NCT01233362

Brief Summary

The absence of a boosting response after a 14 day interval with the two-dose regimen of the modified killed oral cholera vaccine raises the possibility that a longer dosing interval may be required to observe a boost in the immune response. This study will compare the immune responses following 14-day and 28-day dosing intervals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
386

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2010

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2010

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 3, 2010

Completed
28 days until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

September 25, 2013

Status Verified

August 1, 2012

Enrollment Period

2.2 years

First QC Date

October 11, 2010

Last Update Submit

September 24, 2013

Conditions

CholeraDiarrhoeaVibrio Infection

Keywords

CholeraVaccineKolkataWest BengalIndiaImmunogenicityVaccination Schedules

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 last dose of study agent in each dose-interval group

    14 days after the last dose of the study agent

Secondary Outcomes (4)

  • Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline, 14 days after first dose of study agent

    14 days after first dose of study agent

  • Geometric mean serum vibriocidal titers at baseline, 14 days after each dose of the study agent, in each dose-interval group.

    14 days after each dose of study agent

  • Proportion of subjects given 2 doses of study agent given 14 and 28 days apart with adverse events.

    upto 1.5 months after the first dose of study agent

  • Proportion of subjects given 2 doses of vaccine given 14 and 28 days apart with significant immunological responses to the alternate assays under exploration

    upto 1.5 months after the first dose of study agent

Study Arms (6)

Arm 1: Adults; 14 days interval

ACTIVE COMPARATOR

89 Adults (=\> 18 years aged) receiving study agents (Vaccine/Placebo) at 14 days inter-dose interval

Biological: Modified killed oral cholera vaccine at 14 day interval

Arm 2: Adults; 28 days interval

ACTIVE COMPARATOR

89 Adults (=\> 18 years aged) receiving study agents (Vaccine/Placebo) at 28 days inter-dose interval

Biological: Modified killed oral cholera vaccine at 28 day interval

Arm 3: children; 14 days interval

ACTIVE COMPARATOR

89 children (1-17 years aged) receiving study agents (Vaccine/Placebo) at 14 days inter-dose interval

Biological: Modified killed oral cholera vaccine at 14 day interval

Arm 4: children; 28 days interval

ACTIVE COMPARATOR

89 children (1-17 years aged) receiving study agents (Vaccine/Placebo) at 28 days inter-dose interval

Biological: Modified killed oral cholera vaccine at 28 day interval

Arm 5: Adults; 14 days Interval

ACTIVE COMPARATOR

15 Adults (=\> 18 years aged) receiving study agents (Vaccine/Placebo) at 14 days inter-dose interval

Biological: Modified killed oral cholera vaccine at 14 day interval

Arm 6: Adults; 28 days interval

ACTIVE COMPARATOR

15 Adults (=\> 18 years aged) receiving study agents (Vaccine/Placebo) at 28 days inter-dose interval

Biological: Modified killed oral cholera vaccine at 28 day interval

Interventions

Modified killed oral cholera vaccine at 14 day intervalBIOLOGICAL

The modified killed bivalent (O1 and O139)whole cell based oral cholera vaccine is administered orally in 2 liquid doses (without need of any buffer solution) 14 days for individuals aged 1 year and above.

Also known as: Shancol
Arm 1: Adults; 14 days intervalArm 3: children; 14 days intervalArm 5: Adults; 14 days Interval
Modified killed oral cholera vaccine at 28 day intervalBIOLOGICAL

The modified killed bivalent (O1 and O139)whole cell based oral cholera vaccine is administered orally in 2 liquid doses (without need of any buffer solution) 28 days for individuals aged 1 year and above; as an alternate schedule.

Also known as: Shancol
Arm 2: Adults; 28 days intervalArm 4: children; 28 days intervalArm 6: Adults; 28 days interval

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Males or non-pregnant females aged 18 years and above 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).
  • 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
  • For females of reproductive age: Pregnancy (or females planning to become pregnant during the study period; as determined by verbal screening)
  • Immunocompromising condition or therapy (for corticosteroids this would mean ≥0.5 mg/kg/day)
  • Diarrhea (3 or more loose/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 warrants deferral of the vaccination pending recovery of the subject
  • Receipt of immunoglobulin or any blood product during the past 3 months
  • 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)

National Institute of Cholera and Enteric Diseases

Kolkata, West Bengal, 700010, India

Location

MeSH Terms

Conditions

CholeraDiarrheaVibrio Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dipika Sur, MD, DPH

    National Institute of Cholera and Enteric Diseases, Kolkata, 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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2010

First Posted

November 3, 2010

Study Start

December 1, 2010

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

September 25, 2013

Record last verified: 2012-08

Locations

IN(1)