Hana Hakim1, Kim J Allison2, Lee-Ann Van de Velde2, Li Tang3, Yilun Sun3, Patricia M Flynn4, Jonathan A McCullers5. 1. Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, USA; Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA. Electronic address: Hana.Hakim@stjude.org. 2. Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, USA. 3. Department of Biostatistics, St. Jude Children's Research Hospital, Memphis, TN, USA. 4. Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, USA; Department of Pediatrics, University of Tennessee Health Science Center, Memphis, TN, USA; Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, USA. 5. Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, TN, USA; Department of Pediatrics, University of Tennessee Health Science Center, Memphis, TN, USA. Electronic address: jmccullers@uthsc.edu.
Abstract
BACKGROUND: Approaches to improve the immune response of immunocompromised patients to influenza vaccination are needed. METHODS:Children and young adults (3-21 years) with cancer or HIV infection were randomized to receive 2 doses of high-dose (HD) trivalent influenza vaccine (TIV) or of standard-dose (SD) TIV. Hemagglutination inhibition (HAI) antibody titers were measured against H1, H3, and B antigens after each dose and 9 months later. Seroconversion was defined as ≥4-fold rise in HAI titer comparing pre- and post-vaccine sera. Seroprotection was defined as a post-vaccine HAI titer ≥1:40. Reactogenicity events (RE) were solicited using a structured questionnaire 7 and 14 days after each dose of vaccine, and adverse events by medical record review for 21 days after each dose of vaccine. RESULTS:Eighty-five participants were enrolled in the study; 27 with leukemia, 17 with solid tumor (ST), and 41 with HIV. Recipients of HD TIV had significantly greater fold increase in HAI titers to B antigen in leukemia group and to H1 antigen in ST group compared to SD TIV recipients. This increase was not documented in HIV group. There were no differences in seroconversion or seroprotection between HD TIV and SD TIV in all groups. There was no difference in the percentage of solicited RE in recipients of HD TIV (54% after dose 1 and 38% after dose 2) compared to SD TIV (40% after dose 1 and 20% after dose 2, p=0.27 and 0.09 after dose 1 and 2, respectively). CONCLUSION: HD TIV was more immunogenic than SD TIV in children and young adults with leukemia or ST, but not with HIV. HD TIV was safe and well-tolerated in children and young adults with leukemia, ST, or HIV.
RCT Entities:
BACKGROUND: Approaches to improve the immune response of immunocompromised patients to influenza vaccination are needed. METHODS:Children and young adults (3-21 years) with cancer or HIV infection were randomized to receive 2 doses of high-dose (HD) trivalent influenza vaccine (TIV) or of standard-dose (SD) TIV. Hemagglutination inhibition (HAI) antibody titers were measured against H1, H3, and B antigens after each dose and 9 months later. Seroconversion was defined as ≥4-fold rise in HAI titer comparing pre- and post-vaccine sera. Seroprotection was defined as a post-vaccine HAI titer ≥1:40. Reactogenicity events (RE) were solicited using a structured questionnaire 7 and 14 days after each dose of vaccine, and adverse events by medical record review for 21 days after each dose of vaccine. RESULTS: Eighty-five participants were enrolled in the study; 27 with leukemia, 17 with solid tumor (ST), and 41 with HIV. Recipients of HDTIV had significantly greater fold increase in HAI titers to B antigen in leukemia group and to H1 antigen in ST group compared to SD TIV recipients. This increase was not documented in HIV group. There were no differences in seroconversion or seroprotection between HDTIV and SD TIV in all groups. There was no difference in the percentage of solicited RE in recipients of HDTIV (54% after dose 1 and 38% after dose 2) compared to SD TIV (40% after dose 1 and 20% after dose 2, p=0.27 and 0.09 after dose 1 and 2, respectively). CONCLUSION:HDTIV was more immunogenic than SD TIV in children and young adults with leukemia or ST, but not with HIV. HDTIV was safe and well-tolerated in children and young adults with leukemia, ST, or HIV.
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