Enterovirus 71 Inactivated Vaccine Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 1944 |
| Est. completion date | April 2019 |
| Est. primary completion date | December 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 6 Months to 12 Months |
| Eligibility |
Inclusion Criteria: Inclusion criteria for group ?(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 ?(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 ?(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 ?(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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Shandong Provincial Center for Disease Control and Prevention | Jinan | Shandong |
| Lead Sponsor | Collaborator |
|---|---|
| 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 |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | Number of Participants at the Injection Site, Solicited Systemic Reactions, or Any Unsolicited Adverse Events | 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. | within 90 days after the last vaccination |