-EV71 in infants and young children
      and to provide basic data for the future application of EV71 vaccines. The second aim of this
      study is to find dynamic changes of the maternal anti-CVA16 levels in infants and young
      children. The third aim of this study is to discover the risk factors of Hand, Foot and Month
      Disease and to estimate the burden of disease.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population are the health infants born after September 2007 in 6 countries in
        Jinagsu Province.
      
Biospecimen description: 
      Umbilical cord blood serum and blood serum, Nasopharyngeal swabs, rectal swab