Revise phase III trial protocol: CDSCO Panel tells Bharath Biotech on Inactivated Japanese Encephalitis vaccine

The expert panel recommended adding the seroprevalence study of the control group as a secondary goal and incorporating age stratification into Group II, dividing it into two categories: those aged more than 50 to 65 years and those aged 65 years and above.

Additionally, the committee emphasized the need to perform a statistical calculation to determine the appropriate number of subjects in the test group and to revise it accordingly. They also recommended specifying in the exclusion criteria individuals who have received the Seasonal flu vaccine within the past year and the Typhoid Conjugate Vaccine.

This came after the vaccine maker Bharath Biotech presented the proposal for a grant of permission to conduct a Phase III clinical trial for Inactivated Japanese Encephalitis vaccine (JENVAC) at an age group of more than 1 year of age.

Japanese encephalitis is a neurologic infection with a broad range of manifestations. It can range from subtle changes in behavior to serious problems, including blindness, ataxia, weakness, and movement disorders.

The inactivated Japanese Encephalitis vaccine (JENVAC) is a single-dose inactivated Japanese Encephalitis (JE) Vaccine. This Vero cell-derived vaccine is prepared from an Indian strain (Kolar- 821564XY) of the JE virus. JENVAC has been developed in collaboration with the National Institute of Virology, India. It is a safe and highly effective vaccine that protects against all known strains of Japanese Encephalitis.

Data from a 2-dose study shows that a single dose of JENVAC is sufficient to elicit the immune response as the subjects who received a single dose were 98.67% seron-protected and the 4-fold seroconversion was at 93.14% for the ≥1 year to ≤50 years age group.

At the recent SEC meeting for Vaccines held on 14 September 2023, the expert panel reviewed the proposal presented by the vaccine maker Bharath Biotech for permission to conduct the Phase III clinical trial for Inactivated Japanese Encephalitis vaccine (JENVAC) at an age group of more than 1 year of age.

After detailed deliberation, the committee recommended to revise the protocol as below:-

1. Sero-prevalence study of the control group should be included as a secondary objective.

2. Age stratification should be included in Group II. (more than 50 years to 65 years and above 65 years)

3. No. of subjects in the test group should be statistical.

4. Subjects who have been vaccinated with the seasonal flu vaccine in the last year and Typhoid Conjugate Vaccine should be mentioned in the exclusion criteria.

Accordingly, the expert panel suggested that the firm should submit the revised Phase III clinical trial Protocol for further deliberation.

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