Two lots of AIK vaccines were inoculated subcutaneously on a total of 471 healthy children who was thought to have never experienced measles in the past. This live vaccine was prepared by employing a virus strain attenuated by passage through the primary kidney cell culture of sheep at the kitasato Institute.
Of the 471 chidren inoculated, both serological and clinical survey were completed on initially seronegative 321 children (Lot TV-6, 134; Lot TV-7, 187).
Reported in the following are the findings thereof.
1. Antibody responses
All the children, who had previously been confirmed negative, were found to have developed antibodies against measles. In the case of Lot TV-6 the mean of the hemagglutination-inhibition antibody titer was 2
5.7±1.0, and it was 2
5.6±1.0 with Lot TV-7. Follow up of hemagglutination-inhibition antibody titers feasible on 12 children showed the mean value (G.M.T.) of 2
5.6 at the end of 6 weeks, 2
4.4 at I year and 2
4.3 at 1.6 years after inoculation.
2. Clinical reactions
(i) Fever: Frequency of the appearance of fever≥37.5°C was 20.9%, and ≥39.0°C was 3.0% with Lot TV-6. In the case of Lot TV-7 the appearance of fever ≥37.5°C was 12.8%, and ≥39.0°C was 1.1%. The mean highest temperatuie of feverish children observed was 38.3°C with Lot TV-6, and 38.1°C with Lot TV-7. Their duration was in an average of 1.6 days in both cases. The mean incubation period before the onset of fever was 8.3 days with Lot TV-6 and 8.8 days with Lot TV-7. There was not a single case of febrile convulsion nor any other toxic reactions.
(ii) Rash: Rate of the appearance of rash was 22.4% with Lot TV-6, and 14.4% with Lot TV-7. Period to the appearance of rash after inoculation was in an average of 9.7 days with Lot TV-6, and 9.2 days with Lot TV-7. In more than 70% of the total children inoculated, the number of papel-like rashes was less than 10.
Due to the findings described above, the AIK vaccine employed in the present study can be categorized as a further attenuated measles virus vaccine.
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