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Infection and Immunity, February 1999, p. 539-545, Vol. 67, No. 2
0019-9567/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.

Preliminary Assessment of the Safety and Immunogenicity of a New CTXPhi -Negative, Hemagglutinin/Protease-Defective El Tor Strain as a Cholera Vaccine Candidate

Jorge A. Benítez,1,* Luis García,2 Anisia Silva,3 Hilda García,2 Rafael Fando,1 Barbara Cedré,2 Antonio Pérez,4 Javier Campos,1 Boris L. Rodríguez,1 José L. Pérez,2 Tania Valmaseda,2 Oliver Pérez,2 Alberto Pérez,2 Margarita Ramírez,4 Talena Ledón,1 Manuel Díaz Jidy,4 Miriam Lastre,2 Laura Bravo,4 and Gustavo Sierra2

Grupo de Genética, Centro Nacional de Investigaciones Científicas,1 Instituto Finlay, Sueros y Vacunas,2 Departamento de Microbiologia, Facultad de Biología de la Universidad de La Habana,3 and Instituto de Medicina Tropical "Pedro Kouri,"4 Havana, Cuba

Received 18 August 1998/Accepted 12 October 1998

Vibrio cholerae 638 (El Tor, Ogawa), a new CTXPhi -negative hemagglutinin/protease-defective strain that is a cholera vaccine candidate, was examined for safety and immunogenicity in healthy adult volunteers. In a double-blind placebo-controlled study, no significant adverse reactions were observed in volunteers ingesting strain 638. Four volunteers of 42 who ingested strain 638 and 1 of 14 who received placebo experienced loose stools. The strain strongly colonized the human small bowel, as evidenced by its isolation from the stools of 37 of 42 volunteers. V. cholerae 638, at doses ranging from 4 × 107 to 2 × 109 vibrios, elicited significant serum vibriocidal antibody and anti-Ogawa immunoglobulin A antibody secreting cell responses.

* Corresponding author. Present address: Department of Molecular Microbiology and Immunology, School of Medicine, University of Missouri, Allton Bldg., 301 Business Loop 70 W., Columbia, MO 65203. Phone: (573) 882-3417. Fax: (573) 884-7885. E-mail: jbenitez{at}mail.coin.missouri.edu.

Infection and Immunity, February 1999, p. 539-545, Vol. 67, No. 2
0019-9567/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.


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