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BCG Efficacy in Children Aged 1-7 Years in a Rural Area in East Nile Province

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BCG Efficacy in Children Aged 1-7 Years in a Rural Area in East Nile Province University of Khartoum Faculty of Medicine Medical & Health Studies Board BCG Efficacy in Children Aged 1-7 years In A rural Area in East Nile Province By Dr. Mai Mohamed El Hassan Mustafa M.B.B.S (University of Khartoum) A thesis submitted in partial fulfillment for the requirements of the Degree of Clinical MD in Paediatrics and Child Health, February – 2004 Supervisor Dr. Salah Ahmed Ibrahim Associate Professor, Department of Paediatrics and Child Health Faculty of Medicine, U of K 1 TToo …… MMyy lloovveellyy ppaarreennttss …… MMyy hhuussbbaanndd …… MMyy ssiisstteerrss,, bbrrootthheerrss && TToo aallll wwhhoo lloovvee && ttaakkee ccaarree ooff cchhiillddrreenn …… MMaaii 2 ﻗﺎل ﺗﻌﺎﻟﻰ: ﺻﺪق اﷲ اﻟﻌﻈﻴﻢ ﺳﻮرة اﻟﺮﺣﻤﻦ ﺁﻳﺔ رﻗﻢ (4-1) 3 CONTENTS Page - Acknowledgement i - Abstract (English) ii - Abstract (Arabic) iv - Abbreviations vi - List of tables vii - List of figures ix CHAPTER ONE 1. INTRODUCTION & LITERATURE REVIEW 1 1.1. History of tuberculosis 3 1.2. Tuberculosis in Sudan 6 1.3. Aetiology 12 1.4. Epidemiology 13 1.5. Pathology 18 1.6. Clinical Manifestations 19 1.7. Laboratory Diagnosis 39 1.8. Tuberculin skin test 44 1.9. Treatment 55 1.10. BCG vaccine 58 JUSTIFICATIONS 80 OBJECTIVES 81 CHAPTER TWO 2. PATIENTS AND METHODS 82 2.1. Nature of the study 82 2.2. Study area 82 2.3. Duration of the study 83 2.4. Study population 83 2.5. Inclusion criteria 84 2.6. Exclusion criteria 84 2.7. Research methodology 84 2.8. Research team 85 4 2.9. Input of the author 85 2.10. Research tools 86 2.11. Diagnosis 88 2.12. Treatment 89 2.13. Data entry and analysis 89 2.14. Funding 89 CHAPTER THREE 3. RESULTS 90 3.1. Socio demographic characteristics of the study population 90 3.2. Certain characteristics of children 91 3.3. Mantoux test results 93 3.4. Factors affecting vaccination state in the study population 95 3.5. Factors affecting BCG scar 95 3.6. Factors affecting tuberculin reaction 95 3.7. TB cases in the study 97 CHAPTER FOUR DISCUSSION 130 CONCLUSION 142 RECOMMENDATIONS 144 REFERENCES 147 APPENDIX (Questionnaire) 5 ACKNOWLEDGEMENT I am deeply grateful to my supervisor Dr. Salah Ahmed Ibrahim, Department of Paediatrics and Child Health, Faculty of Medicine, University of Khartoum for his continuous supervision, constructive criticism, support, encouragement and guidance. I wish to express my thanks to the children and their parents in El Tukunab, Banant & El Rahana areas who were the core of the study. Thanks are also extended to the working staff at El Tukunab Health Centre for their generous cooperation. My special thanks to my husband for his patience, kindness and encouragement. I am also thankful to Miss Shereen Yousif for her great effort and typing. I am grateful to my lovely sister Nasreen and to all my family for encouragement and support. ABSTRACT 6 Tuberculosis remains the most common single cause of death. Although BCG vaccination was introduced in 1920, yet its protective role remains contraversial. This study was conducted in three rural areas in East Nile Province, during the period from 1st of June to 31ist of August 2003. It was community-based study done through house-to-house survey. The main objectives of this study were to evaluate the efficacy of BCG vaccine and to correlate the efficacy to presence or absence of scar and some social factors. A total of 398 children (50.3% Males and 49.7% Females) aged 12 months to seven years were studied. All relevant informations on medical, social history, history of BCG vaccination including age of vaccination, symptoms suggestive of tuberculosis, physical examination including checking BCG scar and measurement of scar size, were noted on a pre-coded questionnaire. Mantoux test was done and the induration was measured 72 hours later. The study showed that the predominant age group was 12-36 months, which represents 42.7% of the study population; 95% were BCG vaccinated (documented by BCG scar, vaccination card or both). 73.9% of them were vaccinated in the first 3 months of age and 72% of the vaccinated had BCG scar, 39.1% of the scars measured from 2 to 5 mm, reflecting good efficacy of BCG vaccine given.68.85% of children 7 showed tuberculin reaction less than 5mm while only 2.5% showed reaction more than 10 mm. It was found that there is significant association between the size of the scar and tuberculin measurement supporting the fact that BCG scar is a strong indicator for vaccine efficacy. During the study 2(0.5%) cases of TB were diagnosed, their ages were 14 and 18 months and both were BCG vaccinated as documented by BCG scar (in the range of 2-5 mm), infected TB cases represent (0.1%) of the vaccinated children, which reflect high protection although the number of non vaccinated group was small in comparison with the vaccinated group. Social factors such as family income and number of persons per room did not significantly affect TB infection. The study concluded that BCG vaccination was efficient reflected in the good immunity documented by BCG scar and just (0.1%) TB cases among the vaccinated group. ﺧﻼﺻﺔ اﻷﻃﺮوﺣﺔ ﻳﻌﺘﱪ ﻣﺮﺽ ﺍﻟﺴﻞ ﺃﻛﺜﺮ ﺍﻷﻣﺮﺍﺽ ﺍﳌﺴﺒﺒﺔ ﻟﻠﻮﻓﻴﺎﺕ ﻟﻺﻧﺴﺎﻥ ، ﺑﺎﻟﺮﻏﻢ ﻣﻦ ﺍﻛﺘﺸﺎﻑ ﻣﺼﻞ ﺍﻟﺴﻞ ﰲ ﻋﺎﻡ 1920ﻡ ﺇﻻ ﺃﻥ ﺩﻭﺭﻩ ﰲ ﺍﳊﻤﺎﻳﺔ ﻣﻦ ﺍﳌﺮﺽ ﱂ ﻳﻌﺮﻑ ﺣﱴ ﺍﻵﻥ. 8 ﲤﺖ ﻫﺬﻩ ﺍﻟﺪﺭﺍﺳﺔ ﰲ ﺛﻼﺛﺔ ﻣﻨﺎﻃﻖ ﺭﻳﻔﻴﺔ ﰲ ﳏﺎﻓﻈﺔ ﺷﺮﻕ ﺍﻟﻨﻴﻞ ﰲ ﺍﻟﻔﺘﺮﺓ ﻣﻦ 1 ﻳﻮﻧﻴﻮ ﻭﺣﱴ 31 ﺃﻏﺴﻄﺲ ﻋﺎﻡ 2003ﻡ. ﻣﻦ ﺃﻫﻢ ﺃﻫﺪﺍﻑ ﺍﻟﺪﺭﺍﺳﺔ ﺗﻘﻴﻴﻢ ﻣﺪﻯ ﻓﻌﺎﻟﻴﺔ ﻣﺼﻞ ﺍﻟﱯ ﺳﻲ ﺟﻲ ﻭﻣﻘﺎﻭﻣﺔ ﻓﻌﺎﻟﻴﺘﻪ ﺑﻨﺪﺑﺔ ﺍﻟﱯ ﺳﻲ ﺟﻲ ﻭﺑﻌﺾ ﺍﻟﻌﻮﺍﻣﻞ ﺍﻻﺟﺘﻤﺎﻋﻴﺔ. ﲤﺖ ﺍﻟﺪﺭﺍﺳﺔ ﰲ ﺣﻮﺍﱄ 398 ﻃﻔﻞ (50.3% ﺫﻛﺮ ﻭ 49.7% ﺃﻧﺜﻰ) ﺗﺘﺮﺍﻭﺡ ﺃﻋﻤﺎﺭﻫﻢ ﻣﻦ ﺳﻦ 12 ﺷﻬﺮ ﻭﺣﱴ 7 ﺳﻨﻮﺍﺕ. ﰎ ﺗﺴﺠﻴﻞ ﻛﻞ ﺍﳌﻌﻠﻮﻣﺎﺕ ﺍﳌﺘﻌﻠﻘﺔ ﺑﺘﺎﺭﻳﺦ ﺃﻱ ﻣﺮﺽ ، ﺍﻟﺘﻄﻌﻴﻢ ﺑﺎﻟـ ﰊ ﺳﻲ ﺟﻲ ﻭﺍﻟﻌﻤﺮ ﻋﻨﺪ ﺍﻟﺘﻄﻌﻴﻢ ﺃﻱ ﺃﻋﺮﺍﺽ ﳌﺮﺽ ﺍﻟﺴﻞ ﻭﺍﻟﻜﺸﻒ ﺍﻟﻌﺎﻡ ﻋﻠﻰ ﻛﻞ ﺍﻷﻃﻔﺎﻝ ﰲ ﺍﻟﺪﺭﺍﺳﺔ ﻭﻳﺘﻀﻤﻦ ﺫﻟﻚ ﺍﻟﻜﺸﻒ ﻋﻦ ﻧﺪﺑﺔ ﺍﻟﱯ ﺳﻲ ﺟﻲ ﻭﻗﻴﺎﺳﻬﺎ ، ﻭﰎ ﺗﺴﺠﻴﻞ ﺫﻟﻚ ﰲ ﺍﺳﺘﺒﻴﺎﻥ. ﻛﻞ ﺍﻷﻃﻔﺎﻝ ﰲ ﺍﻟﺪﺭﺍﺳﺔ ﰎ ﳍﻢ ﺇﺟﺮﺍﺀ ﺍﺧﺘﺒﺎﺭ ﺍﻟﺘﻴﻮﺑﺮﻛﻠﲔ ﻭﰎ ﺍﻟﻜﺸﻒ ﻋﻦ ﺍﻻﺧﺘﺒﺎﺭ ﺑﻌﺪ 72 ﺳﺎﻋﺔ ﻣﻦ ﺇﺟﺮﺍﺋﻪ. ﺗﻮﺿﺢ ﺍﻟﺪﺭﺍﺳﺔ ﺃﻥ ﺍﻟﻌﻤﺮ ﺍﻟﺴﺎﺋﺪ ﻫﻮ ﺳﻦ 12 ﺷﻬﺮ ﻭﺣﱴ 36 ﺷﻬﺮ ﻭﻫﻲ ﲤﺜﻞ ﺣﻮﺍﱄ 42.7% ﻣﻦ ﲨﻠﺔ ﺍﻷﻃﻔﺎﻝ ﰲ ﺍﻟﺪﺭﺍﺳﺔ. 