Objective: To compare the incidence of tuberculosis over two years in
infants vaccinated at birth with intradermal BCG or with percutaneous
BCGThis was a randomised trial set in South Africa and involving 11 680
newborn infants. Infants were randomised by week of birth to receive
Tokyo 172 BCG vaccine through the percutaneous route (n=5775) or
intradermal route (n=5905) within 24 hours of birth and followed up for
Main outcome measures: The primary outcome measure was documented
Mycobacterium tuberculosis infection or radiological and clinical
evidence of tuberculosis disease. Secondary outcome measures were rates
of adverse events, all cause and tuberculosis specific admissions to
hospital, and mortality.
Results: The difference in the cumulative incidence of definite,
probable, and possible tuberculosis between the intradermal group and
the percutaneous group, as defined using study definitions based on
microbiological, radiological, and clinical findings was - 0.36% (95.5%
confidence interval - 1.27% to 0.54%). No significant differences were
found between the routes in the cumulative incidence of tuberculosis
using a range of equivalence of “within 25%.” Additionally, no
significant differences were found between the routes in the cumulative
incidence of adverse events (risk ratio 0.98, 95% confidence interval
0.91 to 1.06), including deaths (1.19, 0.89 to 1.58).
Conclusion: Equivalence was found between intradermal BCG vaccine and
percutaneous BCG in the incidence of tuberculosis in South African
infants vaccinated at birth and followed up for two years. The World
Health Organization should consider revising its policy of preferential
intradermal vaccination to allow national immunisation programmes to
choose percutaneous vaccination if that is more practical.
Hawkridge, A.; Hatherill, M.; Little, F.; Goetz, M.A.; Barker, L.; Mahomed, H.; Sadoff, J.; Hanekom, W.; Geiter, L.; Hussey, G. Efficacy of percutaneous versus intradermal BCG in the prevention of tuberculosis in South African infants: randomised trial. BMJ (2008) 337 (nov13 1) a2052-a2052. [DOI: 10.1136/bmj.a2052]
Efficacy of percutaneous versus intradermal BCG in the prevention of tuberculosis in South African infants: randomised trial.