Vaccines for viral and bacterial pathogens causing acute gastroenteritis: Part I: Overview, vaccines for enteric viruses and Vibrio cholera

Human Vaccines and Immunotherapeutics

Volumn 11, Issue 3, 2015, Pages 584-600

  O'Ryan, Miguel ^a   Vidal, Roberto ^a   Del Canto, Felipe ^a   Salazar, Juan Carlos ^a   Montero, David ^a  

^a UNIVERSITY OF CHILE   (Chile)

Author keywords

Acute diarrhea; Campylobacter; E. coli; Enteric pathogens; ETEC; Gastroenteritis; Norovirus; Rotavirus; Salmonella; Shigella; STEC; V. cholera; Vaccines

Indexed keywords

BACTERIAL VACCINE; CHOLERA VACCINE; INACTIVATED VACCINE; LANZHOU LAMB ROTAVIRUS VACCINE; LIVE VACCINE; PLACEBO; ROTAVAC; ROTAVIN M1; ROTAVIRUS VACCINE; TLP 01; TRIPLE VACCINE; UNCLASSIFIED DRUG; VIRUS LIKE PARTICLE VACCINE; VIRUS VACCINE;

ACUTE GASTROENTERITIS; ALPHA VIRUS; BACTERIAL STRAIN; CAMPYLOBACTER JEJUNI; CHOLERA; DISEASE ASSOCIATION; DRUG APPROVAL; DRUG EFFICACY; ENTERIC VIRUS; ENTEROHEMORRHAGIC ESCHERICHIA COLI; ENTEROTOXIGENIC ESCHERICHIA COLI; HUMAN; IMMUNOGENICITY; INFECTION PREVENTION; NONHUMAN; NOROVIRUS INFECTION; REVIEW; ROTAVIRUS INFECTION; SALMONELLA; SHIGELLA; VACCINATION; VACCINE PRODUCTION; VIBRIO CHOLERAE; VIRUS STRAIN; CLINICAL TRIAL (TOPIC); DIARRHEA; DRUG DEVELOPMENT; GASTROENTERITIS; IMMUNOLOGY; MICROBIOLOGY; PARASITOLOGY; PRECLINICAL STUDY; VIROLOGY; VIRUS;

CHOLERA VACCINES; CLINICAL TRIALS AS TOPIC; DIARRHEA; DRUG APPROVAL; DRUG DISCOVERY; DRUG EVALUATION, PRECLINICAL; GASTROENTERITIS; HUMANS; VIBRIO CHOLERAE; VIRAL VACCINES; VIRUSES;

EID: 84928658986     PISSN: 21645515     EISSN: 2164554X     Source Type: Journal    
DOI: 10.1080/21645515.2015.1011019     Document Type: Review

References (153)

1. Walker CL, Aryee MJ, Boschi-Pinto C, Black RE. Estimating diarrhea mortality among young children in low and middle income countries. PLoS One 2012; 7:e29151; PMID:22235266; http://dx.doi.org/10.1371/journal.pone.0029151.
2. Walker CLF, Rudan I, Liu L, Nair H, Theodoratou E, Bhutta ZA, O'Brien KL, Campbell H, Black RE. Global burden of childhood pneumonia and diarrhoea. Lancet 2013; 381:1405-16; PMID:23582727; http://dx.doi.org/10.1016/S0140-6736(13)60222-6.
3. Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, Rudan I, Campbell H, Cibulskis R, Li M., et al. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet 2012; 379:2151-61; PMID:22579125; http://dx.doi.org/10.1016/S0140-6736(12)60560-1.
4. O'Ryan GM, Ashkenazi-Hoffnung L, O'Ryan-Soriano MA, Ashkenazi S. Management of acute infectious diarrhea for children living in resource-limited settings. Expert Rev Anti Infect Ther 2014; 12:621- 32; PMID:24661314; http://dx.doi.org/10.1586/14787210.2014.901168.
5. Kotloff KL, Nataro JP, Blackwelder WC, Nasrin D, Farag TH, Panchalingam S, Wu Y, Sow SO, Sur D, Breiman RF., et al. Burden and aetiology of diarrhoeal disease in infants and young children in developing countries (the global enteric multicenter study, GEMS): a prospective, case-control study. Lancet 2013; 382:209-22; PMID:23680352; http://dx.doi.org/10.1016/S0140-6736(13)60844-2.
6. Moyo SJ, Gro N, Matee MI, Kitundu J, Myrmel H, Mylvaganam H, Maselle SY, Langeland N. Age specific aetiological agents of diarrhoea in hospitalized children aged less than five years in dar es salaam, tanzania. BMC pediatr 2011; 11:19; PMID:21345186; http://dx.doi.org/10.1186/1471-2431-11-19.
7. Razafindratsimandresy R, Heraud JM, Ramarokoto CE, Rabemanantsoa S, Randremanana R, Andriamamonjy NS, Richard V, Reynes JM. Rotavirus genotypes in children in the community with diarrhea in Madagascar. J Med Virol 2013; 85:1652-6; PMID:23797859; http://dx.doi.org/10.1002/jmv.23631.
8. Opintan JA, Newman MJ, Ayeh-Kumi PF, Affrim R, Gepi-Attee R, Sevilleja JE, Roche JK, Nataro JP, Warren CA, Guerrant RL. Pediatric diarrhea in southern ghana: etiology and association with intestinal inflammation and malnutrition. Am J Trop Med Hyg 2010; 83:936-43; PMID:20889896; http://dx.doi.org/10.4269/ajtmh.2010.09-0792.
9. Ciarlet M, Schodel F. Development of a rotavirus vaccine: clinical safety, immunogenicity, and efficacy of the pentavalent rotavirus vaccine, rotaTeq. Vaccine 2009; 27:6:72-81; PMID:20006144; http://dx.doi.org/10.1016/j.vaccine.2009.09.107.
10. Giaquinto C, Dominiak-Felden G, Van Damme P, Myint TT, Maldonado YA, Spoulou V, Mast TC, Staat MA. Summary of effectiveness and impact of rotavirus vaccination with the oral pentavalent rotavirus vaccine: a systematic review of the experience in industrialized countries. Hum Vaccin 2011; 7:734- 48; PMID:21734466; http://dx.doi.org/10.4161/hv.7.7.15511.
11. O'Ryan M. Rotarix TM. (RIX4414): an oral human rotavirus vaccine. Expert Rev Vaccines 2007; 6:11-9; PMID:17280473; http://dx.doi.org/10.1586/14760584.6.1.11.
12. O'Ryan M, Linhares AC. Update on rotarix (TM): an oral human rotavirus vaccine. Expert Rev Vaccines 2009; 8:1627-41; PMID:19943758; http://dx.doi.org/10.1586/erv.09.136.
13. O'Ryan M, Lucero Y, Linhares AC. Rotarix (R): vaccine performance 6 years postlicensure. Expert Rev Vaccines 2011; 10:1645-59; PMID:22085167; http://dx.doi.org/10.1586/erv.11.152.
