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The Phase IVa of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell, KMB-17)

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ClinicalTrials.gov Identifier: NCT02999828
Recruitment Status : Unknown
Verified January 2018 by Qihan Li, Chinese Academy of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : December 21, 2016
Last Update Posted : January 23, 2018
Sponsor:
Collaborators:
Beijing Chaoyang District Centre for Disease Control and Prevention
Neimenggu Province Centre for Disease Control and Prevention
Information provided by (Responsible Party):
Qihan Li, Chinese Academy of Medical Sciences

Study Description
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Brief Summary:

Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae. Its infection occasionally leads to severe diseases and death, with central nervous system (CNS) damage.

Recently, except of inactivated vaccine, several EV71 vaccine candidates have been evaluated in animals but no final results of clinical trials, such as attenuated vaccine, subunit vaccine.

A formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been finished phase I, II and III clinical trials and licensed by SFDA in China at Dec. 3, 2015. Based on the results of clinical trials, the protective efficacy of inactivated EV71 vaccine is 97% against HFMD caused by EV71. The phase IV clinical trial has been carried out from July 2016. The purpose of phase IV is to evaluated the safety and efficacy of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old).


Condition or disease Intervention/treatment Phase
Safety of Inactivated EV71 Vaccine Immunization of Inactivated EV71 Vaccine Biological: inactivated EV71 vaccine (KMB-17) Phase 4

Detailed Description:

Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae. Its infection occasionally leads to severe diseases and death, with central nervous system (CNS) damage.

Recently, except of inactivated vaccine, several EV71 vaccine candidates have been evaluated in animals but no final results of clinical trials, such as attenuated vaccine, subunit vaccine.

A formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been finished phase I, II and III clinical trials and licensed by SFDA in China at Dec. 3, 2015. Based on the results of clinical trials, the protective efficacy of inactivated EV71 vaccine is 97% against HFMD caused by EV71. The phase IV clinical trial has been carried out from July 2016. The purpose of phase IV is to evaluated the safety and efficacy of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old).

There are three parts of phase IV clinical trials have been performed. First, to evaluate the safety of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old).

Second, to evaluate the immune persistence of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old).

Third, to evaluate the efficacy of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20770 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Safety, Immune Persistence and Consistency of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell, KMB-17)
Actual Study Start Date : September 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: 3.0 EU in Children
healthy children (6-71 months old) have been injected by inactivated EV71 vaccine (KMB-17) of 3.0 EU (neutralization antibodies titer unit; 100 U in phase III clinical trials, or 320 EU (Elisa assay unit) in phase I and II clinical trials)
 Biological: inactivated EV71 vaccine (KMB-17)
3.0EU of inactivated enterovirus 71 vaccine (KMB-17) on day 0, 28.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of treatment adverse events [ Time Frame: Up to 24 months after finishing 2 doses immunization ]
    The adverse events were observed and recorded within 30 minutes post immunization (p.i.), within 0-7 days post immunization (d.p.i.) and within 8-28 d.p.i after the 1st injection, as well as after the 2nd injection. And the adverse events were also observed and recorded following within 24 months after finishing 2 doses immunization.


Secondary Outcome Measures :
  1. The incidence rates of HFMD [ Time Frame: Up to 24 months after finishing 2 doses immunization ]
    All hand, foot and mouth disease (HFMD) cases from the subjects were observed and recorded, including common cases, severe cases, dead cases, the cases caused by enterovirus 71, the severe cases caused by enterovirus 71, the dead cases caused by enterovirus 71. The incidence rates of the subjects from this clinical trial were calculated.

  2. immune response of inactivated EV71 vaccine (KMB-17) in a large crowd [ Time Frame: Up to 24 months after finishing 2 doses immunization ]
    The blood specimens were obtained at 0, 28, 56, 180, 360 and 720 days post the 1st immunization (p.i.). The levels of neutralization antibodies and cytokines were tested at each time point. The seroconversion rate of anti-EV71 antibodies was evaluated in serum of children. And the specific IFN-γ in subjects were tested and evaluated at 0, 180 and 360 d.p.i..


Other Outcome Measures:
  1. The level of anti-EV71 antibodies was evaluated in serum of children [ Time Frame: Up to 24 months after finishing 2 doses immunization ]
    The blood specimens were obtained at 0, 28, 56, 180, 360 and 720 days post the 1st immunization (p.i.). The levels of neutralization antibodies were tested at each time point. The level of anti-EV71 antibodies was evaluated in serum of children.


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:

  • Healthy subjects (6-71 months old children) as established by medical history and clinical examination
  • The subjects' legal guardian must be aware of this vaccines
  • The subjects' legal guardian voluntarily participate in the study and signed Informed Consent Form
  • Subjects with temperature ≤ 37.0 ℃
  • The subjects' legal guardian with the ability and objective to comply with the requirements of the protocol
  • Persist for a 24-month visit (and receive blood, stool (or specimens by means of a swab) tests according to program requirements in immunogenicity observation group)
  • report the HFMD cases

Exclusion Criteria:

  • Subject who has a clinical diagnosis history of Hand, Foot and Mouth Disease (HFMD)
  • Allergy or serious side-effects to a vaccine or any ingredient of vaccine
  • Epilepsy, seizures, convulsions, neurological illness
  • Congenital or hereditary immunodeficiency
  • Autoimmune disease
  • Severe malnutrition or dysgenopathy
  • Asthma, thyroidectomy, angioneurotic edema, diabetes or cancer
  • Asplenia, functional asplenia, and any circumstances leading to the asplenia or splenectomy
  • Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder
  • Acute illness or acute exacerbation of chronic disease in last 7 days
  • Any prior administration of immunodepressant or corticosteroids in last 6 months
  • Any prior administration of blood products in last 3 months
  • Any prior administration of live-attenuated vaccine in last 15 days
  • Any prior administration of subunit or inactivated vaccines in last 7 days
  • Fever before vaccination, axillary temperature ﹥37.0 ℃
  • The laboratory test abnormalities before vaccination, including blood tests (hemoglobin, total white blood cells, WBC, platelets), blood biochemistry tests (ALT, total bilirubin, direct bilirubin, Cr, BUN) and urine tests (urine protein, urine sugar, blood cells), etc.
  • Hypertension or hypotension. Systolic blood pressure ﹥140 mmHg and/or diastolic blood pressure ﹥90mmHg; systolic blood pressure ﹤90 mmHg and/or diastolic blood pressure ﹤60 mmHg
  • Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
  • take part into other vaccine or drug clinical trials in last half year
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): NCT02999828


Locations
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China
Chaoyang of Provincial Center for Diseases Control and Prevention in Beijing
Beijing, China, 100021
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Beijing Chaoyang District Centre for Disease Control and Prevention
Neimenggu Province Centre for Disease Control and Prevention
Investigators
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Principal Investigator: Nianmin Shi, M.S. Chaoyang Provincial Center for Diseases Control and Prevention in Beijing
Study Chair: Shaohong Yan, M.S. Neimenggu Provincial Center for Diseases Control and Prevention
More Information
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Responsible Party: Qihan Li, Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02999828    
Other Study ID Numbers: CY2016KMEV
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participants do not agree to share individual data.
Keywords provided by Qihan Li, Chinese Academy of Medical Sciences:
safety
immune persistence
Additional relevant MeSH terms:
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Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases