Evidence based guidelines for vaccination practice

Research Doctorate - Doctor of Medicine (MD)Vaccination programs have been so successful that concerns about sequelae of vaccine preventable disease have been replaced by concerns about the safety of vaccines. This context mandates the development and use of the best vaccines and the best vaccination practice (site and route of administration of vaccines). Evidence based medicine has been championed as a way of improving the quality of medical care. Assessment of vaccination guidelines from twelve countries, nine states/provinces and two counties reveals that recommendations for vaccination practice are largely based on expert opinion. In this thesis, clinical studies are presented on: * The preferred route for administration of vaccines (intramuscular or subcutaneous). * The needle length required for intramuscular injection. * The technique for intramuscular injection of vaccines. * The site for intramuscular injection of vaccines These studies have resulted in the following publications in refereed journals: 1. Cook IF, Barr I, Hartel G, Pond D, Hampson AW. Reactogenicity and immunogenicity of an inactivated influenza vaccine administered by intramuscular or subcutaneous injection in elderly adults. Vaccine 2006; 24: 2395-402. 2. Cook IF, Pond D, Hartel G. Comparative reactogenicity and immunogenicity of 23 valent pneumococcal vaccine administered by intramuscular or subcutaneous injection in elderly adults. Vaccine 2007; 25: 4767-74. 3. Cook IF. Evidence based route of administration of vaccines. Human Vaccines 2008; 4: 67-73. 4. Cook IF. Sexual dimorphism of humoral immunity with human vaccines. Vaccine 2008: 26: 3551-5. 5. Cook IF, Murtagh J. Needle length required for intramuscular vaccination of infants and toddlers: an ultrasonographic study. Aust Fam Phys 2002; 3: 295-7. 6. Cook IF, Murtagh J. Paediatric vaccination practice in a division of general practice. Aust Fam Phys 2001; 30: 1185-9. 7. Cook IF, Murtagh J. Ventrogluteal area – a suitable site for intramuscular vaccination of infants and toddlers. Vaccine 2006; 24: 2403-8. 8. Cook IF, Williamson M, Pond D. Definition of needle length required for intramuscular deltoid injection in elderly adults: an ultrasonographic study. Vaccine 2006; 24: 937-40. 9. Cook IF, Murtagh J. Optimal technique for intramuscular injection of infants and toddlers: a randomised trial. Med J Aust 2005; 183: 60-3. 10. Cook IF, Murtagh J. Comparative immunogenicity of hepatitis B vaccine administered into the ventrogluteal area and anterolateral thigh in infants. J Paediatr Child Health 2002; 38: 393-6. 11. Cook IF, Murtagh J. Comparative reactogenicity and parental acceptability of pertussis vaccines administered into the ventrogluteal area and anterolateral thigh in children aged 2, 4, 6 and 18 months. Vaccine 2003; 21: 3330-4. 12. Cook IF. Sex differences in injection site reactions with human vaccines. Human Vaccines 2009; 5: 1-9. These studies allow evidence based guidelines to be formulated for vaccination practice which should help to maintain public confidence in vaccination programs by minimizing the adverse reactions of vaccines whilst maintaining their efficacy. It is noteworthy in this context that some recommendations made in this thesis have been translated into Australian Government policy in the 9th edition of “The Australian Immunisation Handbook” 2008, albeit a long time after their publication. This work also raises questions about contemporary clinical practice and identifies sex as a determinant of immune response and adverse reaction with some vaccines. Further studies in the area of vaccination practice and sex-difference in immune response to vaccines are suggested