Sumarokov A A, Ivanov N R, Dzhaparidze M N, Reznikov Iu B, Rystsova E A, Nikitina G P, Matusevich L Ia, Popov A A, Plotnikova M N, Shustov V Ia
Zh Mikrobiol Epidemiol Immunobiol. 1990 Dec(12):55-62.
276 volunteers aged 19 years and over were placed under observation in the course of the trial of oral cholera vaccine in tablets, containing choleragen toxoid, O-antigens of serovars Inaba and Ogawa and a number of Vibrio cholerae exoenzymes, for safety, reactogenic properties and immunological effectiveness. The vaccine was found to produce no reactions in a dose of 1-4 tablets; the administration of 3 tablets (300,000 binding units of the toxoid and 10,000 units of O-antigens, serovars Inaba and Ogawa) was shown to induce the most intensive synthesis of both antitoxins and vibriocidal antibodies in the blood sera of volunteers, as well as IgA coproantibodies. The oral vaccine was found to have an advantage over parenteral vaccines due to the absence of reactogenic properties and the formation of local immunity: coproantibodies appeared in 80% and 9% of the vaccinees respectively.
276名19岁及以上的志愿者在口服霍乱疫苗片剂试验过程中接受观察,该疫苗片剂含有霍乱类毒素、稻叶型和小川型血清群的O抗原以及多种霍乱弧菌外酶,以观察其安全性、反应原性和免疫效果。发现该疫苗在服用1 - 4片剂量时无反应;服用3片(300,000结合单位类毒素和10,000单位稻叶型和小川型血清群O抗原)显示能在志愿者血清中诱导抗毒素和杀弧菌抗体以及IgA粪抗体的最强烈合成。发现口服疫苗由于无反应原性且能形成局部免疫而优于注射用疫苗:分别有80%和9%的接种者出现粪抗体。