14. Soares-Weiser K, Maclehose H, Bergman H, Ben- Aharon I, Nagpal S, Goldberg E, Pitan F, Cunliffe N. Vaccines for preventing rotavirus diarrhoea: vaccines in use. Cochrane Database Syst Rev 2012; 11: CD008521; PMID:23152260; http://dx.doi.org/10.1002/14651858.CD008521.pub3.
15. Yen C, Tate JE, Hyde TB, Cortese MM, Lopman BA, Jiang B, Glass RI, Parashar UD. Rotavirus vaccines: current status and future considerations. Hum Vaccin Immunother 2014; 10:1436-48; PMID:24755452; http://dx.doi.org/10.4161/hv.28857.
16. Debbink K, Lindesmith LC, Baric RS. The state of norovirus vaccines. Clin Infect Dis 2014; 58:1746-52; PMID:24585561; http://dx.doi.org/10.1093/cid/ciu120.
17. Tan M, Jiang X. Vaccine against norovirus. Hum Vaccin Immunother 2014; 10:1449-56; PMID: 24718366; http://dx.doi.org/10.4161/hv.28626.
18. Kim YJ, Yeo SG, Park JH, Ko HJ. Shigella vaccine development: prospective animal models and current status. Curr Pharm Biotechnol 2014; 14:903-12; PMID:24372251; http://dx.doi.org/10.2174/1389201014666131226123900.
19. McLennan CA, Martin LB, Micoli F. Vaccines against invasive salmonella disease: current status and future directions. Hum Vaccin Immunother 2014; 10:1478- 93; PMID:24804797; http://dx.doi.org/10.4161/hv.29054.
20. Ahmed T, Bhuiyan TR, Zaman K, Sinclair D, Qadri F. Vaccines for preventing enterotoxigenic Escherichia coli (ETEC) diarrhoea. Cochrane Database Syst Rev 2013; 7:CD009029; PMID:23828581; http://dx.doi.org/10.1002/14651858.CD009029.pub2.
21. Pastor M, Pedraz JL, Esquisabel A. The state-of-theart of approved and under-development cholera vaccines. Vaccine 2013; 31:4069-78; PMID:23845813; http://dx.doi.org/10.1016/j.vaccine.2013.06.096.
22. Snedeker KG, Campbell M, Sargeant JM. A systematic review of vaccinations to reduce the shedding of Escherichia coli O157 in the faeces of domestic ruminants. Zoonoses Public Health 2012; 59:126-38; PMID:21824378; http://dx.doi.org/10.1111/j.1863-2378.2011.01426.x.
23. Varela NP, Dick P, Wilson J. Assessing the existing information on the efficacy of bovine vaccination against Escherichia coli O157:H7- A systematic review and meta-analysis. Zoonoses Public Health 2013; 60:253-68; PMID:22856462; http://dx.doi.org/10.1111/j.1863-2378.2012.01523.x.
24. de Zoete, MR, van Putten, JPM, Wagenaar JA. Vaccination of chickens against Campylobacter. Vaccine 2007; 25:5548-57; PMID:17224215; http://dx.doi.org/10.1016/j.vaccine.2006.12.002.
25. Mead JR. Prospects for immunotherapy and vaccines against Cryptosporidium. Hum Vaccin Immunother 2014; 10:1505-13; PMID:24638018; http://dx.doi.org/10.4161/hv.28485.
26. Gladstone BP, Ramani S, Mukhopadhya I, Muliyil J, Sarkar R, Rehman AM, Jaffar S, Gomara MI, Gray JJ, Brown DW., et al. Protective effect of natural rotavirus infection in an Indian birth cohort. N Eng J Med 2011; 365:337-46; PMID:21793745; http://dx.doi.org/10.1056/NEJMoa1006261.
27. Velazquez FR, Matson DO, Calva JJ, Guerrero L, Morrow AL, Carter-Campbell S, Glass RI, Estes MK, Pickering LK, Ruiz-Palacios GM. Rotavirus infections in infants as protection against subsequent infections. N Eng J Med 1996; 335:1022-8; PMID:8793926; http://dx.doi.org/10.1056/NEJM199610033351404.
28. Parashar UD, Burton A, Lanata C, Boschi-Pinto C, Shibuya K, Steele D, Birmingham M, Glass RI. Global mortality associated with rotavirus disease among children in 2004. J Infect Dis 2009; 200 1:S9- S15; PMID:19817620; http://dx.doi.org/10.1086/605025.
29. Tate JE, Burton AH, Boschi-Pinto C, Steele AD, Duque J, Parashar UD. 2008 Estimate of worldwide rotavirus-associated mortality in children younger than 5 years before the introduction of universal rotavirus vaccination programmes: a systematic review and meta-analysis. Lancet Infect Dis 2012; 12:136- 41; PMID:22030330; http://dx.doi.org/10.1016/S1473-3099(11)70253-5.
30. Parashar UD, Hummelman EG, Bresee JS, Miller MA, Glass RI. Global illness and deaths caused by rotavirus disease in children. Emerg Infect Dis 2003; 9:565-72; PMID:12737740; http://dx.doi.org/10.3201/eid0905.020562.
31. Estes MK, Desselberger U. Rotaviruses: cause of vaccine- preventable disease yet many fundamental questions remain to be explored. Curr Opin Virol 2012; 2:369-72; PMID:22762866; http://dx.doi.org/10.1016/j.coviro.2012.06.002.
32. Greenberg HB, Estes MK. Rotaviruses: from pathogenesis to vaccination. Gastroenterology 2009; 136:1939-51; PMID:19457420; http://dx.doi.org/10.1053/j.gastro.2009.02.076.
33. O'Ryan M. The ever-changing landscape of rotavirus serotypes. Pediatr Infect Dis J 2009; 28:60-62; PMID:19252426; http://dx.doi.org/10.1097/INF.0b013e3181967c29.
34. O'Ryan ML, Hermosilla G, Osorio G. Rotavirus vaccines for the developing world. Curr Opin Infect Dis 2009; 22:483-9; PMID:19623063; http://dx.doi.org/10.1097/QCO.0b013e32833040a9.
35. O'Ryan ML, Matson DO, Estes MK, Bartlett AV, Pickering LK. Molecular epidemiology of rotavirus in children attending day care centers in Houston. J Infect Dis 1990; 162:810-6; PMID:2169496; http://dx.doi.org/10.1093/infdis/162.4.810.
36. Bernstein DI, Glass RI, Rodgers G, Davidson BL, Sack DA. Evaluation of rhesus rotavirus monovalent and tetravalent reassortant vaccines in US children. US rotavirus vaccine efficacy group. JAMA 1995; 273:1191-6; PMID:7707626; http://dx.doi.org/10.1001/jama.1995.03520390051032.
37. Joensuu J, Koskenniemi E, Pang XL, Vesikari T. Randomised placebo-controlled trial of rhesus-human reassortant rotavirus vaccine for prevention of severe rotavirus gastroenteritis. Lancet 1997; 350:1205-9; PMID:9652561; http://dx.doi.org/10.1016/S0140-6736(97)05118-0.
