Uji Klinik Vaksin BCG

Isbagio, Dyah Widyaningroem (1995) Uji Klinik Vaksin BCG. Buletin Penelitian Kesehatan. ISSN 0125-9695

Abstract

BCG vaccination was shown to be successful in reducing the severity of infection. This was mainly possible through the use of potent vaccines and its safe application, which was proven by clinical trial. Clinical trial of this kind has not been carried out for a long time and during the 5th Year Development Plan more intensive studies have been conducted on the side effect of vaccination. Therefore it is considered necessary to conduct BCG vaccine trial in order to ensure that safe vaccines with adequate potency can be used. Clinical trial was done on 342 babies in one district centre which consisted of 5 sub-district health centres at 58 intergrated health services (Posyandu) from September 1992 until December 1992. As it has been recommended by WHO, this clinical trial should be carried out on with a freeze-dried (fd) Bio Farma (BF) BCG Vaccine, parallel with a freeze-dried Pasteur BCG Vaccine as the reference vaccine. Two hundred thirty three babies were vaccinated with fd BF BCG Vaccine, while one hundred nine babies were vaccinated with fd Pasteur BCG Vaccine. Before being used, all vaccines were subjected to quality control by viability test. Mantoux test was done twice, the first at the same time with BCG vaccination and the second one 12-16 weeks after vaccination. Results of viability fd Bio Farma BCG Vaccine was 4.14x106 particle/ml, fd Pasteur BCG Vaccine was 2.02x 10 particle/ml. One baby showed tuberculin positivity on the first mantoux test. Both vaccine have a good potency, resulted in a mean induration of tuberculin reaction 9.94 mm and 8.62 mm, conversion rate 85.48% and 69.47% for fd Bio Farma BCG Vaccine and fd Pasteur BCG Vaccine respectively. Superinfection occured in 12 babies (7.02%) and 9 babies (9.57%) who had been vaccinated with fd Bio Farma BCG Vaccine and fd Pasteur BCG Vaccine respectively. In this trial the mean scar size in infants vaccinated with fd Bio Farma BCG Vaccine is 3.69 mm and fd Pasteur BCG Vaccine is 3.66 mm. Other complications or side effects did not occur in this trial. It was concluded that Bio Farma BCG Vaccine is safe and with adequate potency and hence can be used within the framework of the Indonesian Programme of Immunization.

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