Clinical Study on Combined Immune Effect of EV71 Inactivated Vaccine

NCT03519568 | Unknown Phase 4

• 1 other identifier: ShandongCDCP
• Study Type: interventional
• Target: 1,944
• Locations: 1 country
• Sites: 1

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.

Conditions

Enterovirus 71 Inactivated Vaccine; HFMD

Outcome Measures

Primary Outcomes (2)

• Antibody positive rate to vaccinations

  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.

  within 90 days after the last vaccination

• Antibody titer / concentration to vaccination

  Blood samples from the participants were collected before and after vaccination, the changes of serum concentration and titer were determined by serum test.

  within 90 days after the last vaccination

Secondary Outcomes (1)

• Number of Participants at the Injection Site, Solicited Systemic Reactions, or Any Unsolicited Adverse Events

  within 90 days after the last vaccination

Study Arms (3)

Combination inoculation group

EXPERIMENTAL

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)

Separate inoculation control group

ACTIVE COMPARATOR

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 inoculation control group

ACTIVE COMPARATOR

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)

Interventions

EV71 (inoculation vaccine) BIOLOGICAL

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

Combination inoculation group; EV71 inoculation control group; Separate inoculation control group

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• the history or family history of anaphylaxis, convulsion, epilepsy, encephalopathy and psychosis
• the history of severe inoculation allergies
• 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
• Nonspecific immunoglobulin was injected within one month
• temperature≥37.1℃ and infectious diseases
• the history of thrombocytopenia or other thrombocytopenia with a definite diagnosis
• respiratory disease, acute infection or chronic disease activity period
• severe cardiovascular disease, liver and kidney disease, and complications of diabetes
• infectious, suppurative and allergic dermatosis
• other conditions that may affect the evaluation of the trail
• any serious adverse events that have a causal relationship with the inoculation of the upper dose of the vaccine
• the abnormality of 4 levels (local, systemic adverse reactions and vital signs) was judged to be related to vaccination
• other conditions that may affect the evaluation of the trail

Sponsors & Collaborators

• Shandong Province Centers for Disease Control and Prevention: lead
• Hunan Provincial Center for Disease Control and Prevention: collaborator
• Shaanxi Provincial Center for Disease Control and Prevention: collaborator

Study Sites (1)

Shandong Provincial Center for Disease Control and Prevention

Jinan, Shandong, China

RECRUITING

Related Publications (1)

• Liu X, Chang S, Wang R, Xiao Y, Li F, Xu Q, Zhang S, Chen X, Zhang S, Zhang M, Chen X, Cao Q, Liu X, Wang H, Zhan D, Chen H, Chen W, Jiang J, Zhang C, Wang H, Gao L, Shi X, Yang X, Xu A. Immunogenicity and Safety of an Inactivated Enterovirus 71 Vaccine Administered Simultaneously with Hepatitis B Virus Vaccine, Group A Meningococcal Polysaccharide Vaccine, Measles-Rubella Combined Vaccine and Japanese Encephalitis Vaccine: A Multi-Center, Randomized, Controlled Clinical Trial in China. Vaccines (Basel). 2022 Jun 2;10(6):895. doi: 10.3390/vaccines10060895.

  PMID: 35746502 DERIVED

Central Study Contacts

Qing Xu

CONTACT

86-531-82679623; sdcdc@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2018
• First Posted: May 9, 2018
• Study Start: March 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: April 1, 2019
• Last Updated: May 9, 2018

Record last verified: 2018-04

Locations

CN (1)