Randomized Controlled Trial of Killed Oral Cholera Vaccine in Kolkata

NCT00289224 | Completed Phase 3 DMC

• 1 other identifier: C8phIII
• Study Type: interventional
• Target: 69,329
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to estimate the efficacy of a two-dose regimen of the oral killed bivalent cholera vaccine when administered to individual residing in a cholera-endemic area in India.

Conditions

Diarrhea; Cholera; Vibrio Infections

Keywords

bivalent killed whole cell oral cholera vaccine; double blind randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• culture-proven V. cholerae O1 diarrhoea episodes severe enough to require treatment in a health care facility.

  1095 days

Secondary Outcomes (2)

• Episodes of acute watery diarrhoea severe enough to require treatment in a health care facility

  1095 days

• Serum vibriocidal responses, compared to baseline

  14 days and 365 days after second dose

Study Arms (2)

1

EXPERIMENTAL

Cholera Vaccine

Biological: bivalent killed whole cell oral cholera vaccine

2

PLACEBO COMPARATOR

Placebo

Biological: Placebo

Interventions

bivalent killed whole cell oral cholera vaccine BIOLOGICAL

Given as 1.5 mL dose, given orally in 2 doses 14 days apart, each dose contains: V. cholerae O1 Inaba El Tor strain Phil 6973 formalin killed 600 Elisa units (EU) LPS V. cholerae O1 Ogawa classical strain Cairo 50 heat killed 300 EU LPS V. cholerae O1 Ogawa classical strain Cairo 50 formalin killed 300 EU LPS V. cholerae O1 Inaba classical strain Cairo 48 heat killed 300 EU LPS V. cholerae O139 strain 4260B formalin killed 600 EU LPS

1

Placebo BIOLOGICAL

Heat Killed E. coli K12 in an optical turbidity identical to killed oral cholera vaccine, in 1.5 mL oral dose given twice, at least 14 days apart.

2

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All healthy, consenting, non-pregnant (as ascertained by history) residents at least 1 year of age of the study area

You may not qualify if:

• individuals who are too weak to get out of bed to receive the vaccine;
• pregnant women (identified through verbal screening); and
• those less than 1 year of age

Sponsors & Collaborators

• International Vaccine Institute: lead
• National Institute of Cholera and Enteric Diseases, India: collaborator
• Shantha Biotechnics Limited: collaborator

Study Sites (1)

National Institute of Cholera and Enteric Diseases

Kolkata, West Bengal, India

Location

Related Publications (6)

• Sur D, Lopez AL, Kanungo S, Paisley A, Manna B, Ali M, Niyogi SK, Park JK, Sarkar B, Puri MK, Kim DR, Deen JL, Holmgren J, Carbis R, Rao R, Nguyen TV, Donner A, Ganguly NK, Nair GB, Bhattacharya SK, Clemens JD. Efficacy and safety of a modified killed-whole-cell oral cholera vaccine in India: an interim analysis of a cluster-randomised, double-blind, placebo-controlled trial. Lancet. 2009 Nov 14;374(9702):1694-702. doi: 10.1016/S0140-6736(09)61297-6. Epub 2009 Oct 8.

  PMID: 19819004 RESULT

• Islam MT, Im J, Ahmmed F, Kim DR, Tadesse BT, Kang S, Khanam F, Chowdhury F, Ahmed T, Firoj MG, Aziz AB, Hoque M, Park J, Jeon HJ, Kanungo S, Dutta S, Zaman K, Khan AI, Marks F, Kim JH, Qadri F, Clemens JD. Better Existing Water, Sanitation, and Hygiene Can Reduce the Risk of Cholera in an Endemic Setting: Results From a Prospective Cohort Study From Kolkata, India. Open Forum Infect Dis. 2023 Nov 21;10(11):ofad535. doi: 10.1093/ofid/ofad535. eCollection 2023 Nov.

  PMID: 38023545 DERIVED

• Fong Y, Halloran ME, Park JK, Marks F, Clemens JD, Chao DL. Efficacy of a bivalent killed whole-cell cholera vaccine over five years: a re-analysis of a cluster-randomized trial. BMC Infect Dis. 2018 Feb 20;18(1):84. doi: 10.1186/s12879-018-2981-4.

  PMID: 29463233 DERIVED

• Ali M, Debes AK, Luquero FJ, Kim DR, Park JY, Digilio L, Manna B, Kanungo S, Dutta S, Sur D, Bhattacharya SK, Sack DA. Potential for Controlling Cholera Using a Ring Vaccination Strategy: Re-analysis of Data from a Cluster-Randomized Clinical Trial. PLoS Med. 2016 Sep 13;13(9):e1002120. doi: 10.1371/journal.pmed.1002120. eCollection 2016 Sep.

  PMID: 27622507 DERIVED

• Ali M, Sur D, You YA, Kanungo S, Sah B, Manna B, Puri M, Wierzba TF, Donner A, Nair GB, Bhattacharya SK, Dhingra MS, Deen JL, Lopez AL, Clemens J. Herd protection by a bivalent killed whole-cell oral cholera vaccine in the slums of Kolkata, India. Clin Infect Dis. 2013 Apr;56(8):1123-31. doi: 10.1093/cid/cit009. Epub 2013 Jan 29.

  PMID: 23362293 DERIVED

• Sur D, Kanungo S, Sah B, Manna B, Ali M, Paisley AM, Niyogi SK, Park JK, Sarkar B, Puri MK, Kim DR, Deen JL, Holmgren J, Carbis R, Rao R, Nguyen TV, Han SH, Attridge S, Donner A, Ganguly NK, Bhattacharya SK, Nair GB, Clemens JD, Lopez 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 Oct;5(10):e1289. doi: 10.1371/journal.pntd.0001289. Epub 2011 Oct 18.

  PMID: 22028938 DERIVED

MeSH Terms

Conditions

Diarrhea; Cholera; Vibrio Infections

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Dipika Sur, MD

  National Institute of Cholera and Enteric Diseases, India

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 7, 2006
• First Posted: February 9, 2006
• Study Start: July 1, 2006
• Primary Completion: December 1, 2011
• Study Completion: May 1, 2013
• Last Updated: July 31, 2014

Record last verified: 2012-03

Locations

IN (1)