title: The oral cholera vaccine Shanchol™ when stored at elevated temperatures maintains the safety and immunogenicity profile in Bangladeshi participants.
abstract: BACKGROUND
  The oral cholera vaccine (OCV), Shanchol™ has shown protective efficacy lasting up to 5 years, however, requirement for a cold chain limits its use in resource poor settings. The study was conducted to determine the safety and immunogenicity of Shanchol in adult participants in Bangladesh when stored at elevated temperatures.
  
  
  METHODS
  The study was conducted in Mirpur, Dhaka. Four groups of healthy adult participants received two doses of Shanchol™, kept under standard storage temperature (Group A; 2-8°C) or at elevated temperatures (Group B, 25°C; Group C, 37°C; Group D, 42°C) for 14 days, respectively. Vaccine specific antibody responses were determined.
  
  
  RESULTS
  145 participants were assigned to each group. Adverse events were mild not differing among groups. Vaccine stored at elevated temperatures remained stable with cumulative LPS content within admissible limits. Vibriocidal antibody responses were observed in all groups after each dose of vaccine at day 7 and 21 compared to pre-immune levels (P<0.001). Four-fold increases to Vibrio cholerae O1 Ogawa were observed at day 7 and/or day 21 after vaccination in the standard temperature and the three elevated temperature groups, with responder rates of; 76% (95% CI LB; 70%), 80% (95% CI LB; 74%), 69% (95% CI LB; 63%), and 74% (95% CI LB; 68%) in Groups A-D, respectively (P=0.240). Responses were also seen in all groups to V. cholerae O1 Inaba and V. cholerae O139 and in LPS specific IgA response to V. cholerae O1 antigens.
  
  
  CONCLUSIONS
  This is the first report to show that the OCV is stable at elevated temperatures, and the safety and immunogenicity profiles are not altered. This information will help formulate global policies for use of the vaccine at higher temperatures, resulting in easier distribution and vaccination costs and decrease logistical challenges to vaccine delivery.
  
  
  BACKGROUND
  Bill & Melinda Gates Foundation.
  
  
  BACKGROUND
  Clinical Trials.gov number NCT01762930.
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh; University of New South Wales, SPHCM, NSW, Australia.
authors.forename: Amit
authors.initials: A
authors.lastname: Saha
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.
authors.forename: Arifuzzaman
authors.initials: A
authors.lastname: Khan
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.
authors.forename: Umme
authors.initials: U
authors.lastname: Salma
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.
authors.forename: Nusrat
authors.initials: N
authors.lastname: Jahan
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.
authors.forename: Taufiqur Rahman
authors.initials: TR
authors.lastname: Bhuiyan
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.
authors.forename: Fahima
authors.initials: F
authors.lastname: Chowdhury
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.
authors.forename: Ashraful Islam
authors.initials: AI
authors.lastname: Khan
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.
authors.forename: Farhana
authors.initials: F
authors.lastname: Khanam
authors.affiliation: Shantha Biotechnics Private Limited, Hyderabad, India.
authors.forename: Sundaram
authors.initials: S
authors.lastname: Muruganandham
authors.affiliation: Shantha Biotechnics Private Limited, Hyderabad, India.
authors.forename: Sreeramulu
authors.initials: S
authors.lastname: Reddy Kandukuri
authors.affiliation: Shantha Biotechnics Private Limited, Hyderabad, India.
authors.forename: Mandeep
authors.initials: M
authors.lastname: Singh Dhingra
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh; UCLA Fielding School of Public Health, Los Angeles, United States.
authors.forename: John D
authors.initials: JD
authors.lastname: Clemens
authors.affiliation: Global Evaluative Sciences USA, Inc., Seattle, WA 98109, United States.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Cravioto
authors.affiliation: International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh. Electronic address: fqadri@icddrb.org.
authors.forename: Firdausi
authors.initials: F
authors.lastname: Qadri
mesh_terms: D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D000917:Antibody Formation; D001459:Bangladesh; D002771:Cholera / Q000517:prevention & control*; D022121:Cholera Vaccines / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006358:Hot Temperature; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D008297:Male; D012034:Refrigeration; D041241:Vibrio cholerae O1; D055815:Young Adult
chemical_list: D000907:Antibodies, Bacterial; D022121:Cholera Vaccines; D007070:Immunoglobulin A; C000588783:shanchol
keywords: Cold chain; Immune response; Oral cholera vaccine; Shanchol™; Thermal stability