Evaluation of a bivalent (CVD 103-HgR/CVD 111) live oral cholera vaccine in adult volunteers from the United States and Peru

Infection and Immunity

Volumn 65, Issue 9, 1997, Pages 3852-3856

  Taylor, David N ^a,e   Tacket, Carol O ^b   Losonsky, Genevieve ^b   Castro, Oswaldo ^a,c   Gutierrez, James ^c   Meza, Rina ^a   Nataro, James P ^b   Kaper, James B ^b   Wasserman, Steven S ^b   Edelman, Robert ^b   Levine, Myron M ^b   Cryz, Stanley J ^d  

^a California   (Peru)

^b UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^c US Naval Medical Research Unit No 6 (NAMRU 6)   (Peru)

^d Berna Biotech AG   (Switzerland)

^e US Embassy NAMRID   (Peru)

Author keywords

[No Author keywords available]

Indexed keywords

BACTERIUM ANTIBODY; CHOLERA VACCINE; PLACEBO;

ADULT; ANTIBODY TITER; ARTICLE; BACTERICIDAL ACTIVITY; CHOLERA; CLINICAL TRIAL; COLONY FORMING UNIT; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG SAFETY; FREEZE DRYING; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; NORMAL HUMAN; ORAL DRUG ADMINISTRATION; PERU; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEROTYPE; UNITED STATES; VACCINATION; VIBRIO CHOLERAE; VOLUNTEER;

EID: 9844242376     PISSN: 00199567     EISSN: None     Source Type: Journal    
DOI: 10.1128/iai.65.9.3852-3856.1997     Document Type: Article

References (22)

