Single Dose Oral Cholera Vaccine Study in Dhaka, Bangladesh

NCT02027207 | Completed Phase 3 DMC

• 1 other identifier: PR-12090
• Study Type: interventional
• Target: 204,438
• Locations: 1 country
• Sites: 1

Brief Summary

Bangladesh remains endemic for cholera, which experiences biannual outbreaks with additional epidemics seen during times of floods, cyclones or any natural disaster. It affects all age groups with the majority of fatal cases occurring in children . Therefore, immunization against cholera remains an important public health component in the prevention and control of the disease .The current two-dose regimen of the internationally available oral cholera vaccines (OCV) create a logistical and programmatic challenge for use in national programs or during epidemics ,so it is important to determine if a single dose vaccine will be protective in regions where cholera is endemic. If the vaccine is found to be efficacious following a single dose, this will have profound implications for the use of the vaccine in areas with limited resources particularly in complex emergencies where a multiple dose regimen is difficult to deploy. A single-dose regimen of this vaccine will improve its 'field ability' and allow the vaccine to be used for outbreak control, especially in difficult settings where the risk of cholera is extremely high and provisions for clean water and sanitation are not available. With low OCV production rates, larger populations could be immunized against cholera if a single dose is found to be efficacious. A single-dose schedule could facilitate the inclusion of a global stockpile strategy. The study design is a two-arm individually randomized double-blind placebo-controlled trial. The primary outcome of the study is the proportion of persons receiving 1 dose of vaccine or placebo who are detected with diarrhea with faecal excretion of V. cholera O1 in the study treatment centres from 7 days to 6 months after dosage and whose identity is confirmed through home visit.

Conditions

Cholera

Keywords

Cholera; Oral cholera vaccine; Shanchol; Protective efficacy; Bangladesh

Outcome Measures

Primary Outcomes (1)

• Number of participants with a single dose regimen oral cholera vaccine Shanchol will get protection

  Shanchol vaccine will be given to healthy, non-pregnant residents aged one and above in Dhaka, Bangladesh, against culture-proven V. cholerae O1 diarrhea which has been detected in all treatment settings serving the catchment population.

  7 days to 6 months

Secondary Outcomes (6)

• Number of participants get protection with a single dose Shanchol after dosing against culture-proven V. cholerae O1 diarrhea

  7 days to 24 months

• Number of participants get protection with the single dose regimen of Shanchol against culture proven V. Cholerae O1 diarrhea with severe dehydration, V. Cholerae O139 diarrhea,V. Cholerae O139 diarrhea with severe dehydration .

  7 days to 24 months

• Number of participants with a single dose Shanchol with onset of 7 days to 6 months,7 days to 12 months, from 7 days to 18 months and 7 days to 24 months after dosing against acute watery diarrhoea detected in treatment centre

  7 days to 24 months

• Number of participants with a single dose Shanchol with onset of 7 days to 6 months,7 days to 12 months, from 7 days to 18 months and 7 days to 24 months after dosing against acute watery diarrhea with severe dehydration detected in treatment centre

  7 days to 24 months

• Serum vibriocidal antibody responses to oral cholera vaccine Shanchol in healthy,non-pregnant residents, aged one year and older in a subset of population

  14 days

Study Arms (2)

Shanchol

EXPERIMENTAL

Biological: Shanchol

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

Shanchol BIOLOGICAL

We will use the killed whole cell oral cholera vaccine, Shanchol that will be manufactured by Shantha Biotechnics, in Hyderabad, India for the study. The vaccine is registered in India and is prequalified by the WHO. Shanchol is available in a single dose vial. Vaccine will be maintained at 2-8oC. Each participant over the age of one year and non pregnant females living in communities will be individually randomized to receive vaccine.Pregnancy status will be enquired verbally for all married women of child bearing age during the census update as well as before vaccination to exclude them from the study. Prior to vaccination, informed consent will be taken from the adults and guardians of minor participants .Each dose of vaccine will be 1.5 ml in volume.

Shanchol

Placebo BIOLOGICAL

Placebo will be transported from the manufacturer and will be maintained at 2-8oC. Each participant over the age of one year and non pregnant females living in communities will be individually randomized to receive placebo.Each dose of placebo will be 1.5 ml in volume.Placebo will be dispensed in liquid form in identical vials.

Placebo

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects \> 1 year of age and above Living in high risk area for cholera Provision of Informed consent for participating in the study by participant /parent or guardian as well as verbal assent for children 11-17 years.

