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The Phase IVd of Inactivated Enterovirus 71 Vaccine

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ClinicalTrials.gov Identifier: NCT03296410
Recruitment Status : Enrolling by invitation
First Posted : September 28, 2017
Last Update Posted : September 28, 2017
Sponsor:
Collaborator:
Guangdong Center for Disease Prevention and Control
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 IVd is to evaluated the immunogenicity and safety of the inactive EV71 vaccine within two measles attenuated live vaccine and live attenuated Japanese encephalitis vaccine at the same time point in large scale population of Chinese children (8 months old) in Guangdong Province, China.


Condition or disease Intervention/treatment Phase
Hand, Foot and Mouth Disease (HFMD) Biological: EV71 and two measles attenuated live vaccine Biological: EV71 and attenuated Japanese encephalitis vaccine Biological: two measles attenuated live vaccine Biological: live attenuated Japanese encephalitis vaccine Biological: EV71 vaccine Phase 4

Detailed Description:

There are two parts of phase IVd clinical trials have been performed. First, to evaluate the immunogenicity of the inactive EV71 vaccine within two measles attenuated live vaccine and live attenuated Japanese encephalitis vaccine at the same time point in large scale population of Chinese children (8 months old), within 56-day-post-immunized.

Second, to safety of the inactive EV71 vaccine within two measles attenuated live vaccine and live attenuated Japanese encephalitis vaccine at the same time point in large scale population of Chinese children (8 months old), within 56-day-post-immunized.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Safety and Immunogenicity of Enterovirus Type 71 Inactivated Vaccine (Human Diploid Cell) With Two Measles Attenuated Live Vaccine and Live Attenuated Japanese Encephalitis Vaccine at the Same Time Point in Infants (8-month-old)
Actual Study Start Date : September 14, 2017
Estimated Primary Completion Date : September 2, 2019
Estimated Study Completion Date : September 2, 2019


Arm Intervention/treatment
Experimental: EV71 and two measles attenuated live vaccine
infants vaccinated with enterovirus type 71 inactivated vaccine (human diploid cell) and two measles attenuated live vaccine at 8 months old, and vaccinated with the second dose of enterovirus type 71 inactivated vaccine (human diploid cell) at 9 months old.
Biological: EV71 and two measles attenuated live vaccine
infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month). And meanwhile, they routine vaccined with two measles attenuated live vaccine at 8 months old.

Experimental: EV71 and attenuated Japanese encephalitis vaccine
infants vaccinated with enterovirus type 71 inactivated vaccine (human diploid cell) and live attenuated Japanese encephalitis vaccine at 8 months old, and vaccinated with the second dose of enterovirus type 71 inactivated vaccine (human diploid cell) at 9 months old.
Biological: EV71 and attenuated Japanese encephalitis vaccine
infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month). And meanwhile, they routine vaccined with attenuated Japanese encephalitis vaccine at 8 months old.

Active Comparator: two measles attenuated live vaccine
infants vaccinated with two measles attenuated live vaccine at 8 months old
Biological: two measles attenuated live vaccine
infants vaccined with one dose two measles attenuated live vaccine at 8 months old.

Active Comparator: live attenuated Japanese encephalitis vaccine
infants vaccinated with live attenuated Japanese encephalitis vaccine at 8 months old
Biological: live attenuated Japanese encephalitis vaccine
infants vaccined with one dose attenuated Japanese encephalitis vaccine at 8 months old.

Active Comparator: EV71 vaccine
infants vaccinated with enterovirus type 71 inactivated vaccine (human diploid cell) at 8 months old, and vaccinated with the second dose of enterovirus type 71 inactivated vaccine (human diploid cell) at 9 months old.
Biological: EV71 vaccine
infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month).




Primary Outcome Measures :
  1. Evaluate the seropositive rate of anti-EV71 antibodies in serum of children before first vaccination [ Time Frame: at 0 day before finishing 1st doses immunization ]
    Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.

  2. Evaluate the seropositive rate of anti-EBV antibodies in serum of children before first vaccination [ Time Frame: at 0 day before finishing 1st doses immunization ]
    Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.

  3. Evaluate the seropositive rate of anti-measles virus antibodies in serum of children before first vaccination [ Time Frame: at 0 day before finishing 1st doses immunization ]
    Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.

  4. Evaluate the seropositive rate of anti-Rubella virus antibodies in serum of children before first vaccination [ Time Frame: at 0 day before finishing 1st doses immunization ]
    Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.

  5. Evaluate the seroconversion rate of anti-EV71 antibodies in serum of children at 56 days after first vaccination [ Time Frame: at 56 days after finishing 1st doses immunization ]
    Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.

  6. Evaluate the seroconversion rate of anti-EBV antibodies in serum of children at 56 days after first vaccination [ Time Frame: at 56 days after finishing 1st doses immunization ]
    Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.

  7. Evaluate the seroconversion rate of anti-measles virus antibodies in serum of children at 56 days after first vaccination [ Time Frame: at 56 days after finishing 1st doses immunization ]
    Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.

  8. Evaluate the seroconversion rate of anti-Rubella virus antibodies in serum of children at 56 days after first vaccination [ Time Frame: at 56 days after finishing 1st doses immunization ]
    Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.


Secondary Outcome Measures :
  1. Evaluate the antibody titers of anti-EV71 antibodies in serum of children [ Time Frame: at 56 days after finishing 1st doses immunization ]
    Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.

  2. Evaluate the antibody titers of anti-EBV antibodies in serum of children [ Time Frame: at 56 days after finishing 1st doses immunization ]
    Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.

  3. Evaluate the antibody titers of anti-measles virus antibodies in serum of children [ Time Frame: at 56 days after finishing 1st doses immunization ]
    Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.

  4. Evaluate the antibody titers of anti-Rubella virus antibodies in serum of children [ Time Frame: at 56 days after finishing 1st doses immunization ]
    Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.

  5. Incidence of treatment adverse events finishing 1st doses immunization [ Time Frame: within 28 days after finishing 1st 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 28 d.p.i. after the 1st injection.

  6. Incidence of treatment adverse events finishing 2nd doses immunization [ Time Frame: within 28 days after finishing 2nd 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 28 d.p.i. after injection.



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Ages Eligible for Study:   8 Months to 9 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): NCT03296410


Locations
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China, Guangdong
Guangdong Province Center for Diseases Control and Prevention
Guangzhou, Guangdong, China, 511430
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Guangdong Center for Disease Prevention and Control

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Responsible Party: Qihan Li, Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03296410     History of Changes
Other Study ID Numbers: 20170710
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 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:
Hand, Foot and Mouth Disease (HFMD)
immunogenicity
safety

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