To Determine the Safety and Immunogenicity of an Oral Whole Cell ShanChol Cholera Vaccine in Bangladesh

Launched by INTERNATIONAL CENTRE FOR DIARRHOEAL DISEASE RESEARCH, BANGLADESH · Jan 5, 2010

Keywords

ClinConnect Summary

Adults as well as children, both males and females will be recruited in the study from the urban suburbs around Dhaka city in Mirpur where we have been conducting other epidemiological and vaccine related studies. The community will be informed by our field staffs and interested persons might be enrolled in the study on the basis of inclusion/exclusion criteria.

Part I- Adults- 18-45 years of age (n=110):

Since this oral bivalent whole-cell cholera vaccine has not been tested in Bangladesh before, the study will be carried out in 3 age groups, i.e. adults, followed by toddlers and younger...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age: 12-23 months for younger children group, 2-5 years for the toddler group and 18-45 years for the adult group.
• • 2. Sex: Either
• • 3. Consent: Written informed consent from study participants and parents in case of children.
• • 4. Compliance to study procedures: e.g. available for follow-up visits and agrees to specimen collection.
• • 5. Apparently healthy: as determined by medical history, physical examination findings, and clinical judgment of the study physician.
• Exclusion Criteria:
• • 1. Chronic disease: history or evidence of chronic illness.
• • 2. Gastrointestinal symptoms such as abdominal pain or cramps, loss of appetite, nausea, general ill-feeling or vomiting in the past 24 hours or abdominal pain lasting for more than 2 weeks in the past 6 months
• • 3. Intake of any anti-diarrheal medicine or antimicrobial therapy the past week.
• • 4. Acute disease one week prior to enrollment, with or without fever ≥38ºC .
• • 5. Receiving of cholera vaccine any time in the past, and any other live or killed enteric vaccine in the last 4 weeks.
• • 6. Diarrhea within 6 week period at screening.