Hand, Foot and Mouth DiseasePhase 1NCT01267903
A Clinical Trial for Inactivated Vaccine(Vero Cell) Against EV71 in Chinese Healthy Young Adults and Children
A Phase 1 study testing vaccine against EV71 of 320U/0.5ml, vaccine against EV71 of 640U/0.5ml and vaccine against EV71 of 160U/0.5ml in people with Hand, Foot and Mouth Disease, run by Jiangsu Province Centers for Disease Control and Prevention.
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 5 to 22 years
- Conditions the study is for
- Hand, Foot and Mouth Disease
- What is being tested?
- vaccine against EV71 of 320U/0.5ml, vaccine against EV71 of 640U/0.5ml and vaccine against EV71 of 160U/0.5ml
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 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 5 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Healthy subjects aged from 5 to 22 years old as established by medical history and clinical examination
- The subjects or their 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
Who cannot join
- Subject that has a medical history of HFMD
- 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
- Women of pregnancy, lactation or about to be pregnant in 60 days
- Autoimmune disease or immunodeficiency
- Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
- Any prior administration of administration of immunoglobulins
About this study
Official title: A Phase Ia Clinical Trial for Inactivated Vaccine(Vero Cell) Against EV71 in Chinese Healthy Young Adults and Children
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 Ia is armed to evaluate safety and tolerance in Chinese healthy adults and children.
- Conditions
- Hand, Foot and Mouth Disease
- Being tested
- vaccine against EV71 of 320U/0.5ml, vaccine against EV71 of 640U/0.5ml, vaccine against EV71 of 160U/0.5ml
- Keywords
- Vaccines Adverse Reaction
- Medical subject headings
- Hand, Foot and Mouth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaccine against EV71 of 320U/0.5mlBiological
inactivated vaccine(vero cell) against EV71 of 320U/0.5ml on day0,28,modern medicines
vaccine against EV71 of 640U/0.5mlBiological
inactivated vaccine(vero cell) against EV71 of 640U/0.5ml on day0,28
vaccine against EV71 of 160U/0.5mlBiological
inactivated vaccine(vero cell) against EV71 of 160U/0.5ml on 0,28 day
vaccine against EV71 of 320U/0.5mlBiological
inactivated vaccine(vero cell) against EV71 of 320U/0.5ml on day0,28
vaccine against EV71 of 640U/0.5mlBiological
inactivated vaccine(vero cell) against EV71 of 640U/0.5ml on day0,28
| Study group | Role | What they receive |
|---|---|---|
| 320U /0.5ml in young adults | Experimental | inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 20 young adults aged 16-22 years old on day0,28 Receives: Biological: vaccine against EV71 of 320U/0.5ml |
| 640U /0.5ml in young adults | Experimental | inactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 20 young adults aged 16-22 years old on day0,28 Receives: Biological: vaccine against EV71 of 640U/0.5ml |
| 160U /0.5ml in children | Experimental | inactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 20 children aged 5-15 years old on day0,28 Receives: Biological: vaccine against EV71 of 160U/0.5ml |
| 320U /0.5ml in children | Experimental | inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 20 children aged 6-15 years old on day0,28 Receives: Biological: vaccine against EV71 of 320U/0.5ml |
| 640U /0.5ml in children | Experimental | inactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 20 children aged 6-15 years old on day0,28 Receives: Biological: vaccine against EV71 of 640U/0.5ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the safety of EV71 vaccine in Chinese healthy adults and children
to evaluate the Adverse reactions of EV71 vaccine in Chinese healthy adults and children
Measured: 28 days after the first vaccination
to evaluate the safety of EV71 vaccine in Chinese healthy adults and children
to evaluate the Adverse reactions of EV71 vaccine in Chinese healthy adults and children
Measured: 28 days after the second vaccination
Secondary outcomes (4)
to evaluate the seroconversion rate of Antinuclear antibodies in serum after first vaccination
to evaluate the seroconversion rate of Antinuclear antibodies in serum 28 days after first vaccination
Measured: 28 days after the first vaccination
to evaluate the seroconversion rate of Antinuclear antibodies in serum after second vaccination
to evaluate the seroconversion rate of Antinuclear antibodies in serum 28 days after second vaccination
Measured: 28 days after second vaccination
to evaluate the abnormity change of live and kidney function indexes in serum after first vaccination
to evaluate the abnormity change of live and kidney function indexes in serum 3 days after first vaccination
Measured: 3 days after first vaccination
to evaluate the abnormity change of live and kidney function indexes in serum after second vaccination
to evaluate the abnormity change of live and kidney function indexes in serum 3 days after second vaccination
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 posted29 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionMay 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 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
- Investigators
- Fengcai Zhu, Master, Principal investigator, Jiangsu Provincial Center for Diseases Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267903
- Sponsor's protocol ID
- JSVCT003
- Status last verified
- Jan 2011
- First submitted
- 28 Dec 2010
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Meng FY, Li JX, Li XL, Chu K, Zhang YT, Ji H, Li L, Liang ZL, Zhu FC. Tolerability and immunogenicity of an inactivated enterovirus 71 vaccine in Chinese healthy adults and children: an open label, phase 1 clinical trial. Hum Vaccin Immunother. 2012 May;8(5):668-74. doi: 10.4161/hv.19521. Epub 2012 May 1.
