A Safety Study of Inactivated EV71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults, Children and Infants
A Phase I Clinical Trial for Inactivated Enterovirus Type 71 Vaccine (Human Diploid Cell, KMB-17 Cell) in Chinese Adults, Children and Infants
1 other identifier
interventional
288
1 country
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 trial has been carried out, during four months, in Guangxi Province, China. The purpose of this study is to evaluate the safety, tolerability and immunogenicity of the formalin-inactivated EV71 vaccine in Chinese adults (from 18 to 49 years old), children (from 3 to 11 years old) and infants (from 6 to 35 months old).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 11, 2011
CompletedFirst Posted
Study publicly available on registry
July 12, 2011
CompletedOctober 11, 2023
October 1, 2023
4 months
July 11, 2011
October 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Evaluate the Safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults.
Adverse reactions associated with vaccine were observed in Chinese Adults (from 18 to 49 years old) after the first vaccination.
within the first 14 days after the first vaccination
Evaluate the Safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults.
Adverse reactions associated with vaccine were observed in Chinese Adults (from 18 to 49 years old) after the second vaccination.
within the first 4 days after the second vaccination
Evaluate the Safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Children.
Adverse reactions associated with vaccine were observed in Chinese Children (from 3 to 11 years old) after the first vaccination.
within the first 14 days after the first vaccination
Evaluate the Safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Children.
Adverse reactions associated with vaccine were observed in Chinese Children (from 3 to 11 years old) after the second vaccination.
within the first 4 days after the second vaccination
Evaluate the safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants.
Adverse reactions associated with vaccine were observed in Chinese Infants (from 6 to 35 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.
Adverse reactions associated with vaccine were observed in Chinese Infants (from 6 to 35 months old) after the second vaccination.
within the first 28 days after the second vaccination
Secondary Outcomes (8)
Evaluate the seroconversion rate of anti-EV71 antibodies in serum of adults, children and infant, after first vaccination.
within the first 14 or 28 days after the first vaccination
Evaluate the seroconversion rate of anti-EV71 antibodies in serum of adults, children and infant, after second vaccination.
within the first 4 or 28 days after the second vaccination
Evaluate the seroconversion rate of antinuclear antibodies in serum of adults, children and infant, after first vaccination.
within the first 14 or 28 days after the first vaccination
Evaluate the seroconversion rate of antinuclear antibodies in serum of adults, children and infant, after second vaccination.
within the first 4 or 28 days after the second vaccination
Evaluate the abnormity change of live and kidney function indexes in serum of adults, children and infant, after first vaccination.
within the first 14 or 28 days after the first vaccination
- +3 more secondary outcomes
Study Arms (15)
160Eu/0.5ml in adults
EXPERIMENTALinactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 12 adults aged 18-49 years old on day 0, 14.
320Eu/0.5ml in adults
EXPERIMENTALinactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 12 adults aged 18-49 years old on day 0, 14.
640Eu/0.5ml in adults
EXPERIMENTALinactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 12 adults aged 18-49 years old on day 0, 14.
1280Eu/0.5ml (without adjuvant) in adults
EXPERIMENTALinactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 12 adults aged 18-49 years old on day 0, 14.
0Eu/0.5ml in adults
PLACEBO COMPARATOR0Eu/0.5ml placebo in 24 adults aged 18-49 years old on day 0, 14.
160Eu/0.5ml in children
EXPERIMENTALinactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 12 children aged 3-11 years old on day 0, 14.
320Eu/0.5ml in children
EXPERIMENTALinactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 12 children aged 3-11 years old on day 0, 14.
640Eu/0.5ml in children
EXPERIMENTALinactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 12 children aged 3-11 years old on day 0, 14.
1280Eu/0.5ml (without adjuvant) in children
EXPERIMENTALinactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 12 children aged 3-11 years old on day 0, 14.
0Eu/0.5ml in children
PLACEBO COMPARATOR0Eu/0.5ml placebo in 24 children aged 3-11 years old on day 0, 14.
160Eu/0.5ml in infants
EXPERIMENTALinactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 24 infants aged 6-35 months old on day 0, 28.
320Eu/0.5ml in infants
EXPERIMENTALinactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 24 infants aged 6-35 months old on day 0, 28.
640Eu/0.5ml in infants
EXPERIMENTALinactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 24 infants aged 6-35 months old on day 0, 28.
1280Eu/0.5ml (without adjuvant) in infants
EXPERIMENTALinactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 24 infants aged 6-35 months old on day 0, 28.
0Eu/0.5ml in infants
PLACEBO COMPARATOR0Eu/0.5ml placebo in 48 infants aged 6-35 months old on day 0, 28.
Interventions
inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 12 adults aged 18-49 years old on day 0, 14.
inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 12 adults aged 18-49 years old on day 0, 14.
inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 12 adults aged 18-49 years old on day 0, 14.
inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 12 adults aged 18-49 years old on day 0, 14.
0Eu/0.5ml placebo in 24 adults aged 18-49 years old on day 0, 14.
inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 12 children aged 3-11 years old on day 0, 14.
inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 12 children aged 3-11 years old on day 0, 14.
inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 12 children aged 3-11 years old on day 0, 14.
inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 12 children aged 3-11 years old on day 0, 14.
0Eu/0.5ml placebo in 24 children aged 3-11 years old on day 0, 14.
inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 24 infants aged 6-35 months old on day 0, 28.
inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 24 infants aged 6-35 months old on day 0, 28.
inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 24 infants aged 6-35 months old on day 0, 28.
inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 24 infants aged 6-35 months old on day 0, 28.
0Eu/0.5ml placebo in 48 infants aged 6-35 months old on day 0, 28.
Eligibility Criteria
You may qualify if:
- Healthy subjects (18-49 years old adults) as established by medical history and clinical examination
- The subjects oneself or their legal guardian must be aware of this vaccines
- Voluntarily participate in the study and signed Informed Consent Form
- Subjects with temperature ≤ 37.0℃
- 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)
- 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
- Any prior administration of subunit or inactivated vaccines in last 14 days
- Under the anti-TB prevention or therapy
- +63 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangxi Provincial Center for Diseases Control and Prevention
Nanning, Guangxi, 530028, China
Related Publications (1)
Liu L, Zhang Y, Wang J, Zhao H, Jiang L, Che Y, Shi H, Li R, Mo Z, Huang T, Liang Z, Mao Q, Wang L, Dong C, Liao Y, Guo L, Yang E, Pu J, Yue L, Zhou Z, Li Q. Study of the integrated immune response induced by an inactivated EV71 vaccine. PLoS One. 2013;8(1):e54451. doi: 10.1371/journal.pone.0054451. Epub 2013 Jan 23.
PMID: 23372725DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhaojun Mo, Master
Guangxi Provincial Center for Diseases Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 1
- 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
July 11, 2011
First Posted
July 12, 2011
Study Start
February 1, 2011
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
October 11, 2023
Record last verified: 2023-10