title: Randomized controlled trial of high-dose intradermal versus standard-dose intramuscular influenza vaccine in organ transplant recipients.
abstract: The immunogenicity of standard intramuscular (IM) influenza vaccine is suboptimal in transplant recipients. Also, recent studies suggest that alloantibody may be upregulated due to vaccination. We evaluated a novel high-dose intradermal (ID) vaccine strategy. In conjunction, we assessed alloimmunity. Transplant recipients were randomized to receive IM or high-dose ID vaccine. Strain-specific serology and HLA alloantibody production was determined pre- and postimmunization. In 212 evaluable patients (105 IM, 107 ID), seroprotection to H1N1, H3N2 and B strains was 70.5%, 63.8% and 52.4% in the IM group, and 71.0%, 70.1%, 63.6% in the ID group (p=ns). Seroconversion to ≥1 antigen was 46.7% and 51.4% in the IM and ID groups respectively (p=0.49). Response was more likely in those≥6 months posttransplant (53.2% vs. 19.2%; p=0.001). Use of mycophenolate mofetil was inversely associated with vaccine response in a dose-dependent manner (p<0.001). Certain organ subgroups had higher response rates for influenza B in the ID vaccine group. Differences in anti-HLA antibody production were detected in only 3/212(1.4%) patients with no clinical consequences. High-dose intradermal vaccine is an alternative to standard vaccine and has potential enhanced immunogenicity in certain subgroups. In this large cohort, we also show that seasonal influenza does not result in significant alloantibody production.
authors: Alberta Transplant Institute, University of Alberta, Canada.
authors: A
authors: A
authors: Baluch
authors: Alberta Transplant Institute, University of Alberta, Canada.
authors: A
authors: A
authors: Humar
authors: School of Public Health, University of Alberta, Canada.
authors: D
authors: D
authors: Eurich
authors: Alberta Transplant Institute, University of Alberta, Canada.
authors: A
authors: A
authors: Egli
authors: Calgary Laboratory Services & University of Calgary, Canada.
authors: A
authors: A
authors: Liacini
authors: Health Protection Agency, London, United Kingdom.
authors: K
authors: K
authors: Hoschler
authors: Alberta Transplant Institute, University of Alberta, Canada.
authors: P
authors: P
authors: Campbell
authors: Calgary Laboratory Services & University of Calgary, Canada.
authors: N
authors: N
authors: Berka
authors: Alberta Transplant Institute, University of Alberta, Canada.
authors: S
authors: S
authors: Urschel
authors: Alberta Transplant Institute, University of Alberta, Canada.
authors: L
authors: L
authors: Wilson
authors: Alberta Transplant Institute, University of Alberta, Canada.
authors: D
authors: D
authors: Kumar
mesh_terms: D000328:Adult; D000368:Aged; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007165:Immunosuppression Therapy / Q000009:adverse effects; D053118:Influenza A Virus, H1N1 Subtype; D053122:Influenza A Virus, H3N2 Subtype; D009981:Influenza B virus; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects*; D007251:Influenza, Human / Q000517:prevention & control; D007271:Injections, Intradermal / Q000009:adverse effects*; D007273:Injections, Intramuscular / Q000009:adverse effects*; D007518:Isoantibodies / Q000276:immunology; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D016377:Organ Transplantation; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007252:Influenza Vaccines; D007518:Isoantibodies; D009173:Mycophenolic Acid