Back to resultsA Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants
Primary Purpose
Hand, Foot, and Mouth Disease, Enterovirus Infections
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
160U /0.5ml
320U /0.5ml
640U /0.5ml
0/0.5ml placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hand, Foot, and Mouth Disease focused on measuring Safety, Immunogenicity, inactivated EV71 vaccine
Eligibility Criteria
For the subjects aged from 13-60 months:
Inclusion Criteria:
- Healthy subjects aged from 13 to 60 months old as established by medical history and clinical examination
- The subjects' guardians are able to understand and sign the informed consent
- Had never received the vaccine against EV71
- Subjects who can and will comply with the requirements of the protocol
- Subjects with temperature <37.1°C on axillary setting
Exclusion Criteria:
- Subject who has a medical history of HFMD
- <= 37 weeks gestation
- Subjects with a birth weight <2.5 kg
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
- Family history of seizures or progressive neurological disease
- Family history of congenital or hereditary immunodeficiency
- Severe malnutrition or dysgenopathy
- Major congenital defects or serious chronic illness, including perinatal brain damage
- Autoimmune disease
- Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
- Any acute infections in last 7 days
- Any prior administration of immunodepressant or corticosteroids in last 6month
- Any prior administration of blood products in last 3 month
- Any prior administration of other research medicines in last 1month
- Any prior administration of attenuated live vaccine in last 28 days
- Any prior administration of inactivated vaccines in last 14 days, such as pneumococcal vaccine
- Under the anti - TB prevention or therapy
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
For the subjects aged from 6-12 months:
Inclusion Criteria:
- Healthy subjects aged from 6 to 12 months old as established by medical history and clinical examination
- The subjects' guardians are able to understand and sign the informed consent
- Had never received the vaccine against EV71
- Subjects who can and will comply with the requirements of the protocol
- Subjects with temperature <37.1°C on axillary setting
Exclusion Criteria:
- Subject who has a medical history of HFMD
- <= 37 weeks gestation
- Subjects with a birth weight <2.5 kg
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
- Family history of seizures or progressive neurological disease
- Family history of congenital or hereditary immunodeficiency
- Severe malnutrition or dysgenopathy
- Major congenital defects or serious chronic illness, including perinatal brain damage
- Autoimmune disease
- Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
- Any acute infections in last 7 days
- Any prior administration of immunodepressant or corticosteroids in last 6month
- Any prior administration of blood products in last 3 month
- Any prior administration of other research medicines in last 1month
- Any prior administration of attenuated live vaccine in last 28 days
- Any prior administration of inactivated vaccines in last 14 days, such as pneumococcal vaccine
- Under the anti - TB prevention or therapy
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
Sites / Locations
- Donghai Center for Diseases Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
160U /0.5ml in children
320U /0.5ml in children
640U /0.5ml in children
160U /0.5ml in infants
320U /0.5ml in infants
640U /0.5ml in infants
0/0.5ml placebo in children
0/0.5ml placebo in infants
Arm Description
inactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 45 children aged 13-60 months old on day0,28
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 45 children aged 13-60 months old on day0,28
inactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 45 children aged 13-60 months old on day0,28
inactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 45 infants aged 6-12 months old on day0,28
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 45 infants aged 6-12 months old on day0,28
inactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 45 infants aged 6-12 months old on day0,28
0/0.5ml placebo in 45 children aged 13-60 months old on day0,28
0/0.5ml placebo in 45 infants aged 6-12 months old on day0,28
Outcomes
Primary Outcome Measures
Number of participants with adverse events after first vaccination
To evaluate the adverse events of EV71 vaccine in healthy children and infants after first vaccination
Number of participants with adverse events after second vaccination
To evaluate the adverse events of EV71 vaccine in healthy children and infants after second vaccination
Secondary Outcome Measures
The seroconversion rate of anti-EV71 antibodies in serum after first vaccination
To evaluate the seroconversion rate of anti-EV71 antibodies in serum 28 days after first vaccination
The seroconversion rate of anti-EV71 antibodies in serum after second vaccination
To evaluate the seroconversion rate of anti-EV71 antibodies in serum 28 days after second vaccination
The abnormity change of liver and kidney function indexes in serum after first vaccination in children
To evaluate the abnormity change of liver and kidney function indexes in serum 3 days after first vaccination in children
The abnormity change of liver and kidney function indexes in serum after second vaccination in children
To evaluate the abnormity change of liver and kidney function indexes in serum 3 days after second vaccination in children
Full Information
NCT ID
NCT01313715
First Posted
March 10, 2011
Last Updated
December 30, 2011
Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
Bejing Vigoo Biological Co., LTD
1. Study Identification
Unique Protocol Identification Number
NCT01313715
Brief Title
A Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants
Official Title
A Phase Ib Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
Bejing Vigoo Biological Co., LTD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused by viruses that belong to the enterovirus genus of the picornavirus family. Although most HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71 (EV71) can present with a high rate of neurological complications, including meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by EV71 has become a major emerging infectious disease in Asia and the highly pathogenic potential of EV71 clearly requires the attention of world medical community.
