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Typhoid vaccine introduction: An evidence-based pilot implementation project in Nepal and Pakistan M. Imran Khan a,∗ , Alfred Pach 3rd a , Ghulam Mustafa Khan b , Deepak Bajracharya d , Sushant Sahastrabuddhe a , Waqaas Bhutta b , Rehman Tahir b , Sajid Soofi e , Chandra B. Thapa d , Nilesh Joshi c , Mahesh K. Puri a , Parisha Shrestha d , Shyam Raj Upreti f , John D. Clemens a , Zulfiqar Bhutta e , R. Leon Ochiai a a

International Vaccine Institute, Seoul, Republic of Korea Trust for Vaccines & Immunization, Karachi, Pakistan c MITRA Samaj, Kathmandu, Nepal d Group for Technical Assistance, Sanepa, Nepal e Aga Khan University, Karachi, Pakistan f Ministry of Health and Population, Government of Nepal, Nepal b

a r t i c l e

i n f o

Article history: Available online xxx Keywords: Typhoid Asia Enteric fever Pakistan Nepal Vi polysaccharides vaccine Vaccination campaign

a b s t r a c t The World Health Organization (WHO) in 2008 recommended the use of currently licensed typhoid vaccines using a high risk or targeted approach. The epidemiology of disease and the vaccine characteristics make school-based vaccination most feasible in reducing typhoid disease burden in many settings. To assess feasibility of school-based typhoid vaccination, two districts in Kathmandu, Nepal and two towns in Karachi, Pakistan were selected for pilot program. Vaccination campaigns were conducted through the departments of health and in partnerships with not-for-profit organizations. In total 257,015 doses of Vi polysaccharide vaccine were given to students in grades 1–10 of participating schools. The vaccination coverage ranged from 39 percent (38,389/99,503) in Gulshan town in Karachi, to 81 percent (62,615/77,341) in Bhaktapur in Kathmandu valley. No serious adverse event was reported post vaccination. The coverage increased for vaccination of the second district in Pakistan as well as in Nepal. There was an initial concern of vaccine safety. However, as the campaign progressed, parents were more comfortable with vaccinating their children in schools. Supported and conducted by departments of health in Pakistan and Nepal, a school-based typhoid vaccination was found to be safe and feasible. © 2015 Published by Elsevier Ltd.

1. Background Typhoid fever has been in existence since antiquity, with found in ancient Chinese text dating back to 100 AD [1]. Although this disease has been controlled in much of the industrialized world, it continues to affect people in many developing countries [2]. Based on previous global disease burden estimates, typhoid fever has the highest incidence in South Asia and Southeast Asia which constitute 90% of estimated global enteric fever cases (includes Salmonella Typhi and Salmonella Paratyphi A, B and C infections). However, recent estimates for Africa have reported incidences comparable to those in Asia, with reported outbreaks more common in Africa

∗ Corresponding author. Present address: 2000 Pennsylvania Ave NW, Suite 7100, Washington DC 20006, USA. Tel.: +1 202 621 1698; fax: +1 202 842 7689. E-mail address: [email protected] (M.I. Khan).

than in Asia [3]. Children and adolescents are the most affected age-groups in high endemic countries [4–6]. Typhoid fever is caused by the bacterium Salmonella enterica serotype Typhi (S. Typhi) and is spread by the fecal-oral route through contaminated food or water [7,8]. Typhoid fever is characterized by persistent, high-grade fever and abdominal pain; illness often lasts one month or more [9]. In about 10–15% of cases without appropriate antimicrobial therapy, it leads to serious complications, including hypotensive shock, perforation of the gut, and gastrointestinal hemorrhage [7]. Rapidly increasing rates of antibiotic resistance have increased the difficulty and cost of treatment and are threatening to increase case fatality from the currently estimated rates of 1–4% to the pre-antibiotic era rates of 10–20%[10]. Preventive measures include improved water and sanitation systems, but given the huge investment required, they are distant goals for most typhoid-endemic countries. In 2000 and 2007, the

http://dx.doi.org/10.1016/j.vaccine.2015.03.087 0264-410X/© 2015 Published by Elsevier Ltd.

