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  • LSHTM Research Online

    Khan, Mohammad Imran; Ochiai, Rion Leon; Hamza, Hasan Bin; Sahito, Shah Muhammad; Habib, Muhammad Atif; Soofi, Sajid Bashir; Bhutto, Naveed Sarwar; Rasool, Shahid; Puri, Mahesh K; Ali, Mohammad; +12 more... Wasan, Shafi Mohammad; Khan, Mohammad Jawed; Abu-Elyazeed, Remon; Ivanoff, Bernard; Galindo, Claudia M; Pang, Tikki; Donner, Allan; von Seidlein, Lorenz; Acosta, Camilo J; Clemens, John D; Nizami, Shaikh Qamaruddin; Bhutta, Zulfiqar A; (2006) Lessons and implications from a mass immunization campaign in squatter settlements of Karachi, Pakistan: an experience from a cluster-randomized double-blinded vaccine trial [NCT00125047]. Trials, 7 (1). 17-. ISSN 1745-6215 DOI: https://doi.org/10.1186/1745-6215-7-17

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  • BioMed Central

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    Trials

    Open AccessResearch Lessons and implications from a mass immunization campaign in squatter settlements of Karachi, Pakistan: an experience from a cluster-randomized double-blinded vaccine trial [NCT00125047] Mohammad Imran Khan1, Rion Leon Ochiai2, Hasan Bin Hamza1,3, Shah Muhammad Sahito1, Muhammad Atif Habib1, Sajid Bashir Soofi1, Naveed Sarwar Bhutto1, Shahid Rasool1, Mahesh K Puri2, Mohammad Ali2, Shafi Mohammad Wasan1, Mohammad Jawed Khan1, Remon Abu- Elyazeed4,5, Bernard Ivanoff6, Claudia M Galindo2, Tikki Pang7, Allan Donner8, Lorenz von Seidlein2, Camilo J Acosta2, John D Clemens2, Shaikh Qamaruddin Nizami1 and Zulfiqar A Bhutta*1

    Address: 1Department of Pediatrics, Aga Khan University, Karachi, Pakistan, 2International Vaccine Institute, Seoul, Korea, 3Department of Family Medicine, Aga Khan University, Karachi, Pakistan, 4US NAMRU 3, Cairo, Egypt, 5GlaxoSmithKline Biologicals, Singapore, 6Vaccines and Other Biologicals, World Health Organization, Geneva, Switzerland, 7Research Policy and Cooperation, World Health Organization, Geneva, Switzerland and 8University of Western Ontario, Canada

    Email: Mohammad Imran Khan - mohammad.imran@aku.edu; Rion Leon Ochiai - rlochiai@ivi.int; Hasan Bin Hamza - hasan.hamza@aku.edu; Shah Muhammad Sahito - dr_sm1@hotmail.com; Muhammad Atif Habib - atif.habib@aku.edu; Sajid Bashir Soofi - sajid.soofi@aku.edu; Naveed Sarwar Bhutto - naveed.bhutto@aku.edu; Shahid Rasool - shahid.rasool@aku.edu; Mahesh K Puri - mkpuri@ivi.int; Mohammad Ali - mali@ivi.int; Shafi Mohammad Wasan - shafi.muhammad@aku.edu; Mohammad Jawed Khan - jawed.khan@aku.edu; Remon Abu-Elyazeed - Remon.Abu-Elyazeed@gsk.com; Bernard Ivanoff - bivan@bluewin.ch; Claudia M Galindo - claudiagalindo2004@yahoo.com; Tikki Pang - pangt@who.ch; Allan Donner - allan.donner@fmd.uwo.ca; Lorenz von Seidlein - lseidlein@ivi.int; Camilo J Acosta - Camilo_acosta2003@yahoo.com; John D Clemens - jclemens@ivi.int; Shaikh Qamaruddin Nizami - qamaruddin.nizami@aku.edu; Zulfiqar A Bhutta* - zulfiqar.bhutta@aku.edu

    * Corresponding author

    Abstract Objective: To determine the safety and logistic feasibility of a mass immunization strategy outside the local immunization program in the pediatric population of urban squatter settlements in Karachi, Pakistan.

    Methods: A cluster-randomized double blind preventive trial was launched in August 2003 in 60 geographic clusters covering 21,059 children ages 2 to 16 years. After consent was obtained from parents or guardians, eligible children were immunized parenterally at vaccination posts in each cluster with Vi polysaccharide or hepatitis A vaccine. Safety, logistics, and standards were monitored and documented.