38. Perez-Schael I, Guntinas MJ, Perez M, Pagone V, Rojas AM, Gonzalez R, Cunto W, Hoshino Y, Kapikian AZ. Efficacy of the rhesus rotavirus-based quadrivalent vaccine in infants and young children in Venezuela. N Eng J Med 1997; 337:1181-7; PMID:9337376; http://dx.doi.org/10.1056/NEJM199710233371701.
39. Rennels MB, Glass RI, Dennehy PH, Bernstein DI, Pichichero ME, Zito ET, Mack ME, Davidson BL, Kapikian AZ. Safety and efficacy of high-dose rhesushuman reassortant rotavirus vaccines-report of the national multicenter trial. united states rotavirus vaccine efficacy group. Pediatrics 1996; 97:7-13; PMID:8545227.
40. Santosham M, Moulton LH, Reid R, Croll J, Weatherholt R, Ward R, Forro J, Zito E, Mack M, Brenneman G., et al. Efficacy and safety of high-dose rhesushuman reassortant rotavirus vaccine in native american populations. J Pediatr 1997; 131:632-8; PMID:9386673; http://dx.doi.org/10.1016/S0022-3476(97)70076-3.
41. Murphy TV, Gargiullo PM, Massoudi MS, Nelson DB, Jumaan AO, Okoro CA, Zanardi LR, Setia S, Fair E, LeBaron CW., et al. Rotavirus Intussusception Investigation Team. Intussusception among infants given an oral rotavirus vaccine. N Eng J Med 2001; 344:564-72; PMID:11207352; http://dx.doi.org/10.1056/NEJM200102223440804.
42. Armah GE, Kapikian AZ, Vesikari T, Cunliffe N, Jacobson RM, Burlington DB, Ruiz LP Jr. Efficacy, immunogenicity, and safety of two doses of a tetravalent rotavirus vaccine RRV-TV in Ghana with the first dose administered during the neonatal period. J Infect Dis 2013; 208:423-31; PMID:23599316; http://dx.doi.org/10.1093/infdis/jit174.
43. Block SL, Vesikari T, Goveia MG, Rivers SB, Adeyi BA, Dallas MJ, Bauder J, Boslego JW, Heaton PM, Pentavalent Rotavirus Vaccine Dose Confirmation Efficacy Study G. Efficacy, immunogenicity, and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine at the end of shelf life. Pediatrics 2007; 119:11-8; PMID:17200266; http://dx.doi.org/10.1542/peds.2006-2058.
44. Clark HF, Bernstein DI, Dennehy PH, Offit P, Pichichero M, Treanor J, Ward RL, Krah DL, Shaw A, Dallas MJ., et al. Safety, efficacy, and immunogenicity of a live, quadrivalent human-bovine reassortant rotavirus vaccine in healthy infants. J Pediatr 2004; 144:184-90; PMID:14760258; http://dx.doi.org/10.1016/j.jpeds.2003.10.054.
45. Vesikari T, Clark HF, Offit PA, Dallas MJ, DiStefano DJ, Goveia MG, Ward RL, Schodel F, Karvonen A, Drummond JE., et al. Effects of the potency and composition of the multivalent human-bovine (WC3) reassortant rotavirus vaccine on efficacy, safety and immunogenicity in healthy infants. Vaccine 2006; 24:4821-9; PMID:16621194; http://dx.doi.org/10.1016/j.vaccine.2006.03.025.
46. Vesikari T, Matson DO, Dennehy P, Van Damme P, Santosham M, Rodriguez Z, Dallas MJ, Heyse JF, Goveia MG, Black SB., et al. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Eng J Med 2006; 354:23-33; PMID:16394299; http://dx.doi.org/10.1056/NEJMoa052664.
47. Tate JEPM, Cortese MM, Lopman BA, Gentsch JR, Fleming J, Steele AD, Parashar UD. Remaining issues and challenges for rotavirus vaccine in preventing global childhood diarrheal morbidity and mortality. Expert Rev Vaccines 2012; 11:211-20; PMID:22309669; http://dx.doi.org/10.1586/erv.11.184.
48. Patel M, Pedreira C, De Oliveira LH, Umana J, Tate J, Lopman B, Sanchez E, Reyes M, Mercado J, Gonzalez A., et al. Duration of protection of pentavalent rotavirus vaccination in Nicaragua. Pediatrics 2012; 130:e365-72; PMID:22753550; http://dx.doi.org/10.1542/peds.2011-3478.
49. Yih WK, Lieu TA, Kulldorff M, Martin D, McMahill- Walraven CN, Platt R, Selvam N, Selvan M, Lee GM, Nguyen M. Intussusception risk after rotavirus vaccination in US infants. N Eng J Med 2014; 370:503-12; PMID:24422676; http://dx.doi.org/10.1056/NEJMoa1303164.
50. Cunliffe NA, Witte D, Ngwira BM, Todd S, Bostock NJ, Turner AM, Chimpeni P, Victor JC, Steele AD, Bouckenooghe A., et al. Efficacy of human rotavirus vaccine against severe gastroenteritis in malawian children in the first two years of life: a randomized, double- blind, placebo controlled trial. Vaccine 2012; 30 1:36-43; PMID:22520135; http://dx.doi.org/10.1016/j.vaccine.2011.09.120.
51. Kawamura N, Tokoeda Y, Oshima M, Okahata H, Tsutsumi H, Van Doorn LJ, Muto H, Smolenov I, Suryakiran PV, Han HH. Efficacy, safety and immunogenicity of RIX4414 in Japanese infants during the first two years of life. Vaccine 2011; 29:6335-41; PMID:21640780; http://dx.doi.org/10.1016/j. vaccine.2011.05.017.
52. Li RC, Huang T, Li YP, Luo D, Tao J, Fu B, Si G, Nong Y, Mo ZJ, Liao XY., et al. Human rotavirus vaccine (RIX4414) efficacy in the first two years of life: a randomized, placebo-controlled trial in China. Hum Vaccin Immunother 2014; 10:11-8; PMID:24013441; http://dx.doi.org/10.4161/hv.26319.
53. Madhi SA, Kirsten M, Louw C, Bos P, Aspinall S, Bouckenooghe A, Neuzil KM, Steele AD. Efficacy and immunogenicity of two or three dose rotavirusvaccine regimen in South African children over two consecutive rotavirus-seasons: a randomized, doubleblind, placebo-controlled trial. Vaccine 2012; 301: 44-51; PMID:22520136; http://dx.doi.org/10.1016/j.vaccine.2011.08.080.
54. Vesikari T, Karvonen A, Prymula R, Schuster V, Tejedor JC, Cohen R, Meurice F, Han HH, Damaso S, Bouckenooghe A. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in european infants: randomised, double-blind controlled study. Lancet 2007; 370:1757-63; PMID:18037080; http://dx.doi.org/10.1016/S0140-6736(07)61744-9.
55. Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, Abate H, Breuer T, Clemens SC, Cheuvart B, Espinoza F, Gillard P, Innis BL., et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. New Engl J Med 2006; 354:11-22; PMID:16394298; http://dx.doi.org/10.1056/NEJMoa052434.
56. Cortese MM, Immergluck LC, Held M, Jain S, Chan T, Grizas AP, Khizer S, Barrett C, Quaye O, Mijatovic- Rustempasic S., et al. Effectiveness of monovalent and pentavalent rotavirus vaccine. Pediatrics 2013; 132:25-33; PMID:23776114; http://dx.doi.org/10.1542/peds.2012-3804.
57. Fernandes EG, Sato HK, Leshem E, Flannery B, Konstantyner TC, Veras MA, Patel MM. Impact of rotavirus vaccination on diarrhea-related hospitalizations in Sao Paulo state, Brazil. Vaccine 2014; 32:3402-8; PMID:24736002; http://dx.doi.org/10.1016/j.vaccine.2014.04.015.
58. Steele AD, Neuzil KM, Cunliffe NA, Madhi SA, Bos P, Ngwira B, Witte D, Todd S, Louw C, Kirsten M., et al. Human rotavirus vaccine rotarix provides protection against diverse circulating rotavirus strains in African infants: a randomized controlled trial. BMC Infect Dis 2012; 12:213; PMID:22974466; http://dx.doi.org/10.1186/1471-2334-12-213.
59. Patel MM, Lopez-Collada VR, Bulhoes MM, De Oliveira LH, Bautista Marquez A, Flannery B, Esparza- Aguilar M, Montenegro Renoiner EI, Luna-Cruz ME, Sato HK., et al. Intussusception risk and health benefits of rotavirus vaccination in Mexico and Brazil. N Eng J Med 2011; 364:2283-92; PMID:21675888; http://dx.doi.org/10.1056/NEJMoa1012952.
60. Noel GMP, Merrot T. Intussusception risk after rotavirus vaccination in US infants. N Engl J Med 2014; 370:1766; PMID:24785219; http://dx.doi.org/10.1056/NEJMc1402790.
61. Fu C, He Q, Xu J, Xie H, Ding P, Hu W, Dong Z, Liu X, Wang M. Effectiveness of the lanzhou lamb rotavirus vaccine against gastroenteritis among children. Vaccine 2012; 31:154-8; PMID:23127516; http://dx.doi.org/10.1016/j.vaccine.2012.10.078.
62. Dang DA, Nguyen VT, Vu DT, Nguyen TH, Nguyen DM, Yuhuan W, Baoming J, Nguyen DH, Le TL, Rotavin MVTG. A dose-escalation safety and immunogenicity study of a new live attenuated human rotavirus vaccine (rotavin-M1) inVietnamese children. Vaccine 2012; 30 1:114-21; PMID:22520120; http://dx.doi.org/10.1016/j.vaccine.2011.07.118.
63. Danchin M, Kirkwood CD, Lee KJ, Bishop RF, Watts E, Justice FA, Clifford V, Cowley D, Buttery JP, Bines JE. Phase I trial of RV3-BB rotavirus vaccine: a human neonatal rotavirus vaccine. Vaccine 2013; 31:2610-6; PMID:23597719; http://dx.doi.org/10.1016/j.vaccine.2013.04.008.
64. Glass RI, Bhan MK, Ray P, Bahl R, Parashar UD, Greenberg H, Rao CD, Bhandari N, Maldonado Y, Ward RL., et al.Development of candidate rotavirus vaccines derived from neonatal strains in India. J Infect Dis 2005; 192 1:30-5; PMID:16088802; http://dx.doi.org/10.1086/431498.
65. Bhandari N, Sharma P, Taneja S, Kumar T, Rongsen- Chandola T, Appaiahgari MB, Mishra A, Singh S, Vrati S. Rotavirus Vaccine Development G. A doseescalation safety and immunogenicity study of live attenuated oral rotavirus vaccine 116E in infants: a randomized, double-blind, placebo-controlled trial. J Infect Dis 2009; 200:421-9; PMID:19545211; http://dx.doi.org/10.1086/600104.
66. Luna EJ, Frazatti-Gallina NM, Timenetsky MC, Cardoso MR, Veras MA, Miraglia JL, Escobar AM, Grisi SJ, Raw I, Precioso AR. A phase I clinical trial of a new 5-valent rotavirus vaccine. Vaccine 2013; 31:1100-5; PMID:23261048; http://dx.doi.org/10.1016/j.vaccine.2012.12.020.
67. Lappalainen S, Tamminen K, Vesikari T, Blazevic V. Comparative immunogenicity in mice of rotavirus VP6 tubular structures and virus-like particles. Hum Vaccin Immunother 2013; 9:1991-2001; PMID:23777748; http://dx.doi.org/10.4161/hv.25249.
68. Wang L, Huang P, Fang H, Xia M, Zhong W, McNeal MM, Jiang X, Tan M. Polyvalent complexes for vaccine development. Biomaterials 2013; 34:4480-92; PMID:23498893; http://dx.doi.org/10.1016/j.biomaterials.2013.02.041.
69. Moon S, Wang Y, Edens C, Gentsch JR, Prausnitz MR, Jiang B. Dose sparing and enhanced immunogenicity of inactivated rotavirus vaccine administered by skin vaccination using a microneedle patch. Vaccine 2013; 31:3396-402; PMID:23174199; http://dx.doi.org/10.1016/j.vaccine.2012.11.027.
70. Jiang B, Wang Y, Saluzzo JF, Bargeron K, Frachette MJ, Glass RI. Immunogenicity of a thermally inactivated rotavirus vaccine in mice. Hum Vaccin 2008; 4:143-7; PMID:18382129; http://dx.doi.org/10.4161/hv.4.2.5263.
71. Kapikian AZ, Wyatt RG, Dolin R, Thornhill TS, Kalica AR, Chanock RM. Visualization by immune electron microscopy of a 27-nm particle associated with acute infectious nonbacterial gastroenteritis. J Virol 1972; 10:1075-81; PMID:4117963.
72. Dolin R. Norwalk agent-like particles associated with gastroenteritis in human beings. J Am Veterinary Med Association 1978; 173:615-9; PMID:100481.
73. Glass RI, Parashar UD, Estes MK. Norovirus gastroenteritis. N Eng J Med 2009; 361:1776-85; PMID:19864676; http://dx.doi.org/10.1056/NEJMra0804575.
74. Green KY, Ando T, Balayan MS, Berke T, Clarke IN, Estes MK, Matson DO, Nakata S, Neill JD, Studdert MJ, et al. Taxonomy of the caliciviruses. J Infect Dis 2000; 181 2:322-30; PMID:10804145; http://dx.doi.org/10.1086/315591.
