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| Name | Class |
|---|---|
| Hubei Provincial Center for Disease Control and Prevention | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vaccine (3.0EU) | Experimental | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated EV71 vaccine (human diploid cell, KMB-17) | Biological | 3.0 EU of inactivated enterovirus 71 vaccine (KMB-17) on day 0, 28. |
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the seroconversion rate of anti-EV71 antibodies in serum of children | 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. | at 28 days after finishing 2 doses immunization |
| Evaluate the antibody titers of anti-EV71 antibodies in serum of children | 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. | at 28 days after finishing 2 doses immunization |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate long-term of the seroconversion rate of anti-EV71 antibodies in serum of children | 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. | Up to 3 years after finishing 2 doses immunization |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment adverse events | 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. | Up to 3 years after finishing 2 doses immunization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xuhua Guan, M.S. | Hubei Province Center for Diseases Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hubei Province Center for Diseases Control and Prevention | Wuhan | Hubei | China |
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| ID | Term |
|---|---|
| D006232 | Hand, Foot and Mouth Disease |
| ID | Term |
|---|---|
| D003384 | Coxsackievirus Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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Inactivated EV71 vaccine (KMB-17 cells)
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| Evaluate long-term of the antibody titers of anti-EV71 antibodies in serum of children | 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. | Up to 3 years after finishing 2 doses immunization |
| D014777 | Virus Diseases |
| D007239 | Infections |