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Efficacy Trial of a Commercial EV71 Vaccine

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ClinicalTrials.gov Identifier: NCT03903926
Recruitment Status : Active, not recruiting
First Posted : April 4, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd

Study Description
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Brief Summary:
The purpose of this post-marketing study is to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine post marketing, and explore the protective levels of various enterovirus neutralizing antibodies

Condition or disease Intervention/treatment Phase
Hand, Foot and Mouth Disease Biological: 5000 volunteers (6-35 months)-EV71 vaccine Phase 4

Detailed Description:
This study is a post-marketing aims to evaluate the efficacy, immunogenicity, and safety of the EV71 vaccine, and explore the protective levels of various enterovirus neutralizing antibodies. This study includes the following three sections: (1) efficacy study of EV71 vaccine based on enhanced cases monitoring, using prospective cohort study design (2) study on correlation between EV71 vaccine protection and EV71 antibody levels, using case-control study design (3) pathogenic spectrum and sero-epidemiological investigation of hand, foot and mouth disease (HFMD) in children. 15500 volunteers aged 6-71 months are expected to participate in this study, among which 5000 volunteers aged 6-35 months will receive two doses EV71 vaccine manufactured by Sinovac Biotech Co., Ltd, and constitute the experimental cohort. 10000 unvaccinated volunteers aged 6-35 months will constitute the the control cohort. The efficacy evaluation will be conducted based on the abovementioned two cohort. Enhanced HFMD surveillance system will be established to report the HFMD cases in the abovementioned 2 cohorts, as well as another cohort consisting of 500 volunteers aged 36-71 months. The case surveillance period of this study is one year. Laboratory tests will be conducted for case confirmation.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase Ⅳ Clinical Trial, to Evaluate the Efficacy of the Enterovirus 71 (EV71) Inactivated Vaccine and Its Correlation With EV71 Antibody Level
Actual Study Start Date : March 26, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : October 30, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort one
5000 volunteers (6-35 months)-EV71 vaccine
 Biological: 5000 volunteers (6-35 months)-EV71 vaccine
two doses EV71 vaccines will be administrated on day 0, 30 respectively
No Intervention: Cohort two
10000 unvaccinated volunteers (6-35 months)
No Intervention: Cohort three
500 unvaccinated volunteers (36-71 months)


Outcome Measures
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Primary Outcome Measures :
  1. The efficacy of two doses EV71 vaccine in the 6-35 months old subjects [ Time Frame: During the case monitoring period of 1 year ]
    Vaccine Efficacy (VE)=(incidence difference between vaccinated and unvaccinated group/incidence of vaccinated group)*100%

  2. The seroprotective titers of the EV71 neutralizing antibody in the 6-35 months old subjects [ Time Frame: Through study completion, an average of 1 year ]
    Immune correlates of protection


Secondary Outcome Measures :
  1. The incidence of adverse events after the EV71 vaccination in the 6-35 months old subjects [ Time Frame: Within 6 months after each dose injection ]
    Safety index

  2. The seroprotective titers of the CA16, CA6, CA10 neutralizing antibody in the 6-35 months old subjects [ Time Frame: Through study completion, an average of 1 year ]
    Immune correlates of protection

  3. The seropositive rate of the EV71, CA16, CA6, CA10 neutralizing antibody in the 6-71 months old subjects [ Time Frame: During the study period, 2 months after the study beginning ]
    Serum epidemiological index

  4. The geometric mean titer (GMT) of the EV71, CA16, CA6, CA10 neutralizing antibody in the 6-71 months old subjects [ Time Frame: During the study period, 2 months after the study beginning ]
    Serum epidemiological index

  5. The seroconversion rate of the EV71 neutralizing antibody after vaccination in the 6-35 months old subjects [ Time Frame: 30 days after two doses ]
    Immunogenicity index

  6. The geometric mean increase (GMI) of the EV71 neutralizing antibody after vaccination in the 6-35 months old subjects [ Time Frame: 30 days after two doses ]
    Immunogenicity index

  7. Proportions of various pathogens in the confirmed HFMD cases [ Time Frame: Through study completion, an average of 1 year ]
    Pathogen spectrum index


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 71 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Volunteers aged 6-71 months;
  • Guardians of the participants voluntarily to vaccinate the participants with EV71 vaccine at their own expense;
  • Guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrollment;
  • Complying with the requirement of the study protocol;

Exclusion Criteria:

  • History of HFMD prior to the study entry;
  • Prior vaccination with EV71 vaccine;
  • History of allergy to any vaccine, or any ingredient, excipients and Gentamycin Sulfate of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc. (only for 6-35 months old subjects of the vaccinated group) ;
  • Congenital malformation, developmental disorders, genetic defects, or severe malnutrition (only for 6-35 months old subjects of the vaccinated group);
  • Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness (only for 6-35 months old subjects of the vaccinated group);
  • Autoimmune disease or immunodeficiency/immunosuppressive (only for 6-35 months old subjects of the vaccinated group) ;
  • History of asthma, angioedema, diabetes or malignancy (only for 6-35 months old subjects of the vaccinated group);
  • Acute disease or acute stage of chronic disease within 7 days prior to study entry (only for 6-35 months old subjects of the vaccinated group);
  • Axillary temperature > 37.0 Celsius (only for 6-35 months old subjects of the vaccinated group)；
  • Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators.
Contacts and Locations
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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): NCT03903926


Locations
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China, Hubei
Songzi Center for Disease Control and Prevention
Jingzhou, Hubei, China, 434200
Xiantao Center for Disease Control and Prevention
Xiantao, Hubei, China, 433000
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Investigators
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Principal Investigator: Xuhua Guan, Doctor Hubei Provincial Center for Disease Control and Prevention
More Information
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Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT03903926    
Other Study ID Numbers: PRO-EV71-4013
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sinovac Biotech Co., Ltd:
EV71 vaccine; Efficacy; Seroprotective correlates
Additional relevant MeSH terms:
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Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Mouth Diseases
Stomatognathic Diseases
Picornaviridae Infections
 RNA Virus Infections
Virus Diseases
Coxsackievirus Infections
Enterovirus Infections