1. Besser, R. E., D. R. Feikin, J. E. Eberhart-Phillips, L. Mascola, and P. M. Griffin. 1994. Diagnosis and treatment of cholera in the United States: are we prepared? JAMA 272:1203-1253.
2. Clemens, J. D., F. van Loon, D. A. Sack, M. R. Rao, F. Ahmed, J. Chakraborty, B. A. Kay, M. R. Khan, M. Yunus, J. R. Harris, A.-M. Svennerholm, and J. Holmgren. 1991. Biotype as determinant of natural immunising effect of cholera. Lancet 337:883-884.
3. Clements, M. L., M. M. Levine, C. R. Young, R. E. Black, Y.-L. Lim, and R. M. Robins-Browne. 1982. Magnitude, kinetics and duration of vibriocidal antibody response in North Americans after ingestion of Vibrio cholerae. J. Infect. Dis. 145:465-473.
4. Gicquelais, K. G., M. M. Baldini, J. Martinez, L. Maggi, W. C. Martin, V. Prado, J. B. Kaper, and M. M. Levine. 1990. Practical and economical method for using biotinylated DNA probes with bacterial colony blots to identify diarrhea-causing Escherichia coli. J. Clin. Microbiol. 28:2485-2490.
5. Glass, R. I., M. Libel, and A. D. Brandling-Bennett. 1992. Epidemic cholera in the Americas. Science 256:1524-1525.
6. Goma Epidemiology Group. 1995. Public health impact of Rwandan refugee crisis: what happened in Goma, Zaire, in July 1994? Lancet 345:339-344.
7. Gotuzzo, E., B. Butron, C. Seas, M. Penny, R. Ruiz, G. Losonsky, C. F. Lanata, S. S. Wasserman, E. Salazar, J. B. Kaper, S. Cryz, and M. M. Levine. 1993. Safety, immunogenicity, and excretion pattern of single-dose live oral cholera vaccine CVD 103-HgR in Peruvian adults of high and low socioeconomic levels. Infect. Immun. 64:3994-3997.
8. Kaper, J. B., J. Michalski, J. M. Ketley, and M. M. Levine. 1994. Potential for reacquisition of cholera enterotoxin genes by attenuated Vibrio cholerae vaccine strain CVD 103-HgR. Infect. Immun. 62:1480-1483.
9. Kenner, J. R., T. S. Coster, D. N. Taylor, A. F. Trofa, M. Barrera-Oro, T. Hyman, J. M. Adams, D. T. Beattie, K. P. Killeen, D. R. Spriggs, J. J. Mekalanos, and J. C. Sadoff. 1995. Peru-15, an improved live attenuated oral vaccine candidate for Vibrio cholerae O1. J. Infect. Dis. 172:1126-1129.
10. Lagos, R., A. Avendano, V. Prado, I. Horwitz, S. Wasserman, G. Losonsky, S. Cryz, J. B. Kaper, and M. M. Levine. 1995. Attenuated live cholera vaccine strain CVD 103-HgR elicits significantly higher serum vibriocidal antibody titers in persons of blood group O. Infect. Immun. 63:707-709.
11. Levine, M. M., R. E. Black, M. L. Clements, D. R. Nalin, L. Cisneros, and R. A. Finkelstein. 1981. Volunteer studies in development of vaccines against cholera and enterotoxigenic Escherichia coli: a review. In T. Holme, J. Holmgren, M. H. Merson, and R. Molby (ed.), Acute enteric infections in children, new prospects for treatment and prevention. Elsevier/North-Holland Biomedical Press, Amsterdam, The Netherlands.
12. Levine, M. M., J. B. Kaper, D. Herrington, J. Ketley, G. Losonsky, C. O. Tacket, B. Tall, and S. Cryz. 1988. Safety, immunogenicity, and efficacy of recombinant live oral cholera vaccines, CVD 103 and CVD103-HgR. Lancet ii:467-470.
13. Levine, M. M., C. R. Young, R. E. Black, Y. Takeda, and R. A. Finkelstein. 1985. Enzyme-linked immunosorbent assay to measure antibodies to purified heat-labile enterotoxins from human and porcine strains and to cholera toxin: application in serodiagnosis and seroepidemiology. J. Clin. Microbiol. 21:174-179.
14. Lockman, H., and J. B. Kaper. 1983. Nucleotide sequnce analysis of the A2 and B subunits of Vibrio cholerae enterotoxin. J. Biol. Chem. 258:13722-13726.
15. Simanjuntak, C., P. O'Hanley, N. H. Punjabi, F. Noriega, G. Pazzaglia, P. Dykstra, B. Kay, Suharyono, A. Budiarso, A. R. Rifai, S. S. Wasserman, G. Losonsky, J. Kaper, S. Cryz, and M. M. Levine. 1993. Safety, immunogenicity, and transmissibility of single-dose live oral cholera vaccine strain CVD 103-HgR in 24-59-month-old Indonesian children. J. Infect. Dis 168:1169-1176.
16. Su-Arehawaratana, P., P. Singharaj, D. N. Taylor, C. Hoge, A. Trofa, K. Kuvanont, S. Migasena, P. Pitisuttitham, Y. L. Lim, G. Losonsky, J. B. Kaper, S. S. Wasserman, S. Cryz, P. Echeverria, and M. M. Levine. 1992. Safety and immunogenicity of different immunization regimens of CVD 103-HgR live oral cholera vaccine in soldiers and civilians in Thailand. J. Infect. Dis. 165:1042-1048.
17. Suharyono, C. Simanjuntak, N. Witham, N. Punjabi, D. G. Heppner, G. Losonsky, H. Totosudirjo, A. R. Rifai, J. Clemens, Y. L. Lim, D. Burr, S. S. Wasserman, J. Kaper, K. Sorenson, S. Cryz, and M. M. Levine. 1992. Safety and immunogenicity of a single-dose, live oral cholera vaccine CVD 103-HgR in 5-9-year old Indonesian children. Lancet 340:689-694.
18. Tacket, C. O., K. L. Kotloff, G. Losonsky, J. P. Nataro, J. Michalski, J. B. Kaper, R. Edelman, and M. M. Levine. Volunteer studies investigating the safety and efficacy of live oral El Tor Vibrio cholerae O1 vaccine strain CVD 111. Submitted for publication.
19. Tacket, C. O., G. Losonsky, J. P. Nataro, S. J. Cryz, R. Edelman, J. B. Kaper, and M. M. Levine. 1992. Onset and duration of protective immunity in challenged volunteers after vaccination with live oral cholera vaccine CVD 103-HgR. J. Infect. Dis. 166:837-841.
20. Tacket, C. O., G. Losonsky, J. P. Nataro, S. J. Cryz, R. Edelman, A. Fasano, J. Michalski, J. B. Kaper, and M. M. Levine. 1993. Safety, immunogenicity, and transmissibility of live oral cholera vaccine candidate CVD 110, Δctx, Δzot, Δace derivative of El Tor Ogawa Vibrio cholerae. J. Infect. Dis. 168: 1536-1540.
21. Taylor D. N., K. P. Killeen, D. C. Hack, J. R. Kenner, T. S. Coster, D. T. Beattie, J. Ezzell, T. Hyman, A. Trofa, M. H. Sjogren, A. Friedlander, J. J. Mekalanos, and J. C. Sadoff. 1994. Development of a live, oral, attenuated vaccine against El Tor cholera. J. Infect. Dis. 170:1518-1523.
22. Waldor, M. K., and J. J. Mekalanos. 1996. Lysogenic conversion by a filamentous phage encoding cholera toxin. Science 272:1910-1914.