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AzTrials

Enterovirus InfectionsPhase 2NCT03268083

A Study to Evaluate the Immunogenicity and Safety of EV71 Vaccine in Pediatric Subjects

A Phase 2 study testing EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose), EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose) and EV71 vaccine ([1 μg total protein ] per dose) in people with Enterovirus Infections, run by Enimmune Corporation at 4 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objectives of this study are to evaluate the immune response and safety profiles of two injections of EV71 vaccine administrated with or without adjuvant Al(OH)3 at 0.5-μg and 1-μg dose in children aged 3 to 6 years old and 2 to 35 months old infants/toddlers. Read more about this study

Who is it for?
Ages 2 months to 6 yearsHealthy volunteers can take part
Conditions the study is for
Enterovirus Infections
What is being tested?
EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose), EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose) and EV71 vaccine ([1 μg total protein ] per dose)
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
4 sitesTaiwan
Study dates
Jul 2016to Dec 2017
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 2 months to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy children aged from 3 to 6 years old (i.e. ≥ 3 years old and < 7 years old) for Part A,and from 2 to 35 months old (i.e. ≥ 2 months old and < 36 months old) for Part B at the time of first vaccination.
  • Subject's guardians are able and willing to comply with study procedures and provide the signed informed consent.
  • Subject is able and can comply with the requirements of the protocol.
  • Subject with body temperature ≤38°C.

Who cannot join

  • Subject with previous known exposure to Enterovirus 71 (EV71).
  • Subject with a history of herpangina, hand-foot-mouth disease,and acute hemorrhagic conjunctivitis associated with enterovirus infection in the past 3 months.
  • Subject with gestation < 37 weeks.
  • Subject with birth weight <2.5 kg.
  • Subject with a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component of the 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.
  • Subject diagnosed of having autoimmune disease (e.g., celiac disease, type I diabetes, lupus (SLE), juvenile dermatomyositis, scleroderma, juvenile idiopathic arthritis (JIA), immune (or idiopathic) thrombocytopenia purpura).
  • Bleeding disorder diagnosed by a doctor or significant bruising or hemostatic difficulties with IM injections or blood draws.
  • Any acute infections 7 days prior to administrating the first vaccination.
  • Use of any investigational product (including drug, vaccine) within 30 days prior to vaccination or planned use during the study period.
  • Administration of any vaccines within 14 days prior to randomization.
  • Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the study period.
  • Chronic administration (defined as > 14 days) of immunosuppressants or other immunomodulators or systemic corticosteroids within 6 months prior to vaccination or planned use during the study period.
  • Subjects who had ever received investigational EV-71 vaccine prior to randomization.
  • Under anti-tuberculosis prevention or therapy.
  • Any condition that in the opinion of the investigator may interfere with the evaluation of study objectives.

Trial locations and contacts

4 sites in 1 country.

Taiwan4 sites

  • China Medical University Hospital

    Taichung

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

  • Linkou Chang Gung Memorial Hospital

    Taoyuan

Other trials in Taiwan

About this study

Official title: An Open-Label, Dose-Finding, Phase II Study to Evaluate the Immunogenicity and Safety of the Bioreactor-generated EV71 Vaccine in Pediatric Subjects Aged 3 to 6 Years and 2 to 35 Months Old

The objectives of this study are to evaluate the immune response and safety profiles of two injections of EV71 vaccine administrated with or without adjuvant Al(OH)3 at 0.5-μg and 1-μg dose in children aged 3 to 6 years old and 2 to 35 months old infants/toddlers.

Being tested
EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose), EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose), EV71 vaccine ([1 μg total protein ] per dose)
Keywords
Foot-and-Mouth Disease, Vaccines, Hand, Foot and Mouth Disease, EV71 vaccine
Medical subject headings
Enterovirus Infections, Foot-and-Mouth Disease, Hand, Foot and Mouth Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose)Biological

    Two vaccinations at 28 days apart

  • EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose)Biological

    Two vaccinations at 28 days apart

  • EV71 vaccine ([1 μg total protein ] per dose)Biological

    Two vaccinations at 28 days apart

Study groups in NCT03268083
Study groupRoleWhat they receive
Group A1Experimental3 to 6 years
Receives: Biological: EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose)
Group A2Experimental3 to 6 years
Receives: Biological: EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose)
Group A3Experimental3 to 6 years
Receives: Biological: EV71 vaccine ([1 μg total protein ] per dose)
Group B1Experimental2 to 35 months
Receives: Biological: EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose)
Group B2Experimental2 to 35 months
Receives: Biological: EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose)
Group B3Experimental2 to 35 months
Receives: Biological: EV71 vaccine ([1 μg total protein ] per dose)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum neutralizing antibody titers (NT) induced by the EV71 vaccine

    Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 56

    Measured: Day 56

  2. Seroconversion rate (SCR) based on neutralizing antibody titers

    Evaluate the immunogenicity change of SCR from baseline on Day 56

    Measured: Day 56

  3. Serum neutralizing antibody titers (NT) induced by the EV71 vaccine

    Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 28

    Measured: Day 28

  4. Serum neutralizing antibody titers (NT) induced by the EV71 vaccine

    Evaluate the immunogenicity change of serum neutralizing antibody titers induced by the EV71 vaccine from baseline on Day 196

    Measured: Day 196

  5. Seroconversion rate (SCR) based on neutralizing antibody titers

    Evaluate the immunogenicity change of SCR from baseline on Day 28

    Measured: Day 28

  6. Seroconversion rate (SCR) based on neutralizing antibody titers

    Evaluate the immunogenicity change of SCR from baseline on Day 196

    Measured: Day 196

Secondary outcomes (5)

  1. Solicited adverse events

    Measured: 7 days after each vaccination

  2. Unsolicited adverse events

    Measured: 28 days after each vaccination

  3. The occurrence of overall adverse events (AEs) and serious adverse event (SAEs)

    Measured: Day 0 to Day 196

  4. The occurrence of EV 71 breakthrough infection after Visit 3

    Measured: Day 57 to Day 364

  5. Serum neutralizing antibody titers (NT) induced by the EV71 vaccine

    Evaluate the immunogenicity of serum neutralization antibody titer induced by the EV 71 vaccine on Day 364

    Measured: Day 364

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2017
  2. Study startJul 2016
  3. Primary completionAug 2017
  4. Study completionDec 2017

Resources

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
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03268083
Sponsor's protocol ID
EV-BR1501
Status last verified
Oct 2021
First submitted
4 Aug 2016
Last updated
26 Oct 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Hung MC, Cho CY, Chen CJ, Lai CC, Wu KG. Immunogenicity and safety of an inactivated enterovirus A71 vaccine in children 3-6 years and 2-35 months of age- an open-label, randomized phase IIb clinical trial. Vaccine. 2019 Sep 3;37(37):5559-5566. doi: 10.1016/j.vaccine.2019.07.096. Epub 2019 Aug 6.

    PubMed 31399275

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose), EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose) and EV71 vaccine ([1 μg total protein ] per dose) in people with Enterovirus Infections, run by Enimmune Corporation at 4 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 4 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 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 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?

Serum neutralizing antibody titers (NT) induced by the EV71 vaccine (time frame: Day 56). The study lists 6 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 NCT03268083, 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 26 Oct 2021.

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