The Phase IVc of Inactivated Enterovirus 71 Vaccine (Human Diploid Cell)

NCT03240744 | Unknown Phase 4

• 1 other identifier: 2017-003-02
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hand, Foot and Mouth Disease (HFMD)

Keywords

immunogenicity; safety; Hand, Foot and Mouth Disease (HFMD)

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Evaluate long-term of the seroconversion rate of anti-EV71 antibodies in serum of children

  Up to 3 years after finishing 2 doses immunization

• Evaluate long-term of the antibody titers of anti-EV71 antibodies in serum of children

  Up to 3 years after finishing 2 doses immunization

Other Outcomes (1)

• Incidence of treatment adverse events

  Up to 3 years after finishing 2 doses immunization

Study Arms (1)

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)

Biological: Inactivated EV71 vaccine (human diploid cell, KMB-17)

Interventions

Inactivated EV71 vaccine (human diploid cell, KMB-17) BIOLOGICAL

3.0 EU of inactivated enterovirus 71 vaccine (KMB-17) on day 0, 28.

vaccine (3.0EU)

Eligibility Criteria

• Age: 6 Months - 71 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• Hubei Provincial Center for Disease Control and Prevention: collaborator

Study Sites (1)

Hubei Province Center for Diseases Control and Prevention

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Hand, Foot and Mouth Disease

Condition Hierarchy (Ancestors)

Coxsackievirus Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Xuhua Guan, M.S.

  Hubei Province Center for Diseases Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Inactivated EV71 vaccine (KMB-17 cells)

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: August 7, 2017
• Study Start: June 22, 2017
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: September 6, 2017

Record last verified: 2017-04

Locations

CN (1)