A Protected Study of Inactivated EV71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants and Children

NCT01569581 | Completed Phase 3 DMC

• 1 other identifier: EV71-KMB17-III-IMB-CAMS
• Study Type: interventional
• Target: 12,000
• Locations: 1 country
• Sites: 1

Brief Summary

Enterovirus 71 (EV71), a major pathogen that is responsible for causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae. Since the late 1990s, a series of large HFMD epidemics caused by EV71 have been reported in the Asia-Pacific region. Notably, there is evidence that the most severe cases from these epidemic outbreaks are associated with neurological disorders with CNS involvement caused by EV71 infection. Because of these EV71 infection-related public health issues, the research and development of EV71 vaccine candidates have been heavily promoted. Recently, several EV71 vaccine candidates have been evaluated in animals but no final results of clinical trials, including inactivated vaccine, attenuated vaccine, subunit vaccine, DNA vaccine, epitope peptide vaccine, virus-like particles (VLPs). Basing on the previous studies of elicited protection in mice and rhesus monkeys, a formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been licensed by SFDA in China, Dec. 2010. The phase I clinical and phase II trials were completed, in Guangxi Province, China. The results of these clinical trials showed that this vaccine was safe and could induce effective antibodies for the infants. The purpose of phase III is to evaluate the protected and efficacy of the formalin-inactivated EV71 vaccine in Chinese infants and children (from 6 to 71 months old).

Conditions

The Efficacy of Inactivated EV71 Vaccine (KMB17) Against HFMD in Chinese Children and Infants

Keywords

Human Enterovirus 71 (EV71); Hand, Foot and Mouth Disease (HFMD); Inactivated Vaccine; Human Diploid cell (KMB17); Adverse reactions associated with vaccine; Efficacy

Outcome Measures

Primary Outcomes (3)

• Evaluate the safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants and children (from 6 to 71 months old)

  Adverse reactions associated with vaccine and protection efficiency were observed in Chinese Infants and children (from 6 to 71 months old) after the first vaccination.

  within the first 28 days after the first vaccination

• Evaluate the safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants and children (from 6 to 71 months old)

  Adverse reactions associated with vaccine were observed in Chinese Infants and children (from 6 to 71 months old) after the first vaccination.

  at the 28 days after the second vaccination

• Evaluate the efficacy of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants and children (from 6 to 71 months old)

  The preventive efficacy were observed in Chinese Infants and children (from 6 to 71 months old) after the second vaccination

  within two years after the second vaccination

Secondary Outcomes (2)

• Evaluate the seroconversion rate of anti-EV71 antibodies in serum of children and infant, after first vaccination

  at the 28 day after the first vaccination

• Evaluate the seroconversion rate of anti-EV71 antibodies in serum of children and infant, after second vaccination

  at the 28 days after the second vaccination

Study Arms (8)

100U/0.5ml in 6-11 months old infants

EXPERIMENTAL

inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1750 infants aged 6-11 months old on day 0, 28

Biological: 100U/0.5ml in 6-11 months old infants

100U/0.5ml in 12-23 months old infants

EXPERIMENTAL

inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1750 infants aged 12-23 months old on day 0, 28

Biological: 100U/0.5ml in 12-23 months old infants

100U/0.5ml in 24-35 months old children

EXPERIMENTAL

inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1500 children aged 24-35 months old on day 0, 28

Biological: 100U/0.5ml in 24-35 months old children

100U/0.5ml in 36-71 months old children

EXPERIMENTAL

inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1000 children aged 36-71 months old on day 0, 28

Biological: 100U/0.5ml in 36-71 months old children

0U/0.5ml in infants (6-11 months old)

NO INTERVENTION

0U/0.5ml (0Eu/0.5ml) placebo in 1750 infants aged 6-11 months old on day 0, 28

0U/0.5ml in infants (12-23 months old)

NO INTERVENTION

0U/0.5ml (0Eu/0.5ml) placebo in 1750 infants aged 12-23 months old on day 0, 28

0U/0.5ml in children (24-35 months old)

