title: Clinical reactogenicity of intradermal bacille Calmette-Guérin vaccination.
abstract: Clinical, microbiological, and immunologic responses were evaluated in volunteers vaccinated intradermally with bacille Calmette-Guérin (BCG). Most volunteers (98%) developed ulcerative lesions that drained for a mean +/- SE of 4.3 +/- 0.29 weeks. Mycobacterial DNA was detected by a polymerase chain reaction-based amplification technique in biopsy specimens from BCG ulcers 2 weeks after vaccination and in blood specimens 3 days after vaccination. Mycobacteria were cultured from ulcer drainage 2 months after vaccination, demonstrating a prolonged potential risk of contact spread of the vaccine strain. The duration of ulcer drainage was inversely correlated with prevaccination lymphoproliferative (r = -0.515; P < .002) and interferon gamma (r = -0.841; P < .002) responses specific to mycobacteria and directly correlated with postvaccination increases in lymphoproliferative (r = 0.498; P < .002) and interferon gamma (r = 0.688; P < .02) responses specific to mycobacteria. These results demonstrate the clinical reactogenicity of BCG and the potential risk of contact spread of the vaccine strain and suggest that clinical reactogenicity is a trade-off for the induction of protective mycobacterial immunity.
authors.affiliation: Department of Internal Medicine, Saint Louis University Health Sciences Center, Missouri, USA. hoftdf@slu.edu
authors.forename: D F
authors.initials: DF
authors.lastname: Hoft
authors.forename: C
authors.initials: C
authors.lastname: Leonardi
authors.forename: T
authors.initials: T
authors.lastname: Milligan
authors.forename: G T
authors.initials: GT
authors.lastname: Nahass
authors.forename: B
authors.initials: B
authors.lastname: Kemp
authors.forename: S
authors.initials: S
authors.lastname: Cook
authors.forename: J
authors.initials: J
authors.lastname: Tennant
authors.forename: M
authors.initials: M
authors.lastname: Carey
mesh_terms: D000293:Adolescent; D000328:Adult; D001500:BCG Vaccine / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology / Q000382:microbiology; D004269:DNA, Bacterial / Q000097:blood; D006801:Humans; D008875:Middle Aged; D009163:Mycobacterium bovis / Q000235:genetics / Q000302:isolation & purification*; D016133:Polymerase Chain Reaction; D012883:Skin Ulcer / Q000382:microbiology / Q000473:pathology; D014373:Tuberculin; D014376:Tuberculosis / Q000517:prevention & control*; D014611:Vaccination
chemical_list: D001500:BCG Vaccine; D004269:DNA, Bacterial; D014373:Tuberculin