A Phase 3 interventional study of JEVAX and JECEVAX in Japanese Encephalitis, sponsored by National Institute of Hygiene and Epidemiology, Vietnam. Completed at 4 sites in Vietnam. Open to participants aged 9 Months to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-17.
Sponsored by National Institute of Hygiene and Epidemiology, Vietnam · Phase 3, Interventional, and Prevention
A study of the study 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 of the study vaccine compares to licenced vaccine. Two hundred and twenty children are enrolled and randomly assigned into 2 groups (110 children/group), each of which receive 2 doses of study / control vaccine subcutaneously, at 28-34 days interval. Safety data included immediate reaction at the injection site and systemic reaction within 30 min of administration, solicited and unsolicited adverse events occurs from the 1st dose to 28-34 days after first dose and from the second dose to 28-34 days after 2nd dose. SAE (from start of first dose to 28-34 days after second dose).
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 and in phase 2 which evaluated the safety and immunogenicity of 3 difference antigen concentrations.
In this study, a selected dose of the studied vaccine (JECEVAX) derived from phase 2 will be compared the safety with a licensed vaccine (JEVAX-VABIOTECH Vietnam) in Vietnamese children, aged 9-24 months to assess the safety and immunogenicity. Two hundred and twenty children are enrolled and randomly assigned into 2 groups (110 children/group), each of which receive 2 doses of investigate vaccines or control vaccine subcutaneously, at 28-34 days interval. Safety data included immediate reaction at the injection site and systemic reaction within 30 min of administration, solicited and unsolicited adverse events occurs from the 1st dose to 28-34 days after first dose (up to date of 2nd dose) and from the second dose to 28-34 days after 2nd dose (up to date of 3rd visit). SAE (from start of first dose to 28-34 days after second dose - date of 3rd visit).
Exclusion Criteria:
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days
Biological: JECEVAX
JEVAX - VABIOTECH Vietnam Liquid form Composition: 1,0 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days
Biological: JEVAX
JEVAX - VABIOTECH Vietnam Liquid form Subcutaneous injection 0.5ml/dose, 2 doses, 28-34 days interval
JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days
Percent of participants with treatment-related adverse events during study period.
Percent 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 AEs within 7 days after each dose, unsolicited AEs from date 1st dose 1 to date of dose 2 and from date of 2nd dose to 28-34 day post 2nd dose (3rd visit), as assessed by CTCAE v.4.0.
Time frame: Up to 28-34 days after 2nd dose
Percent of participants who has antibody sero-conversion in study group and control group at 28-34 days post dose 2.
Serum samples will be taken before 1 dose and 28-34 days post 2nd dose to be tested for JE antibody by PRNT.
Time frame: Up to 28-34 days after 2nd dose
Frequencies of participants with treatment-related SAE during study period
Frequencies of participants with treatment-related SAE during study period of JECEVAX compared to that of JEVAX, as assessed by CTCAE ver 4.0
Time frame: Up to 28-34 days after the 2nd dose (3rd visit)
Plan to share: 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.
No publications or documents are linked to this record.
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National Institute of Hygiene and Epidemiology, Vietnam