Randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of live oral cholera vaccine 638 in Cuban adults.
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.
Valera
Rodrigo
R
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
García
Hilda María
HM
Jidy
Manuel Díaz
MD
Mirabal
Mayelin
M
Armesto
Marlene Isabel
MI
Fando
Rafael
R
García
Luis
L
Fernández
Roberto
R
Año
Gemma
G
Cedré
Bárbara
B
Ramírez
Margarita
M
Bravo
Laura
L
Serrano
Teresita
T
Palma
Sara
S
González
Daniel
D
Miralles
Fernando
F
Medina
Vilma
V
Nuñez
Felicita
F
Plasencia
Yilian
Y
Martínez
Juan Carlos
JC
Mandarioti
Aleyda
A
Lugones
Juan
J
Rodríguez
Boris Luis
BL
Moreno
Arlenis
A
González
Domingo
D
Baro
Morelia
M
Solis
Rosa Lidia
RL
Sierra
Gustavo
G
Barbera
Ramón
R
Domínguez
Francisco
F
Gutiérrez
Carlos
C
Kouri
Gustavo
G
Campa
Concepción
C
Menéndez
Jorge
J
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
D000907:Antibodies, Bacterial; D022121:Cholera Vaccines; D014613:Vaccines, Attenuated