Study of Alternative Vaccination Schedule of Oral Cholera Vaccine

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01233362
• Date of registration: 11/10/2010
• Prospective Registration: Yes
• Primary sponsor: International Vaccine Institute
• Public title: Study of Alternative Vaccination Schedule of Oral Cholera Vaccine
• Scientific title: A Randomized Controlled Trial To Evaluate the Immunogenicity of Two Doses of the Modified Killed Whole-Cell Oral Cholera Vaccine Under Two Alternative Vaccination Schedules.
• Date of first enrolment: December 2010
• Target sample size: 386
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01233362
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 2

Countries of recruitment

India

Contacts

• Name: Dipika Sur, MD, DPH
• Affiliation: National Institute of Cholera and Enteric Diseases, Kolkata, India

Key inclusion & exclusion criteria

Healthy, non-pregnant adults aged 18 years and above and healthy children aged 1 - 17 will
be recruited in Kolkata.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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



Age minimum: 1 Year
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Vibrio Infection

Cholera

Diarrhoea

Intervention(s)

Biological: Modified killed oral cholera vaccine at 28 day interval

Biological: Modified killed oral cholera vaccine at 14 day interval

Primary Outcome(s)

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 [Time Frame: 14 days after the last dose of the study agent]

Secondary Outcome(s)

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 [Time Frame: 14 days after 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 [Time Frame: upto 1.5 months after the 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. [Time Frame: 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. [Time Frame: upto 1.5 months after the first dose of study agent]

Secondary ID(s)

CR-WC-05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Indian Council of Medical Research

National Institute of Cholera and Enteric Diseases, India

Shantha Biotechnics Limited