Immunogenicity of One Versus Two Doses of Killed Oral Cholera Vaccine

Brief Title

Immunogenicity of One Versus Two Doses of Killed Oral Cholera Vaccine

Official Title

Immune Responses Following One Versus Two Doses of Killed Oral Cholera Vaccine in Eastern Kolkata, West Bengal, India

Brief Summary

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

Detailed Description

      Cholera is an important public health problem worldwide, particularly in endemic areas of the
      developing world. In 2004, 101 383 cholera cases and 2345 deaths were reported to the WHO.
      Provision of safe water and food, adequate sanitation and improved personal and community
      hygiene are the main public health interventions against cholera. These measures cannot be
      implemented in the near future in the most cholera-endemic areas.

      Phase II trials of this reformulated killed oral cholera vaccine were performed in SonLa,
      Vietnam and Kolkata, India. Significant vibriocidal antibody responses were observed among
      vaccine recipients.

      Distribution of 2 doses of the cholera vaccine is often difficult in field settings and
      limits its utility in emergency situations, since an interval of 2 weeks is usually required
      between doses. Recent data from Vietnam suggests that greater vibriocidal responses following
      2 doses are elicited compared to previous formulations. Furthermore, in a study in Bangladesh
      comparing immune responses to the vaccine among children supplemented with vitamin A and
      zinc, seroconversion after the first dose was robust in all groups suggesting that one dose
      may be used in the control of cholera.

      Data regarding the immune response following one dose of this reformulated vaccine is
      currently unavailable. If a single dose of this vaccine is confirmed to be immunogenic to
      recipients, then this vaccine may be used more extensively for public health purposes,
      especially during times of outbreaks.

      The objective of this study is to confirm the safety of the killed oral cholera vaccine among
      adult and children volunteers.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline

Secondary Outcome

 Geometric mean serum vibriocidal titers compared to baseline

Condition

Cholera

Intervention

Killed bivalent whole cell oral cholera vaccine

Study Arms / Comparison Groups

 1

Description:  Cholera Vaccine

Publications

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

Recruitment Status

Biological

Estimated Enrollment

160

Start Date

June 2007

Completion Date

August 2007

Primary Completion Date

August 2007

Eligibility Criteria

        Inclusion Criteria:

          -  Healthy adult male and non-pregnant female adults aged 18-40 years and healthy
             children aged 1-17 years

        All subjects must satisfy the following criteria at study entry:

          -  Male or female adult residents aged 18-40 years or children aged 1- 17 years who the
             investigator believes will comply with the requirements of the protocol (i.e.
             available for follow-up visits and specimen collection)

          -  For females of reproductive age, they must not be pregnant (as determined by verbal
             screening)

          -  Written informed consent obtained from subjects or their guardians, and written assent
             for children aged 12-17 years.

          -  Healthy subjects as determined by: medical history, physical examination, clinical
             judgement of the investigator.

        Exclusion Criteria:

          -  Ongoing serious chronic disease

          -  Immunocompromising condition or therapy

          -  Diarrhea (3 or more loose stools within a 24-hour period) 6 weeks prior to enrollment

          -  one or two episodes of diarrhea lasting for more than 2 weeks in the past 6 months

          -  one or two episodes of abdominal pain lasting for more than 2 weeks in the past 6
             months

          -  intake of any anti-diarrhoeal medicine in the past week

          -  abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in
             the past 24 hours

          -  acute disease one week prior to enrollment, with or without fever. Temperature > or =
             38 degrees C (oral) or axillary temperature > or = 37.5 degrees C warrants deferral of
             the vaccination pending recovery of the subject

          -  receipt of antibiotics in past 14 days

          -  receipt of live or killed enteric vaccine in last month

          -  receipt of killed oral cholear vaccine
      

Gender

All

Ages

1 Year - 40 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Sujit K Bhattacharya, , 

Location Countries

India

Location Countries

India

NCT ID

NCT00419133

Organization ID

C-8IR

Study Sponsor

International Vaccine Institute

Collaborators

 National Institute of Cholera and Enteric Diseases, India

Study Sponsor

Sujit K Bhattacharya, Principal Investigator, National Institute of Cholera and Enteric Diseases, India

Verification Date

December 2009