Recently, an inactivated vaccine(vero cell) against EV71 has been licensed by SFDA in China, this clinical trial phase Ib is armed to evaluate safety in Chinese healthy children (from 13 to 60 months old) and infants (from 6 to 12 months old) and also provide the evidences for the EV71 vaccine immunogenicity and the probable immunizing dose.
Detailed Description
Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused by viruses that belong to the enterovirus genus of the picornavirus family. Although most HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71 (EV71) can present with a high rate of neurological complications, including meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by EV71 has become a major emerging infectious disease in Asia and the highly pathogenic potential of EV71 clearly requires the attention of world medical community.
The development of vaccine against EV71 is active and ongoing in Asian countries now. Several studies have examined the effectiveness of inactivated viral vaccines against EV71 in animal model. A wide range of experimental EV71 vaccine approaches have been studied including heat-inactivated or formaldehyde-inactivated virion, EV71 virus-like particles (VLP) , VP1 recombinant protein ,VP1 DNA vaccine , VP1 peptide-based vaccine targeting the neutralizing domain, bacterial or viral vector expressing VP1, and a Vero cell-adapted live attenuated virus. Furthermore, neutralizing antibodies against EV71 have been suggested as one of the most important factors in prevention of the severe EV71 infection.
Recently, an inactivated vaccine(vero cell) against EV71 has been licensed by SFDA in China, this clinical trial phase Ib is armed to evaluate safety in Chinese healthy children and infants and also provide the evidences for the EV71 vaccine immunogenicity and the probable immunizing dose.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand, Foot, and Mouth Disease, Enterovirus Infections
Keywords
Safety, Immunogenicity, inactivated EV71 vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
160U /0.5ml in children
Arm Type
Experimental
Arm Description
inactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 45 children aged 13-60 months old on day0,28
Arm Title
320U /0.5ml in children
Arm Type
Experimental
Arm Description
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 45 children aged 13-60 months old on day0,28
Arm Title
640U /0.5ml in children
Arm Type
Experimental
Arm Description
inactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 45 children aged 13-60 months old on day0,28
Arm Title
160U /0.5ml in infants
Arm Type
Experimental
Arm Description
inactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 45 infants aged 6-12 months old on day0,28
Arm Title
320U /0.5ml in infants
Arm Type
Experimental
Arm Description
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 45 infants aged 6-12 months old on day0,28
Arm Title
640U /0.5ml in infants
Arm Type
Experimental
Arm Description
inactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 45 infants aged 6-12 months old on day0,28
Arm Title
0/0.5ml placebo in children
Arm Type
Placebo Comparator
Arm Description
0/0.5ml placebo in 45 children aged 13-60 months old on day0,28
Arm Title
0/0.5ml placebo in infants
Arm Type
Placebo Comparator
Arm Description
0/0.5ml placebo in 45 infants aged 6-12 months old on day0,28
Intervention Type
Biological
Intervention Name(s)
160U /0.5ml
Intervention Description
inactivated vaccine(vero cell) against EV71 of 160U /0.5ml, two doses, one month interval
Intervention Type
Biological
Intervention Name(s)
320U /0.5ml
Intervention Description
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, one month interval
Intervention Type
Biological
Intervention Name(s)
640U /0.5ml
Intervention Description
inactivated vaccine(vero cell) against EV71 of 640U /0.5ml, two doses, one month interval
Intervention Type
Biological
Intervention Name(s)
0/0.5ml placebo
Intervention Description
0/0.5ml placebo, two doses, one month interval
Primary Outcome Measure Information:
Title
Number of participants with adverse events after first vaccination
Description
To evaluate the adverse events of EV71 vaccine in healthy children and infants after first vaccination
Time Frame
28 days after the first vaccination
Title
Number of participants with adverse events after second vaccination
Description
To evaluate the adverse events of EV71 vaccine in healthy children and infants after second vaccination
Time Frame
28 days after the second vaccination
Secondary Outcome Measure Information:
Title
The seroconversion rate of anti-EV71 antibodies in serum after first vaccination
