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The Phase IVc of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell)

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ClinicalTrials.gov Identifier: NCT03240744
Recruitment Status : Active, not recruiting
First Posted : August 7, 2017
Last Update Posted : September 6, 2017
Sponsor:
Collaborator:
Hubei Provincial Center for Disease Control and Prevention
Information provided by (Responsible Party):
Qihan Li, Chinese Academy of Medical Sciences

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 IVc is to evaluated the immunogenicity of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old) in Hubei Province, China.


Condition or disease Intervention/treatment Phase
Hand, Foot and Mouth Disease (HFMD) Biological: Inactivated EV71 vaccine (human diploid cell, KMB-17) Phase 4

Detailed Description:

There are two parts of phase IVc clinical trials have been performed. First, to evaluate the immunogenicity of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old), within 56-day-post-immunized.

Second, to long-term immunogenicity of the inactive EV71 vaccine in large scale population of Chinese children (from 6 to 71 months old).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Inactivated EV71 vaccine (KMB-17 cells)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study on Immunogenicity of Inactivated Enterovirus 71 (EV71) Vaccine (Human Diploid Cell, KMB-17) in Large-scale Healthy Children in China
Actual Study Start Date : June 22, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: vaccine (3.0EU)
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 (human diploid cell, KMB-17)
3.0 EU of inactivated enterovirus 71 vaccine (KMB-17) on day 0, 28.




Primary Outcome Measures :
  1. Evaluate the seroconversion rate of anti-EV71 antibodies in serum of children [ Time Frame: at 28 days after finishing 2 doses immunization ]
    Bloods were obtained at 0 and 56 days after first vaccination. The antibody titers were tested in serum of children. And the seroconversion rate of anti-EV71 antibodies was calculated.

  2. Evaluate the antibody titers of anti-EV71 antibodies in serum of children [ Time Frame: at 28 days after finishing 2 doses immunization ]
    Bloods were obtained at 0 and 56 days after first vaccination. The antibody titers were tested in serum of children. And the seroconversion rate of anti-EV71 antibodies was calculated.


Secondary Outcome Measures :
  1. Evaluate long-term of the seroconversion rate of anti-EV71 antibodies in serum of children [ Time Frame: Up to 3 years after finishing 2 doses immunization ]
    Bloods were obtained at 0, 28 and 56 days after first vaccination, and 180, 360 and 720 days after 2 doses immunization. The antibody titers were tested in serum of children. And the seroconversion rate of anti-EV71 antibodies was calculated.

  2. Evaluate long-term of the antibody titers of anti-EV71 antibodies in serum of children [ Time Frame: Up to 3 years after finishing 2 doses immunization ]
    Bloods were obtained at 0, 28 and 56 days after first vaccination, and 180, 360 and 720 days after 2 doses immunization. The antibody titers were tested in serum of children. And the seroconversion rate of anti-EV71 antibodies was calculated.


Other Outcome Measures:
  1. Incidence of treatment adverse events [ Time Frame: Up to 3 years after finishing 2 doses immunization ]
    The adverse events were observed and recorded within 30 minutes post immunization (p.i.), within 0-1 days post immunization (d.p.i.), within 1-3 d.p.i. and within 3-7 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 3 years after finishing 2 doses immunization.



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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 14-month visit (and receive blood, stool (or specimens by means of a swab) tests according to program requirements in immunogenicity observation group)

Exclusion Criteria:

  • Allergy or serious side-effects to a vaccine or any ingredient of vaccine
  • Epilepsy, seizures, convulsions, neurological illness
  • Congenital or hereditary immunodeficiency
  • Autoimmune disease
  • 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 ﹥90 mmHg; 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

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): NCT03240744


Locations
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China, Hubei
Hubei Province Center for Diseases Control and Prevention
Wuhan, Hubei, China
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Hubei Provincial Center for Disease Control and Prevention
Investigators
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Principal Investigator: Xuhua Guan, M.S. Hubei Province Center for Diseases Control and Prevention

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Responsible Party: Qihan Li, Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03240744     History of Changes
Other Study ID Numbers: 2017-003-02
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: April 2017

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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 Qihan Li, Chinese Academy of Medical Sciences:
immunogenicity
safety
Hand, Foot and Mouth Disease (HFMD)

Additional relevant MeSH terms:
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Mouth Diseases
Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Stomatognathic Diseases
Coxsackievirus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs