Hand, Foot, and Mouth DiseasePhase 1NCT01313715
A Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants
A Phase 1 study testing 160U /0.5ml, 320U /0.5ml and 640U /0.5ml in people with Hand, Foot, and Mouth Disease and Enterovirus Infections, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 60 months
- Conditions the study is for
- Hand, Foot, and Mouth Disease, Enterovirus Infections
- What is being tested?
- 160U /0.5ml, 320U /0.5ml and 640U /0.5ml
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- Mar 2011to Jun 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- Healthy subjects aged from 6 to 12 months old as established by medical history and clinical examination
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- 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
Who cannot join
- 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
Show all 37Show fewer
- 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:
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Donghai Center for Diseases Control and Prevention
Lianyungang, Jiangsu, 222300
About this study
Official title: A Phase Ib Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants
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.
Read the 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.
- Being tested
- 160U /0.5ml, 320U /0.5ml, 640U /0.5ml, 0/0.5ml placebo
- Keywords
- Safety, Immunogenicity, inactivated EV71 vaccine
- Medical subject headings
- Hand, Foot and Mouth Disease, Enterovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
160U /0.5mlBiological
inactivated vaccine(vero cell) against EV71 of 160U /0.5ml, two doses, one month interval
320U /0.5mlBiological
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, one month interval
640U /0.5mlBiological
inactivated vaccine(vero cell) against EV71 of 640U /0.5ml, two doses, one month interval
0/0.5ml placeboBiological
0/0.5ml placebo, two doses, one month interval
| Study group | Role | What they receive |
|---|---|---|
| 160U /0.5ml in children | Experimental | inactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 45 children aged 13-60 months old on day0,28 Receives: Biological: 160U /0.5ml |
| 320U /0.5ml in children | Experimental | inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 45 children aged 13-60 months old on day0,28 Receives: Biological: 320U /0.5ml |
| 640U /0.5ml in children | Experimental | inactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 45 children aged 13-60 months old on day0,28 Receives: Biological: 640U /0.5ml |
| 160U /0.5ml in infants | Experimental | inactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 45 infants aged 6-12 months old on day0,28 Receives: Biological: 160U /0.5ml |
| 320U /0.5ml in infants | Experimental | inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 45 infants aged 6-12 months old on day0,28 Receives: Biological: 320U /0.5ml |
| 640U /0.5ml in infants | Experimental | inactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 45 infants aged 6-12 months old on day0,28 Receives: Biological: 640U /0.5ml |
| 0/0.5ml placebo in children | Placebo comparator | 0/0.5ml placebo in 45 children aged 13-60 months old on day0,28 Receives: Biological: 0/0.5ml placebo |
| 0/0.5ml placebo in infants | Placebo comparator | 0/0.5ml placebo in 45 infants aged 6-12 months old on day0,28 Receives: Biological: 0/0.5ml placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days after the 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
Measured: 28 days after the second vaccination
Secondary outcomes (4)
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
Measured: 28 days after the 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
Measured: 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
Measured: 3 days after first vaccination
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
Measured: 3 days after second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand, Foot, and Mouth DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- Bejing Vigoo Biological Co., LTD
- Responsible party
- Sponsor
- Investigators
- Fengcai Zhu, Master, Principal investigator, Jiangsu Provincial Center for Diseases Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313715
- Sponsor's protocol ID
- JSVCT004
- Status last verified
- Mar 2011
- First submitted
- 10 Mar 2011
- Last updated
- 2 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24260259
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants
- ClinicalTrials.gov ID
- NCT01313715
- Acronym / sponsor ID
- JSVCT004
- Keywords
- Safety, Immunogenicity, inactivated EV71 vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Bejing Vigoo Biological Co., LTD
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 14 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 160U /0.5ml in children | Experimental | Biological: 160U /0.5mlinactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 45 children aged 13-60 months old on day0,28 |
| 320U /0.5ml in children | Experimental | Biological: 320U /0.5mlinactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 45 children aged 13-60 months old on day0,28 |
| 640U /0.5ml in children | Experimental | Biological: 640U /0.5mlinactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 45 children aged 13-60 months old on day0,28 |
| 160U /0.5ml in infants | Experimental | Biological: 160U /0.5mlinactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 45 infants aged 6-12 months old on day0,28 |
| 320U /0.5ml in infants | Experimental | Biological: 320U /0.5mlinactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 45 infants aged 6-12 months old on day0,28 |
| 640U /0.5ml in infants | Experimental | Biological: 640U /0.5mlinactivated 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 children | Placebo comparator | Biological: 0/0.5ml placebo0/0.5ml placebo in 45 children aged 13-60 months old on day0,28 |
| 0/0.5ml placebo in infants | Placebo comparator | Biological: 0/0.5ml placebo0/0.5ml placebo in 45 infants aged 6-12 months old on day0,28 |
Who may qualify
- Ages
- 6 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (37 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 160U /0.5mlinactivated vaccine(vero cell) against EV71 of 160U /0.5ml, two doses, one month interval | Biological | 160U /0.5ml in children, 160U /0.5ml in infants |
| 320U /0.5mlinactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, one month interval | Biological | 320U /0.5ml in children, 320U /0.5ml in infants |
| 640U /0.5mlinactivated vaccine(vero cell) against EV71 of 640U /0.5ml, two doses, one month interval | Biological | 640U /0.5ml in children, 640U /0.5ml in infants |
| 0/0.5ml placebo0/0.5ml placebo, two doses, one month interval | Biological | 0/0.5ml placebo in children, 0/0.5ml placebo in infants |
Primary outcome
Number of participants with adverse events after first vaccination
Time frame: 28 days after the 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
Time frame: 28 days after the second vaccination
To evaluate the adverse events of EV71 vaccine in healthy children and infants after second vaccination
4 secondary outcomes
The seroconversion rate of anti-EV71 antibodies in serum after first vaccination
Time frame: 28 days after the first vaccination
The seroconversion rate of anti-EV71 antibodies in serum after second vaccination
Time frame: 28 days after second vaccination
The abnormity change of liver and kidney function indexes in serum after first vaccination in children
Time frame: 3 days after first vaccination
The abnormity change of liver and kidney function indexes in serum after second vaccination in children
Time frame: 3 days after second vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2012.
- Derived from this study: PubMed 24260259Mao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fengcai Zhu, Master principal investigator
Jiangsu Provincial Center for Diseases Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 160U /0.5ml, 320U /0.5ml and 640U /0.5ml in people with Hand, Foot, and Mouth Disease and Enterovirus Infections, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events after first vaccination (time frame: 28 days after the first vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01313715, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2012.