Japanese EncephalitisPhase 2NCT02816554

Safety and Immunogenicity of JECEVAX in Young Children

A Phase 2 study testing JEVAX, JECEVAX-1 and JECEVAX-0.8 in people with Japanese Encephalitis, run by National Institute of Hygiene and Epidemiology, Vietnam at 2 sites in Vietnam.

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

Who is it for?: Ages 9 to 24 monthsHealthy volunteers can take part
Conditions the study is for: Japanese Encephalitis
What is being tested?: JEVAX, JECEVAX-1 and JECEVAX-0.8
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 2 sitesVietnam
Study dates: Apr 2015to Nov 2015
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 9 to 24 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy children of both sexes, 9-24 months of age;
Have not been vaccinated with JE vaccine;
Not have any chronic disease;
Parents/legal guardians agree to participate their children in this study and sign the informed consent.

Who cannot join

Currently has chronic diseases (cardiovascular, liver and spleen related etc);
Currently has acute diseases;
Use (orally or injection) with corticosteroid containing drug (>1 mg / kg dose);
Use of immunocompromised treatment within 4 weeks of enrollment;
Being immunocompromised and autoimmune diseases (HIV, lupus);
The family history of immunocompromised;

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History of febrile seizure;
Allergic to any vaccine component;
Fever (>38 Celsius degree) within 3 days before vaccination or at enrollment;
Malnourished (3rd grade or above);
Blood disorder;
Use of vaccines which have not been licenced 7 days before enrolment in this study

Trial locations and contacts

2 sites in 1 country.

Vietnam2 sites

District Health Center
Thanh Sơn, Phu Tho
Phu Tho Preventive Medicine Center
Viet Tri, Phu Tho

Other trials in Vietnam

About this study

Official title: Safety and Immunogenicity of an Inactivated Japanese Encephalitis Vaccine (JECEVAX) in Vietnamese Children

A dose escalating study with 3 different dosing regimens of the studied vaccine (JECEVAX- VABIOTECH-Vietnam) and a licensed vaccine (JEVAX-VABIOTECH-Vietnam) is conducted in Vietnamese children, aged 9 to 24 months to assess the safety and immunogenicity. Two hundred children are enrolled and randomly assigned into 4 groups (50 children/group), each of which receive 2 doses of study / control vaccine subcutaneously, at 10-12 days interval. Safety issues included immediate reaction at the site of injection and systemic reaction within 30 min of administration, solicited and unsolicited adverse events occurs from the first dose to 30 days after second dose; SAE (from start of first dose to 30 days after second dose), blood cell count, urea, ALT, AST. Immunogenicity outcomes include seroconversion of neutralizing antibodies (blood samples are taken prior to 1st dose and 20-22 days post 2nd dose).

Read the detailed description

Mouse brain-derived Japanese Encephalitis (JE) vaccine was developed in Vietnam since 1989 with the support from WHO and BIKEN institute, Japan. It helped Viet Nam prevents Japanese Encephalitis outbreaks successfully during those years.

However, mouse brain-derived JE vaccine production requires companies to compliance various requirements from WHO. Especially, WHO has a plan to replace the mouse brain-derived JE vaccines with Cell culture-derived JE vaccines.

Vero cell-derived vaccine technology shows many advantages compares to Mouse brain-derived vaccine technology. VABIOTECH has been approved and sponsored by the Ministry of Science and Technology to produce Vero cell - derived JE vaccine. The vaccine demonstrated a good safety and immunogenicity profile in animal models. The vaccine has been proven safety in volunteer adults.

In this study, a dose escalating study with 3 different dosing regimens of the studied vaccine (JECEVAX) and a licensed vaccine (JEVAX-VABIOTECH Vietnam) is conducted in Vietnamese children, aged 9-24 months to assess the safety and immunogenicity. Two hundred children are enrolled and randomly assigned into 4 groups (50 children/group), each of which receive 2 doses of investigate vaccines or control vaccine subcutaneously, at 10-12 days interval. Safety issues included immediate reaction at the site of injection and systemic reaction within 30 min of administration, solicited and unsolicited adverse events occurs from the first dose to 30 days after second dose; SAE (from start of first dose to 30 days after second dose), blood cell count, urea, ALT, AST. Immunogenicity outcomes include seroconversion of neutralizing antibodies (blood samples are taken prior to 1st dose and 20-22 days post 2nd dose).

