Oral Cholera Vaccine Delivery in Rural Bangladesh (ROCV)
Recruitment status was Recruiting
Vibrio cholerae is one of the major causes of severe diarrheal disease in Bangladesh. It is estimated that there are about 450,000 cholera cases each year in Bangladesh. Cholera is prevalent in both urban and rural settings in the country. Policy decisions about how best a new public health tool can be incorporated into the system requires evidence. Investigators have recently carried out a feasibility study of oral cholera vaccine in urban Dhaka in Mirpur (Protocol #10061). However, whether a similar system can also be utilized in a rural area in Bangladesh needs to be studied.
The hospital disease surveillance data from International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) reveals a substantial burden of cholera from Keraniganj upazila. Investigators propose a feasibility study of oral cholera vaccination by using the existing national immunization service delivery mechanism in Keraniganj. This study will help to provide evidence for the policy makers in introducing oral cholera vaccine in preventing cholera in high risk rural areas in Bangladesh.
That icddr,b in collaboration with the Government of Bangladesh will be able to implement an oral cholera vaccine program that;
- reaches residents of rural union of Keraniganj
- reduces the incidence of diarrhea due to Vibrio cholerae
- Carry out cholera vaccination in one rural union in Keraniganj.
- Evaluate the impact of vaccination in reducing cholera in the study area
Two unions in Keraniganj will be selected; around 30,000 individuals in one union will be vaccinated and impact evaluated by comparison with another similar union. After vaccination, passive cholera surveillance at the Upazila hospital will be conducted for two years on the patients from the two unions.
Cholera vaccination programme will be assessed by the number of doses administered, drop-out rates between the two rounds, the proportion of vaccine wastage, and the vaccine coverage.
Proportion of diarrheal hospitalizations that are due to V. cholerae O1 between the vaccinated and non vaccinated union will be calculated and compared to assess the impact of intervention.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Impact Evaluation of Oral Cholera Vaccination in a Rural Setting Using the National Immunization System of Bangladesh|
- Proportion of diarrheal hospitalizations that are due to V. cholerae O1 between the vaccinated and non vaccinated union will be calculated and compared to assess the impact of intervention [ Time Frame: within 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Shanchol vaccine
Around 30,000 individuals will be vaccinated with two doses of oral cholera vaccine at least 14 days apart.All male and non-pregnant female residents above one year age will be targeted for vaccination.
Biological: Shanchol vaccine
Shanchol vaccine contains whole cell inactivated heat killed and formalin killed bacteria consisting of 600 ELISA Units (EU) of lipopolysaccharide (LPS). It consists of formalin-killed V. cholerae Inaba, El Tor biotype (strain Phil 6973). It also contains 300 EU LPS of heat-killed V. cholerae Ogawa classical biotype (Cairo 50); 300 EU LPS of formalin killed V. cholerae Ogawa classical biotype (Cairo 50); 300 EU LPS of heat-killed V. cholerae Inaba, classical biotype (Cairo 48); and 600 EU LPS of formalin killed V. cholerae O139 (4260B) (9). The vaccine has no detectable cholera toxin. Vaccine is packaged as liquid formulations in 1.5-ml doses. No buffer is needed for administered.This vaccine is licensed in India and WHO prequalified.
No Intervention: Non-intervention
No intervention will be given. Health education will be provided to the study participants.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01811771
|Contact: Firdausi Qadri, PhD||+88-028860525-32 ext email@example.com|
|Contact: Iqbal Ansary Khan, Msc||+88-028860525-32 ext firstname.lastname@example.org|
|International Centre for Diarrhoeal Disease Research,Bangladesh||Recruiting|
|Dhaka, Bangladesh, 1212|
|Contact: Firdausi Qadri, PhD 880-2-9840525 ext 2431 email@example.com|