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Cholera clinical trials

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NCT ID: NCT02027207 Completed - Cholera Clinical Trials

Single Dose Oral Cholera Vaccine Study in Dhaka, Bangladesh

SCVB
Start date: December 9, 2012
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT01949675 Completed - Cholera Clinical Trials

A Study of Two Doses of Oral Cholera Vaccine (Shanchol™) in Subjects Aged 1 Year and Older in the Philippines

Start date: March 2014
Phase: Phase 4
Study type: Interventional

The aim of the study is to generate safety and immunogenicity data with Oral Cholera Vaccine (Shanchol™) in The Philippines Objectives: - To describe the safety after each dose of Shanchol vaccine. - To describe the immunogenicity after each dose of Shanchol vaccine.

NCT ID: NCT01895855 Completed - Cholera Clinical Trials

Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera

Start date: September 2013
Phase: Phase 3
Study type: Interventional

The purpose of the study is to determine if PXVX0200 is safe and effective in preventing cholera infection

NCT ID: NCT01823939 Completed - Diarrhea Clinical Trials

PK Study of iOWH032 in Adult Male/Female Healthy Volunteers & Adult Males With Cholera

PISCES
Start date: May 2013
Phase: Phase 1
Study type: Interventional

This study will assess if the pharmacokinetics, safety and tolerability of iOWH032 are grossly different in 1) Bangladeshi healthy population and 2) Bangladeshi cholera patients. This is not a hypothesis-driven research study.

NCT ID: NCT01811771 Completed - Cholera Clinical Trials

Oral Cholera Vaccine Delivery in Rural Bangladesh

ROCV
Start date: August 2012
Phase: N/A
Study type: Interventional

Background: 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. Hypothesis: That icddr,b in collaboration with the Government of Bangladesh will be able to implement an oral cholera vaccine program that; 1. reaches residents of rural union of Keraniganj 2. reduces the incidence of diarrhea due to Vibrio cholerae Objectives: 1. Carry out cholera vaccination in one rural union in Keraniganj. 2. Evaluate the impact of vaccination in reducing cholera in the study area Methods: 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. Outcome measures/variables: 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.

NCT ID: NCT01707537 Completed - Clinical trials for Prevention Harmful Effects

To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in Healthy Adult Men

OCV
Start date: September 2012
Phase: Phase 1
Study type: Interventional

To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in Healthy Adult Men

NCT ID: NCT01585181 Completed - Cholera Clinical Trials

Safety and Immunogenicity of the Live Oral Cholera Vaccine Candidate PXVX0200

Start date: April 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare the safety and immunogenicity of a single dose of the PXVX0200 live cholera vaccine versus placebo in volunteers (Vaccinees) and whether PXVX0200, which is a live attenuated bacteria, can be transmitted to other adults living in the same household.

NCT ID: NCT01579448 Completed - Cholera Clinical Trials

Evaluation of a Boosting Regimen With Oral Cholera Vaccine

Boost
Start date: December 2012
Phase: Phase 4
Study type: Interventional

Data demonstrates that Shanchol™ (killed bivalent oral cholera vaccine) provides protection over 3 years and data regarding the protective efficacy over five years is anticipated for 2012. Regardless at the end of five years, it may still be necessary to provide a booster dose or reimmunize with two doses to maintain protection in previously immunized populations. This study examines the immune protection and safety of providing a one and two dose boosting regimen of Shanchol™ given five years after the initial dose.

NCT ID: NCT01524640 Completed - Cholera Clinical Trials

Bridging Study for Killed Oral Cholera Vaccine in Ethiopia

Start date: December 2012
Phase: Phase 4
Study type: Interventional

This is a randomized, double blind, placebo controlled trial to confirm the safety and determine the immune response of the killed oral cholera vaccine in healthy adults and children in Ethiopia.

NCT ID: NCT01365442 Completed - Cholera Clinical Trials

Pilot Introduction of Oral Cholera Vaccine in Orissa, India

Start date: May 2011
Phase: N/A
Study type: Observational

The purpose of this study is to provide evidence for policymakers and key opinion leaders on the pilot implementation of cholera vaccination using the newly licensed Oral Cholera Vaccine (OCV) in India. The pilot introduction will provide the evidence for the feasibility, costs and population acceptance of large-scale cholera vaccination using the Indian vaccine (using vaccination coverage rates and other measures).