95% ﻣﻦ ﲨﻠﺔ ﺍﻷﻃﻔﺎﻝ ﺍﳌﺪﺭﻭﺳﲔ ﺗﻠﻘﻮﺍ ﻣﺼﻞ ﺍﻟﱯ ﺳﻲ ﺟﻲ ، 73.9% ﻓﻴﻬﻢ ﺗﻠﻘﻮﺍ ﺍﳌﺼﻞ ﰲ ﺍﻟﺜﻼﺛﺔ ﺷﻬﻮﺭ ﺍﻷﻭﱃ ﺑﻌﺪ ﺍﻟﻮﻻﺩﺓ ، 72% ﻓﻴﻬﻢ ﳍﻢ ﻧﺪﺑﺔ ﺍﳌﺼﻞ ﻭ %39.1 ﻣﻦ ﺍﻟﻨﺪﺏ ﺣﺠﻤﻬﺎ ﻳﺘﺮﺍﻭﺡ ﺑﲔ 2 ﺇﱃ 5 ﻣﻠﻢ ﳑﺎ ﻳﺪﻝ ﻋﻠﻰ ﺍﻟﻔﻌﺎﻟﻴﺔ ﺍﻟﻌﺎﻟﻴﺔ ﻟﻠﻤﺼﻞ ﺍﳌﺄﺧﻮﺫ. ﰲ 68.85% ﻣﻦ ﺍﻷﻃﻔﺎﻝ ﰲ ﺍﻟﺪﺭﺍﺳﺔ ﻛﺎﻥ ﻗﻴﺎﺱ ﺍﺧﺘﺒﺎﺭ ﺍﻟﺘﻴﻮﺑﺮﻛﻠﲔ ﺃﻗﻞ ﻣﻦ 5ﻣﻠﻢ ﻭﰲ 2.5% ﻛﺎﻥ ﻗﻴﺎﺱ ﺍﺧﺘﺒﺎﺭ ﺍﻟﺘﻴﻮﺑﺮﻛﻠﲔ ﺃﻛﺜﺮ ﻣﻦ 10ﻣﻠﻢ. ﻭﻗﺪ ﻭﺟﺪ ﺃﻥ ﻫﻨﺎﻙ ﻋﻼﻗﺔ ﺑﲔ ﺣﺠﻢ ﻧﺪﺑﺔ ﺍﻟﱯ ﺳﻲ ﺟﻲ ﻭﺍﺧﺘﺒﺎﺭ ﺍﻟﺘﻴﻮﺑﺮﻛﻠﲔ ﳑﺎ ﻳﺪﻝ ﻋﻠﻰ ﺃﻥ ﻧﺪﺑﺔ ﺍﻟﺘﻄﻌﻴﻢ ﻣﺆﺷﺮ ﻫﺎﻡ ﻟﻔﻌﺎﻟﻴﺔ ﺍﳌﺼﻞ. ﰎ ﺗﺸﺨﻴﺺ ﺣﺎﻟﺘﲔ ﻣﻦ ﺍﻟﺪﺭﻥ ﺃﻋﻤﺎﺭﻫﻢ 14 ﺷﻬﺮ ﻭ 18 ﺷﻬﺮ ﻭﻫﻲ ﲤﺜﻞ %0.5 ﻣﻦ ﲨﻠﺔ ﺃﻃﻔﺎﻝ ﺍﻟﺪﺭﺍﺳﺔ ﻭﺣﻮﺍﱄ 0.1% ﻣﻦ ﲨﻠﺔ ﺍﻷﻃﻔﺎﻝ ﺍﳌﻄﻌﻤﲔ ﰲ ﺍﻟﺪﺭﺍﺳﺔ ﻣﻦ ﻣﺎ ﻳﺪﻝ ﻋﻠﻰ ﺍﳊﻤﺎﻳﺔ ﺍﻟﻌﺎﻟﻴﺔ ﻟﻠﻤﺼﻞ ﻣﻦ ﺍﳌﺮﺽ ﺑﺎﻟﺮﻏﻢ ﻣﻦ ﺃﻥ ﺍﳌﻘﺎﺭﻧﺔ ﻟﻴﺴﺖ ﻋﺎﺩﻟﺔ ﺑﲔ ﺍﻤﻮﻋﺘﲔ. 9 ﻭﺟﺪ ﺃﻥ ﺍﳊﺎﻟﺔ ﺍﳌﺎﺩﻳﺔ ﻟﻸﺳﺮﺓ ﻭﻧﺴﺒﺔ ﺍﻻﺯﺩﺣﺎﻡ ﰲ ﺍﻟﻐﺮﻑ ﻻ ﺗﺆﺛﺮ ﻋﻠﻰ ﺍﻹﺻﺎﺑﺔ ﲟﺮﺽ ﺍﻟﺪﺭﻥ. ﺩﻟﺖ ﺍﻟﺪﺭﺍﺳﺔ ﻋﻠﻰ ﺃﻥ ﻣﺼﻞ ﺍﻟﱯ ﺳﻲ ﺟﻲ ﻋﻨﺪ ﺍﻷﻃﻔﺎﻝ ﰲ ﺍﻟﺪﺭﺍﺳﺔ ﻟﻪ ﲪﺎﻳﺔ ﻋﺎﻟﻴﺔ ﻣﺘﻤﺜﻠﺔ ﰲ ﺍﻟﻨﺴﺒﺔ ﺍﻟﻌﺎﻟﻴﺔ ﻟﻮﺟﻮﺩ ﻧﺪﺑﺔ ﺍﻟﱯ ﺳﻲ ﺟﻲ ﻭﻭﺟﻮﺩ 0.1% ﻓﻘﻂ ﻣﻦ ﺣﺎﻻﺕ ﺍﻟﺪﺭﻥ. LIST OF ABBREVIATIONS AIDS Acquired Immuno Deficiency Syndrome BCG Bacilli Calmete Guérin CD4 Cluster Differentiation 10 CNS Central Nervous System CSF Cerebrospinal Fluid DNA Deoxy Ribonucleic Acid EPI Expanded Programme of Immunization HIV Human Immunodeficiency Virus IUATLD International Union Against Tuberculosis and Lung Diseases NTP National Tuberculosis Programme OT Old Tuberculin PCR Polymerase Chain Reaction PPD Purified Protein Derivative RFLPs Restriction Fragment Polymorphisms RNA Ribonucleic Acid SPSS Statistical Package for Social Science T12 Thoracic Vertebra Number 12 TB Tuberculosis TU Tuberculin Unit UNICEF United Nation of Children Emergency Fund USA United States of America WHO World Health Organization ZN Ziehl Neelsen Stain LIST OF TABLES Page Table 1: Age in month in relation to BCG vaccination of children 11 in the study population 99 Table 2: Fathers’ education in relation to BCG vaccination in children of the study population 100 Table 3: Mothers’ education in relation to BCG vaccination of children in the study population 101 Table 4: Mothers’ education in relation to age when BCG vaccinated of children in the study population 102 Table 5: BCG scar in relation to age when BCG vaccinated (in months) in children of the study population 103 Table 6: BCG scar in relation to sex in children of the study population 104 Table 7: Age in month in relation to