You may not qualify if:

• Pregnant women Aged less than 1 year History of taking cholera vaccine

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• International Vaccine Institute: collaborator
• Government of Bangladesh: collaborator

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Dhaka, 1212, Bangladesh

Location

Related Publications (7)

• Kanungo S, Paisley A, Lopez AL, Bhattacharya M, Manna B, Kim DR, Han SH, Attridge S, Carbis R, Rao R, Holmgren J, Clemens JD, Sur D. Immune responses following one and two doses of the reformulated, bivalent, killed, whole-cell, oral cholera vaccine among adults and children in Kolkata, India: a randomized, placebo-controlled trial. Vaccine. 2009 Nov 16;27(49):6887-93. doi: 10.1016/j.vaccine.2009.09.008. Epub 2009 Sep 15.

  PMID: 19761838 RESULT

• Saha A, Chowdhury MI, Khanam F, Bhuiyan MS, Chowdhury F, Khan AI, Khan IA, Clemens J, Ali M, Cravioto A, Qadri F. Safety and immunogenicity study of a killed bivalent (O1 and O139) whole-cell oral cholera vaccine Shanchol, in Bangladeshi adults and children as young as 1 year of age. Vaccine. 2011 Oct 26;29(46):8285-92. doi: 10.1016/j.vaccine.2011.08.108. Epub 2011 Sep 9.

  PMID: 21907255 RESULT

• Khan IA, Saha A, Chowdhury F, Khan AI, Uddin MJ, Begum YA, Riaz BK, Islam S, Ali M, Luby SP, Clemens JD, Cravioto A, Qadri F. Coverage and cost of a large oral cholera vaccination program in a high-risk cholera endemic urban population in Dhaka, Bangladesh. Vaccine. 2013 Dec 9;31(51):6058-64. doi: 10.1016/j.vaccine.2013.10.021. Epub 2013 Oct 22.

  PMID: 24161413 RESULT

• Chowdhury F, Bhuiyan TR, Akter A, Bhuiyan MS, Khan AI, Tauheed I, Ahmed T, Ferdous J, Dash P, Basher SR, Hakim A, Lynch J, Kim JH, Excler JL, Kim DR, Clemens JD, Qadri F. Augmented immune responses to a booster dose of oral cholera vaccine in Bangladeshi children less than 5 years of age: Revaccination after an interval of over three years of primary vaccination with a single dose of vaccine. Vaccine. 2020 Feb 11;38(7):1753-1761. doi: 10.1016/j.vaccine.2019.12.034. Epub 2019 Dec 24.

  PMID: 31879124 DERIVED

• Khan AI, Ali M, Lynch J, Kabir A, Excler JL, Khan MA, Islam MT, Akter A, Chowdhury F, Saha A, Khan IA, Desai SN, Kim DR, Saha NC, Singh AP, Clemens JD, Qadri F. Safety of a bivalent, killed, whole-cell oral cholera vaccine in pregnant women in Bangladesh: evidence from a randomized placebo-controlled trial. BMC Infect Dis. 2019 May 15;19(1):422. doi: 10.1186/s12879-019-4006-3.

  PMID: 31092224 DERIVED

• Qadri F, Ali M, Lynch J, Chowdhury F, Khan AI, Wierzba TF, Excler JL, Saha A, Islam MT, Begum YA, Bhuiyan TR, Khanam F, Chowdhury MI, Khan IA, Kabir A, Riaz BK, Akter A, Khan A, Asaduzzaman M, Kim DR, Siddik AU, Saha NC, Cravioto A, Singh AP, Clemens JD. Efficacy of a single-dose regimen of inactivated whole-cell oral cholera vaccine: results from 2 years of follow-up of a randomised trial. Lancet Infect Dis. 2018 Jun;18(6):666-674. doi: 10.1016/S1473-3099(18)30108-7. Epub 2018 Mar 14.

  PMID: 29550406 DERIVED

• Qadri F, Wierzba TF, Ali M, Chowdhury F, Khan AI, Saha A, Khan IA, Asaduzzaman M, Akter A, Khan A, Begum YA, Bhuiyan TR, Khanam F, Chowdhury MI, Islam T, Chowdhury AI, Rahman A, Siddique SA, You YA, Kim DR, Siddik AU, Saha NC, Kabir A, Cravioto A, Desai SN, Singh AP, Clemens JD. Efficacy of a Single-Dose, Inactivated Oral Cholera Vaccine in Bangladesh. N Engl J Med. 2016 May 5;374(18):1723-32. doi: 10.1056/NEJMoa1510330.

  PMID: 27144848 DERIVED

MeSH Terms

Conditions

Cholera

Interventions

shanchol

Condition Hierarchy (Ancestors)

Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: January 6, 2014
• Study Start: December 9, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 31, 2017
• Last Updated: March 20, 2018

Record last verified: 2015-06

Locations

BA (1)