CLINICAL TRIAL OF THE HEAT-STABLE BCG VACCINE 1993/1994

Prijanto, Muljati and Musa, Dahlan Ali and Gunawan, Suriadi (1994) CLINICAL TRIAL OF THE HEAT-STABLE BCG VACCINE 1993/1994. Project Report. Pusat Penelititan dan Pengembangan Pemberantasan Penyakit.

Abstract

Cold chain system is still a big problem in the Expanded Programme on Immunization in several developing countries especially in tropical areas. For this reason heat-stable BCG vaccines have been developed in Japan since 1987. A field trial of heat-stable BCG vaccine was conducted in Indonesia in 1993-1994. In this field produced heat-stable BCG vaccine was compared with ordinary BCG vaccine produced in Japan and BCG vaccine used in EPI in Indonesia made from Paris 1173-P2 strain produced by Bio Farma, Bandung, Indonesia. The objective of this study is to know the immune response and safety of the heat-stable BCG vaccine (after 3 months storage at 40°C) in comparison with the ordinary Japanese dried BCG vaccine and the BCG vaccine used for EPI in Indonesia. The immune response is indicated by the tuberculin test with the mean diameter of the post-vaccinal allergic reaction. The safety of the vaccine is characterised by the local reaction on the site of inoculation, reaction on regional lymph node and the development of complications caused by BCG vaccination. The study was carried out in 4 Health Centres in Jakarta . The health centers are Cempaka Putih, Johar Baru located in Central Jakarta and Matraman, Pulo Gadung located in East Jakarta. There were 440 infants included in this study. In this study no side reaction of immunization were found on examinination. The mean diameter of tuberculin reaction in the groups receiving heat-stable BCG, BCG Japan and BCG Indonesia were 9.75 mm, 10.25 mm and 7.43 mm, respectively. The tuberculin conversion rates in the groups of heat-stable BCG vaccine, ordinary BCG vaccine and Bio Farma vaccine are 85.70%, 89.90% and 70.00%, respectively. Conclusions of this study are The heat-stable BCG vaccine produced by Japan BCG Laboratory gives no significant differences in tuberculin conversion-rates, tuberculin reaction and scar formation when compared with ordinary Japanese BCG vaccine and Indonesian BCG vaccine. - All three Vaccines used in this study are safe. - The heat-stable BCG vaccine can be kept at 40°C for at least 3 months.

Actions (login required)

View Item