Immunogenicity of One Versus Two Doses of Killed Oral Cholera Vaccine

NCT00419133 | Completed Phase 2 DMC

• 1 other identifier: C-8IR
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholera; Diarrhea; Vibrio Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  14 days after each dose of vaccine or placebo

Secondary Outcomes (2)

• Geometric mean serum vibriocidal titers compared to baseline

  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.

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

Study Arms (2)

1

EXPERIMENTAL

Cholera Vaccine

Biological: Killed bivalent whole cell oral cholera vaccine

2

PLACEBO COMPARATOR

Placebo

Biological: Heat Killed E. coli Placebo

Interventions

Killed bivalent whole cell oral cholera vaccine BIOLOGICAL

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

1

Heat Killed E. coli Placebo BIOLOGICAL

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

2

Eligibility Criteria

• Age: 1 Year - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• International Vaccine Institute: lead
• National Institute of Cholera and Enteric Diseases, India: collaborator
• Shantha Biotechnics Limited: collaborator

Study Sites (1)

National Institute of Cholera and Enteric Diseases

Kolkata, West Bengal, 700010, India

Location

Related Publications (1)

• 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.

  PMID: 19761838 RESULT

MeSH Terms

Conditions

Cholera; Diarrhea; Vibrio Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sujit K Bhattacharya

  National Institute of Cholera and Enteric Diseases, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 4, 2007
• First Posted: January 8, 2007
• Study Start: June 1, 2007
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: December 7, 2009

Record last verified: 2009-12

Locations

IN (1)