Safety and Immunogenicity of JECEVAX in Young Children

Japanese Encephalitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02816554
• Other study ID #: 2015-JECEVAX-2R
• Status: Completed
• Phase: Phase 2
• First received: June 23, 2016
• Last updated: June 24, 2016
• Start date: April 2015
• Est. completion date: November 2015

Study information

• Verified date: June 2016
• Source: National Institute of Hygiene and Epidemiology, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Months to 24 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis

Intervention

Biological:
• JEVAX
JEVAX - VABIOTECH Vietnam Liquid form Subcutaneous injection 0.5ml/dose, 2 doses, 10-12 days interval
• JECEVAX-1
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 1 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
• JECEVAX-0.8
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.8 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
• JECEVAX-0.5
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days

Locations

Country	Name	City	State
Vietnam	District Health Center	Thanh Son	Phu Tho
Vietnam	Phu Tho Preventive Medicine Center	Viet tri	Phu Tho

Sponsors (3)

Lead Sponsor	Collaborator
National Institute of Hygiene and Epidemiology, Vietnam	Company for vaccine and biological production No 1, Ministry of Health, Vietnam, Ministry of Science and Technology, Vietnam

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 30 days after 2nd dose	Yes
Primary	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	Up to 20-22 days after the 2nd dose	No
Secondary	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	Up to 30 days after the 2nd dose	Yes
Secondary	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.	Up to 20-22 days after the 2nd dose.	Yes