    Results: The vaccine coverage of the population was 74% and was higher in those under age 10 years. No life-threatening serious adverse events were reported. Adverse events occurred in less than 1% of all vaccine recipients and the main reactions reported were fever and local pain. The proportion of adverse events in Vi polysaccharide and hepatitis A recipients will not be known until

    Published: 25 May 2006

    Trials 2006, 7:17 doi:10.1186/1745-6215-7-17

    Received: 30 December 2005 Accepted: 25 May 2006

    This article is available from: http://www.trialsjournal.com/content/7/1/17

    © 2006 Khan et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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  • Trials 2006, 7:17 http://www.trialsjournal.com/content/7/1/17

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    the end of the trial when the code is broken. Throughout the vaccination campaign safe injection practices were maintained and the cold chain was not interrupted. Mass vaccination in slums had good acceptance. Because populations in such areas are highly mobile, settlement conditions could affect coverage. Systemic reactions were uncommon and local reactions were mild and transient. Close community involvement was pivotal for information dissemination and immunization coverage.

    Conclusion: This vaccine strategy described together with other information that will soon be available in the area (cost/effectiveness, vaccine delivery costs, etc) will make typhoid fever control become a reality in the near future.

    Background Despite major breakthroughs in the development of new vaccines over the past two decades, the gap in access to vaccines between wealthy and poorer countries has wid- ened. As a result, immunization schedules offer more vac- cines in high-income countries than in those with low income [1]. Children in low-income countries are also at a disadvantage because vaccine research and development agendas are tailored to the needs of developed countries. The focus the International Vaccine Institute typhoid fever program is to enable people at risk to get access to the vac- cines and decrease the burden of typhoid fever [2]. The program is being conducted in five urban slums of Indo- nesia, China, Vietnam, India and Pakistan.

    Two typhoid fever vaccines, Ty21a and Vi polysaccharide (PS) are currently licensed for use. A recent Cochrane review [3] on typhoid fever vaccines found that the two vaccines i.e. Ty 21 and Vi have similar results with Vi hav- ing an advantage of heat stability and single dose regimen. ViPS was thus chosen for use in the DOMI trial as it would suit the public health program for immunization in the countries of south east Asia. The use of Vi requiring a sin- gle, injectable dose was thought to be logistically easier than use of Ty21 which requires three doses.

    In Pakistan, DOMI program aims to introduce an availa- ble, affordable Vi polysaccharide vaccine [4,5] for chil- dren 2 to 16 years of age living in urban low socio economic settings. The study setting has a high typhoid fever burden and treatment is increasingly costly [6] and difficult due to high drug resistance[7,8]. Vi PS vaccine, which has moderate efficacy (64–77%), seems to be an immediate and affordable option for impoverished popu- lations exposed to typhoid fever[9]. Unfortunately, there is no evidence about its cost-effectiveness and no delivery strategy has been envisaged that would enable policymak- ers to make rational decisions about the use of this vaccine as a public health tool.

    To determine the effectiveness of Vi PS in reducing typhoid fever burden in slum areas and the cost-effective- ness of the vaccine, DOMI investigators designed a clus-

    ter-randomized double blind trial [2]. Given the apparent immunological limitation of PS vaccines in early age groups [10] and the fact that the high-risk group in Kara- chi is the entire pediatric population, the local Expanded Program of Immunization (EPI), which usually reaches children under age 5 years, is unlikely to be the best deliv- ery structure. Also, national reported immunization cov- erage rates for Pakistan have been very variable (range of 60–90%) since 1998 [11]. In addition to a lack of resources, other documented reasons for low vaccine cov- erage in Pakistan include lack of awareness of need, moth- ers unable to attend the vaccine posts, and inconvenient immunization sites [12-14] For these reasons, the DOMI program decided to implement the mass immunization campaign outside the EPI delivery system. Here we report initial results from this mass vaccination in two slums in Karachi, Pakistan.

    Methods Study site The vaccination campaign was carried out in two adjacent squatter settlements, Sultanabad and Hijrat Colony, in Karachi. The population is a mix of Punjabi-Pathan ethnic groups from northern Pakistan. The total population of the two areas is 53,738 (project census 2003), with 21,059 children (aged 2–16 years) in the study target pediatric population. There are 8,278 households in the combined settlement areas of 0.54 km2. Most health-ca