Enterovirus InfectionPhase 1NCT01268787
A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine
A Phase 1 study testing EV71 vaccine in people with Enterovirus Infection, run by National Health Research Institutes, Taiwan at 2 sites in Taiwan.
Trial summary
This study is aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine at a 0.25ml or 0.5ml dose in health volunteers Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Enterovirus Infection
- What is being tested?
- EV71 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTaiwan
- Study dates
- Dec 2010to Sep 2012
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject who is free of obvious health problems
- Able and willing to comply with the study procedure adn give written informed consent
Who cannot join
- Female who is pregnant/lactating or planning to be pregnant
- Body mass index(BMI) > 35
- Oral temperature > 37.5 Celsius at the time of planned vaccination
- Subject with any abnormal laboratory results at screening
- With a history of herpangina, hand-foot-mouth disease, acute hemorrhagic conjunctivitis or acute gastrointestinal illness associated with enterovirus infection in the past 3 months
- Has been diagnosed with neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder
Show all 10Show fewer
- With a history of hypersensitivity to vaccine or allergic disease
- Use of any investigational/non-registered product within 30 days prior to vaccination
- Use of immunoglobulins or any blood products within 3 months prior to vaccination
- Chronic administration of immunosuppressants or other immunomodulators within 5 months prior to vaccination
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Taipei Veterans General Hospital
Taipei, Shihlin District, 112
National Taiwan University Hospital
Taipei, Zhongshan Distric, 104
About this study
Official title: A Phase I, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine Administrated With Adjuvant AlPO4 in Health Volunteers
This study is aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine at a 0.25ml or 0.5ml dose in health volunteers
Read the detailed description
This is a phase I, prospective, randomized, open-label, two-center study. A total 60 healthy volunteers will be screened for baseline characteristic inclusion/exclusion criteria after providing a written informed consent. Eligible subjects will be recruited and equally randomized to either receive 2 doses of EV71 vaccine 0.25ml or 0.5ml. All subjects should be followed till Day 210.
- Conditions
- Enterovirus Infection
- Being tested
- EV71 vaccine
- Medical subject headings
- Enterovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV71 vaccineBiological
Also called EV71 vac
Two-vaccination 0.25ml or 0.5ml dose assigned to two groups.
| Study group | Role | What they receive |
|---|---|---|
| EV 71 vaccine 5ug | Active comparator | EV71 Vaccine 5ug Receives: Biological: EV71 vaccine |
| EV 71 vaccine 10ug | Experimental | EV71 vaccine 10ug Receives: Biological: EV71 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
The percentage, intensity and relationship to vaccination of local and systemic signs and symptoms at a 0.25ml and 0.5ml dose
Measured: 210 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionMar 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Enterovirus InfectionStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pele Chong, Ph.D., Study chair, National Health Research Institutes, TaiwanChia-Chyi Liu, Ph.D., Study director, National Health Research Institutes, TaiwanC P Fung, M.D., Principal investigator, Taipei Veterans General Hospital, TaiwanS M Hsieh, M.D, Principal investigator, Taipei Meidcal College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268787
- Sponsor's protocol ID
- QCR-10013
- Status last verified
- Oct 2013
- First submitted
- 30 Dec 2010
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chou AH, Liu CC, Chang JY, Jiang R, Hsieh YC, Tsao A, Wu CL, Huang JL, Fung CP, Hsieh SM, Wang YF, Wang JR, Hu MH, Chiang JR, Su IJ, Chong PC. Formalin-inactivated EV71 vaccine candidate induced cross-neutralizing antibody against subgenotypes B1, B4, B5 and C4A in adult volunteers. PLoS One. 2013 Nov 21;8(11):e79783. doi: 10.1371/journal.pone.0079783. eCollection 2013.
