Combined Vi Vaccination and Health Education Program on the Burden of Typhoid in Childhood
Study Details
Study Description
Brief Summary
This study is part of the International Vaccine Institute's (IVI's) typhoid Vi demonstration project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic countries. The purpose of this study is to determine the effectiveness of the Vi vaccine following a mass typhoid immunization campaign in an endemic area in Karachi, Pakistan. The cost-effectiveness of Vi vaccination and the logistic feasibility of a mass typhoid immunization campaign will also be evaluated.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Typhoid fever is a major cause of morbidity worldwide. The disease predominantly affects school-aged children, is more prevalent in urban areas, may last for several weeks and can lead to serious complications. Management of this disease is further complicated by the emergence of multi-drug resistant strains. Vaccination of high risk populations is considered the most promising strategy for the control of typhoid fever. The Vi polysaccharide vaccine has been targeted for accelerated introduction into public health programs due to the following reasons: it has been shown to have consistent efficacy results even in areas of high typhoid incidence; is given as a single dose; lacks patent protection and requires less strict cold chain requirements. A cluster-randomized trial involving the Vi polysaccharide vaccine and an active control (hepatitis A) was designed to determine the effectiveness and the feasibility of providing Vi vaccine under actual programmatic conditions in 3 urban slums in Pakistan. The vaccines used in this study are internationally produced and locally licensed. A complimentary, targeted, basic typhoid prevention health education program for the entire population at the initiation of the project will be provided and the actual Vi-demonstration project will be preceded by a 12-month typhoid surveillance activity.
Secondary objectives of this trial are:
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To monitor the adverse events following a routine Vi mass vaccination campaign;
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To assess the knowledge, attitudes, beliefs and practices among parents and health care providers regarding typhoid illness, treatment and prevention; and
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To study typhoid fever risk factors in the population.
A nested, prospective matched case-control study is included in the trial in order to study typhoid risk factors among children in Karachi.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Typhoid Vi polysaccharide vaccine |
Biological: Typhoid Vi vaccine
Single 0.5ml dose containing 25ug purified Vi polysaccharide of S. typhi.
Other Names:
|
| Active Comparator: 2 Inactivated Hepatitis A vaccine |
Biological: Hepatitis A vaccine
single 0.5ml dose contains 720 EL.U. of inactivated hepatitis A viral antigen
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Total protection against S. typhi [2 years from zero time]
Secondary Outcome Measures
- Indirect protection against s. typhi [two years from zero time]
- Overall protection against s. typhi [2 years from zero time]
- Adverse event(s) following immunization [30 days from vaccination]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Registered in the project census
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Age: 2-16 years
Exclusion Criteria:
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Fever >37.5 degrees Celsius, axillary
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Pregnancy
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Lactating
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aga Khan University | Karachi | Pakistan |
Sponsors and Collaborators
- International Vaccine Institute
- Aga Khan University
- Wellcome Trust
- University of Western Ontario, Canada
- GlaxoSmithKline
Investigators
- Principal Investigator: Zulfiqar A Bhutta, MBBS, PhD, Aga Khan University
Study Documents (Full-Text)
None provided.More Information
Publications
- Acosta CJ, Galindo CM, Ochiai RL, Danovaro-Holliday MC, Page AL, Thiem VD, Park JK, Park E, Koo H, Wang XY, Abu-Elyazeed R, Ali M, Albert MJ, Ivanoff B, Pang T, Xu ZY, Clemens JD. The role of epidemiology in the introduction of vi polysaccharide typhoid fever vaccines in Asia. J Health Popul Nutr. 2004 Sep;22(3):240-5.
- Ali M, Rasool S, Park JK, Saeed S, Ochiai RL, Nizami Q, Acosta CJ, Bhutta Z. Use of satellite imagery in constructing a household GIS database for health studies in Karachi, Pakistan. Int J Health Geogr. 2004 Sep 28;3(1):20.
- T-7