NO INTERVENTION

0U/0.5ml (0Eu/0.5ml) placebo in 1500 children aged 24-35 months old on day 0, 28

0U/0.5ml in children (36-71 months old)

NO INTERVENTION

0U/0.5ml (0Eu/0.5ml) placebo in 1000 children aged 36-71 months old on day 0, 28

Interventions

100U/0.5ml in 6-11 months old infants BIOLOGICAL

inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1750 infants aged 6-11 months old on day 0, 28

100U/0.5ml in 6-11 months old infants

100U/0.5ml in 12-23 months old infants BIOLOGICAL

inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1750 infants aged 12-23 months old on day 0, 28

100U/0.5ml in 12-23 months old infants

100U/0.5ml in 24-35 months old children BIOLOGICAL

inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1500 children aged 24-35 months old on day 0, 28

100U/0.5ml in 24-35 months old children

100U/0.5ml in 36-71 months old children BIOLOGICAL

inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1000 children aged 36-71 months old on day 0, 28

100U/0.5ml in 36-71 months old children

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 infants) as established by medical history and clinical examination
• Full-term (37-42 weeks), weight ≥ 2500 g when it was born
• 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 2-month visit and receive blood tests according to program requirements

You may not qualify if:

• Subject who has a clinical diagnosis history of Hand, Foot and Mouth Disease (HFMD)
• Participated in the phase I or phase II clinical trails of the inactivated EV71 vaccine
• weight ≤ 2500 g when it was born
• Allergy or serious side-effects to a vaccine or any ingredient of vaccine
• Epilepsy, seizures, convulsions, neurological illness
• Congenital or hereditary immunodeficiency
• Autoimmune disease
• Severe malnutrition or dysgenopathy
• 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 28 days or 1 months

Sponsors & Collaborators

• Institute of Medical Biology, Chinese Academy of Medical Sciences: lead
• Guangxi Center for Disease Control and Prevention: collaborator

Study Sites (1)

Guangxi Provincial Center for Diseases Control and Prevention

Nanning, Guangxi, China

Location

Related Publications (3)

• Zhang W, Kong Y, Jiang Z, Li C, Wang L, Xia J. Comprehensive safety assessment of a human inactivated diploid enterovirus 71 vaccine based on a phase III clinical trial. Hum Vaccin Immunother. 2016 Apr 2;12(4):922-30. doi: 10.1080/21645515.2015.1115934. Epub 2016 Feb 2.

  PMID: 26837471 DERIVED

• Liu L, Mo Z, Liang Z, Zhang Y, Li R, Ong KC, Wong KT, Yang E, Che Y, Wang J, Dong C, Feng M, Pu J, Wang L, Liao Y, Jiang L, Tan SH, David P, Huang T, Zhou Z, Wang X, Xia J, Guo L, Wang L, Xie Z, Cui W, Mao Q, Liang Y, Zhao H, Na R, Cui P, Shi H, Wang J, Li Q. Immunity and clinical efficacy of an inactivated enterovirus 71 vaccine in healthy Chinese children: a report of further observations. BMC Med. 2015 Sep 17;13:226. doi: 10.1186/s12916-015-0448-7.

  PMID: 26381232 DERIVED

• Li R, Liu L, Mo Z, Wang X, Xia J, Liang Z, Zhang Y, Li Y, Mao Q, Wang J, Jiang L, Dong C, Che Y, Huang T, Jiang Z, Xie Z, Wang L, Liao Y, Liang Y, Nong Y, Liu J, Zhao H, Na R, Guo L, Pu J, Yang E, Sun L, Cui P, Shi H, Wang J, Li Q. An inactivated enterovirus 71 vaccine in healthy children. N Engl J Med. 2014 Feb 27;370(9):829-37. doi: 10.1056/NEJMoa1303224.

  PMID: 24571755 DERIVED

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

• Zhaojun Mo, Master

  Guangxi Provincial Center for Diseases Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2012
• First Posted: April 3, 2012
• Study Start: March 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

CN (1)