EV71-associated DiseasePhase 2NCT01734408
A Booster Dose of Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children
A Phase 2 study testing alum-adjuvant 160U /0.5ml, alum-adjuvant 320U /0.5ml and alum-adjuvant 640U /0.5ml in people with EV71-associated Disease, 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 21 to 51 months
- Conditions the study is for
- EV71-associated Disease
- What is being tested?
- alum-adjuvant 160U /0.5ml, alum-adjuvant 320U /0.5ml and alum-adjuvant 640U /0.5ml
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 773 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Feb 2013
- Phase
- Phase 2
- 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 21 to 51 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Had participated in the previous phase II trial and received at least 1 dose of EV71 vaccine.
- Healthy children as established by medical history and clinical examination
- The subjects' guardians are able to understand and sign the informed consent
- Subjects who can and will comply with the requirements of the protocol
- Subjects with temperature <=37.0°C on axillary setting
Who cannot join
- Had participated in the previous phase II trial and received placebo.
- Subject who has a medical history of EV71-associated disease with specific laboratory evidence
- <= 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
Show all 19Show fewer
- 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 1 month
- Any prior administration of attenuated live vaccine in last 14 days
- Any prior administration of subunit or inactivated vaccines in last 7 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
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, 210009
About this study
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 phase II study of inactivated vaccine (vero cell) against EV71 has completed last month in Jiangsu Province in China. The data from the phase II study suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese children and infants. But the antibody titer against EV71 was found decreased significantly at month 8 compared to that at day 56. Considering the similar dynamic trend had also been found in the antibody against poliovirus induced by polio vaccines, and whose immunization schedule contains a booster dose administrated at 1 to 1.5 year after the first 3 doses of fundamental immunity. In order to find a better immunization schedule for children, the investigators decided to perform this booster immunity trial among these children who had received two doses of EV71 vaccines (around one year after the fundamental immunity). The investigators do the recruitment among these children who had participated in the previous phase II trial and received EV71 vaccines, and randomize them in a ratio of 2:1 to receive either a booster dose of EV71 vaccines or placebo.
- Conditions
- EV71-associated Disease
- Being tested
- alum-adjuvant 160U /0.5ml, alum-adjuvant 320U /0.5ml, alum-adjuvant 640U /0.5ml, adjuvant-free 640U /0.5ml, 0/0.5ml placebo
- Keywords
- immunogenicity, safety, inactivated EV71 vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alum-adjuvant 160U /0.5mlBiological
inactivated vaccine (vero cell) alum-adjuvant 160U /0.5ml EV71 vaccine
alum-adjuvant 320U /0.5mlBiological
inactivated vaccine (vero cell) alum-adjuvant 320U /0.5ml EV71 vaccine
alum-adjuvant 640U /0.5mlBiological
inactivated vaccine (vero cell) alum-adjuvant 640U /0.5ml EV71 vaccine
adjuvant-free 640U /0.5mlBiological
inactivated vaccine (vero cell) adjuvant-free 640U /0.5ml EV71 vaccine
0/0.5ml placeboBiological
0/0.5ml placebo
| Study group | Role | What they receive |
|---|---|---|
| alum-adjuvant 160U /0.5ml EV71 vaccine | Experimental | A booster dose of alum-adjuvant 160U /0.5ml EV71 vaccine in 160 children whom had received two doses of alum-adjuvant 160U/0.5ml EV71 vaccines one year before. Receives: Biological: alum-adjuvant 160U /0.5ml |
| placebo A | Placebo comparator | A 0/0.5ml placebo in 80 children whom had received two doses of alum-adjuvant 160U/0.5ml EV71 vaccines one year before. Receives: Biological: 0/0.5ml placebo |
| alum-adjuvant 320U /0.5ml EV71 vaccine | Experimental | A booster dose of alum-adjuvant 320U /0.5ml EV71 vaccine in 160 children whom had received two doses of alum-adjuvant 320U/0.5ml EV71 vaccines one year before. Receives: Biological: alum-adjuvant 320U /0.5ml |