Please cite this article in press as: Khan MI, et al. Typhoid vaccine introduction: An evidence-based pilot implementation project in Nepal and Pakistan. Vaccine (2015), http://dx.doi.org/10.1016/j.vaccine.2015.03.087

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World Health Organization (WHO) recommended typhoid vaccination as a control strategy [11]. In its 2009 meeting, the WHO South East Asia Regional Office (SEARO) recommended prioritization of typhoid vaccines for “immediate” implementation.1 However, typhoid vaccines have not yet been regularly used in typhoidendemic regions. Safe and effective typhoid vaccines have been available since the early 1990s [12]. But public-sector use has been limited and they have never been used in a large scale vaccination program. In response to this, the International Vaccine Institute’s Vi-based Vaccines for Asia (VIVA) Initiative accelerated the adoption of the typhoid Vi-polysaccharide vaccine in high risk areas. To determine program feasibility and population acceptance of typhoid vaccination, pilot typhoid vaccination programs were carried out in two districts in Kathmandu, Nepal and two towns of Karachi, Pakistan.2 Nepal and Pakistan were selected based on their high disease burden, their previous use of typhoid vaccines, and their governments’ willingness to take the lead in the conduct of the vaccination campaigns. A school-based vaccination campaign was designed for this project, as governments in the Southeast Asia region have demonstrated that school-based programs are an effective approach for achieving high coverage [13–15]. Furthermore, since approximately 70% of cases occur in children less than 15 years of age in high risk regions [16], vaccinating students will likely be critical for the reduction of typhoid fever disease burden. 2. Methods 2.1. Planning phase

previous experiences in piloting national vaccination program(s); existing collaborations between health and education bodies; and potentially influential districts/towns, so that the success of the program could inform other districts/towns. In Nepal, the pilot school-based vaccination programs were planned in two districts of the Kathmandu Valley, Lalitpur and Bhaktapur. In Pakistan, they were planned in two out of 18 towns in Karachi, Gulshan and Jamshed. 2.1.3. Study population and eligibility criteria The target for the school-based vaccination was children in grades 1–10 (approximate ages 5–15 years old). The governing bodies for public and private schools are different in both countries. These entities were repeatedly visited and informed about the benefits of vaccination, and subsequently included in the program. In Pakistan, an important addition was the religious schools, madrasahs, which were in neither the public nor private school systems. 2.1.4. Advocacy and endorsement Appropriate approvals and support for the vaccination program were sought from relevant local authorities in both countries. This process was initiated in partnership with key stakeholders. The first step was to gain the support of local authorities through repeated advocacy visits, and providing scientific information on the disease, preventive methods, available vaccines, and the profile of the Vi polysaccharide vaccine. In response to the advocacy visits, local authorities granted the necessary approvals and support to facilitate social mobilization activities.

2.1.1. Designing the pilot vaccination program Key stakeholders needed to implement the pilot typhoid vaccination program were identified. In both countries, the key stakeholders included government public health officials (Department of Child Health, Ministry of Health and Population in Nepal; and the Expanded Program on Immunization, Ministry of Health, Sindh, in Pakistan), pediatricians, academics, and, in the case of Nepal, the Program for Immunization Preventable Diseases Office of WHO. A series of discussions with these stakeholders were held to identify: (1) the sites for vaccination; (2) target ages for vaccination; (3) the modality of vaccine introduction; and (4) support organizations and groups required for vaccine introduction. Upon discussion with government officials, it was found that participation of the government immunization program was essential for the planning, management, and execution of the pilot vaccination program. Their recommendation was to share the tasks. The local governments in Nepal agreed to conduct the vaccination, whereas the Trust for Vaccines and Immunization (TVI) took the lead in Pakistan with support from the Ministry of Health. Due to extensive nature of research data collection, public officials suggested that other non-governmental agencies could be involved in planning, managing, recording, and analyzing the results of the pilot vaccination program.

2.1.5. Formative research, social mobilization, and communication activities Since typhoid vaccination is not routinely done in these countries, and a range of stakeholders (e.g., parents, health care providers, community representatives, religious leaders, and school and health officials) were involved, it was deemed necessary to inform and mobilize these groups to increase participation in the school-based typhoid vaccination. Formative research was conducted among parents, teachers, and local health care providers to assess their perceptions, knowledge, attitudes, and interest in typhoid fever and use of the Vi polysaccharide vaccine against the disease. We also explored credible and common sources of information for acquiring additional knowledge about the disease and the vaccine. The study was conducted between June 2009 and March 2011 in Nepal and Pakistan. The project utilized a comprehensive communication strategy that took into account the concerns and questions of the target groups. IEC materials (brochures, posters, flyers, and banners), radio jingles, television announcements, and a documentary were developed and pre-tested. Additionally, a series of orientation meetings was carried out with teachers, students, and parents when requested by school staff.

