BACKGROUND:BCG vaccination using the multipuncture device (the Heaf gun) is recommended in the UK for infants and very small children only. The aim of this study was to investigate the rate of conversion of the tuberculin test, the safety and acceptability of BCG vaccination using the multipuncture device and to compare it with the conventional intradermal method in schoolchildren. METHODS:Schoolchildren attending schools in Tower Hamlets who were eligible for BCG vaccination were tuberculin tested using the Heaf gun. Those with grade 0-1 reaction were randomised to receive BCG vaccination using either the multipuncture or the intradermal method. The site of BCG vaccination was inspected after eight weeks for inflammatory changes and scarring. A questionnaire about pain and inflammation at the site of vaccination was completed. The Heaf test was repeated at eight weeks and its results were assessed by an examiner unaware of the results of the previous Heaf test and the method of BCG administration. The Heaf test conversion was deemed to have occurred if there was a change of at least one grade in the response. RESULTS:One hundred and sixty nine children (83 girls) of mean age 11.8 years completed the study, of which 81 received BCG by the multipuncture method. The Heaf test did not convert in 22 of 81 (27. 2%) receiving BCG by the multipuncture device compared with six of 88 (6.8%) who received the vaccine by the intradermal method (odds ratio 0.2, 95% confidence interval 0.07 to 0.55). The BCG scar was visible in all children who had intradermal BCG compared with 67 of 81 (81.8%) of the multipuncture group. The multipuncture method was less painful and caused fewer inflammatory changes than the intradermal method. CONCLUSIONS: In schoolchildren the multi-puncture device for administering BCG caused a lower rate of tuberculin conversion as measured by the Heaf test and less of an inflammatory response than the intradermal method. The method needs to be modified before it is applied on a wider scale to schoolchildren.
RCT Entities:
BACKGROUND: BCG vaccination using the multipuncture device (the Heaf gun) is recommended in the UK for infants and very small children only. The aim of this study was to investigate the rate of conversion of the tuberculin test, the safety and acceptability of BCG vaccination using the multipuncture device and to compare it with the conventional intradermal method in schoolchildren. METHODS: Schoolchildren attending schools in Tower Hamlets who were eligible for BCG vaccination were tuberculin tested using the Heaf gun. Those with grade 0-1 reaction were randomised to receive BCG vaccination using either the multipuncture or the intradermal method. The site of BCG vaccination was inspected after eight weeks for inflammatory changes and scarring. A questionnaire about pain and inflammation at the site of vaccination was completed. The Heaf test was repeated at eight weeks and its results were assessed by an examiner unaware of the results of the previous Heaf test and the method of BCG administration. The Heaf test conversion was deemed to have occurred if there was a change of at least one grade in the response. RESULTS: One hundred and sixty nine children (83 girls) of mean age 11.8 years completed the study, of which 81 received BCG by the multipuncture method. The Heaf test did not convert in 22 of 81 (27. 2%) receiving BCG by the multipuncture device compared with six of 88 (6.8%) who received the vaccine by the intradermal method (odds ratio 0.2, 95% confidence interval 0.07 to 0.55). The BCG scar was visible in all children who had intradermal BCG compared with 67 of 81 (81.8%) of the multipuncture group. The multipuncture method was less painful and caused fewer inflammatory changes than the intradermal method. CONCLUSIONS: In schoolchildren the multi-puncture device for administering BCG caused a lower rate of tuberculin conversion as measured by the Heaf test and less of an inflammatory response than the intradermal method. The method needs to be modified before it is applied on a wider scale to schoolchildren.
Authors: Gregory D Hussey; Marcia L V Watkins; Elizabeth A Goddard; Sean Gottschalk; Elizabeth J Hughes; Karen Iloni; Maurice A Kibel; Stanley R Ress Journal: Immunology Date: 2002-03 Impact factor: 7.397
Authors: Patricia L Semple; Marcia Watkins; Virginia Davids; Alan M Krensky; Willem A Hanekom; Gilla Kaplan; Stanley Ress Journal: Clin Dev Immunol Date: 2010-12-28
Authors: Anthony Hawkridge; Mark Hatherill; Francesca Little; Margaret Ann Goetz; Lew Barker; Hassan Mahomed; Jerald Sadoff; Willem Hanekom; Larry Geiter; Greg Hussey Journal: BMJ Date: 2008-11-13