| placebo B | Placebo comparator | A 0/0.5ml placebo in 80 children whom had received two doses of alum-adjuvant 320U/0.5ml EV71 vaccines one year before. Receives: Biological: 0/0.5ml placebo |
| alum-adjuvant 640U /0.5ml EV71 vaccine | Experimental | A booster dose of alum-adjuvant 640U /0.5ml EV71 vaccine in 160 children whom had received two doses of alum-adjuvant 640U/0.5ml EV71 vaccines one year before. Receives: Biological: alum-adjuvant 640U /0.5ml |
| placebo C | Placebo comparator | A 0/0.5ml placebo in 80 children whom had received two doses of alum-adjuvant 640U/0.5ml EV71 vaccines one year before. Receives: Biological: 0/0.5ml placebo |
| adjuvant-free 640U /0.5ml EV71 vaccine | Experimental | A booster dose of adjuvant-free 640U /0.5ml EV71 vaccine in 160 children whom had received two doses of adjuvant-free 640U/0.5ml EV71 vaccines one year before. Receives: Biological: adjuvant-free 640U /0.5ml |
| placebo D | Placebo comparator | A 0/0.5ml placebo in 80 children whom had received two doses of adjuvant-free 640U/0.5ml EV71 vaccines one year before. Receives: Biological: 0/0.5ml placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titer (GMT) of anti-EV71 antibodies
GMT of anti-EV71 antibodies in serum 28 days after booster dose injection
Measured: 28 days after vaccination
Secondary outcomes (3)
Safety of EV71 vaccine in healthy children
Frequency of systemic and local adverse reactions in healthy children following 28 days after the boosting dose of EV71 vaccine
Measured: 28 days after vaccination
Geometric mean fold increase (GMFI) of anti-EV71 antibodies
GMFI of anti-EV71 antibodies in serum 28 days after vaccination
Measured: 28 days after vaccination
Seroconversion of anti-EV71 antibodies
Seroconversion of anti-EV71 antibodies in serum 28 days after vaccination
Measured: 28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJan 2013
- Study completionFeb 2013
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 EV71-associated 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 773 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
- Principal investigator, Fengcai Zhu, Jiangsu Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734408
- Sponsor's protocol ID
- JSVCT005b
- Status last verified
- Oct 2013
- First submitted
- 22 Nov 2012
- Last updated
- 23 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Shenyu W, Jingxin L, Zhenglun L, Xiuling L, Qunying M, Fanyue M, Hua W, Yuntao Z, Fan G, Qinghua C, Yuemei H, Xin Y, Huijie G, Fengcai Z. A booster dose of an inactivated enterovirus 71 vaccine in chinese young children: a randomized, double-blind, placebo-controlled clinical trial. J Infect Dis. 2014 Oct 1;210(7):1073-82. doi: 10.1093/infdis/jiu113. Epub 2014 Mar 12.
PubMed 24625805
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Booster Dose of Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children
- ClinicalTrials.gov ID
- NCT01734408
- Acronym / sponsor ID
- JSVCT005b
- Conditions
- EV71-associated Disease
- Keywords
- immunogenicity, safety, inactivated EV71 vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 773 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Bejing Vigoo Biological Co., LTD
- Study start
- Nov 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 27 Nov 2012 (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 phase II study of inactivated vaccine (vero cell) against EV71 has completed last month in Jiangsu Province in China. The data from the phase II study suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese children and infants. But the antibody titer against EV71 was found decreased significantly at month 8 compared to that at day 56. Considering the similar dynamic trend had also been found in the antibody against poliovirus induced by polio vaccines, and whose immunization schedule contains a booster dose administrated at 1 to 1.5 year after the first 3 doses of fundamental immunity. In order to find a better immunization schedule for children, the investigators decided to perform this booster immunity trial among these children who had received two doses of EV71 vaccines (around one year after the fundamental immunity). The investigators do the recruitment among these children who had participated in the previous phase II trial and received EV71 vaccines, and randomize them in a ratio of 2:1 to receive either a booster dose of EV71 vaccines or placebo.
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 |
|---|---|---|
| alum-adjuvant 160U /0.5ml EV71 vaccine | Experimental | Biological: alum-adjuvant 160U /0.5mlA booster dose of alum-adjuvant 160U /0.5ml EV71 vaccine in 160 children whom had received two doses of alum-adjuvant 160U/0.5ml EV71 vaccines one year before. |
| placebo A | Placebo comparator | Biological: 0/0.5ml placeboA 0/0.5ml placebo in 80 children whom had received two doses of alum-adjuvant 160U/0.5ml EV71 vaccines one year before. |
| alum-adjuvant 320U /0.5ml EV71 vaccine | Experimental | Biological: alum-adjuvant 320U /0.5mlA booster dose of alum-adjuvant 320U /0.5ml EV71 vaccine in 160 children whom had received two doses of alum-adjuvant 320U/0.5ml EV71 vaccines one year before. |
| placebo B | Placebo comparator | Biological: 0/0.5ml placeboA 0/0.5ml placebo in 80 children whom had received two doses of alum-adjuvant 320U/0.5ml EV71 vaccines one year before. |
| alum-adjuvant 640U /0.5ml EV71 vaccine | Experimental | Biological: alum-adjuvant 640U /0.5mlA booster dose of alum-adjuvant 640U /0.5ml EV71 vaccine in 160 children whom had received two doses of alum-adjuvant 640U/0.5ml EV71 vaccines one year before. |
| placebo C | Placebo comparator | Biological: 0/0.5ml placeboA 0/0.5ml placebo in 80 children whom had received two doses of alum-adjuvant 640U/0.5ml EV71 vaccines one year before. |
| adjuvant-free 640U /0.5ml EV71 vaccine | Experimental | Biological: adjuvant-free 640U /0.5mlA booster dose of adjuvant-free 640U /0.5ml EV71 vaccine in 160 children whom had received two doses of adjuvant-free 640U/0.5ml EV71 vaccines one year before. |
| placebo D | Placebo comparator | Biological: 0/0.5ml placeboA 0/0.5ml placebo in 80 children whom had received two doses of adjuvant-free 640U/0.5ml EV71 vaccines one year before. |
Who may qualify
- Ages
- 21 to 51 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Had participated in the previous phase II trial and received at least 1 dose of EV71 vaccine.
- Healthy children as established by medical history and clinical examination
- The subjects' guardians are able to understand and sign the informed consent
- Subjects who can and will comply with the requirements of the protocol
- Subjects with temperature <=37.0°C on axillary setting
Key exclusion criteria (19 listed)
- Had participated in the previous phase II trial and received placebo.
- Subject who has a medical history of EV71-associated disease with specific laboratory evidence
- <= 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
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 |
|---|---|---|
| alum-adjuvant 160U /0.5mlinactivated vaccine (vero cell) alum-adjuvant 160U /0.5ml EV71 vaccine | Biological | alum-adjuvant 160U /0.5ml EV71 vaccine |
| alum-adjuvant 320U /0.5mlinactivated vaccine (vero cell) alum-adjuvant 320U /0.5ml EV71 vaccine | Biological | alum-adjuvant 320U /0.5ml EV71 vaccine |
| alum-adjuvant 640U /0.5mlinactivated vaccine (vero cell) alum-adjuvant 640U /0.5ml EV71 vaccine | Biological | alum-adjuvant 640U /0.5ml EV71 vaccine |
| adjuvant-free 640U /0.5mlinactivated vaccine (vero cell) adjuvant-free 640U /0.5ml EV71 vaccine | Biological | adjuvant-free 640U /0.5ml EV71 vaccine |
| 0/0.5ml placebo0/0.5ml placebo | Biological | placebo A, placebo B, placebo C, placebo D |
Primary outcome
Geometric mean titer (GMT) of anti-EV71 antibodies
Time frame: 28 days after vaccination
GMT of anti-EV71 antibodies in serum 28 days after booster dose injection
3 secondary outcomes
Safety of EV71 vaccine in healthy children
Time frame: 28 days after vaccination
Geometric mean fold increase (GMFI) of anti-EV71 antibodies
Time frame: 28 days after vaccination
Seroconversion of anti-EV71 antibodies
Time frame: 28 days after 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 23 Oct 2013.
- Derived from this study: PubMed 24625805Shenyu W, Jingxin L, Zhenglun L, Xiuling L, Qunying M, Fanyue M, Hua W, Yuntao Z, Fan G, Qinghua C, Yuemei H, Xin Y, Huijie G, Fengcai Z. A booster dose of an inactivated enterovirus 71 vaccine in chinese young children: a randomized, double-blind, placebo-controlled clinical trial. J Infect Dis. 2014 Oct 1;210(7):1073-82. doi: 10.1093/infdis/jiu113. Epub 2014 Mar 12.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing alum-adjuvant 160U /0.5ml, alum-adjuvant 320U /0.5ml and alum-adjuvant 640U /0.5ml in people with EV71-associated Disease, 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 5 inclusion and 19 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 23 Oct 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Geometric mean titer (GMT) of anti-EV71 antibodies (time frame: 28 days after vaccination). 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 NCT01734408, 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 23 Oct 2013.