75. Jung K, Wang Q, Kim Y, Scheuer K, Zhang Z, Shen Q, Chang KO, Saif LJ. The effects of simvastatin or interferon-a on infectivity of human norovirus using a gnotobiotic pig model for the study of antivirals. PLoS One 2012; 7:e41619; PMID:22911825; http://dx.doi.org/10.1371/journal.pone.0041619.
76. Taube S, Kolawole AO, Hohne M, Wilkinson JE, Handley SA, Perry JW, Thackray LB, Akkina R, Wobus CE. A mouse model for human norovirus. mBio 2013; 4:450-13; PMID:23860770; http://dx.doi.org/10.1128/mBio.00450-13.
77. Cukor G, Blacklow NR, Echeverria P, Bedigian MK, Puruggan H, Basaca-Sevilla V. Comparative study of the acquisition of antibody to norwalk virus in pediatric populations. Infect Immun 1980; 29:822-3; PMID:7216438.
78. Greenberg HB, Valdesuso J, Kapikian AZ, Chanock RM, Wyatt RG, Szmuness W, Larrick J, Kaplan J, Gilman RH, Sack DA. Prevalence of antibody to the norwalk virus in various countries. Infect Immun 1979; 26:270-3; PMID:227798.
79. Greenberg HB, Valdesuso J, Yolken RH, Gangarosa E, Gary W, Wyatt RG, Konno T, Suzuki H, Chanock RM, Kapikian AZ. Role of norwalk virus in outbreaks of nonbacterial gastroenteritis. J Infect Dis 1979; 139:564-8; PMID:220341; http://dx.doi.org/10.1093/infdis/139.5.564.
80. O'Ryan ML, Mamani N, Gaggero A, Avendano LF, Prieto S, Pena A, Jiang X, Matson DO. Human caliciviruses are a significant pathogen of acute sporadic diarrhea in children of Santiago, Chile. J Infect Dis 2000; 182:1519-22; PMID:11023476; http://dx.doi.org/10.1086/315874.
81. O'Ryan ML, Vial PA, Mamani N, Jiang X, Estes MK, Ferrecio C, Lakkis H, Matson DO. Seroprevalence of norwalk virus and mexico virus in chilean individuals: assessment of independent risk factors for antibody acquisition. Clin Infect Dis 1998; 27:789-95; PMID:9798035; http://dx.doi.org/10.1086/514949.
82. Jiang X, Wang M, Graham DY, Estes MK. Expression, self-assembly, and antigenicity of the norwalk virus capsid protein. J Virol 1992; 66:6527-32; PMID:1328679.
83. Xi JN, Graham DY, Wang KN, Estes MK. Norwalk virus genome cloning and characterization. Science 1990; 250:1580-3; PMID:2177224; http://dx.doi.org/10.1126/science.2177224.
84. Bucardo F, Reyes Y, Svensson L, Nordgren J. Predominance of norovirus and sapovirus in nicaragua after implementation of universal rotavirus vaccination. PLoS One 2014; 9:e98201; PMID:24849288; http://dx.doi.org/10.1371/journal.pone.0098201.
85. Kobayashi S, Fujiwara N, Yasui Y, Yamashita T, Hiramatsu R, Minagawa H. A foodborne outbreak of sapovirus linked to catered box lunches in japan. Arch Virol 2012; 157:1995-7; PMID:22752792; http://dx.doi.org/10.1007/s00705-012-1394-8.
86. Tam CC, O'Brien SJ, Tompkins DS, Bolton FJ, Berry L, Dodds J, Choudhury D, Halstead F, Iturriza- Gomara M, Mather K., et al. Changes in causes of acute gastroenteritis in the united kingdom over 15 years: microbiologic findings from 2 prospective, population-based studies of infectious intestinal disease. Clin Infect Dis 2012; 54:1275-86; PMID:22412058; http://dx.doi.org/10.1093/cid/cis028.
87. Ramani S, Atmar RL, Estes MK. Epidemiology of human noroviruses and updates on vaccine development. Curr Opin Gastroenterol 2014; 30:25-33; PMID:24232370 http://dx.doi.org/10.1097/MOG.0000000000000022.
88. Desai R, Hembree CD, Handel A, Matthews JE, Dickey BW, McDonald S, Hall AJ, Parashar UD, Leon JS, Lopman B. Severe outcomes are associated with genogroup 2 genotype 4 norovirus outbreaks: a systematic literature review. Clin Infect Dis 2012; 55:189-93; PMID:22491335; http://dx.doi.org/10.1093/cid/cis372.
89. Patel MM, Hall AJ, Vinje J, Parashar UD. Noroviruses: a comprehensive review. J Clin Virol 2009; 44:1-8; PMID:19084472; http://dx.doi.org/10.1016/j.jcv.2008.10.009.
90. Vidal R, Solari V, Mamani N, Jiang X, Vollaire J, Roessler P, Prado V, Matson DO, O'Ryan ML. Caliciviruses and foodborne gastroenteritis, Chile. Emerg Infect Dis 2005; 11:1134-7; PMID:16022799; http://dx.doi.org/10.3201/eid1107.041062.
91. Monica B, Ramani S, Banerjee I, Primrose B, Iturriza-Gomara M, Gallimore CI, Brown DW, M F, Moses PD, Gray JJ, Kang G. Human caliciviruses in symptomatic and asymptomatic infections in children in Vellore, South India. J Med Virol 2007; 79:544-51; PMID:17385696; http://dx.doi.org/10.1002/jmv.20862.
92. O'Ryan ML, Pena A, Vergara R, Diaz J, Mamani N, Cortes H, Lucero Y, Vidal R, Osorio G, Santolaya ME, Hermosilla G, Prado VJ. Prospective characterization of norovirus compared with rotavirus acute diarrhea episodes in chilean children. Pediatr Infect Dis J 2010; 29:855-9; PMID:20581736; http://dx.doi.org/10.1097/INF.0b013e3181e8b346.
93. Patel MM, Widdowson MA, Glass RI, Akazawa K, Vinje J, Parashar UD. Systematic literature review of role of noroviruses in sporadic gastroenteritis. Emerg Infect Dis 2008; 14:1224-31; PMID:18680645; http://dx.doi.org/10.3201/eid1408.071114.
94. Hemming M, Rasanen S, Huhti L, Paloniemi M, Salminen M, Vesikari T. Major reduction of rotavirus, but not norovirus, gastroenteritis in children seen in hospital after the introduction of RotaTeq vaccine into the national immunization programme in Finland. Eur J Pediatr 2013; 172:739-46; PMID:23361964; http://dx.doi.org/10.1007/s00431-013-1945-3.
95. Payne DC, Vinje J, Szilagyi PG, Edwards KM, Staat MA, Weinberg GA, Hall CB, Chappell J, Bernstein DI, Curns AT., et al. Norovirus and medically attended gastroenteritis in US children. N Eng J Med 2013; 368:1121-30; PMID:23514289; http://dx.doi.org/10.1056/NEJMsa1206589.
