Field Application of Shanchol in Adults in Bangladesh
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
Summary
Background:
Cholera is a public health problem globally and in Bangladesh and its prevention is
important. Despite recent availability of an effective and affordable oral cholera vaccine
(OCV), its field application remains a challenge and needs to be addressed in carefully
conducted research studies.There is lack of information on temperature sensitivity and
resulting immunogenicity of Shanchol OCV and it is not known if administration of two doses
of OCVs, one month apart, instead of currently recommended 14 days, to improve success of
vaccination programme will be effective;also if one dose of the vaccine, instead of currently
recommended two doses, would result in adequate immune response in population exposed to V.
cholerae in an endemic country like Bangladesh.
Objectives:
To determine immunogenicity of Shanchol in adults. when:
1. the vaccine is stored at three defined temperatures(25 oC ,37 oC and 42oC) for 14 days,
before putting back in cold box for administration in the field and compare them with
the response when the vaccine is stored under currently recommended temperatures.
2. two doses of the vaccine administered one month apart and compared vaccines administered
at currently recommended interval of 14 days.
3. a single dose is administered and compare them with responses after recommended two
doses.
Methods: The study will be conducted among adults living in the Mirpur community in urban
Dhaka, the capital of Bangladesh.Studying safety and acute and long-term immune responses
over a period of one year.
Outcome measures/variables:
1. Objective 1: safety and immunogenicity of vaccine in adults after its storage at three
defined temperatures (25oC ,37oC and 42oC) by measuring vibriocidal antibody responses
and compare them with the findings when the vaccine is stored at currently recommended
temperature of 2-8oC (recommended by manufacturer, Shantha Biotechnic).
2. Objective 2: compare vibriocidal responses following administration of two doses of the
vaccine one month apart and compare them with vaccination 14 days apart over a period of
one year, with study of the memory responses over a one year period as a secondary
outcome.
3. Objective 3: compare acute immune responses (vibriocidal antibody) following one and two
doses of vaccine, and compare memory response as a secondary outcome measure, over a one
year period.
The above information is needed urgently for developing effective vaccination strategies for
prevention and control of cholera in endemic countries.
Phase:
Phase 2
Details
Lead Sponsor:
International Centre for Diarrhoeal Disease Research, Bangladesh