Comparison of Two High-Dose Versus Two Standard-Dose Influenza Vaccines in Adult Allogeneic Hematopoietic Cell Transplant Recipients

Author:

Thomas Lora D1ORCID,Batarseh Einas2,Hamdan Lubna2,Haddadin Zaid2,Dulek Daniel2,Kalams Spyros2,Stewart Laura S3,Stahl Anna L2,Rahman Herdi2,Amarin Justin Z2,Hayek Haya2,Ison Michael4,Overton Edgar T5,Pergam Steven A6,Spieker Andrew J7,Halasa Natasha B2,Savani B,Kassim ,Logue M,Barto S,McHenry R,Tanna S,Bezler L,Al-Saden P,Marshall M,Salzman D,Greenstein A,Jackson A,Wright S,Flowers M,Loeffelholz M,Marquis S,Nguyen E,

Affiliation:

1. Department of Medicine, Virginia Commonwealth University Medical Center , Richmond, Virginia , USA

2. Department of Pediatrics, Vanderbilt University Medical Center , Nashville, Tennessee , USA

3. 3Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA

4. Respiratory Disease Branch, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health , Rockville, Maryland , USA

5. Department of Medicine, University Hospital, University of Alabama at Birmingham , Birmingham, Alabama , USA

6. Department of Medicine, Fred Hutchinson Cancer Center , Seattle, Washington , USA

7. Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USA

Abstract

Abstract Background Adult hematopoietic cell transplant (HCT) recipients are at high risk for influenza-related morbidity and mortality and have suboptimal influenza vaccine immune responses compared to healthy adults, particularly within 2 years of transplant. Methods This phase II, double-blind, multicenter randomized controlled trial compared 2 doses of high-dose trivalent (HD-TIV) to 2 doses of standard-dose quadrivalent (SD-QIV) influenza vaccine administered 1 month apart in adults 3–23 months post-allogeneic HCT. Hemagglutinin antibody inhibition (HAI) titers were measured at baseline, 4 weeks following each vaccine dose, and approximately 7 months post-second vaccination. Injection-site and systemic reactions were assessed for 7 days post-vaccination. The primary immunogenicity comparison was geometric mean HAI titer (GMT) at visit 3 (4 weeks after the second dose); we used linear mixed models to estimate adjusted GMT ratios (aGMRs) comparing HD-TIV/SD-QIV for each antigen. Results We randomized 124 adults; 64 received SD-QIV and 60 received HD-TIV. Following the second vaccination, HD-TIV was associated with higher GMTs compared to SD-QIV for A/H3N2 (aGMR = 2.09; 95% confidence interval [CI]: [1.19, 3.68]) and B/Victoria (aGMR = 1.61; 95% CI: [1.00, 2.58]). The increase was not statistically significant for A/H1N1 (aGMR = 1.16; 95% CI: [0.67, 2.02]). There was a trend to more injection-site reactions for HD-TIV after the second vaccination compared to SD-QIV (50% vs 33%; adjusted odds ratio [aOR] = 4.53; 95% CI: [0.71, 28.9]), whereas systemic reactions were similar between groups with both injections. Conclusions Adult allogeneic HCT recipients who received 2 doses of HD-TIV produced higher HAI antibody responses for A/H3N2 and B/Victoria compared with 2 doses of SD-QIV, with comparable injection-site or systemic reactions.

Funder

NIH

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Microbiology (medical)

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