Effect of Probiotic on Immunogenicity of Oral Cholera Vaccine

2014-08-27 03:38:56 | BioPortfolio


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.

Study Design

Allocation: Randomized, Control: Placebo Control, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention




Whole cell killed cholera vaccine & probiotic






International Centre for Diarrhoeal Disease Research, Bangladesh

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:38:56-0400

Clinical Trials [2714 Associated Clinical Trials listed on BioPortfolio]

Safety and Immunogenicity of a Killed Oral Cholera Vaccine in Infants

In order to assess whether the bivalent killed oral cholera vaccine may be used safely among infants who are most at risk for cholera, the investigators need to determine the safety and im...

Bridging Study of the Third Generation Killed Whole Cell Oral Cholera Vaccine

A study is necessary in order to assess the safety and immunogenicity of the bivalent killed oral cholera vaccine produced in India by Shantha Biotechnics among healthy adult and children ...

Randomized Controlled Trial of Killed Oral Cholera Vaccine in Kolkata

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-endemi...

Immunogenicity of One Versus Two Doses of Killed Oral Cholera Vaccine

The purpose of this study is to compare the safety and immunogenicity of one and two doses of the killed oral cholera vaccine.

Safety and Immunogenicity of a New Formulation of a Bivalent Killed, Whole-Cell Oral Cholera Vaccine

The purpose of this study is to evaluate the safety and immunogenicity of a new formulation of a locally-produced bivalent, (O-1 and O-139) killed whole cell oral cholera vaccine among Vie...

PubMed Articles [17228 Associated PubMed Articles listed on BioPortfolio]

Cholera: Immunity and Prospects in Vaccine Development.

Vibriocholerae is a prototypical noninvasive mucosal pathogen, yet infection generates long-lasting protection against subsequent disease. Vibriocidal antibody responses are an imperfect but establish...

Confirmation of cholera by rapid diagnostic test amongst patients admitted to the cholera treatment centre in Uvira, Democratic Republic of the Congo.

Cholera is endemic in the Eastern provinces of the Democratic Republic of the Congo since 1978, and Uvira in South-Kivu has been reporting suspected cholera cases nearly every week for over a decade. ...

Engineered Bacteria for Cholera Prophylaxis.

Over 1.3 billion persons are at risk for cholera globally. Vaccination campaigns are growing, but intervention options providing nearly immediate protection are also needed. Two recent papers in Scien...

The impact and cost-effectiveness of controlling cholera through the use of oral cholera vaccines in urban Bangladesh: A disease modeling and economic analysis.

Cholera remains an important public health problem in major cities in Bangladesh, especially in slum areas. In response to growing interest among local policymakers to control this disease, this study...

Herd protection of unvaccinated adults by oral cholera vaccines in rural Bangladesh.

Past research has suggested that the most cost-effective approach to using oral cholera vaccines (OCVs) to control endemic cholera may be to target only children

Medical and Biotech [MESH] Definitions

Vaccines or candidate vaccines used to prevent infection with VIBRIO CHOLERAE. The original cholera vaccine consisted of killed bacteria, but other kinds of vaccines now exist.

An old term that is no longer used in the scientific literature. Cholera morbus refers to acute GASTROENTERITIS occurring in summer or autumn; characterized by severe cramps, diarrhea, and vomiting.

A live vaccine containing attenuated poliovirus, types I, II, and III, grown in monkey kidney cell tissue culture, used for routine immunization of children against polio. This vaccine induces long-lasting intestinal and humoral immunity. Killed vaccine induces only humoral immunity. Oral poliovirus vaccine should not be administered to immunocompromised individuals or their household contacts. (Dorland, 28th ed)

A suspension of killed Bordetella pertussis organisms, used for immunization against pertussis (WHOOPING COUGH). It is generally used in a mixture with diphtheria and tetanus toxoids (DTP). There is an acellular pertussis vaccine prepared from the purified antigenic components of Bordetella pertussis, which causes fewer adverse reactions than whole-cell vaccine and, like the whole-cell vaccine, is generally used in a mixture with diphtheria and tetanus toxoids. (From Dorland, 28th ed)

An ENTEROTOXIN from VIBRIO CHOLERAE. It consists of two major protomers, the heavy (H) or A subunit and the B protomer which consists of 5 light (L) or B subunits. The catalytic A subunit is proteolytically cleaved into fragments A1 and A2. The A1 fragment is a MONO(ADP-RIBOSE) TRANSFERASE. The B protomer binds cholera toxin to intestinal epithelial cells, and facilitates the uptake of the A1 fragment. The A1 catalyzed transfer of ADP-RIBOSE to the alpha subunits of heterotrimeric G PROTEINS activates the production of CYCLIC AMP. Increased levels of cyclic AMP are thought to modulate release of fluid and electrolytes from intestinal crypt cells.

More From BioPortfolio on "Effect of Probiotic on Immunogenicity of Oral Cholera Vaccine"

Quick Search


Relevant Topics

Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...

Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Searches Linking to this Trial