Double-blind vaccine-controlled randomised efficacy trial of an investigational Shigella sonnei conjugate vaccine in young adults

Lancet

Volumn 349, Issue 9046, 1997, Pages 155-159

  Cohen, Dani ^a   Ashkenazi, Shai ^a   Green, Manfred S ^a   Gdalevich, Michael ^e   Robin, Guy ^e   Slepon, Raphael ^e   Yavzori, Miri ^e   Orr, Nadav ^e   Block, Colin ^b   Ashkenazi, Isaac ^a   Shemer, Joshua ^a   Taylor, David N ^c   Hale, Thomas L ^c   Sadoff, Jerald C ^c   Pavliakova, Danka ^d   Schneerson, Rachel ^d   Robbins, John B ^d  

^a TEL AVIV UNIVERSITY   (Israel)

^b HEBREW UNIVERSITY   (Israel)

^c WALTER REED ARMY INSTITUTE OF RESEARCH   (United States)

^d EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

^e NONE

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBODY; IMMUNOGLOBULIN A; IMMUNOGLOBULIN G; LIPOPOLYSACCHARIDE; MENINGOCOCCUS VACCINE; POLYSACCHARIDE; SHIGELLA VACCINE;

ADULT; ANTIBODY TITER; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; ENZYME LINKED IMMUNOSORBENT ASSAY; ESCHERICHIA COLI; FECES CULTURE; HUMAN; HUMAN EXPERIMENT; IMMUNOGLOBULIN BLOOD LEVEL; ISRAEL; MALE; NORMAL HUMAN; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; PSEUDOMONAS AERUGINOSA; RANDOMIZED CONTROLLED TRIAL; SHIGELLA SONNEI; SHIGELLOSIS; SOLDIER;

EID: 0031036053     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(96)06255-1     Document Type: Article

References (28)

