Seguridad e inmunogenicidad de la vacuna oral contra el cólera: estudio en 20 voluntarios

Abstract

The safety and immunogenicity of a three-doce course of oral recombinant B subunit whole-cell cholera vaccine (rBSNVC) was evaluated on 20 healthy volunteers from the Instituto Nacional de Salud. Participants received three doses, separated by two-week intewals. Blood was taken on the day of the first dose administration, and weekly during the following eight weeks. Side effects were registered during the 5 days following the ingestion of each dose. Sera were tested for antibacterial antibodies using vibriocidal techniques and antitoxin antibodies (class IgG and IgA) using the ELlSA test. Side effects such as nausea, headache and abdominal discomfort were negligible. The highest seroconversion percentage (50%) for antibacterial antibodies when vibriocidal techniques were employed, and the highest geometric mean titer (GMT 21.38) were obtained three weeks after the administration of the first doce. Seroconversion for antitoxin antibodies was obtained in 84% (IgG) and 89% (IgA) of the participants at eight and six weeks, respectively. Athree-dose course of the oral vaccine (rBSNVC) was found to be safe and immunogenic in the population studied.