Conditions: Japanese Encephalitis
Being tested: JEVAX, JECEVAX-1, JECEVAX-0.8, JECEVAX-0.5
Keywords: Japanese Encephalitis, JECEVAX, Vietnam
Medical subject headings: Encephalitis, Japanese

What participants receive

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

JEVAXBiological
JEVAX - VABIOTECH Vietnam Liquid form Subcutaneous injection 0.5ml/dose, 2 doses, 10-12 days interval
JECEVAX-1Biological
Also called JECEVAX-HI
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 1 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
JECEVAX-0.8Biological
Also called JECVAX-MED
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.8 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
JECEVAX-0.5Biological
Also called JECEVAX-LOW
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days

Study groups in NCT02816554
Study group	Role	What they receive
JECEVAX-1	Experimental	JECEVAX - VABIOTECH Vietnam Liquid form Composition: 1.0 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12days Receives: Biological: JECEVAX-1
JECEVAX-0.8	Experimental	JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.8 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days Receives: Biological: JECEVAX-0.8
JECEVAX-0.5	Experimental	JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days Receives: Biological: JECEVAX-0.5
JEVAX	Active comparator	JEVAX - VABIOTECH Vietnam Liquid form Composition: 1,0 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days Receives: Biological: JEVAX

What is being measured

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

Number of participants with treatment-related adverse events during study period.
Number of participants with solicited and unsolicited adverse events after each dose of vaccine: immediately injection site and systemic AEs after vaccination (within 30 min), solicited and unsolicited AEs within 7 days after each dose, unsolicited AEs from day 8 after dose 1 to date of dose 2 and from day 8 after dose 2 to day 30 post 2nd dose, as assessed by CTCAE v.4.0.
Measured: Up to 30 days after 2nd dose
Number of participants have sero-conversion at 20-22 days post 2nd dose (compared to pre-vaccination)
Sero-conversion rate of each JECEVAX regimen and JEVAX at 20-22 days after 2 doses of vaccines
Measured: Up to 20-22 days after the 2nd dose

Secondary outcomes (2)

Number of participants with treatment-related SAE during study period
Number of participants with treatment-related SAE during study period of JECEVAX compared to that of JEVAX, as assessed by CTCAE ver 4.0
Measured: Up to 30 days after the 2nd dose
Number of participants with abnormal laboratory value.
Numbers of participants with abnormal laboratory values (blood cell counts, urea concentration, liver function (ALT, AST concentration) when administered with different JECEVAX formulations and with JEVAX before the first dose and 20-22 days after the 2nd dose.
Measured: Up to 20-22 days after the 2nd dose.

Timeline

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

Apr 2015Nov 2015

First posted28 Jun 2016 (estimated)
Study startApr 2015
Primary completionSep 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Japanese EncephalitisStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02816554
Sponsor's protocol ID: 2015-JECEVAX-2R
Status last verified: Jun 2016
First submitted: 23 Jun 2016
Last updated: 28 Jun 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No: Individual data with identification removed are to be available for Ethical committee, Ministry of Health and National Foundation of Science and Technology Development to avoid misuse of data. Public shared data will be in the form of summarised tables and figures.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 4
Immunogenicity, Safety, and Antibody Persistence of Different Immunization Strategies Against Japanese Encephalitis
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Diagnostics and Surveillance of Acute Meningo-encephalitis Among Children in Cambodia With a Focus on Japanese Encephalitis Virus
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Active, not recruitingPhase 4
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All Japanese Encephalitis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity of an Inactivated Japanese Encephalitis Vaccine (JECEVAX) in Vietnamese Children
ClinicalTrials.gov ID: NCT02816554
Acronym / sponsor ID: 2015-JECEVAX-2R
Conditions: Japanese Encephalitis
Keywords: Japanese Encephalitis, JECEVAX, Vietnam
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: National Institute of Hygiene and Epidemiology, VietnamUniversity, hospital or other
Collaborators: Ministry of Science and Technology, Vietnam, Ministry of Health, Vietnam
Study start: Apr 2015
Primary completion: Sep 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 28 Jun 2016 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
JECEVAX-1	Experimental	Biological: JECEVAX-1JECEVAX - VABIOTECH Vietnam Liquid form Composition: 1.0 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12days
JECEVAX-0.8	Experimental	Biological: JECEVAX-0.8JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.8 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
JECEVAX-0.5	Experimental	Biological: JECEVAX-0.5JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
JEVAX	Active comparator	Biological: JEVAXJEVAX - VABIOTECH Vietnam Liquid form Composition: 1,0 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days