96. Hall AJ, Rosenthal M, Gregoricus N, Greene SA, Ferguson J, Henao OL, Vinje J, Lopman BA, Parashar UD, Widdowson MA. Incidence of acute gastroenteritis and role of norovirus, georgia, USA, 2004-2005. Emerg Infect Dis 2011; 17:1381-8; PMID:21801613; http://dx.doi.org/10.3201/eid1708.101533.
97. Trivedi TK, Desai R, Hall AJ, Patel M, Parashar UD, Lopman BA. Clinical characteristics of norovirus-associated deaths: a systematic literature review. Am J Infect Control 2013; 41:654-7; PMID:23266383; http://dx.doi.org/10.1016/j.ajic.2012.08.002.
98. Bok K, Green KY. Norovirus gastroenteritis in immunocompromised patients. N Eng J Med 2012; 367:2126-32; PMID:23190223; http://dx.doi.org/10.1056/NEJMra1207742.
99. Simon A, Schildgen O, Maria Eis-Hubinger A, Hasan C, Bode U, Buderus S, Engelhart S, Fleischhack G. Norovirus outbreak in a pediatric oncology unit. Scand J Gastroenterol 2006; 41:693-9; PMID:16716968; http://dx.doi.org/10.1080/00365520500421694.
100. Hall AJ, Lopman BA, Payne DC, Patel MM, Gastanaduy PA, Vinje J, Parashar UD. Norovirus disease in the United States. Emerg Infect Dis 2013; 19:1198- 205; PMID:23876403; http://dx.doi.org/10.3201/eid1908.130465.
101. Vidal R, Roessler P, Solari V, Vollaire J, Jiang X, Matson DO, Mamani N, Prado V, O'Ryan ML. Novel recombinant norovirus causing outbreaks of gastroenteritis in Santiago, Chile. J Clin Microbiol 2006; 44:2271-5; PMID:16757638; http://dx.doi.org/10.1128/JCM.01890-05.
102. Kroneman A, Vega E, Vennema H, Vinje J, White PA, Hansman G, Green K, Martella V, Katayama K, Koopmans M. Proposal for a unified norovirus nomenclature and genotyping. Arch Virol 2013; 158:2059-68; PMID:23615870; http://dx.doi.org/10.1007/s00705-013-1708-5.
103. Siebenga JJ, Vennema H, Zheng DP, Vinje J, Lee BE, Pang XL, Ho ECM, Lim W, Choudekar A, Broor S., et al. Norovirus illness is a global problem: emergence and spread of norovirus GII.4 variants, 2001-2007. J Infect Dis 2009; 200:802-12; PMID:19627248; http://dx.doi.org/10.1086/605127.
104. Parrino TA, Schreiber DS, Trier JS, Kapikian AZ, Blacklow NR. Clinical immunity in acute gastroenteritis caused by norwalk agent. N Eng J Med 1977; 297:86-9; PMID:405590; http://dx.doi.org/10.1056/NEJM197707142970204.
105. LoBue AD, Lindesmith L, Yount B, Harrington PR, Thompson JM, Johnston RE, Moe CL, Baric RS. Multivalent norovirus vaccines induce strong mucosal and systemic blocking antibodies against multiple strains. Vaccine 2006; 24:5220-34; PMID:16650512; http://dx.doi.org/10.1016/j.vaccine.2006.03.080.
106. Teunis PF, Moe CL, Liu P, Miller SE, Lindesmith L, Baric RS, Le Pendu J, Calderon RL. Norwalk virus: how infectious is it? J Med Virol 2008; 80:1468-76; PMID:18551613; http://dx.doi.org/10.1002/jmv.21237.
107. Simmons K, Gambhir M, Leon J, Lopman B. Duration of immunity to norovirus gastroenteritis. Emerg Infect Dis 2013; 19:1260-7; PMID:23876612; http://dx.doi.org/10.3201/eid1908.130472.
108. O'Ryan ML, Lucero Y, Prado V, Santolaya ME, Rabello M, Solis Y, Berrios D, O'Ryan-Soriano MA, Cortes H, Mamani N. Symptomatic and asymptomatic rotavirus and norovirus infections during infancy in a Chilean birth cohort. Pediatr Infect Dis J 2009; 28:879-84; PMID:19672213; http://dx.doi.org/10.1097/INF.0b013e3181a4bb60.
109. Czako R, Atmar RL, Opekun AR, Gilger MA, Graham DY, Estes MK. Serum hemagglutination inhibition activity correlates with protection from gastroenteritis in persons infected with norwalk virus. Clin Vaccine Immunol 2012; 19:284-7; PMID:22190401; http://dx.doi.org/10.1128/CVI.05592-11.
110. Reeck A, Kavanagh O, Estes MK, Opekun AR, Gilger MA, Graham DY, Atmar RL. Serological correlate of protection against norovirus-induced gastroenteritis. J Infect Dis 2010; 202:1212-8; PMID:20815703; http://dx.doi.org/10.1086/656364.
111. Atmar RL, Bernstein DI, Harro CD, Al-Ibrahim MS, Chen WH, Ferreira J, Estes MK, Graham DY, Opekun AR, Richardson C, et al. Norovirus vaccine against experimental human norwalk virus illness. N Eng J Med 2011; 365:2178-87; PMID:22150036; http://dx.doi.org/10.1056/NEJMoa1101245.
112. Fang H, Tan M, Xia M, Wang L, Jiang X. Norovirus P particle efficiently elicits innate, humoral and cellular immunity. PLoS One 2013; 8:e63269; PMID:23638188; http://dx.doi.org/10.1371/journal.pone.0063269.
113. LoBue AD, Thompson JM, Lindesmith L, Johnston RE, Baric RS. Alphavirus-adjuvanted norovirus-like particle vaccines: heterologous, humoral, and mucosal immune responses protect against murine norovirus challenge. J Virol 2009; 83:3212-27; PMID:19176631; http://dx.doi.org/10.1128/JVI.01650-08.
114. Ramirez K, Wahid R, Richardson C, Bargatze RF, El- Kamary SS, Sztein MB, Pasetti MF. Intranasal vaccination with an adjuvanted norwalk virus-like particle vaccine elicits antigen-specific B memory responses in human adult volunteers. Clin Immunol 2012; 144:98-108; PMID:22710446; http://dx.doi.org/10.1016/j.clim.2012.05.006.
115. Tamminen K, Lappalainen S, Huhti L, Vesikari T, Blazevic V. Trivalent combination vaccine induces broad heterologous immune responses to norovirus and rotavirus in mice. PLoS One 2013; 8:e70409; PMID:23922988; http://dx.doi.org/10.1371/journal.pone.0070409.
116. El-Kamary SS, Pasetti MF, Mendelman PM, Frey SE, Bernstein DI, Treanor JJ, Ferreira J, Chen WH, Sublett R, Richardson C, et al. Adjuvanted intranasal norwalk virus-like particle vaccine elicits antibodies and antibody-secreting cells that express homing receptors for mucosal and peripheral lymphoid tissues. J Infect Dis 2010; 202:1649-58; PMID:20979455; http://dx.doi.org/10.1086/657087.
