A Randomized Trial of Two 2-Dose Influenza Vaccination Strategies for Patients Following Autologous Hematopoietic Stem Cell Transplantation
| العنوان: | A Randomized Trial of Two 2-Dose Influenza Vaccination Strategies for Patients Following Autologous Hematopoietic Stem Cell Transplantation |
|---|---|
| المؤلفون: | Vivian K.Y. Leung, Trish Joyce, Leon J Worth, Simon J. Harrison, Benjamin W Teh, Monica A. Slavin, Ian G. Barr, Francesca L Mordant, Kanta Subbarao, Arseniy Khvorov, Sheena G. Sullivan |
| المصدر: | Clinical Infectious Diseases. 73:e4269-e4277 |
| بيانات النشر: | Oxford University Press (OUP), 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Male, Microbiology (medical), medicine.medical_specialty, Antibodies, Viral, law.invention, 03 medical and health sciences, Influenza A Virus, H1N1 Subtype, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Influenza, Human, medicine, Humans, Single-Blind Method, Seroconversion, Adverse effect, business.industry, Influenza A Virus, H3N2 Subtype, Vaccination, Australia, Hematopoietic Stem Cell Transplantation, Hemagglutination Inhibition Tests, Middle Aged, Transplantation, Titer, Infectious Diseases, Clinical research, Vaccines, Inactivated, Immunization, Influenza Vaccines, 030220 oncology & carcinogenesis, business, 030215 immunology |
| الوصف: | 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. |
| تدمد: | 1537-6591 1058-4838 1261-9000 |
| DOI: | 10.1093/cid/ciaa1711 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d8f8d0ff0bf1b7627b06fb1c87bac038 https://doi.org/10.1093/cid/ciaa1711 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....d8f8d0ff0bf1b7627b06fb1c87bac038 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15376591 10584838 12619000 |
|---|---|
| DOI: | 10.1093/cid/ciaa1711 |