Who may qualify

Ages: 9 to 24 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Healthy children of both sexes, 9-24 months of age;
Have not been vaccinated with JE vaccine;
Not have any chronic disease;
Parents/legal guardians agree to participate their children in this study and sign the informed consent.

Key exclusion criteria (12 listed)

Currently has chronic diseases (cardiovascular, liver and spleen related etc);
Currently has acute diseases;
Use (orally or injection) with corticosteroid containing drug (>1 mg / kg dose);
Use of immunocompromised treatment within 4 weeks of enrollment;
Being immunocompromised and autoimmune diseases (HIV, lupus);

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
JEVAXJEVAX - VABIOTECH Vietnam Liquid form Subcutaneous injection 0.5ml/dose, 2 doses, 10-12 days interval	Biological	JEVAX
JECEVAX-1Also: JECEVAX-HIJECEVAX - VABIOTECH Vietnam Liquid form Composition: 1 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days	Biological	JECEVAX-1
JECEVAX-0.8Also: JECVAX-MEDJECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.8 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days	Biological	JECEVAX-0.8
JECEVAX-0.5Also: JECEVAX-LOWJECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days	Biological	JECEVAX-0.5

Primary outcome

Number of participants with treatment-related adverse events during study period.
Time frame: Up to 30 days after 2nd dose
Number of participants with solicited and unsolicited adverse events after each dose of vaccine: immediately injection site and systemic AEs after vaccination (within 30 min), solicited and unsolicited AEs within 7 days after each dose, unsolicited AEs from day 8 after dose 1 to date of dose 2 and from day 8 after dose 2 to day 30 post 2nd dose, as assessed by CTCAE v.4.0.
Number of participants have sero-conversion at 20-22 days post 2nd dose (compared to pre-vaccination)
Time frame: Up to 20-22 days after the 2nd dose
Sero-conversion rate of each JECEVAX regimen and JEVAX at 20-22 days after 2 doses of vaccines

2 secondary outcomes

Number of participants with treatment-related SAE during study period
Time frame: Up to 30 days after the 2nd dose
Number of participants with abnormal laboratory value.
Time frame: Up to 20-22 days after the 2nd 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 28 Jun 2016.
Individual participant dataSharing planned: No. Individual data with identification removed are to be available for Ethical committee, Ministry of Health and National Foundation of Science and Technology Development to avoid misuse of data. Public shared data will be in the form of summarised tables and figures.

Related trials for Japanese Encephalitis

Active, not recruitingPhase 4
Immunogenicity, Safety, and Antibody Persistence of Different Immunization Strategies Against Japanese Encephalitis
Japanese Encephalitis Vaccine
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
Not yet recruitingObservational study
Diagnostics and Surveillance of Acute Meningo-encephalitis Among Children in Cambodia With a Focus on Japanese Encephalitis Virus
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Active, not recruitingPhase 4
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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.

Thiem D Vu, MD., PhD. principal investigator

National Institute of Hygiene and Epidemiology, Vietnam

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JEVAX, JECEVAX-1 and JECEVAX-0.8 in people with Japanese Encephalitis, run by National Institute of Hygiene and Epidemiology, Vietnam at 2 sites in Vietnam.

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 12 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 28 Jun 2016. 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 Vietnam. 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?

Number of participants with treatment-related adverse events during study period. (time frame: Up to 30 days after 2nd dose). 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 NCT02816554.

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 28 Jun 2016.