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Clinical Study on Combined Immune Effect of EV71 Inactivated Vaccine

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ClinicalTrials.gov Identifier: NCT03519568
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : May 9, 2018
Sponsor:
Collaborators:
Hunan Province Centers for Disease Control and Prevention
Shaanxi Province Centers for Disease Control and Prevention
Shanxi Province Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Shandong Province Centers for Disease Control and Prevention

Brief Summary:

Background: To prevent and control the epidemic of HFMD and related diseases caused by EV71 infection, the development of EV71 vaccine has been developed in many countries or regions. According to the requirements of drug registration approval, we need to evaluate immunogenicity and safety effect on combined immune effect of EV71 inactivated vaccine and other vaccines (HepB、MPSV-A、MR、JE-L).

Method: Four experimental groups (HepB:3+EV71, MPSV-A:1+EV71, MR+EV71, JE-L+EV71) were included in this clinical trail. In addition to the meningococcal vaccine research group, the other three groups were followed up for the 4 times. The initial blood samples were collected, and the first dose vaccine was inoculated at the same time. EV71 second doses of vaccine were inoculated at 30 day, the blood was collected after 30 days of immunization with second doses. 6 months of safety follow-up was carried out in the whole clinical trial after vaccination. The meningococcal vaccine research group increased 1 follow-up after the second dose of MPSV-A vaccine. The index of immunogenicity and safety effect in four experimental groups need to be evaluated.


Condition or disease Intervention/treatment Phase
Enterovirus 71 Inactivated Vaccine HFMD Biological: EV71 (inoculation vaccine) Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1944 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Evaluating Immunogenicity and Safety Effect on Combined Immune Effect of EV71 Inactivated Vaccine and HepB、MPSV-A、MR、JE-L:A Multi-center Randomized Controlled Trial
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: Combination inoculation group
GroupⅠ: HepB:3 and EV71 were injected at 6 months old, EV71 second dose was injected at 7 months old GroupⅡ: MPSV-A:1 and EV71 were injected at 6 months old, EV71 second dose was injected at 7 months old, MPSV-A:1 second dose was injected at 9 months old GroupⅢ: MR and EV71 were injected at 8 months old, EV71 second dose was injected at 9 months old GroupⅣ: JE-Land EV71 were injected at 8 months old, EV71 second dose was injected at 9 months old
Biological: EV71 (inoculation vaccine)
EV71 vaccine 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China 10μg HepB 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China 30ug MPSV-A 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China MR 0.5ml per dose, Beijiing Biological Products Co., Ltd., Beijing, China JE-L 0.5ml per dose, Chengdu Biological Products Co., Ltd., Chengdu,Sichuan Province, China

Active Comparator: Separate inoculation control group
GroupⅠ: HepB:3 third dose was injected at 6 months old GroupⅡ: MPSV-A:1 was injected at 6 months old, then MPSV-A:1 second dose was injected at 9 months old GroupⅢ: MR was injected at 8 months old GroupⅣ: JE-L was injected at 8 months old
Biological: EV71 (inoculation vaccine)
EV71 vaccine 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China 10μg HepB 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China 30ug MPSV-A 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China MR 0.5ml per dose, Beijiing Biological Products Co., Ltd., Beijing, China JE-L 0.5ml per dose, Chengdu Biological Products Co., Ltd., Chengdu,Sichuan Province, China

Active Comparator: EV71 inoculation control group
GroupⅠ: EV71 was injected at 8 months old, then EV71 second dose was injected at 9 months old GroupⅡ: EV71 was injected at 8 months old, then EV71 second dose was injected at 9 months old GroupⅢ: EV71 was injected at 8 months old, then EV71 second dose was injected at 9 months old GroupⅣ: EV71 was injected at 8 months old, then EV71 second dose was injected at 9 months old
Biological: EV71 (inoculation vaccine)
EV71 vaccine 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China 10μg HepB 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China 30ug MPSV-A 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China MR 0.5ml per dose, Beijiing Biological Products Co., Ltd., Beijing, China JE-L 0.5ml per dose, Chengdu Biological Products Co., Ltd., Chengdu,Sichuan Province, China




Primary Outcome Measures :
  1. Antibody positive rate to vaccinations [ Time Frame: within 90 days after the last vaccination ]
    The definition of EV71 vaccine positive for antibody titers <1:8 before inoculation, antibody titers ≥ 1:8 after inoculation; or before inoculation antibody titer is above 1:8,the titer after vaccination appeared more than 4 times growth.Hepatitis B vaccine seroconversion was defined as Anti-HBs<10mIU/ml before inoculation, Anti-HBs after inoculation was more than 10mIU/ml.Leprosy vaccine using ELISA detection test, measles >200U/ml positive for rubella >20U/ml positive or positive before inoculation, antibody positive growth is more than 4 times.Japanese encephalitis vaccine using PRNT test before immunization antibody titer after inoculation was less than 1:5, at 1:10, or after vaccination antibody titer than before inoculation is no less than 4 times of growth is positive. A meningococcal bactericidal antibody level in serum by micro bactericidal antibody test, the antibody titer after inoculation than before inoculation is more than 4 times growth is positive.