2.1.2. Study geographic setting When deciding on the pilot vaccination sites, the key stakeholders suggested considering: the number of doses available;

2.1.6. Social mobilization monitoring To assess social mobilization and communication strategy, head teachers and parents were regularly interviewed during the course of the field implementation.

1 http://www.who.int/immunization/sage/Report SEARO Vaccine Prioritization wshop.pdf. 2 Vi-based Vaccines for Asia (VIVA) Initiative: The Vi-based Vaccines for Asia (VIVA) Initiative was a 5-year project implemented by the International Vaccine Institute. The VIVA Initiative aims to reduce the burden of typhoid fever in developing countries through the adoption of Vi-polysaccharide vaccines, and the development, testing, and licensure of affordable next-generation Vi-conjugate vaccines.

2.2. Vaccination campaign 2.2.1. Strategy development and training Standard operating guidelines were developed for the vaccination activities. Vaccinators and other staff were trained on the nature of typhoid fever, the typhoid vaccine, safe injection practices, adverse event following immunization (AEFI) management,

Please cite this article in press as: Khan MI, et al. Typhoid vaccine introduction: An evidence-based pilot implementation project in Nepal and Pakistan. Vaccine (2015), http://dx.doi.org/10.1016/j.vaccine.2015.03.087

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cold chain logistics.

maintenance,

waste

disposal,

and

vaccination

2.2.2. Vaccination The Vi polysaccharide vaccines (Typhim Vi® ) was donated by Sanofi Pasteur, France, in 20 dose vials for Nepal. In Pakistan (Typbar® ) was purchased on a subsidized price from a local manufacturer (AMSON Vaccines and Pharma, Pakistan) and was a mono-dose ampoule. Vaccines were given intramuscularly. Because it was the first time the typhoid vaccine was to be delivered through the schools, a consent form was used to ensure that parents were adequately informed about the pilot vaccination project. Only students who had completed informed consent forms were allowed to be vaccinated. Students with fever were considered ineligible for receiving the vaccine. All schools were informed of the visit by the vaccination teams in advance. In case the vaccination coverage was lower than expected and a school wanted a follow-up visit, the school was revisited by the vaccination teams. 2.2.3. Adverse event following immunization (AEFI) monitoring and management Each vaccination team included a medical professional who was responsible for observing the students for 15–30 min after vaccination for the detection and management of immediate serious adverse events. Each vaccination site had an AEFI kit, and a hospital was identified in case of serious reactions. All of the vaccination staff members were trained in AEFI management. Every student that was vaccinated was given contact numbers of the physicians in charge of the campaign, in case of complaints outside of working hours. A call center was set up at the campaign office that handled questions from parents and school staff regarding typhoid fever, venue and dates for vaccination, eligibility requirements, and information on vaccine safety. 2.2.4. Institutional review board approvals The study was approved by the institutional review boards of the International Vaccine Institute, the Nepal Health Research Council, and the Ethical Review Board of Aga Khan University, Karachi, Pakistan. 3. Results 3.1. Planning phase 3.1.1. Formative research The formative research involved qualitative data collection in nine focus group discussions (FGD) and 10 in-depth interviews (IDIs). Trained teams were organized to collect and analyze the data. This data was used to guide the development of social mobilization strategies and IEC materials and messages through consultative meetings with two nonprofit organizations, MITRA Samaj in Nepal and Trust for Vaccines and Immunization (TVI) in Pakistan. The findings of the formative research indicated that: (1) there is a need to clarify what the symptoms of typhoid fever are; (2) there was awareness of risks for the disease, but also misconceptions regarding its causes; (3) many thought there were effective preventive measures (e.g., safe water, clean food) but they also thought they were at risk in some situations; (4) all thought the vaccine would be beneficial, but they needed confirmation that the pilot vaccination was not a clinical trial, and requested more information on the vaccine side effects and duration of protection; (5) teachers, medical personnel, and local government administrators were considered credible sources of information; and (6) radio,

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television stations and print materials (e.g., posters) were identified as common sources of information.

3.1.2. Information communication strategy The social mobilization teams were trained on typhoid fever, the project’s aims and objectives, communication skills, and the delivery of social mobilization materials and messages. There was also an orientation session for the call center attendants, which involved recording incoming queries and providing initial responses. A comprehensive communication strategy was designed based on the formative research that included direct approaches as well as indirect approaches. Direct approaches included banners, posters, and one page information sheets were distributed. Radio jingles and television commercials were broadcasted for one week prior to the start of vaccination. A media sensitization workshop was organized for journalists at this time. Three different visits for social mobilization were made at all of the sites (Table 1).

3.2. Vaccination campaign 3.2.1. Strategy development and training Both Nepal and Pakistan had school-based vaccinations in the past – measles vaccination in Pakistan, and measles and Japanese encephalitis vaccinations in Nepal. The vaccination strategies and training programs were built upon the experiences from those vaccination programs. Some elements were modified and/or strengthened, including social mobilization activities and vaccine safety monitoring. Each vaccination team consisted of two vaccinators and a vaccination assistant. The teams in Pakistan were led by a physician. In Nepal, vaccination teams were led by vaccinators at the vaccination centers (schools) with proper supervision by senior project staff. Physicians, however, regularly visited each vaccination site with medicine and an Adverse Event Following Immunization (AEFI) management kit to observe and respond to any adverse reactions.

3.2.2. Vaccination Vaccination in these settings was conducted at different time points based on the field requirements and modifications in the implementation strategy. Overall, the vaccination began on October 2010 in Gulshan town of Karachi, Pakistan, and ended in Lalitpur District in Nepal on January 2012. Nepal: The vaccination program began in Lalitpur District in August 2011 and was completed in January 2012. The municipality (LSMC) schools were vaccinated first followed by Village Development Committees (VDCs) (rural area). Students in the Bhaktapur municipalities (Bhaktapur and Thimi) and Bhaktapur Village Development Committees were vaccinated from December 2011 through January 2012. In Lalitpur, there were 122,044 students in the target age group (grades 1–10) in 498 schools. The majority were in private schools (70%). Vaccination coverage ranged between 63% in private schools of VDCs and 65% in public schools. In Bhaktapur, a total of 62,615 students, among 77,341, in 349 schools (171 public and 178 private) were vaccinated, with a coverage rate of 76% in public schools and 85% in private schools (Table 2). Pakistan: A total of 437 and 941 schools were selected for vaccination in Gulshan town and Jamshed town, respectively. In Gulshan town, 38,419 (38.6%) students were vaccinated in total. In Jamshed town, 78,246 (59.6%) students were vaccinated in total. Most of those vaccinated were from private schools. The coverage by the types of school ranged between 33% and 68% and was highest in the madrasahs (Table 3).

Please cite this article in press as: Khan MI, et al. Typhoid vaccine introduction: An evidence-based pilot implementation project in Nepal and Pakistan. Vaccine (2015), http://dx.doi.org/10.1016/j.vaccine.2015.03.087

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Weeks since the start of the social Mobilization

Seminar

Headteacher Madrasah Admin Teachers

Meetings

Awerness Programs

Parents Health Care Providers

Announcements

Parents/Mosques

Exhibition

General Population

Pamphlets/Brochures

Parents Teachers Health care providers

Hand Bills/Flyers Print Media

Teachers Poster

Mass Media

Parents

Health Care Providers/Hospitals

W1-4

W1-3

W1-2

W1-1

W1

W2

W3

W4

W5

W6

W7

Vaccination W8

W9

V1

V2

Post Vaccination W1

W2

~ 70 30 schools at least 30 schools at least ~ 1000 150,000 - 200,000 2 Million 150,000 - 200,000 ~ 5000 ~ 1000 150,000 - 200,000 ~ 5000 ~ 1000

Parents/Students

150,000 - 200,000

Banners

Parents

150,000 - 200,000

Cable TV

General Population

1.2 Million

TV Health Shows

General Population

1.2 Million

-

Radio (Public Service message)

General Population

1.2 Million

-

News Paper (typhoid related articles)

General Population

1.2 Million

-

Press Release

General Population

1.2 Million

-

Pre testing Monitoring Social Mobilization Data Collection Evaluation

W3

200 - 300

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Table 1 Social mobilization and communication plan for school based typhloid vaccination in Nepal and Pakistan.

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Table 2 Vaccination coverage results from the school based vaccination campaign in Lalitpur and Bhaktapur District, Nepal. Lalitpur Educational institutions Public Private Total number of children Public Private Total children vaccinated Public Private Adverse events

Bhaktapur

498 207 291 122,044 36,320 85,724 77,765 23,662 54,043 155

349 171 178 77,341 32,025 45,316 62,615 24,243 38,372 68

42% 58% 30% 70% 64% 65% 63%