title: Negligible adjuvant effect for antibody responses and frequent adverse events associated with IL-12 treatment in humans vaccinated with pneumococcal polysaccharide.
abstract: To assess whether co-administration of recombinant human IL-12 (rhIL-12) and 23-valent pneumococcal polysaccharide vaccine (PPV) enhances the antibody response to this T cell-independent antigen, healthy immunocompetent volunteers (n=34, 55-65 years old) were vaccinated intramusculary with PPV and concurrently-treated subcutaneously with either rhIL-12 (1 or 4 microg) or placebo. The increases of total anti-pneumococcal IgG antibodies were numerically higher among the rhIL-12 recipients compared with placebo recipients, but the difference was not significant. The rhIL-12 recipients had a high incidence of local and systemic side effects. Given the lack of convincing evidence that rhIL-12 enhances the antibody response to PPV, the frequency and severity of the side effects was unacceptable.
authors.affiliation: Department of Infectious Diseases, Karolinska Institute, Karolinska Hospital, S-17176, Stockholm, Sweden. jonas.hedlund@ks.se
authors.forename: J
authors.initials: J
authors.lastname: Hedlund
authors.forename: B
authors.initials: B
authors.lastname: Langer
authors.forename: H B
authors.initials: HB
authors.lastname: Konradsen
authors.forename: A
authors.initials: A
authors.lastname: Ortqvist
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects; D000368:Aged; D000907:Antibodies, Bacterial / Q000096:biosynthesis / Q000276:immunology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000096:biosynthesis / Q000276:immunology; D018664:Interleukin-12 / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000139:chemically induced; D010865:Pilot Projects; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000276:immunology*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D012449:Safety; D013296:Streptococcus pneumoniae / Q000276:immunology; D014611:Vaccination; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000276:immunology
chemical_list: D000276:Adjuvants, Immunologic; D000907:Antibodies, Bacterial; D007074:Immunoglobulin G; D022242:Pneumococcal Vaccines; D011994:Recombinant Proteins; D017778:Vaccines, Combined; D018664:Interleukin-12