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Immunogenicity of One Versus Two Doses of Killed Oral Cholera Vaccine

Primary Purpose

Cholera, Diarrhea, Vibrio Infections

Status

Completed

Phase

Phase 2

Locations

India

Study Type

Interventional

Intervention

Killed bivalent whole cell oral cholera vaccine

Heat Killed E. coli Placebo

About this trial

This is an interventional prevention trial for Cholera focused on measuring Cholera, Vaccine, Kolkata, West Bengal, India, Immunogenicity, Safety

Eligibility Criteria

1 Year - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

National Institute of Cholera and Enteric Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Cholera Vaccine

Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Geometric mean serum vibriocidal titers compared to baseline

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.

Full Information

NCT ID

NCT00419133

First Posted

January 4, 2007

Last Updated

December 4, 2009

Sponsor

International Vaccine Institute

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00419133

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

August 2007 (Actual)

Study Completion Date

August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

International Vaccine Institute

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholera, Diarrhea, Vibrio Infections

Keywords

Cholera, Vaccine, Kolkata, West Bengal, India, Immunogenicity, Safety

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

160 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Cholera Vaccine

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Biological

Intervention Name(s)

Killed bivalent whole cell oral cholera vaccine

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Heat Killed E. coli Placebo

Intervention Description

Heat Killed E.coli in an optical turbidity identical to cholera vaccine, given in a 1.5 mL oral dose.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Geometric mean serum vibriocidal titers compared to baseline

Time Frame

14 days after each dose

Title

Time Frame

after dosing: 30 minutes to 3 days for adverse events, 28 days for serious adverse events

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sujit K Bhattacharya

Organizational Affiliation

National Institute of Cholera and Enteric Diseases, India

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institute of Cholera and Enteric Diseases

City

Kolkata

State/Province

West Bengal

ZIP/Postal Code

700010

Country

India

12. IPD Sharing Statement

Citations:

PubMed Identifier

19761838

Citation

Kanungo S, Paisley A, Lopez AL, Bhattacharya M, Manna B, Kim DR, Han SH, Attridge S, Carbis R, Rao R, Holmgren J, Clemens JD, Sur D. Immune responses following one and two doses of the reformulated, bivalent, killed, whole-cell, oral cholera vaccine among adults and children in Kolkata, India: a randomized, placebo-controlled trial. Vaccine. 2009 Nov 16;27(49):6887-93. doi: 10.1016/j.vaccine.2009.09.008. Epub 2009 Sep 15.

Results Reference

result

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Immunogenicity of One Versus Two Doses of Killed Oral Cholera Vaccine

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