Immunogenicity of One Versus Two Doses of Killed Oral Cholera Vaccine

December 4, 2009 updated by: International Vaccine Institute

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • West Bengal
      • Kolkata, West Bengal, India, 700010
        • National Institute of Cholera and Enteric Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Biological: Heat Killed E. coli Placebo
Heat Killed E.coli in an optical turbidity identical to cholera vaccine, given in a 1.5 mL oral dose.
Experimental: 1
Cholera Vaccine
Biological: Killed bivalent whole cell oral cholera vaccine

Each 1.5 mL dose, given orally, contains:

V. cholerae O1 Inaba El Tor strain Phil 6973 formalin killed, 600 Elisa units (EU) LPS V. cholerae O1 Ogawa classical strain Cairo 50 heat killed 300 EU LPS V. cholerae O1 Ogawa classical strain Cairo 50 formalin killed 300 EU LPS V. cholerae O1 Inaba classical strain Cairo 48 heat killed 300 EU LPS V. cholerae O139 strain 4260B formalin killed 600 EU LPS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline
Time Frame: 14 days after each dose of vaccine or placebo
14 days after each dose of vaccine or placebo

Secondary Outcome Measures

Outcome Measure
Time Frame
Geometric mean serum vibriocidal titers compared to baseline
Time Frame: 14 days after each dose
14 days after each dose
Proportion of subjects with any of the following adverse events: immediate reactions within 30 minutes after each dose and up to 3 days after each dose and serious adverse events occurring throughout the trial.
Time Frame: after dosing: 30 minutes to 3 days for adverse events, 28 days for serious adverse events
after dosing: 30 minutes to 3 days for adverse events, 28 days for serious adverse events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Vaccine Institute

Collaborators

National Institute of Cholera and Enteric Diseases, India
Shantha Biotechnics Limited

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

January 4, 2007

First Submitted That Met QC Criteria

January 4, 2007

First Posted (Estimate)

January 8, 2007

Study Record Updates

Last Update Posted (Estimate)

December 7, 2009

Last Update Submitted That Met QC Criteria

December 4, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-8IR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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