Improved immunogenicity of high-dose influenza vaccine compared to standard-dose influenza vaccine in adult oncology patients younger than 65 years receiving chemotherapy: A pilot randomized clinical trial |
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| Affiliation: | 1. Rochester General Hospital, 1425 Portland Ave, Rochester, NY 14621, USA;2. Department of Medicine University of Rochester School of Medicine and Rochester General Hospital, 1425 Portland Ave, Rochester, NY 14621, USA;3. Nazareth College, Department of Nursing, 4245 East Avenue, Rochester, NY 14618, USA;1. Investigational Cancer Therapeutics (Phase I Program), University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA;2. Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada;3. Early Phase Clinical Drug Development in Oncology, START Madrid-CIOCC, Centro Integral Oncológico Clara Campal, Madrid, Spain;4. Department of Medical Oncology, Erasmus MC Cancer Institute, Erasmus University Medical Center Rotterdam, Rotterdam, Netherlands;5. Early Phase Clinical Trials Program, Yale University Medical Center, New Haven, CT, USA;6. Department of Drug Development, Gustave Roussy Cancer Institute, University Paris Saclay, Villejuif, France;7. Northern Institute for Cancer Care, Freeman Hospital and Newcastle University, Newcastle upon Tyne, UK;8. The Institute of Cancer Research, London, UK;9. Royal Marsden NHS Foundation Trust, London, UK;10. Department of Medical Oncology, Vall d''Hebron Institute of Oncology, Vall d''Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain;1. Department of Infectious Diseases, Belarusian State Medical University, Minsk, Belarus;2. Minsk Scientific and Practical Center of Surgery, Transplantology and Hematology, Belarus;1. Servicio de Medicina Preventiva, Calidad y Seguridad del paciente, Gerencia de Atención Especializada Áreas III y IV, Hospital de Sierrallana, Torrelavega, Cantabria, España;2. Servicio de Medicina Preventiva, Hospital Obispo Polanco, Teruel, España;3. Servicio de Hematología y Hemoterapia, Hospital San Jorge, Huesca, España;1. Multi-Organ Transplant Program, University Health Network, Toronto, Ontario, Canada;2. Division of Infectious Diseases, Moffitt Cancer Center, Tampa, FL, United States;1. Department of Medical Oncology, Centre Léon Bérard Cancer Center, Lyon, France;2. Department of Pharmaceutical Oncology, Centre Léon Bérard Cancer Center, Lyon, France;3. Department of Surgery, Centre Léon Bérard Cancer Center, Lyon, France;4. Lyon East Faculty of Medicine, Université Claude Bernard Lyon 1, Lyon, France;5. President, Unicancer, Paris, France;1. Protein Sciences Corporation, Meriden, CT, United States;2. Yale University School of Medicine, New Haven, CT, United States;3. University of Colorado Denver School of Medicine, Aurora, CO, United States;4. Biologics Consulting Group, Inc., Bethesda, MD, United States |
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| Abstract: | PurposePatients undergoing chemotherapy often fail to develop robust responses to influenza vaccination. Compared to standard-dose influenza vaccine (SD), high-dose influenza vaccine (HD) has shown improved immunogenicity and protection against influenza illness in adults 65 years and older. This study compared the immunogenicity and tolerability of HD to SD in adults younger than 65 years of age receiving chemotherapy.MethodsThis double-blind study randomized patients receiving chemotherapy to vaccination with either SD or HD influenza vaccine. Hemagglutination inhibition assays (HAI) were performed prior to and 4 weeks after vaccination. HAI were summarized as geometric mean titers (GMT), seroconversion rates, and seroprotection rates.ResultsA total of 105 subjects were enrolled in the trial (51 received SD and 54 received HD). Subjects were well matched for demographic and medical conditions. Both vaccines were well tolerated with no SAEs. Of the 100 subjects with evaluable data, seroconversion rates for all 3 influenza antigens & post-vaccination GMTs for H3N2 & B strains were significantly improved with HD compared to SD. Seroprotection was excellent and equivalent in both groups.ConclusionsTrivalent high-dose influenza vaccine can be safely administered to patients receiving chemotherapy with improved immunogenicity and seroconversion compared to standard-dose vaccine. Post-vaccination seroprotection rates were similar in both groups. A larger study is needed to show clinical benefits with HD in this population.This study was registered at ClinicalTrials.gov as NCT01666782. |
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