Active clinical trials for "Cholera"

The purpose of the study is to confirm the safety and immunogenicity of the oral killed bivalent cholera vaccine in adult and pediatric volunteers in Eastern Kolkata, West Bengal, India.

The Cholera Hospital Based Intervention for 7 Days (CHoBI7) randomized controlled trial for transition to scale aimed to: (1) Develop and evaluate scalable approaches to integrate the CHoBI7 intervention into the services provided for hospitalized diarrhea patients at health facilities in Bangladesh; and (2) Evaluate the ability of the CHoBI7 intervention to lead to a sustained uptake of the promoted hand washing with soap and water treatment behaviors and significant reductions in diarrheal disease over time.

The primary hypothesis is that administration of iOWH032 to adult and pediatric males and females with acute cholera due to V. cholerae O1 reduces stool output in the first 24 hours significantly more than does the current standard of care.

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; reaches residents of rural union of Keraniganj reduces the incidence of diarrhea due to Vibrio cholerae Objectives: Carry out cholera vaccination in one rural union in Keraniganj. 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.

Demonstrate that the vaccine offers protection based on antibody levels in older adults and is similar to antibody levels in adults aged 18-45 following vaccination with PXVX0200.

Cholera is a major health problem of many developing countries and marked increase in the prevalence has been seen on all continents in the last decade (WHO 1998). There is a great need for an appropriate vaccine to protect children the principal suffers in endemic countries, from the live threatening consequences of cholera. The B subunit-whole cell killed vaccine (Dukoral) developed in Sweden and used in field trials all over the world. It is licensed in many counties of the world and recommended by WHO. Protective efficacy to the killed vaccine has been demonstrated in adults in Bangladesh as well as in other countries, but less so in children (Clemens et al. 1986). Thus there is an urgency for developing strategies to improve the immunogenicity of vaccines especially for protection of children in cholera endemic countries of the world. Different options for improved cholera vaccines are being considered including new and improved formulations of killed or live oral candidate vaccines (Qadri et al. 2004, Sack et al. 1997, Levine et al. 1993) as well as the use of micronutrient supplementation during the course of immunization (Albert et al. 2003, Karlsen et al. 2003, Qadri et al. 2004). Another option that appears promising is the use of probiotics as adjunct to oral immunization based on the understanding that these agents could improve the mucosal immune responses, both innate and adaptive and help reducing inflammation (Blum and Schiffrin 2003, Fang et al. 2000). A therapeutic as well as preventive role of probiotics has been suggested from results of different studies using different probiotics that have been tested, usually lactic acid producing bacteria such as lactobacillus, Bifidobacterium and Steptococcus species. The supplemention of probiotics to infants may also have a prophylactic effect against acute diarrheal diseases. In pediatric populations, the effect of probiotic agents appears to be most significant against rotavirus diarrhea, suggesting that an immunological mechanism is responsible for the beneficial effects (Saavedra, 2000). In the present proposal we would like to examine if supplementation with the probiotic Bifidobacterium breve has a beneficial role in enhancing the immunogenicity of Dukoral in children. A two cell study will be conducted in which one group of children will be given B. breve every day for four weeks and another group will be given placebo. Two doses of the oral cholera vaccine will be administered at two week interval following initiation of the probiotic/placebo administration. Pre- and post- vaccination blood sample will be collected and assayed for immune response to the vaccine. The frequency and magnitude of the immune response to the vaccine will be compared among the two groups of children to assess whether the probiotic treatment enhances the immune responses to the vaccine. If probiotic supplemenation has a positive effect on the immune response it may be adopted as adjunct to enhance the efficacy of the cholera vaccine in immunization programmes and perhaps also of other enteric vaccines.

To compare the ability of a single dose of PXVX0200 at two different dose levels, to placebo to elicit a significant antibody response 14 days after vaccination, compared to baseline. To compare the ability of a single dose of PXVX0200 to a comparator vaccine Shanchol, a two dose administration, to elicit antibody response by 14 days after vaccination.

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.

Assessment of the immunogenicity and safety of immunization against cholera in children with inflammatory bowel disease.

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