A Randomized Trial of Two 2-Dose Influenza Vaccination Strategies for Patients Following Autologous Hematopoietic Stem Cell Transplantation. (11th November 2020)

• Record Type: Journal Article
• Authors: Teh, Benjamin W; Leung, Vivian K Y; Mordant, Francesca L; Sullivan, Sheena G; Joyce, Trish; Harrison, Simon J; Khvorov, Arseniy; Barr, Ian G; Subbarao, Kanta; Slavin, Monica A; Worth, Leon J
• Is Part Of: Clinical infectious diseases. Volume 73:Number 11(2021)
• Page Start: e4269
• Page End: e4277
• Publication Date: 2020-11-11
• Subjects: influenza -- vaccination -- high-dose -- autologous stem cell transplant; Communicable diseases -- Periodicals; 616.905
• DOI: 10.1093/cid/ciaa1711
• Languages: English
• ISSNs: 1058-4838

Abstract

Abstract: Background: Seroprotection and seroconversion rates are not well understood for 2-dose inactivated influenza vaccination (IIV) schedules in autologous hematopoietic stem cell transplantation (autoHCT) patients. Methods: A randomized, single-blind, controlled trial of IIV in autoHCT patients in their first year post-transplant was conducted. Patients were randomized 1:1 to high-dose (HD) IIV followed by standard dose (SD) vaccine (HD-SD arm) or 2 SD vaccines (SD-SD arm) 4 weeks apart. Hemagglutination inhibition (HI) assay for IIV strains was performed at baseline, 1, 2, and 6 months post–first dose. Evaluable primary outcomes were seroprotection (HI titer ≥40) and seroconversion (4-fold titer increase) rates and secondary outcomes were geometric mean titers (GMTs), GMT ratios (GMRs), adverse events, influenza-like illness (ILI), and laboratory-confirmed influenza (LCI) rates and factors associated with seroconversion. Results: Sixty-eight patients were enrolled (34/arm) with median age of 61.5 years, majority male (68%) with myeloma (68%). Median time from autoHCT to vaccination was 2.3 months. For HD-SD and SD-SD arms, percentages of patients achieving seroprotection were 75.8% and 79.4% for H1N1, 84.9% and 88.2% for H3N2 (all P > .05), and 78.8% and 97.1% for influenza-B/Yamagata ( P = .03), respectively. Seroconversion rates, GMTs and GMRs, and number of ILI or LCIs were not significantly different between arms. Adverse event rates were similar. Receipt of concurrent cancer therapy was independently associated with higher odds of seroconversion (OR, 4.3; 95% CI, 1.2–14.9; P = .02). Conclusions: High seroprotection and seroconversion rates against all influenza strains can be achieved with vaccination as early as 2 months post-autoHCT with either 2-dose vaccine schedules. Clinical Trials Registration: Australian New Zealand Clinical Trials Registry: ACTRN12619000617167. Abstract : This study supports early influenza vaccination (IIV) following autologous hematopoietic stem cell transplantation (HCT) and 2-dose IIV schedules with high rates of seroprotection and seroconversion to all influenza vaccine strains reported with vaccination as early as 2 months following HCT.