Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01267903
Recruitment Status : Completed
First Posted : December 29, 2010
Last Update Posted : June 10, 2011
Sponsor:
Collaborator:
Bejing Vigoo Biological Co., LTD
Information provided by:
Jiangsu Province Centers for Disease Control and Prevention

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Hand, Foot and Mouth Disease Biological: vaccine against EV71 of 320U/0.5ml Biological: vaccine against EV71 of 640U/0.5ml Biological: vaccine against EV71 of 160U/0.5ml Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase Ia Clinical Trial for Inactivated Vaccine(Vero Cell) Against EV71 in Chinese Healthy Young Adults and Children
Study Start Date : January 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 320U /0.5ml in young adults
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 20 young adults aged 16-22 years old on day0,28
 Biological: vaccine against EV71 of 320U/0.5ml
inactivated vaccine(vero cell) against EV71 of 320U/0.5ml on day0,28,modern medicines
Experimental: 640U /0.5ml in young adults
inactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 20 young adults aged 16-22 years old on day0,28
 Biological: vaccine against EV71 of 640U/0.5ml
inactivated vaccine(vero cell) against EV71 of 640U/0.5ml on day0,28
Experimental: 160U /0.5ml in children
inactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 20 children aged 5-15 years old on day0,28
 Biological: vaccine against EV71 of 160U/0.5ml
inactivated vaccine(vero cell) against EV71 of 160U/0.5ml on 0,28 day
Experimental: 320U /0.5ml in children
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 20 children aged 6-15 years old on day0,28
 Biological: vaccine against EV71 of 320U/0.5ml
inactivated vaccine(vero cell) against EV71 of 320U/0.5ml on day0,28
Experimental: 640U /0.5ml in children
inactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 20 children aged 6-15 years old on day0,28
 Biological: vaccine against EV71 of 640U/0.5ml
inactivated vaccine(vero cell) against EV71 of 640U/0.5ml on day0,28


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy subjects aged from 5 to 22 years old as established by medical history and clinical examination
  • The subjects or their guardians are able to understand and sign the informed consent
  • Had never received the vaccine against EV71
  • Subjects who can and will comply with the requirements of the protocol

Exclusion Criteria:

  • Subject that has a medical history of HFMD
  • subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
  • Family history of seizures or progressive neurological disease
  • Family history of congenital or hereditary immunodeficiency
  • Women of pregnancy, lactation or about to be pregnant in 60 days
  • Autoimmune disease or immunodeficiency
  • Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
  • Any prior administration of administration of immunoglobulins
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01267903


Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention
Bejing Vigoo Biological Co., LTD
Investigators
Layout table for investigator information
Principal Investigator: Fengcai Zhu, Master Jiangsu Provincial Center for Diseases Control and Prevention
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Zhu Fengcai, Jiangsu Provincial Center for Diseases Control and Prevention
ClinicalTrials.gov Identifier: NCT01267903    
Other Study ID Numbers: JSVCT003
First Posted: December 29, 2010    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: January 2011
Keywords provided by Jiangsu Province Centers for Disease Control and Prevention:
Vaccines Adverse Reaction
Additional relevant MeSH terms:
Layout table for MeSH terms
Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Mouth Diseases
Stomatognathic Diseases
Picornaviridae Infections
RNA Virus Infections
 Virus Diseases
Coxsackievirus Infections
Enterovirus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs