Effect of Probiotic on Immunogenicity of Oral Cholera Vaccine

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Brief Title

Effect of Probiotic on Immunogenicity of Oral Cholera Vaccine


Brief Summary

      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 Type

Interventional


Primary Outcome

Determine vibriocidal antibody response among Bangladeshi children aged 2-5 years given the whole cell killed cholera vaccine


Condition

Cholera

Intervention

Whole cell killed cholera vaccine & probiotic


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

128

Start Date

January 2006

Completion Date

December 2008

Primary Completion Date

January 2006

Eligibility Criteria

        Inclusion Criteria:

          -  Children of either sex aged 2-5 years

          -  Eligible for screening

          -  Written informed consent from parents

          -  Free from any chronic illness

          -  Free from any recent illness

          -  Apparently healthy without known underlying illness

        Exclusion Criteria:

          -  Children below -2SD of the NCHS reference median

          -  Severe parasitic and helminthic load

          -  Presence of enteric pathogen in stool

          -  History of diarrhoea in the preceding 2 weeks.
      

Gender

All

Ages

2 Years - 5 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Firdausi Qadri, PhD, , 

Location Countries

Bangladesh

Location Countries

Bangladesh

Administrative Informations


NCT ID

NCT00464867

Organization ID

2004-032


Responsible Party

Sponsor

Study Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Collaborators

 Kyoto University

Study Sponsor

Firdausi Qadri, PhD, Principal Investigator, International Centre for Diarrhoeal Disease Research, Bangladesh


Verification Date

June 2012