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Systems BiologyPhase 2NCT01679665

Systems Biology of Vaccination for EV71 Vaccine in Humans

A Phase 2 study testing 320U /0.5ml in people with Systems Biology and Early Gene, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.

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

Recently, an inactivated vaccine (vero cell) against EV71 has been investigated in Phase 1 and Phase 2 clinical trials. Data from these trials showed that the EV71 vaccine has good safety profile and was immunogenic. 320 U alum-adjuvant vaccine has been chosen as the candidate vaccine for the phase 3 clinical trial. Read more about this study

Who is it for?
Ages 2 to 5 years
Conditions the study is for
Systems Biology, Early Gene, EV71 Vaccine
What is being tested?
320U /0.5ml
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteChina
Study dates
Aug 2012to May 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 2 to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Healthy subjects aged from 2 to 5 years old as established by medical history and clinical examination
  • The pre-vaccination neutralizing antibody against EV71 <1:8 which is determined by ELISA
  • 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 18Show 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jiangsu Provincial Center for Diseases Control and Prevention

    Nanjing, Jiangsu, 210009

Other trials in China

About this study

Official title: Systems Biology of Vaccination for EV71 Vaccine in Chinese Healthy Children Aged From 2 to 5 Years Old

Recently, an inactivated vaccine (vero cell) against EV71 has been investigated in Phase 1 and Phase 2 clinical trials. Data from these trials showed that the EV71 vaccine has good safety profile and was immunogenic. 320 U alum-adjuvant vaccine has been chosen as the candidate vaccine for the phase 3 clinical trial.

This clinical trial is a supplementary phase 2 trial, which is designed to study the gene expression patterns induced by EV71 vaccine in Chinese healthy children aged from 2 to 5 years old use a systems biology approach combined with microarray analysis，RT-PCR and neutralizing antibody testing for PBMC and serum collected form the studied children population, to predict immunogenicity, and explore mechanistic insights about the EV71 vaccine.

Being tested
320U /0.5ml, 0/0.5ml placebo

What participants receive

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

  • 320U /0.5mlBiological

    inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 4 weeks interval

  • 0/0.5ml placeboBiological

    0/0.5ml placebo, two doses, 4 weeks interval

Study groups in NCT01679665
Study groupRoleWhat they receive
320U /0.5ml in children (from 2 to 5 years old)Experimentalinactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 48 children aged 2-5 years old on day 0,28
Receives: Biological: 320U /0.5ml
0/0.5ml placebo in children (from 2 to 5 years old)Placebo comparator0/0.5ml placebo in 24 children aged 2-5 years old on day 0, 28
Receives: Biological: 0/0.5ml placebo

What is being measured

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

  1. Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine

    Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 3 in children aged 2-5 years

    Measured: Frame: 3 days after first dose

  2. Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine

    Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 7 in children aged 2-5 years

    Measured: 7 days after first dose

  3. Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine

    Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 28 in children aged 2-5 years

    Measured: 28 days after first dose

  4. Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine

    Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at day 56 in children aged 2-5 years

    Measured: 28 days after second dose

  5. Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine

    Identifying genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine at month 6 in children aged 2-5 years

    Measured: 6 months after first dose

Secondary outcomes (4)

  1. GMT, seroconversion rate of anti-EV71 antibodies in serum after first vaccination

    GMT, seroconversion rate of anti-EV71 antibodies in serum 28 days after first vaccination

    Measured: 28 days after the first vaccination

  2. GMT, seroconversion rate of anti-EV71 antibodies in serum after second vaccination

    GMT, seroconversion rate of anti-EV71 antibodies in serum 28 days after second vaccination

    Measured: 28 days after second vaccination

  3. the safety of EV71 vaccine in healthy children aged 2-5 years

    Frequency of systemic and local adverse reactions within 28 days after the first dose of EV71 vaccine in healthy children aged 2-5 years

    Measured: 28 days after the first dose

  4. the safety of EV71 vaccine in healthy children aged 2-5 years

    Frequency of systemic and local adverse reactions within 28 days after the second dose of EV71 vaccine in healthy children aged 2-5 years

    Measured: 28 days after the second dose

Timeline

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

  1. First posted6 Sep 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionMay 2013
  4. Study completionMay 2013

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01679665
Sponsor's protocol ID
JSVCT012
Status last verified
May 2013
First submitted
1 Sep 2012
Last updated
8 May 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 320U /0.5ml in people with Systems Biology and Early Gene, 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 6 inclusion and 18 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 8 May 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?

Genomic signatures that predicted immune responses in infants vaccinated with EV71 vaccine (time frame: Frame: 3 days after first dose). The study lists 5 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 NCT01679665.

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 8 May 2013.

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