title: The risk of disseminated Bacille Calmette-Guerin (BCG) disease in HIV-infected children.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Health Sciences, Stellenbosch University, P.O. Box 19063, Tygerberg, 7505, South Africa. Anneke.Hesseling@lshtm.ac.uk
authors.forename: Anneke C
authors.initials: AC
authors.lastname: Hesseling
authors.forename: Ben J
authors.initials: BJ
authors.lastname: Marais
authors.forename: Robert P
authors.initials: RP
authors.lastname: Gie
authors.forename: H Simon
authors.initials: HS
authors.lastname: Schaaf
authors.forename: Paul E M
authors.initials: PE
authors.lastname: Fine
authors.forename: Peter
authors.initials: P
authors.lastname: Godfrey-Faussett
authors.forename: Nulda
authors.initials: N
authors.lastname: Beyers
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000453:epidemiology* / Q000382:microbiology; D000293:Adolescent; D001500:BCG Vaccine / Q000008:administration & dosage / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D005260:Female; D015658:HIV Infections / Q000150:complications* / Q000453:epidemiology / Q000276:immunology; D006801:Humans; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical; D009163:Mycobacterium bovis / Q000276:immunology / Q000472:pathogenicity*; D012307:Risk Factors; D013019:South Africa / Q000453:epidemiology; D014376:Tuberculosis / Q000150:complications / Q000453:epidemiology* / Q000382:microbiology / Q000517:prevention & control; D014611:Vaccination / Q000706:statistics & numerical data
chemical_list: D001500:BCG Vaccine