Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study on Dynamic Changes of the Maternal Anti-EV71 and Anti-CVA16 Antibody Levels in Infants and Young Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01255124
First received: December 4, 2010
Last updated: September 12, 2011
Last verified: September 2011
  Purpose

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.


Condition
Hand, Foot and Mouth Disease
Anti-EV71
Anti-CVA16

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on Dynamic Changes of the Maternal Anti-EV71 and Anti-CVA16 Antibody Levels in Infants and Young Children

Resource links provided by NLM:


Further study details as provided by Jiangsu Province Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • dynamic changes of the maternal anti-EV71 [ Time Frame: from birth to 3 years old ] [ Designated as safety issue: No ]
    dynamic changes of the maternal anti-EV71 in infants and young children


Secondary Outcome Measures:
  • dynamic changes of the maternal anti-CVA16 [ Time Frame: from birth to 3 years old ] [ Designated as safety issue: No ]
    dynamic changes of the maternal anti-CVA16 in infants and young children

  • incidence of HFMD [ Time Frame: from birth to 3 years old ] [ Designated as safety issue: No ]
    retrospectively investigate their HFMD histories from birth and follow-up for another year to get the information about the incidence of HFMD.


Biospecimen Retention:   Samples Without DNA

Umbilical cord blood serum and blood serum, Nasopharyngeal swabs, rectal swab


Enrollment: 1297
Study Start Date: October 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Health infants (ClinicalTrials.gov ID: NCT01183611)
The subjects participated in the clinical trial 'The Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Health Neonates' in 2007 (ClinicalTrials.gov ID: NCT01183611).

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.

  Eligibility

Ages Eligible for Study:   2 Years to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population are the health infants born after September 2007 in 6 countries in Jinagsu Province.

Criteria

Inclusion Criteria:

  • The subjects participated in the clinical trial named 'The Safety and Immunogenicity of Recombinant Hepatitis B Vaccines in the Health Neonates'in 2007 (ClinicalTrials.gov ID: NCT01183611).
  • Written informed consent obtained from the parent(s) of the subject.
  • Subjects who the investigator believes will comply with the requirements of the protocol.

Exclusion Criteria:

  • Neonatal jaundice requiring systemic treatment.
  • Major congenital defects or serious chronic illness.
  • Maldevelopment
  • Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255124

Locations
China, Jiangsu
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention
Investigators
Principal Investigator: Feng-cai Zhu, Master Jiangsu Provincial Center for Diseases Control and Prevention
  More Information

No publications provided

Responsible Party: Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01255124     History of Changes
Other Study ID Numbers: JSVCT002
Study First Received: December 4, 2010
Last Updated: September 12, 2011
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Mouth Diseases
Coxsackievirus Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Stomatognathic Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014