PubMed 22634437
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia Clinical Trial for Inactivated Vaccine(Vero Cell) Against EV71 in Chinese Healthy Young Adults and Children
- ClinicalTrials.gov ID
- NCT01267903
- Acronym / sponsor ID
- JSVCT003
- Conditions
- Hand, Foot and Mouth Disease
- Keywords
- Vaccines Adverse Reaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Bejing Vigoo Biological Co., LTD
- Study start
- Jan 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 29 Dec 2010 (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.
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 Ia is armed to evaluate safety and tolerance in Chinese healthy adults and children.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 320U /0.5ml in young adults | Experimental | Biological: vaccine against EV71 of 320U/0.5mlinactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 20 young adults aged 16-22 years old on day0,28 |
| 640U /0.5ml in young adults | Experimental | Biological: vaccine against EV71 of 640U/0.5mlinactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 20 young adults aged 16-22 years old on day0,28 |
| 160U /0.5ml in children | Experimental | Biological: vaccine against EV71 of 160U/0.5mlinactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 20 children aged 5-15 years old on day0,28 |
| 320U /0.5ml in children | Experimental | Biological: vaccine against EV71 of 320U/0.5mlinactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 20 children aged 6-15 years old on day0,28 |
| 640U /0.5ml in children | Experimental | Biological: vaccine against EV71 of 640U/0.5mlinactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 20 children aged 6-15 years old on day0,28 |
Who may qualify
- Ages
- 5 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Healthy subjects aged from 5 to 22 years old as established by medical history and clinical examination
- The subjects or their 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
Key exclusion criteria (8 listed)
- Subject that has a medical history of HFMD
- 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
- Women of pregnancy, lactation or about to be pregnant in 60 days
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 |
|---|---|---|
| vaccine against EV71 of 320U/0.5mlinactivated vaccine(vero cell) against EV71 of 320U/0.5ml on day0,28,modern medicines | Biological | 320U /0.5ml in young adults |
| vaccine against EV71 of 640U/0.5mlinactivated vaccine(vero cell) against EV71 of 640U/0.5ml on day0,28 | Biological | 640U /0.5ml in young adults |
| vaccine against EV71 of 160U/0.5mlinactivated vaccine(vero cell) against EV71 of 160U/0.5ml on 0,28 day | Biological | 160U /0.5ml in children |
| vaccine against EV71 of 320U/0.5mlinactivated vaccine(vero cell) against EV71 of 320U/0.5ml on day0,28 | Biological | 320U /0.5ml in children |
| vaccine against EV71 of 640U/0.5mlinactivated vaccine(vero cell) against EV71 of 640U/0.5ml on day0,28 | Biological | 640U /0.5ml in children |
Primary outcome
to evaluate the safety of EV71 vaccine in Chinese healthy adults and children
Time frame: 28 days after the first vaccination
to evaluate the Adverse reactions of EV71 vaccine in Chinese healthy adults and children
to evaluate the safety of EV71 vaccine in Chinese healthy adults and children
Time frame: 28 days after the second vaccination
to evaluate the Adverse reactions of EV71 vaccine in Chinese healthy adults and children
4 secondary outcomes
to evaluate the seroconversion rate of Antinuclear antibodies in serum after first vaccination
Time frame: 28 days after the first vaccination
to evaluate the seroconversion rate of Antinuclear antibodies in serum after second vaccination
Time frame: 28 days after second vaccination
to evaluate the abnormity change of live and kidney function indexes in serum after first vaccination
Time frame: 3 days after first vaccination
to evaluate the abnormity change of live and kidney function indexes in serum after second vaccination
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 10 Jun 2011.
- Derived from this study: PubMed 22634437Meng FY, Li JX, Li XL, Chu K, Zhang YT, Ji H, Li L, Liang ZL, Zhu FC. Tolerability and immunogenicity of an inactivated enterovirus 71 vaccine in Chinese healthy adults and children: an open label, phase 1 clinical trial. Hum Vaccin Immunother. 2012 May;8(5):668-74. doi: 10.4161/hv.19521. Epub 2012 May 1.
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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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing vaccine against EV71 of 320U/0.5ml, vaccine against EV71 of 640U/0.5ml and vaccine against EV71 of 160U/0.5ml in people with Hand, Foot and Mouth Disease, run by Jiangsu Province Centers for Disease Control and Prevention.
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 4 inclusion and 8 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 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
to evaluate the safety of EV71 vaccine in Chinese healthy adults and children (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 NCT01267903, 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 10 Jun 2011.