P0326 INCORPORATING HEPATITIS B VACCINE IN THE EPI, FOR INDIAN INFANTS: SEROEFFICACY OF 0, 6 WEEKS AND 9 MONTHS IMMUNIZATION SCHEDULE (ALONG WITH DPT AND MEASLES VACCINE)

Abstract

Introduction: Hepatitis B is one of the major diseases of mankind and is a serious global public health problem. Although safe and effective hepatitis B vaccines have been available for over 10 years, the WHO schedule of immunization (0,1 and 6 months) does not coincide with the schedule for other vaccines in India. As a consequence, a greater number of visits are required for immunization, causing a strain on the health care facilities, burden on patients and resulting in poor compliance greater drop out rates, incomplete dosing and non-adherence to immunization program. This study was carried out to evaluate the adequacy of seroconversion when Hepatitis B vaccine was given along with other vaccines at 0, 6 weeks (along with DPT and OPV) and at 9 months (along with measles). Methods: The study was a randomized trial where 750 infants born to HbsAg Negative mothers were enrolled to receive the hepatitis B vaccine at 0, 6 weeks and 9 months (Group A) or at 0, 1 and 6 months (WHO Schedule) – Group B. Baseline HbsAg testing was carried out and the babies were immunized with the first dose of hepatitis B vaccine within 48 hours of birth. BCG and the other EPI vaccines were given as per schedule. Serum samples were collected 4 weeks after the second and the third immunizations. 622 infants (82.9%) completed the study. The testing for HbsAg and Anti Hbs titers were conducted in the Department of Microbiology, Maulana Azad Medical College, New Delhi utilizing standard ELISA kits. Results: The seroconversion rates (seroprotective titers >=10 IU/ml), 4 weeks after the second dose of the vaccine were 90.42% (GMT = 48.41) and 91.75% (GMT = 44.12) (P=0.8) in Group A and Group B respectively. After 4 weeks of the third dose the seroconversion rates were 98.87 (GMT = 160.82) and 97.82 (GMT = 149.20) (p=0.17) in Group A and Group B respectively. The two schedules were comparable on using the Kruskal-Wallis H method for analysis. No adverse reactions to the immunization were noted. Patient compliance and adherence to the schedule were improved in Group A. Conclusion: The schedule of hepatitis B vaccination at 0, 6 weeks and 9 months has the same seroefficacy as the currently recommended WHO schedule of 0,1 and 6 months; it also has improved patient compliance and adherence to the schedule. This schedule could be incorporated into the National EPI schedule. Reference(s)Truncated . . .