Vaccine 25 (2007) 14–18 Short communication The risk of disseminated Bacille Calmette-Guerin (BCG) disease in HIV-infected children Anneke C. Hesseling a,b,∗ , Ben J. Marais a , Robert P. Gie a , H. Simon Schaaf a , Paul E.M. Fine b , Peter Godfrey-Faussett b , Nulda Beyers a a Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Health Sciences, Stellenbosch University, P.O. Box 19063, Tygerberg, 7505, South Africa b Department of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, UK Received 16 May 2006; received in revised form 15 July 2006; accepted 16 July 2006 Available online 1 August 2006 Abstract Objectives: Bacille Calmette-Guerin (BCG), a live attenuated Mycobacterium bovis vaccine, poses a risk to human immunodeficiency virus (HIV)-infected children; this risk has not been well quantified. We estimate the risk of disseminated BCG disease in HIV-infected children in a setting highly endemic for tuberculosis and HIV. Design and methods: We conducted a prospective hospital-based surveillance study in the Western Cape Province, South Africa. Clinical and laboratory-confirmed cases of disseminated BCG disease in children <1 year of age from January 2002 to December 2004 at a referral hospital were used as numerator data. Denominator data for calculations of disseminated BCG risk were obtained through estimating the total number of HIV-infected infants receiving BCG based on the known vaccination coverage in the study setting, combined with population data on the total number of children <1 year of age, the known HIV prevalence amongst women attending public antenatal care facilities and different scenarios (5–15%) for the rate of vertical HIV transmission. Results: Nine cases of disseminated BCG disease were identified over the study period, seven of these were in HIV-infected infants. The estimated risk for HIV-infected infants to develop disseminated BCG disease, given a 95% BCG coverage and an HIV prevalence of 12.4–15.4% amongst women, were as follows for different scenarios of vertical HIV transmission: 329–417/100,000 vaccinees (assuming 5% vertical HIV transmission), 164–208/100,000 vaccinees (assuming 10% vertical HIV transmission) and 110–139/100,000 vaccinees (assuming 15% vertical HIV transmission). Conclusions: The risk of disseminated BCG disease is increased several hundred fold in HIV-infected infants compared to the documented risk in HIV-uninfected infants. Data on the protective effect of BCG in HIV-exposed and infected children is lacking. Population- and hospital-based surveillance is vitally important to more accurately estimate the safety and benefits of BCG in HIV-exposed and infected infants. © 2006 Elsevier Ltd. All rights reserved. Keywords: BCG; HIV; Disseminated; Incidence 1. Introduction Bacille Calmette-Guerin (BCG), a live attenuated Mycobacterium bovis strain vaccine, is routinely given to infants at birth or shortly thereafter, in regions where tuber- ∗ Corresponding author. Tel.: +27 21 9389177; fax: +27 21 9389719. E-mail addresses: Anneke.Hesseling@lshtm.ac.uk, annekeh@sun.ac.za (A.C. Hesseling). culosis is endemic. The World Health Organization (WHO) currently recommends that BCG be given to all asymp- tomatic infants, irrespective of human immunodeficiency virus (HIV) exposure [1]. This policy has practical limi- tations, as most HIV-exposed infants are infected perina- tally, and are therefore asymptomatic at birth. Vaccination with BCG has remained the standard of care for tuberculo- sis prevention in most developing countries because of its documented efficacy in preventing life-threatening forms of disease in HIV-uninfected infants and young children. It is the 0264-410X/$ – see front matter © 2006 Elsevier Ltd. All rights reserved. doi:10.1016/j.vaccine.2006.07.020