tuberculin reaction in children of the study population 105 Table 8: Age when BCG vaccinated (in month) in relation to Tuberculin reaction in children of the study population 106 Table 9: Tuberculin reaction in relation to sex in children of the study population 107 BCG scar in relation to tuberculin reaction in children Table 10: 108 of the study population Age in month in relation to TB cases in children of the Table 11: 109 study population Table 12: TB cases in relation to age when BCG vaccinated in children of the study population 110 Table 13: TB cases in relation to family income (in Sudanese Dinars) in children of the study population 111 Table 14: TB cases in relation to number of persons per room in children of the study population 112 Table 15: BCG scar in relation to TB cases in children of the study population 113 12 Table 16: TB cases in relation to tuberculin reaction in children of the study population 114 Table 17: TB cases in relation to BCG vaccination of children in the study population 115 LIST OF FIGURES Page Figure 1: Age distribution of children in the study population 116 13 Figure 2: Sex distribution of children in the study population 117 Figure 3: Tribe distribution of children in the study population 118 Figure 4: Parents education of children in the study population 119 Figure 5: Fathers' occupation of children in the study population 120 Figure 6: Mothers' occupation of children in the study population 121 Figure 7: Family income of children in the study population in Sudanese Dinars 122 Figure 8: Number of persons per room of children in the study population 123 Figure 9: BCG vaccination state of children in the study population 124 Figure 10: Age of studied children (in months) when 125 BCG vaccinated Figure 11: Size of BCG scar in children of the study population 126 Figure 12: Contact with TB cases in children in the study 127 population Figure 13: Clinical cases of TB in children in the study 128 population Figure 14: Tuberculin reaction in children in the study 129 14 population 15 1.
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