117. Parra GI, Bok K, Taylor R, Haynes JR, Sosnovtsev SV, Richardson C, Green KY. Immunogenicity and specificity of norovirus consensus GII.4 virus-like particles in monovalent and bivalent vaccine formulations. Vaccine 2012; 30:3580-6; PMID:22469864; http://dx.doi.org/10.1016/j.vaccine.2012.03.050.
118. Treanor JJ, Atmar RL, Frey SE, Gormley R, Chen WH, Ferreira J, Goodwin R, Borkowski A, Clemens R, Mendelman PM. A novel intramuscular bivalent norovirus VLP vaccine candidate - reactogenicity, safety and immunogenicity in a phase I trial in healthy adults. J Infect Dis 2014; 210:1763-71; PMID:24951828; http://dx.doi.org/10.1093/infdis/jiu337.
119. Treanor JJ, Atmar RL, Frey SE, Gormley R, Chen WH, Ferreira J, Goodwin R, Borkowski A, Clemens R, Mendelman PM. A novel intramuscular bivalent norovirus virus-like particle vaccine candidate-reactogenicity, safety, and immunogenicity in a phase 1 trial in healthy adults. J Infect Dis 2014; 210:1763-71; PMID:24951828; http://dx.doi.org/10.1093/infdis/jiu337.
120. Tan M, Huang P, Xia M, Fang PA, Zhong W, McNeal M, Wei C, Jiang W, Jiang X. Norovirus P particle, a novel platform for vaccine development and antibody production. J Virol 2011; 85:753-64; PMID:21068235; http://dx.doi.org/10.1128/JVI.01835-10.
121. Baric RS, Yount B, Lindesmith L, Harrington PR, Greene SR, Tseng FC, Davis N, Johnston RE, Klapper DG, Moe CL. Expression and self-assembly of norwalk virus capsid protein from venezuelan equine encephalitis virus replicons. J Virol 2002; 76:3023- 30; PMID:11861868; http://dx.doi.org/10.1128/JVI.76.6.3023-3030.2002.
122. Harris JB, LaRocque RC, Qadri F, Ryan ET, Calderwood SB. Cholera. Lancet 2012; 379:2466-76; PMID:22748592;http://dx.doi.org/10.1016/S0140-6736(12)60436-X.
123. World Health Organization. Cholera, 2013. Wkly Epidemiol Rec 2014; 89:345-56; PMID:25136711.
124. Safa A, Nair GB, Kong RYC. Evolution of new variants of vibrio cholerae O1. Trends Microbiol 2010; 18:46-54; PMID:19942436; http://dx.doi.org/10.1016/j.tim.2009.10.003.
125. Wang J, Villeneuve S, Zhang J, Lei P, Miller CE, Lafaye P, Nato F, Szu SC, Karpas A, Bystricky S., et al. On the antigenic determinants of the lipopolysaccharides of vibrio cholerae O1, serotypes ogawa and inaba. J Biol Chem 1998; 273:2777-83; PMID:9446585http://dx.doi.org/10.1074/jbc.273.5.2777.
126. Sears CL, Kaper JB. Enteric bacterial toxins: mechanisms of action and linkage to intestinal secretion. Microbiol Rev 1996; 60:167-215; PMID:8852900.
127. World Health Organization. Oral cholera vaccine stockpile for cholera emergency response. [Internet] 09/16/2013. Available from: http://www.who.int/cholera/vaccines/Briefing-OCV-stockpile.pdf?ua=1.
128. Chen WH, Greenberg RN, Pasetti MF, Livio S, Lock M, Gurwith M, Levine MM. Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR, prepared from new master and working cell banks. Clin Vaccine Immnunol 2014; 21:66- 73; PMID:24173028; http://dx.doi.org/10.1128/CVI.00601-13.
129. Begue RE, Castellares G, Ruiz R, Hayashi KE, Sanchez JL, Gotuzzo E, Oberst RB, Taylor DN, Svennerholm AM. Community-based assessment of safety and immunogenicity of the whole cell plus recombinant B subunit (WC/rBS) oral cholera vaccine in Peru. Vaccine 1995; 13:691-4; PMID:7668039; http://dx.doi.org/10.1016/0264-410X(94)00056-S.
130. van Loon, FP, Clemens JD, Chakraborty J, Rao MR, Kay BA, Sack DA, Yunus M, Ali M, Svennerholm AM, Holmgren J. Field trial of inactivated oral cholera vaccines in Bangladesh: results from 5 years of follow- up. Vaccine 1996; 14:162-6; PMID:8852414; http://dx.doi.org/10.1016/0264-410X(95)00122-H.
131. Clemens JD, Sack DA, Harris JR, Chakraborty J, Khan MR, Stanton BF, Kay BA, Khan MU, Yunus M, Atkinson W, et al. Field trial of oral cholera vaccines in Bangladesh. Lancet 1986; 2:124-7; PMID:2873397; http://dx.doi.org/10.1016/S0140-6736(86)91944-6.
132. Taylor DN, Cardenas V, Sanchez JL, Begue RE, Gilman R, Bautista C, Perez J, Puga R, Gaillour A, Meza R, et al. Two-year study of the protective efficacy of the oral whole cell plus recombinant B subunit cholera vaccine in Peru. J Infect Dis 2000; 181:1667-73; PMID:10823767; http://dx.doi.org/10.1086/315462.
133. Mahalanabis DLA, Sur D, Deen J, Manna B, Kanungo S, von Seidlein L, Carbis R, Han SH, Shin SH, Attridge S, et al. A randomized, placebo-controlled trial of the bivalent killed, whole-cell, oral cholera vaccine in adults and children in a cholera endemic area in Kolkata, India. PLoS One 2008; 3::2323; PMID:18523643; http://dx.doi.org/10.1371/journal.pone.0002323.
134. Sur D, Kanungo S, Sah B, Manna B, Ali M, Paisley AM, Niyogi SK, Park JK, Sarkar B, Puri MK., et al. Efficacy of a low-cost, inactivated whole-cell oral cholera vaccine: results from 3 years of follow-up of a randomized, controlled trial. PLoS Negl Trop Dis 2011; 5:e1289; PMID:22028938; http://dx.doi.org/10.1371/journal.pntd.0001289.
135. Luquero FJGL, Ciglenecki I, Sakoba K, Traore B, Heile M, Diallo AA, Itama C, Page AL, Quilici ML, Mengel MA., et al. Use of Vibrio cholerae vaccine in an outbreak in Guinea. N Engl J Med 2014; 370:2111-20; PMID:24869721; http://dx.doi.org/10.1056/NEJMoa1312680.
136. Anh DDCdG, Lopez AL, Thiem VD, Long PT, Son NH, Deen J, von Seidlein L, Carbis R, Han SH, Shin SH., et al.Safety and immunogenicity of a reformulated vietnamese bivalent killed, whole-cell, oral cholera vaccine in adults. Vaccine 2007; 25:1149-55; PMID:17055622http://dx.doi.org/10.1016/j.vaccine.2006.09.049.
