title: Tolerance and efficacy of intranasal administration of recombinant beta serine interferon in healthy adults.
abstract: We performed two studies to determine the dose-related tolerance and the efficacy of recombinant beta serine interferon (rIFN-beta ser) in experimental rhinovirus infection. In the tolerance study, 120 healthy adults received intranasal sprays of rIFN-beta ser or placebo daily for 25 d. No differences in nasal symptoms were found. Rhinoscopy detected more mucosal bleeding sites in high-dose (38%) versus low-dose (12.5%) or placebo (12.5%) recipients. There were more subepithelial lymphocytes in nasal biopsy specimens in the high-dose (54%) than the low-dose (17%) or placebo (17%) groups. In the efficacy study, 34 volunteers received daily nasal drops of IFN, beginning 36 h before challenge and for three days afterwards. The numbers of infections and days of shedding of virus were not reduced, but colds occurred less often in the high-dose (25%) than in the low-dose (55%) or placebo (64%) recipients. Nasal mucus weights were lower in the high-dose (mean +/- SD g per five days; 5 +/- 4) than placebo (31 +/- 37) recipients. Thus, rIFN-beta ser may have a more favorable therapeutic ratio than do previously tested alpha interferons.
authors.affiliation: Department of Internal Medicine, University of Virginia School of Medicine, Charlottesville.
authors.forename: S J
authors.initials: SJ
authors.lastname: Sperber
authors.forename: P A
authors.initials: PA
authors.lastname: Levine
authors.forename: D J
authors.initials: DJ
authors.lastname: Innes
authors.forename: S E
authors.initials: SE
authors.lastname: Mills
authors.forename: F G
authors.initials: FG
authors.lastname: Hayden
mesh_terms: D000281:Administration, Intranasal; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003139:Common Cold / Q000382:microbiology / Q000473:pathology / Q000517:prevention & control*; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D007370:Interferon Type I / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000068556:Interferon beta-1a; D000068576:Interferon beta-1b; D016899:Interferon-beta; D008214:Lymphocytes / Q000473:pathology; D008297:Male; D009297:Nasal Mucosa / Q000473:pathology; D010342:Patient Acceptance of Health Care; D011994:Recombinant Proteins / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D012229:Rhinovirus / Q000302:isolation & purification; D012646:Self Administration
chemical_list: D000998:Antiviral Agents; D007370:Interferon Type I; D011994:Recombinant Proteins; D000068576:Interferon beta-1b; D016899:Interferon-beta; D000068556:Interferon beta-1a