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

This study has been completed.
Sponsor:
Collaborator:
Bejing Vigoo Biological Co., LTD
Information provided by:
Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01267903
First received: December 28, 2010
Last updated: June 9, 2011
Last verified: January 2011
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • to evaluate the safety of EV71 vaccine in Chinese healthy adults and children [ Time Frame: 28 days after the first vaccination ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    to evaluate the Adverse reactions of EV71 vaccine in Chinese healthy adults and children


Secondary Outcome Measures:
  • to evaluate the seroconversion rate of Antinuclear antibodies in serum after first vaccination [ Time Frame: 28 days after the first vaccination ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    to evaluate the abnormity change of live and kidney function indexes in serum 3 days after second vaccination


Enrollment: 100
Study Start Date: January 2011
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   5 Years to 22 Years
Genders Eligible for Study:   Both
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
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: NCT01267903

Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention
Bejing Vigoo Biological Co., LTD
Investigators
Principal Investigator: Fengcai Zhu, Master Jiangsu Provincial Center for Diseases Control and Prevention
  More Information

No publications provided by Jiangsu Province Centers for Disease Control and Prevention

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zhu Fengcai, Jiangsu Provincial Center for Diseases Control and Prevention
ClinicalTrials.gov Identifier: NCT01267903     History of Changes
Other Study ID Numbers: JSVCT003
Study First Received: December 28, 2010
Last Updated: June 9, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Jiangsu Province Centers for Disease Control and Prevention:
Vaccines Adverse Reaction

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

ClinicalTrials.gov processed this record on October 16, 2014