[The characteristics of the reactogenicity and immunological activity of a new cholera bivalent chemical vaccine based on the results of controlled trials]. / Kharakteristika reaktogennosti i immunologicheskoi aktivnosti novoi kholernoi bivalentnoi khimicheskoi vaktsiny po itogam kontroliruemykh ispytanii.

The reactogenic properties and immunological potency of modified cholera chemical vaccine (choleragen-toxoid + O-antigens Inaba and Ogawa) were tested in 278 volunteers aged 18 years and over in comparison with those of a commercial batch of monovalent cholera vaccine (choleragen-toxoid + O-antigen Inaba). The cholera vaccine, enriched with O-antigen Ogawa, was found to be safe; vaccination with this vaccine was not accompanied by the development of systemic and local reactions whose frequency and intensity met the requirements for the reactogenic properties of commercial cholera vaccine. The immunological potency of the bivalent vaccine with respect to strain Inaba was not inferior to that of the commercial vaccine; at the same time in persons immunized with the new preparation the titers of vibriocidal antibodies to strain of serovar Inaba were five-fold higher. The conclusion on the expediency of using cholera chemical vaccine enriched with O-antigen Ogawa was made.

[The determination of the optimal inoculation dose of an oral cholera chemical bivalent vaccine in a controlled experiment]. / Opredelenie optimal'noi privivochnoi dozy oral'noi kholernoi khimicheskoi bivalentnoi vaktsiny v kontroliruemom opyte.

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.

[Biochemical and immunochemical characteristics of a new oral, chemical cholera bivalent vaccine and results of a trial of the preparation on volunteers]. / Biokhimicheskaia i immunokhimicheskaia kharakteristika novoi oral'noi kholernoi knimicheskoi bivalentnoi vaktsiny i rezul'taty ispytaniia preparata na dobrovol'tsakh.

Oral cholera vaccine contains 45% of O-antigen (serovars Ogawa and Inaba in equal parts) and at least 9 serologically active proteins; of these, toxoid (about 60% of the total amount of protein) and 5 enzymes have been identified: neuraminidase, proteinase, ribonuclease, phospholipase and ATPase. The safety, absence of reactogenicity and definite immunological effectiveness of the preparation in the primary immunization of volunteers have been shown.