NCT00760825

Brief Summary

The purpose of this study is to determine whether the killed bivalent (O1 and O139)whole cell oral cholera vaccine(Shanchol™) is safe and effective in the treatment of Vibrio cholerae.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2008

Completed
3.4 years until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

June 17, 2014

Status Verified

June 1, 2014

Enrollment Period

1.1 years

First QC Date

September 25, 2008

Last Update Submit

June 16, 2014

Conditions

Vibrio Cholerae

Keywords

choleravibriosoral cholera vaccine

Outcome Measures

Primary Outcomes (2)

  • Proportion of subjects with diarrhea

    28 days

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

    14 days after each dose

Secondary Outcomes (2)

  • Geometric mean serum vibriocidal titers

    baseline and 14 days after each dose

  • Proportion of subjects with any of the following adverse events: immediate reactions, serious adverse events, reactogenicity: headache, vomiting, nausea, abdominal pain/cramps, gas, diarrhea, fever, loss of appetite, general ill feeling

    28 days

Study Arms (1)

Vaccine

EXPERIMENTAL

killed bivalent (O1 and O139)whole cell oral cholera vaccine(Shanchol™)

Biological: killed bivalent (O1 and O139)whole cell oral cholera vaccine

Interventions

killed bivalent (O1 and O139)whole cell oral cholera vaccineBIOLOGICAL

1.5 ml given twice orally, 14 days apart

Also known as: Shanchol™
Vaccine

Eligibility Criteria

Age1 Year - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male or female adults aged 18-40 years and 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 the subjects or their parents/guardians, and written assent for children aged 12 - 17 years.
  • Healthy subjects as determined by: Medical history, Physical examination, Clinical judgment of the investigator

You may not qualify if:

  • Ongoing serious chronic disease
  • Immunocompromising condition or therapy
  • Diarrhea (3 or more loose/more watery 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-diarrhea 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 ≥38ºC (oral) or axillary temperature ≥ 37.5ºC 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 past 4 weeks
  • Receipt of killed oral cholera vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christian Medical College

Vellore, Tamil Nadu, 632 002, India

Location

Related Publications (1)

  • Raghava Mohan V, Raj S, Dhingra MS, Aloysia D'Cor N, Singh AP, Saluja T, Kim DR, Midde VJ, Kim Y, Vemula S, Narla SK, Sah B, Ali M. Safety and immunogenicity of a killed bivalent (O1 and O139) whole-cell oral cholera vaccine in adults and children in Vellore, South India. PLoS One. 2019 Jun 18;14(6):e0218033. doi: 10.1371/journal.pone.0218033. eCollection 2019.

    PMID: 31211792DERIVED

MeSH Terms

Conditions

Cholera

Interventions

shanchol

Condition Hierarchy (Ancestors)

Vibrio InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Venkata R Mohan, M.D., MPH

    Christian Medical College, Vellore, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2008

First Posted

September 26, 2008

Study Start

March 1, 2012

Primary Completion

April 1, 2013

Study Completion

August 1, 2013

Last Updated

June 17, 2014

Record last verified: 2014-06

Locations

IN(1)