137. Anh DDLA, Thiem VD, Grahek SL, Duong TN, Park JK, Kwon HJ, Favorov M, Hien NT, Clemens JD. Use of oral cholera vaccines in an outbreak in Vietnam: a case control study. PLoS Negl Trop Dis 2011; 25:e1006; PMID:21283616; http://dx.doi.org/10.1371/journal.pntd.0001006.
138. Richie EE, Punjabi NH, Sidharta YY, Peetosutan KK, Sukandar MM, Wasserman SS, Lesmana MM, Wangsasaputra FF, Pandam SS, Levine MM., et al.Efficacy trial of single-dose live oral cholera vaccine CVD 103- HgR in North Jakarta, Indonesia, a cholera-endemic area. Vaccine 2000; 18:2399-410; PMID:10738097; http://dx.doi.org/10.1016/S0264-410X(00)00006-2.
139. Ali M, Emch M, von Seidlein L, Yunus M, Sack DA, Rao M, Holmgren J, Clemens JD. Herd immunity conferred by killed oral cholera vaccines in Bangladesh: a reanalysis. Lancet 2005; 366:44-9; PMID:15993232; http://dx.doi.org/10.1016/S0140-6736(05)66550-6.
140. Sack DA, Sack RB, Shimko J, Gomes G, O'Sullivan D, Metcalfe K, Spriggs D. Evaluation of peru-15, a new live oral vaccine for cholera, in volunteers. J Infect Dis 1997; 176:201-5; PMID:9207368; http://dx.doi.org/10.1086/514025.
141. Cohen MB, Giannella RA, Bean J, Taylor DN, Parker S, Hoeper A, Wowk S, Hawkins J, Kochi SK, Schiff G., et al. Randomized, controlled human challenge study of the safety, immunogenicity, and protective efficacy of a single dose of peru-15, a live attenuated oral cholera vaccine. Infect Immun 2002; 70:1965-70; PMID:11895960; http://dx.doi.org/10.1128/IAI.70.4.1965-1970.2002.
142. Qadri F, Chowdhury MI, Faruque SM, Salam MA, Ahmed T, Begum YA, Saha A, Alam MS, Zaman K, Seidlein LV., et al. Randomized, controlled study of the safety and immunogenicity of peru-15, a live attenuated oral vaccine candidate for cholera, in adult volunteers in Bangladesh. J Infect Dis 2005; 192:573- 9; PMID:16028125; http://dx.doi.org/10.1086/432074.
143. Qadri F, Chowdhury MI, Faruque SM, Salam MA, Ahmed T, Begum YA, Saha A, Al Tarique A, Seidlein LV, Park E., et al. Peru-15, a live attenuated oral cholera vaccine, is safe and immunogenic in Bangladeshi toddlers and infants. Vaccine 2007; 25:231-8; PMID:16996172; http://dx.doi.org/10.1016/j.vaccine.2006.08.031.
144. Talavera A, Ano G, Pino Y, Castano J, Uribarri E, Riveron L, Gil S, Fernandez S, Cedre B, Valmaseda T., et al. Formulation in tablets of a cholera whole cells inactivated vaccine candidate. Vaccine 2006; 24:3381-7; PMID:16460846; http://dx.doi.org/10.1016/j.vaccine.2005.12.064.
145. Valera R, Garcia HM, Jidy MD, Mirabal M, Armesto MI, Fando R, Garcia L, Fernandez R, Ano G, Cedre B., et al. Randomized, double-blind, placebo-controlled trial to evaluate the safety and immunogenicity of live oral cholera vaccine 638 in Cuban adults. Vaccine 2009; 27:6564-9; PMID:19720365; http://dx.doi.org/10.1016/j.vaccine.2009.08.042.
146. Garcia L, Jidy MD, Garcia H, Rodriguez BL, Fernandez R, Ano G, Cedre B, Valmaseda T, Suzarte E, Ramirez M., et al. The vaccine candidate Vibrio cholerae 638 is protective against cholera in healthy volunteers. Infect Immun 2005; 73:3018-24; PMID:15845509; http://dx.doi.org/10.1128/IAI.73.5.3018-3024.2005.
147. Diaz Jidy M, Perez Rodriguez A, Fernandez Llanes R, Bravo Farinas L, Garcia Sanchez H, Valera Fernandez R, Garcia Imia L, Fando Calzada R, Menendez Hernandez J. Challenge clinical trial for evaluation of a vaccine candidate strain against cholera. Rev Cubana Med Trop 2010; 62:194-9; PMID:23437548.
148. Tacket CO, Losonsky G, Nataro JP, Comstock L, Michalski J, Edelman R, Kaper JB, Levine MM. Initial clinical studies of CVD 112 Vibrio cholerae O139 live oral vaccine: safety and efficacy against experimental challenge. J Infect Dis 1995; 172:883-6; PMID:7658089; http://dx.doi.org/10.1093/infdis/172.3.883.
149. Mahalanabis D, Ramamurthy T, Nair GB, Ghosh A, Shaikh S, Sen B, Thungapathra M, Ghosh RK, Pazhani GP, Nandy RK., et al. Randomized placebo controlled human volunteer trial of a live oral cholera vaccine VA1.3 for safety and immune response. Vaccine 2009; 27:4850-6; PMID:19523608; http://dx.doi.org/10.1016/j.vaccine.2009.05.065.
150. Kanungo SSB, Ramamurthy T, Sur D, Manna B, Pazhani GP, Chowdhury G, Jhunjhunwala P, Nandy RK, Koley H, Bhattacharya MK., et al. Safety and immunogenicity of a live oral recombinant cholera vaccine VA1.4: a randomized, placebo controlled trial in healthy adults in a cholera endemic area in Kolkata, India. PLoS One 2014; 9:e99381; PMID:24983989; http://dx.doi.org/10.1371/journal.pone.0099381.
151. Liang W, Wang S, Yu F, Zhang L, Qi G, Liu Y, Gao S, Kan B. Construction and evaluation of a safe, live, oral Vibrio cholerae vaccine candidate, IEM108. Infect Immun 2003; 71:5498-504; PMID:14500467; http://dx.doi.org/10.1128/IAI.71.10.5498-5504.2003.
152. Ravichandran M, Ali SA, Rashid NHA, Kurunathan S, Yean CY, Ting LC, Bakar ASA, Lalitha P, Zainuddin ZF. Construction and evaluation of a O139 Vibrio cholerae vaccine candidate based on a hemA gene mutation. Vaccine 2006; 24:3750-61; PMID:16102875; http://dx.doi.org/10.1016/j.vaccine.2005.07.016.
153. Ledon T, Ferran B, Perez C, Suzarte E, Vichi J, Marrero K, Oliva R, Fando R. TLP01, an mshA mutant of Vibrio cholerae O139 as vaccine candidate against cholera. Microbes Infect 2012; 14:968-78; PMID:22546527; http://dx.doi.org/10.1016/j.micinf.2012.04.004.