Description
To evaluate the seroconversion rate of anti-EV71 antibodies in serum 28 days after first vaccination
Time Frame
28 days after the first vaccination
Title
The seroconversion rate of anti-EV71 antibodies in serum after second vaccination
Description
To evaluate the seroconversion rate of anti-EV71 antibodies in serum 28 days after second vaccination
Time Frame
28 days after second vaccination
Title
The abnormity change of liver and kidney function indexes in serum after first vaccination in children
Description
To evaluate the abnormity change of liver and kidney function indexes in serum 3 days after first vaccination in children
Time Frame
3 days after first vaccination
Title
The abnormity change of liver and kidney function indexes in serum after second vaccination in children
Description
To evaluate the abnormity change of liver and kidney function indexes in serum 3 days after second vaccination in children
Time Frame
3 days after second vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
For the subjects aged from 13-60 months:
Inclusion Criteria:
Healthy subjects aged from 13 to 60 months old as established by medical history and clinical examination
The subjects' guardians are able to understand and sign the informed consent
Had never received the vaccine against EV71
Subjects who can and will comply with the requirements of the protocol
Subjects with temperature <37.1°C on axillary setting
Exclusion Criteria:
Subject who has a medical history of HFMD
<= 37 weeks gestation
Subjects with a birth weight <2.5 kg
Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
Family history of seizures or progressive neurological disease
Family history of congenital or hereditary immunodeficiency
Severe malnutrition or dysgenopathy
Major congenital defects or serious chronic illness, including perinatal brain damage
Autoimmune disease
Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
Any acute infections in last 7 days
Any prior administration of immunodepressant or corticosteroids in last 6month
Any prior administration of blood products in last 3 month
Any prior administration of other research medicines in last 1month
Any prior administration of attenuated live vaccine in last 28 days
Any prior administration of inactivated vaccines in last 14 days, such as pneumococcal vaccine
Under the anti - TB prevention or therapy
Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
For the subjects aged from 6-12 months:
Inclusion Criteria:
Healthy subjects aged from 6 to 12 months old as established by medical history and clinical examination
The subjects' guardians are able to understand and sign the informed consent
Had never received the vaccine against EV71
Subjects who can and will comply with the requirements of the protocol
Subjects with temperature <37.1°C on axillary setting
Exclusion Criteria:
Subject who has a medical history of HFMD
<= 37 weeks gestation
Subjects with a birth weight <2.5 kg
Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
Family history of seizures or progressive neurological disease
Family history of congenital or hereditary immunodeficiency
Severe malnutrition or dysgenopathy
Major congenital defects or serious chronic illness, including perinatal brain damage
Autoimmune disease
Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
Any acute infections in last 7 days
Any prior administration of immunodepressant or corticosteroids in last 6month
Any prior administration of blood products in last 3 month
Any prior administration of other research medicines in last 1month
Any prior administration of attenuated live vaccine in last 28 days
Any prior administration of inactivated vaccines in last 14 days, such as pneumococcal vaccine
Under the anti - TB prevention or therapy
Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fengcai Zhu, Master
Organizational Affiliation
Jiangsu Provincial Center for Diseases Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Donghai Center for Diseases Control and Prevention
City
Lianyungang
State/Province
Jiangsu
ZIP/Postal Code
222300
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
24260259
Citation
Mao Q, Cheng T, Zhu F, Li J, Wang Y, Li Y, Gao F, Yang L, Yao X, Shao J, Xia N, Liang Z, Wang J. The cross-neutralizing activity of enterovirus 71 subgenotype c4 vaccines in healthy chinese infants and children. PLoS One. 2013 Nov 19;8(11):e79599. doi: 10.1371/journal.pone.0079599. eCollection 2013.
Results Reference
derived
Learn more about this trial
A Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants
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