THE CLINICAL TRIAL OF DPT HEAT-STABLE VACCINE

Prijanto, Muljati and Musa, Dahlan Ali and Simanjuntak, Cyrus H. and Handayani, Sarwo (1995) THE CLINICAL TRIAL OF DPT HEAT-STABLE VACCINE. Project Report. Pusat Penelitian dan Pengembangan Penyakit Menular.

Abstract

DTP acelluler vaccine freeze dried has been developed by Kaketsuken, Japan to solve the cold chain problems especially in tropical countries. The pertussis acelluler vaccine contain 2 mcg PN of Pertussis toxin (PT) and 8 mcg PN of FHA (filamentous haemagglutinin) per mililiter. The aim of this study is to know the immunogenicity and adversed reaction of DTaP heat-stable vaccine (treated 40°C for 3 months), compared with 2 kinds of liquid DTP vaccine (whole cell and acelluler pertussis vaccine) and freeze -dried DTaP vaccine not treated at 40°C. Subject of the study are 1625 infants of 2-3 months of age selected randomly and devided into 4 groups. Group A consist of 500 healthy infants immunized with DTaP heat-stable (HS). Group B, C, and D each consist of 375 healthy infants immunized with DTwP, DTaP liquid and DTaP not treated, respectively. Side reactions were monitored for 7 days, twice of the first day and once a day for the rest. A hundred sera were collected from each groups examined for diphtheria, tetanus and pertussis antibody. Diphtheria and tetanus antibody were measured by neutralization test using vero well and Passive haemaglutination test (PHA). Anti PT and anti FHA antibody of pertussis were measured by ELISA. The local and sistemic reactions in infants post vaccination with 3 different DTaP vaccines were not significantly different observed within 2 and 7 days of each injection of each vaccine. There was significant different of side reaction between infants immunized with DTwP comparing with 3 groups of infants received DTaP vaccine (p<0.005). There was no severe reactions observed during this trial.

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