title: Recombinant interferon-alpha2b improves immune response to hepatitis B vaccination in haemodialysis patients: results of a randomised clinical trial.
abstract: The use of adjuvants capable of improving the deficient immune response to hepatitis B virus (HBV) vaccine in haemodialysis patients is highly needed. Among potential adjuvants, type I interferons deserve a special attention in view of their known effects promoting cellular and humoral immune responses. The aim of the present trial was to evaluate the effects of recombinant interferon-alpha2b (IFN) administered as an adjuvant of HBV vaccine in unvaccinated haemodialysis patients. A significant and early enhancing effect on the antibody response was observed in patients receiving IFN. In addition, a predominance of IgG1 anti-HBs along with a transient normalization of circulating Th1 lymphocytes was only found in patients receiving IFN who achieved an early seroprotection. However, 6 months after the last vaccine dose, no significant differences were observed in the seroprotection rate achieved in patients vaccinated with IFN compared to that in patients receiving HBV vaccine alone. Mild to moderate fever, asthenia, and arthromyalgia were the most common reactions that occurred in vaccinees given IFN. In conclusion, addition of IFN to HBV vaccine, under the conditions used in this trial, is safe and achieves an earlier and higher seroprotection rate improving Th1-dependent immune response in haemodialysis patients.
authors.affiliation: Liver Research Unit, Hospital Universitario Santa Cristina-CIBERehd, C/Maestro Vives, 2. 28009 Madrid, Spain.
authors.forename: María E
authors.initials: ME
authors.lastname: Miquilena-Colina
authors.forename: Tamara
authors.initials: T
authors.lastname: Lozano-Rodríguez
authors.forename: Leonor
authors.initials: L
authors.lastname: García-Pozo
authors.forename: Alicia
authors.initials: A
authors.lastname: Sáez
authors.forename: Paola
authors.initials: P
authors.lastname: Rizza
authors.forename: Imerio
authors.initials: I
authors.lastname: Capone
authors.forename: Maria
authors.initials: M
authors.lastname: Rapicetta
authors.forename: Paola
authors.initials: P
authors.lastname: Chionne
authors.forename: Maria
authors.initials: M
authors.lastname: Capobianchi
authors.forename: Marina
authors.initials: M
authors.lastname: Selleri
authors.forename: Concetta
authors.initials: C
authors.lastname: Castilletti
authors.forename: Filippo
authors.initials: F
authors.lastname: Belardelli
authors.forename: Oreste Lo
authors.initials: OL
authors.lastname: Iacono
authors.forename: Carmelo
authors.initials: C
authors.lastname: García-Monzón
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D000368:Aged; D018771:Arthralgia / Q000139:chemically induced; D001247:Asthenia / Q000139:chemically induced; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005334:Fever / Q000139:chemically induced; D006509:Hepatitis B / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000097:blood; D017325:Hepatitis B Vaccines / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage; D006435:Renal Dialysis; D051437:Renal Insufficiency / Q000628:therapy; D018417:Th1 Cells / Q000276:immunology
chemical_list: D000276:Adjuvants, Immunologic; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D007074:Immunoglobulin G; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins