title: Randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of live oral cholera vaccine 638 in Cuban adults.
abstract: A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the safety, reactogenicity and the immunogenicity of a 2 x 10(9)CFU dose of the 638 lyophilized live attenuated cholera vaccine for oral administration, formulated and produced at Finlay Institute, City of Havana, Cuba. Thirty-six healthy female and male adult volunteers from 18 to 40 years old were involved, clinically examined and laboratory tested after the informed consent signature. Adverse events were monitored and seroconversion rates and geometrical mean titer (GMT) of vibriocidal antibodies were tested in volunteer's sera samples. Neither serious adverse events nor other damages to the volunteers due to vaccine or placebo feeding were reported during the clinical follow-up period of this study; none of the adverse events registered within the first 72 h after inoculation were life-threatening for volunteers. Neither severe nor moderate adverse events were reported. Sixty-one percent of subjects showed mild expected adverse events in an interval lower than 24h up to the first 72 h, 75% of these in the vaccinated group and 18% in the placebo group. Fourteen days after inoculation the GMT of vibriocidal antibodies in the vaccine group significantly increased in comparison to the placebo group. All subjects in the vaccine group (24) seroconverted (100%). Results show that this vaccine is safe, well tolerated and immunogenic in healthy female and male volunteers.
authors.affiliation: Instituto Finlay, Centro de Investigación, Desarrollo y Producción de Vacunas, P.O. Box 16017, La Lisa, Ciudad de La Habana 11600, Cuba. rvalera@finlay.edu.cu
authors.forename: Rodrigo
authors.initials: R
authors.lastname: Valera
authors.forename: Hilda María
authors.initials: HM
authors.lastname: García
authors.forename: Manuel Díaz
authors.initials: MD
authors.lastname: Jidy
authors.forename: Mayelin
authors.initials: M
authors.lastname: Mirabal
authors.forename: Marlene Isabel
authors.initials: MI
authors.lastname: Armesto
authors.forename: Rafael
authors.initials: R
authors.lastname: Fando
authors.forename: Luis
authors.initials: L
authors.lastname: García
authors.forename: Roberto
authors.initials: R
authors.lastname: Fernández
authors.forename: Gemma
authors.initials: G
authors.lastname: Año
authors.forename: Bárbara
authors.initials: B
authors.lastname: Cedré
authors.forename: Margarita
authors.initials: M
authors.lastname: Ramírez
authors.forename: Laura
authors.initials: L
authors.lastname: Bravo
authors.forename: Teresita
authors.initials: T
authors.lastname: Serrano
authors.forename: Sara
authors.initials: S
authors.lastname: Palma
authors.forename: Daniel
authors.initials: D
authors.lastname: González
authors.forename: Fernando
authors.initials: F
authors.lastname: Miralles
authors.forename: Vilma
authors.initials: V
authors.lastname: Medina
authors.forename: Felicita
authors.initials: F
authors.lastname: Nuñez
authors.forename: Yilian
authors.initials: Y
authors.lastname: Plasencia
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Martínez
authors.forename: Aleyda
authors.initials: A
authors.lastname: Mandarioti
authors.forename: Juan
authors.initials: J
authors.lastname: Lugones
authors.forename: Boris Luis
authors.initials: BL
authors.lastname: Rodríguez
authors.forename: Arlenis
authors.initials: A
authors.lastname: Moreno
authors.forename: Domingo
authors.initials: D
authors.lastname: González
authors.forename: Morelia
authors.initials: M
authors.lastname: Baro
authors.forename: Rosa Lidia
authors.initials: RL
authors.lastname: Solis
authors.forename: Gustavo
authors.initials: G
authors.lastname: Sierra
authors.forename: Ramón
authors.initials: R
authors.lastname: Barbera
authors.forename: Francisco
authors.initials: F
authors.lastname: Domínguez
authors.forename: Carlos
authors.initials: C
authors.lastname: Gutiérrez
authors.forename: Gustavo
authors.initials: G
authors.lastname: Kouri
authors.forename: Concepción
authors.initials: C
authors.lastname: Campa
authors.forename: Jorge
authors.initials: J
authors.lastname: Menéndez
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D002771:Cholera / Q000276:immunology / Q000517:prevention & control*; D022121:Cholera Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D003462:Cuba; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: D000907:Antibodies, Bacterial; D022121:Cholera Vaccines; D014613:Vaccines, Attenuated