1. Institute of Medicine. Prospects for immunizing against Shigella spp. In: new vaccine development: establishing priorities; diseases of importance in developing countries, vol 2. Washington, DC: National Academic Press, 1986: 329-37.
2. Keusch TG, Bennish ML. Shigellosis. In: Evans AS, Brachman PS, ed. Bacterial infections in humans. New York: Plenum Medical Book Company, 1991: 593-620.
3. Green MS, Cohen D, Block C, Rouach T, Dycian R. A prospective epidemiologic study of shigellosis: implications for the new Shigella vaccines. Isr J Med Sci 1987; 23: 811-15.
4. Cohen D, Green M, Block C, et al. Reduction of transmission of shigellosis by control of house flies (Musca domestica). Lancet 1991; 337: 993-97.
5. Henry FJ, Alam N, Aziz KMS, Rahaman MM. Dysentery, not watery diarrhoea, is associated with stunting in Bangladeshi children. Hum Nutr Clin Nutr 1987; 41C: 243-49.
6. DuPont HL, Levine MM, Hornick RB, Formal SB. Inoculum size in shigellosis and implications for expected mode of transmission. J Infect Dis 1989; 159: 1126-28.
7. Khau MU. Interruption of shigellosis by hand washing. Trans R Soc Trop Med Hyg 1982; 76: 164-68.
8. Ashkenazi S, May-Zahav M, Dinari G, Gabbay U, Zilberman A, Samra Z. Recent trends in the epidemiology of Shigella infections. Clin Infect Dis 1993; 17: 897-99.
9. DuPont HL, Hornick RB, Dawkins AT, Synder MJ, Formal SB. The response of man to Shigella flexneri 2a. J Infect Dis 1969; 119: 296-99.
10. Herrington DA, van de Verg L, Formal SB, et al. Studies in volunteers to evaluate candidate Shigella vaccines: further experience with a bivalent Salmonella typhi-Shigella sonnei vaccine and protection conferred by previous Shigella sonnei disease. Vaccine 1990; 8: 353-57.
11. Cohen D, Green MS, Block C, Rouach T, Ofek I. Serum antibodies to liposaccharide and natural immunity to shigellosis in an Israeli military population. J Infect Dis 1988; 157: 1068-71.
12. Cohen D, Green MS, Block C, Slepon R, Ofek I. A prospective study on the association between serum antibodies to lipopolysaccharide and attack rate of shigellosis. J Clin Microbiol 1991; 29: 386-89.
13. Robbins JB, Chu CY, Schneerson R. Hypothesis for vaccine development: serum IgG LPS antibodies confer protective immunity to non-typhoidal Salmonellae and Shigellae. Clin Infect Dis 1992; 15: 346-61.
14. Chu CY, Liu B, Watson D, et al. Preparation, characterization and immunogenicity of conjugates composed of the O-specific polysaccharide of Shigella dysenteriae type 1 (Shiga's bacillus) bound to tetanus toxoid. Infect Immun 1992; 59: 4450-58.
15. Taylor DN, Trofa AC, Sadoff J, et al. Synthesis, characterization, and clinical evaluation of conjugate vaccines composed of the O-specific polysaccharides of Shigella dysenteriae type 1, Shigella flexneri type 2, Shigella sonnei (Plesiomonas shigelloides) bound to bacterial toxoids. Infect Immun 1993; 61: 3678-87.
16. Cohen D, Ashkenazi S, Green M, et al. Safety and immunogenicity of investigational Shigella conjugate vaccines in Israeli volunteers. Infect Immun 1996; 64: 4074-77.
17. Formal SB, Hale TL, Kapfer C, et al. Oral vaccination of monkeys with an invasive Escherichia coli K-12 hybrid expressing Shigella flexneri 2a somatic antigen. Infect Immun 1984; 46: 465-69.
18. Lindberg AA, Karnell A, Stocker BAD. Aromatic-dependent Shigella strains as oral live vaccines. In: Woodrow GC, Levine MM, eds. New generation vaccines: vaccines against Shigella, part II. New York: Marcel Dekker, 1990: 677-87.
19. Sansonnetti PJ, Arondel J. Construction and evaluation of a double mutant of Shigella flexneri as a candidate for oral vaccination against shigellosis. Vaccine 1989; 7: 443-50.
20. Cohen D, Ashkenazi S, Green M, et al. Safety and immunogenicity of the oral E coli K12-S flexneri 2a vaccine (EcSf2a-2) among Israeli soldiers. Vaccine 1994; 12: 1436-42.
21. Cohen D, Green M, Block C, Lowell G, Ofek I. Immunoglobulin M, A, and G antibody response to lipopolysaccharide O antigen in symptomatic and asymptomatic Shigella infections. J Clin Microbiol 1989; 27: 162-67.
22. Higgins AR, Floyd TM, Kader AD. Studies in shigellosis, 3: a controlled evaluation of a monovalent Shigella vaccine in a highly endemic environment. Am J Trop Med Hyg 1955; 4: 281-88.
23. DeMaria A, Johns MA, Bebeerich H, McCabe WR. Immunization with rough mutants of Salmonella minnesota: initial studies in human subjects. J Infect Dis 1988; 158: 301-11.
24. Schwartzer TA, Alcid DV, Numsuwan V, Gocke DJ. Characterization of the human antibody response to an Escherichia coli O 111:B4 and J5 vaccine. J Infect Dis 1988; 158: 1135-36.
25. Robbins JB, Schneerson R, Szu SC. Perspective: hypothesis: serum IgG antibody is sufficient to confer protection against infectious diseases by inactivating the inoculum. J Infect Dis 1985; 171: 1378-98.
26. Murphy TV, Pastor P, Medley F, Osterholm MT, Granoff DM. Decreased Haemophilus colonization in children vaccinated with Haemophilus influenzae type b conjugate vaccine. J Pediatr 1993; 122: 517-23.
27. Kauppi M, Eskola J, Kayhty M. Anti-capsular polysaccharide antibody concentrations in saliva after immunization with Haemophilus influenzae type b conjugate vaccine. Pediatr Infect Dis J 1995; 14: 286-94.
28. Cohen D, Orr O, Robin G, et al. Detection of antibodies to Shigella lipopolysaccharide in urine following natural Shigella infection or vacccination. Clin Lab Diagn Immunol 1996; 3: 451-55.