PubMed 24278177Cheng A, Fung CP, Liu CC, Lin YT, Tsai HY, Chang SC, Chou AH, Chang JY, Jiang RH, Hsieh YC, Su IJ, Chong PC, Hsieh SM. A Phase I, randomized, open-label study to evaluate the safety and immunogenicity of an enterovirus 71 vaccine. Vaccine. 2013 May 7;31(20):2471-6. doi: 10.1016/j.vaccine.2013.03.015. Epub 2013 Mar 27.
PubMed 23541623
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine Administrated With Adjuvant AlPO4 in Health Volunteers
- ClinicalTrials.gov ID
- NCT01268787
- Acronym / sponsor ID
- QCR-10013
- Conditions
- Enterovirus Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 31 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.
This study is aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine at a 0.25ml or 0.5ml dose in health volunteers
Detailed description
This is a phase I, prospective, randomized, open-label, two-center study. A total 60 healthy volunteers will be screened for baseline characteristic inclusion/exclusion criteria after providing a written informed consent. Eligible subjects will be recruited and equally randomized to either receive 2 doses of EV71 vaccine 0.25ml or 0.5ml. All subjects should be followed till Day 210.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EV 71 vaccine 5ug | Active comparator | Biological: EV71 vaccineEV71 Vaccine 5ug |
| EV 71 vaccine 10ug | Experimental | Biological: EV71 vaccineEV71 vaccine 10ug |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subject who is free of obvious health problems
- Able and willing to comply with the study procedure adn give written informed consent
Key exclusion criteria (10 listed)
- Female who is pregnant/lactating or planning to be pregnant
- Body mass index(BMI) > 35
- Oral temperature > 37.5 Celsius at the time of planned vaccination
- Subject with any abnormal laboratory results at screening
- With a history of herpangina, hand-foot-mouth disease, acute hemorrhagic conjunctivitis or acute gastrointestinal illness associated with enterovirus infection in the past 3 months
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 |
|---|---|---|
| EV71 vaccineAlso: EV71 vacTwo-vaccination 0.25ml or 0.5ml dose assigned to two groups. | Biological | EV 71 vaccine 10ug, EV 71 vaccine 5ug |
Primary outcome
Primary endpoint
Time frame: 210 Days
The percentage, intensity and relationship to vaccination of local and systemic signs and symptoms at a 0.25ml and 0.5ml dose
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 16 Apr 2015.
- Derived from this study: PubMed 24278177Chou AH, Liu CC, Chang JY, Jiang R, Hsieh YC, Tsao A, Wu CL, Huang JL, Fung CP, Hsieh SM, Wang YF, Wang JR, Hu MH, Chiang JR, Su IJ, Chong PC. Formalin-inactivated EV71 vaccine candidate induced cross-neutralizing antibody against subgenotypes B1, B4, B5 and C4A in adult volunteers. PLoS One. 2013 Nov 21;8(11):e79783. doi: 10.1371/journal.pone.0079783. eCollection 2013.
- Derived from this study: PubMed 23541623Cheng A, Fung CP, Liu CC, Lin YT, Tsai HY, Chang SC, Chou AH, Chang JY, Jiang RH, Hsieh YC, Su IJ, Chong PC, Hsieh SM. A Phase I, randomized, open-label study to evaluate the safety and immunogenicity of an enterovirus 71 vaccine. Vaccine. 2013 May 7;31(20):2471-6. doi: 10.1016/j.vaccine.2013.03.015. Epub 2013 Mar 27.
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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.
Pele Chong, Ph.D. study chair
National Health Research Institutes, Taiwan
Chia-Chyi Liu, Ph.D. study director
National Health Research Institutes, Taiwan
C P Fung, M.D. principal investigator
Taipei Veterans General Hospital, Taiwan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EV71 vaccine in people with Enterovirus Infection, run by National Health Research Institutes, Taiwan at 2 sites in Taiwan.
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 2 inclusion and 10 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 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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. 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?
Primary endpoint (time frame: 210 Days). 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 NCT01268787, which also lists 2 linked publications.
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 16 Apr 2015.