  2. Antibody titer / concentration to vaccination [ Time Frame: within 90 days after the last vaccination ]
    Blood samples from the participants were collected before and after vaccination, the changes of serum concentration and titer were determined by serum test.


Secondary Outcome Measures :
  1. Number of Participants at the Injection Site, Solicited Systemic Reactions, or Any Unsolicited Adverse Events [ Time Frame: within 90 days after the last vaccination ]
    Participants were provided with diary cards to record the occurrence and severity of solicited local reactions at the injection site (pain, induration, erythema, edema, pruritus) during 7 days after vaccination, solicited systemic reactions (fever, headache, fatigued, cough, myalgia, asthenia, vertigo, diarrhea), and any unsolicited adverse during 29 days after vaccination.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion criteria for group Ⅰ(HepB:3+EV71)were as follows:

  1. aged ≥ 6 months
  2. sign the informed consent form
  3. the legal guardians participate in all the planned follow-up and be able to comply with all research procedures
  4. the subjects have completed the basic immunization of 2 needle recombinant hepatitis B vaccine, there is no inoculation history of EV71 vaccine, and no history of EV71 infection
  5. the last vaccination intervals ≥ 14 days
  6. temperature ≤ 37℃

Inclusion criteria for group Ⅱ(MPSV-A:1+EV71)were as follows:

  1. aged ≥ 6 months
  2. sign the informed consent form
  3. the legal guardians participate in all the planned follow-up and be able to comply with all research procedures
  4. there is no inoculation history of EV71 vaccine, and there is no history of EV71 infection
  5. the last vaccination intervals ≥ 14 days
  6. temperature ≤ 37℃

Inclusion criteria for group Ⅲ(MR+EV71)were as follows:

  1. aged ≥ 8 months
  2. sign the informed consent form
  3. the legal guardians participate in all the planned follow-up and be able to comply with all research procedures
  4. there is no inoculation history of EV71 vaccine, and there is no history of EV71 infection
  5. the last vaccination intervals ≥ 14 days and the last attenuated live vaccine intervals≥28days
  6. temperature ≤ 37℃

Inclusion criteria for group Ⅳ(JE-L+EV71)were as follows:

  1. aged ≥ 8 months
  2. sign the informed consent form
  3. the legal guardians participate in all the planned follow-up and be able to comply with all research procedures
  4. there is no inoculation history of EV71 vaccine, and there is no history of EV71 infection
  5. the last vaccination intervals ≥ 14 days and the last attenuated live vaccine intervals ≥ 28 days
  6. temperature ≤ 37℃

Exclusion Criteria:

Exclusion criteria for first needle:

  1. the history or family history of anaphylaxis, convulsion, epilepsy, encephalopathy and psychosis
  2. the history of severe inoculation allergies
  3. patients with immunodeficiency and malignant tumors during the treatment period, receiving immunosuppressive therapy (oral steroid) or HIV due to low immunity, or family members have congenital immune disease
  4. Nonspecific immunoglobulin was injected within one month
  5. temperature≥37.1℃ and infectious diseases
  6. the history of thrombocytopenia or other thrombocytopenia with a definite diagnosis
  7. respiratory disease, acute infection or chronic disease activity period
  8. severe cardiovascular disease, liver and kidney disease, and complications of diabetes
  9. infectious, suppurative and allergic dermatosis
  10. other conditions that may affect the evaluation of the trail

Exclusion criteria for follow-up needle:

  1. any serious adverse events that have a causal relationship with the inoculation of the upper dose of the vaccine
  2. the abnormality of 4 levels (local, systemic adverse reactions and vital signs) was judged to be related to vaccination
  3. other new standards of exclusion criteria for first needle
  4. other conditions that may affect the evaluation of the trail

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): NCT03519568


Contacts
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Contact: Qing Xu 86-531-82679623 sdcdc@vip.163.com

Locations
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China, Shandong
Shandong Provincial Center for Disease Control and Prevention Recruiting
Jinan, Shandong, China
Contact: Qing Xu    86-531-82679623    sdcdc@vip.163.com   
Sponsors and Collaborators
Shandong Province Centers for Disease Control and Prevention
Hunan Province Centers for Disease Control and Prevention
Shaanxi Province Centers for Disease Control and Prevention
Shanxi Province Centers for Disease Control and Prevention
  Study Documents (Full-Text)

Documents provided by Shandong Province Centers for Disease Control and Prevention:
Study Protocol  [PDF] January 5, 2018
Statistical Analysis Plan  [PDF] January 5, 2018
Informed Consent Form  [PDF] October 27, 2017


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Responsible Party: Shandong Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT03519568     History of Changes
Other Study ID Numbers: ShandongCDCP
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs