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The Introduction of Hepatitis B Vaccine in Rural Vietnam

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The Introduction of Hepatitis B Vaccine in Rural Vietnam - -~ The Introduction of Hepatitis B Vaccine in Rural Vietnam A thesis submitted in total fulfilment of the requirements for the degree of Doctor of Philosophy by David_ Barry Hipgrave BSc, MBBS Department of Paediatrics University of Melbourne I January 2004 Produced on acid-free paper This volume contains in the following order: Abstract Declaration Acknowledgements Table of contents and list of appendices List of tables by chapter List of figures by chapter List of abbreviations Statement of ethical approval from local partner in Vietnam The thesis chapters 1 - 9 Reference list Appendices by number 1. Action Plan For the Introduction of Hepatitis B Vaccine 2. Organisational structure of the Vietnamese Health Sector 3. Description of government health services in Vietnam 4. EPI Review in 1998 - Report 5. Maps of Vietnam, Thanh Hoa, Quang Xuong and Ngoc Lac 6. Chapter 2A Health Worker Survey Instrument 7. Chapter 2B Householder Survey Instrument 8. Figures 9. Village-level Birth Registration and EPI Record Form 10. Check list for supervising and monitoring hepatitis b vaccine administration 11. Chapter 7B Householder Survey Instrument Abstract Vietnam, a nation of almost 80 million people with a high rate of chronic infection with the hepatitis B virus (HBV), is currently expanding its introduction of hepatitis B vaccine (HepB vaccine) for infants across the nation. This is occurring within an immunisation program widely commended for its high coverage and achievements in disease control. During 1997, HepB vaccine was introduced for a small proportion of infants in urban areas, using a locally manufactured product which had not previously been objectively evaluated in the field. In addition, the problem ofHBV infection itself had not been adequately quantitated, making subsequent evaluation of the program difficult. To make HepB vaccine available more widely and at birth, as is needed to prevent the perinatal infection responsible for a large proportion of chronic HBV infection, its storage outside the cold chain has been suggested. This would enable its use for infants born in remote areas lacking access and refrigeration, but scientific verification of the vaccine's immuno&enicity and protective efficacy (PE) when used in this way is lacking. In addition, it is not certain that birth dosing, nor indeed the three required doses of the vaccine itself will be acceptable to Vietnamese mothers, who are unused to infants receiving any vaccines before the age of two months and not unreasonably concerned about injection safety. In this thesis I examine the situation with respect to the conduct of the Expanded Program on Immunisation (BPI) in one rural province of central northern Vietnam, and community attitudes towards this program and the introduction of HepB vaccine. Grave concerns about the planning, safety, effectiveness and veracity of reporting of the Program are raised, and health worker and community education programs recommended prior to the introduction of birth dosing with HepB vaccine. " I report on a survey of the seroprevalence ofHBV infection in this location, confirming very high rates of perinatal infection and a monotonous increase in exposure with age. I also compare the immunogenicity of the locally produced vaccine in two different formulations with that of two internationally licensed Korean vaccines, concluding that the dose currently used in the Vietnamese EPI should be increased. I evaluate three different strategies for the introduction ofHepB vaccine in varying geographic and demographic milieu, both scientifically in terms of their immunogenicity and PE, and for their operational feasibility and likely generalisability throughout Vietnam. I provide further evidence in support of the immunogeniciiy of HepB vaccine stored at ambient temperature, but only limited evidence relating to PE, probably because of the low dose of vaccine available. I compare the responses of local communities to differing levels of dissemination of information relevant to the introduction ofHepB vaccine, and of health workers to , training to improve their conduct of the EPI. Improving the EPI, including introduction of HepB vaccine with a birth dose, seems both feasible and acceptable to all concerned. Finally, I evaluate the activities conducted by examining changes in the prevalence of two objectively measurable indicators of the conduct of the EPI. Whilst rates of scars following bacille Calmette-Guerin vaccine increased substantially, rates of immunity to measles amongst older infants did not. Abstract and Declaration 2 Declaration This is to certify that: (i) With certain exceptions, this thesis comprises only my original work towards the PhD. The exceptions include: the initial design of the project during which the research was conducted. This was undertaken by one of my supervisors, Dr Beverley-Ann Biggs at the University of Melbourne, and the project co-director, Dr James Maynard of the Program for Appropriate Technology in Health, Seattle, Washington, USA, before being refined by the three of us prior to and after project commencement. field work, during the preparation and conduct of which I was assisted by local assistant~ and government health staff participating in activities I designed, and the majority of statistical calculations. Whilst these were entirely designed and interpreted by me, the data entry and computation of all but the crudest statistics were mostly (90%) conducted by hired assistants and Dr Trung Nam Tran, a Vietnamese biostatistician working closely with me in Hanoi. (ii) due acknowledgement has been made in the text to all other material used, and (iii) the thesis is less than 100,000 words in length, exclusive of tables, maps, bibliographies and appendices. Abstract and Declaration 3 Acknowledgements The activities and research described herein were conducted as part of a project funded entirely by the Australian Agency for International Development. I am extremely grateful to them for supporting this work, and to my project directors, Drs James Maynard and Beverley-Ann Biggs. Dr Maynard represented the Program for Appropriate Technology in Health (PATH) on this project, and I am also indebted to the administrative and library staff at the PATH headquarters in Seattle, Washington, USA, particularly David Alii and Jane Goett. Also at PATH, I am grateful to Dr David Mercer for epidemiological advice given early in the project. Dr Biggs represented the other two project partners, the University of Melbourne and the International Health Unit at the Macfarlane Burnet Centre (MBC) for Medical Research, now The Burnet Institute. Apart from being a reliable supporter and an excellent source of information, Dr Biggs has also been my main thesis supervisor for which I am again very grateful. I also thank the support staff at these two institutions, particularly Ms Virginia de Crespigny at the University and Dr Mike Toole, Mr Kelvin Margetts and Mr GeoffDrenkhahn at MBC. Also at the University, I am grateful to Professor Terry Nolan, my other thesis supervisor, for his assistance by email and in person over the years. In Vietnam, I am deeply indebted to two people in particular- Dr Vu Minh Huong, project officer, for his reliable and mature assistance in the organization and arrangement of field activities and assistance with data entry; and Dr Trung Nam Tran, consultant epidemiologist and biostatistician, for his outstanding assistance with statistical analysis and for his tuition. In addition, I am grateful to other project staff, Ms Hoang Thu Huong (administrator), Bui Phuong Lan (education officer), Dr LeVan Hung (field assistant) and Quan Huu Tung (driver). At the project's local partner, the National Institute ofHygiene and Epidemiology, I thank Drs Do Tuan Dat and Nguyen Tuyet Nga and Professors Hoang Thuy Long and Nguyen Thu Van and her laboratory staff. In the field, I wish to acknowledge the support and high standard of conduct of our activities in Quang Xuong and Ngoc Lac districts, led by Drs Vinh and Xuan at the district health services, and assisted at commune level by numerous local staff. In Thanh Hoa city, I thank the staff of the Preventive Medicine Centre, particularly Drs Ngoan and Dien, and their laboratory staff. In the Thanh Hoa Obstetric Hospital, I thank Dr Nguyen Thi Phuong, Ms Nguyen Thi Phuong, Nurse, Dr Nguyen Van Giap, Director and the staff of the wards and outpatient clinics of the hospital. Finally, I am deeply grateful to the mothers and infants who participated in all field activities. Other collaborators to whom I am grateful include Associate Professor Stephen Locamini and Mr Alan Breschkin at the Victorian Infectious Diseases Reference Laboratory, and Associate Professor Damien Jolley, formerly at the University of Melbourne, now at Deakin University, for his expert and entertaining statistical and epidemiological advice. Finally, I would like to most gratefully acknowledge my wife, Lucinda, and children - D' Arcy, Louis, Lyndsey and Diana- who have experienced my ups and downs during over six years in Vietnam. Without their support, this report would still be merely a good idea. David Hipgrave, January, 2004 Table of Contents and List of Appendices Brief description Chapter 1: Introduction, situation analysis and literature review Chapter 2: The situation at baseline Section A An assessment of immunisation practices in the two project districts during 1998 Section B Community perspectives on liver disease, hepatitis B infection and the Expanded Program on
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