Immunogenicity of One Versus Two Doses of Killed Oral Cholera Vaccine

This study has been completed.
Sponsor:
Collaborators:
National Institute of Cholera and Enteric Diseases, India
Shantha Biotechnics Limited
Information provided by:
International Vaccine Institute
ClinicalTrials.gov Identifier:
NCT00419133
First received: January 4, 2007
Last updated: December 4, 2009
Last verified: December 2009
  Purpose

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


Condition Intervention Phase
Cholera
Diarrhea
Vibrio Infections
Biological: Killed bivalent whole cell oral cholera vaccine
Biological: Heat Killed E. coli Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immune Responses Following One Versus Two Doses of Killed Oral Cholera Vaccine in Eastern Kolkata, West Bengal, India

Resource links provided by NLM:


Further study details as provided by International Vaccine Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Geometric mean serum vibriocidal titers compared to baseline [ Time Frame: 14 days after each dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 160
Study Start Date: June 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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.

  Eligibility

Ages Eligible for Study:   1 Year to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419133

Locations
India
National Institute of Cholera and Enteric Diseases
Kolkata, West Bengal, India, 700010
Sponsors and Collaborators
International Vaccine Institute
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
  More Information

Publications:
Responsible Party: Director General, International Vaccine Institute
ClinicalTrials.gov Identifier: NCT00419133     History of Changes
Other Study ID Numbers: C-8IR
Study First Received: January 4, 2007
Last Updated: December 4, 2009
Health Authority: India: Indian Council of Medical Research

Keywords provided by International Vaccine Institute:
Cholera
Vaccine
Kolkata
West Bengal
India
Immunogenicity
Safety

Additional relevant MeSH terms:
Cholera
Diarrhea
Vibrio Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014