Clinical trial NCT02816554: Safety and Immunogenicity of JECEVAX in Young Children
Official title: Safety and Immunogenicity of an Inactivated Japanese Encephalitis Vaccine (JECEVAX) in Vietnamese Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Japanese Encephalitis
Keywords: Japanese Encephalitis
JECEVAX
Vietnam
Lead sponsor: National Institute of Hygiene and Epidemiology, Vietnam
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Vietnam
name: Ministry of Health, Vietnam
First posted: 2016-06-28
Enrollment: 200
Sex: ALL
Minimum age (years): 9
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).

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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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

Primary outcomes:
measure: Number of participants with treatment-related adverse events during study period.
timeFrame: Up to 30 days after 2nd dose
measure: Number of participants have sero-conversion at 20-22 days post 2nd dose (compared to pre-vaccination)
timeFrame: Up to 20-22 days after the 2nd dose
Secondary outcomes:
measure: Number of participants with treatment-related SAE during study period
timeFrame: Up to 30 days after the 2nd dose
measure: Number of participants with abnormal laboratory value.
timeFrame: Up to 20-22 days after the 2nd dose.
Other outcomes:
Locations:
city: Thanh Son
country: Vietnam
facility: District Health Center
state: Phu Tho
city: Viet tri
country: Vietnam
facility: Phu Tho Preventive Medicine Center
state: Phu Tho
Study officials:
affiliation: National Institute of Hygiene and Epidemiology, Vietnam
name: Thiem D Vu, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References: