tetano
Editor, Senior Moderator
Biol Blood Marrow Transplant. 2015 Dec 16. pii: S1083-8791(15)01864-9. doi: 10.1016/j.bbmt.2015.12.003. [Epub ahead of print]
[h=1]Randomized, Double Blind, Study of the safety and Immunogenicity of Standard-Dose Trivalent Inactivated Influenza Vaccine versus High-Dose Trivalent Inactivated Influenza Vaccine in Adult Hematopoietic Stem Cell Transplant Patients.[/h] Halasa NB[SUP]1[/SUP], Savani BN[SUP]2[/SUP], Asokan I[SUP]3[/SUP], Kassim A[SUP]2[/SUP], Simons R[SUP]2[/SUP], Summers C[SUP]2[/SUP], Bourgeois J[SUP]2[/SUP], Clifton C[SUP]2[/SUP], Vaughan LA[SUP]2[/SUP], Lucid C[SUP]4[/SUP], Wang L[SUP]5[/SUP], Fonnesbeck C[SUP]5[/SUP], Jagasia M[SUP]2[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Hematopoietic stem cell transplantation (HCT) survivors are less likely to mount a strong immune response to trivalent inactivated influenza vaccine (TIV) when compared to matched, healthy controls.
[h=4]METHODS:[/h] High-dose (HD) or standard-dose (SD) TIV was given to adult HCT subjects 18 years or older at least six months post-transplant. Subjects were randomized 2:1 to receive either the HD (60μg hemagglutinin [HA]/strain/dose) or the SD (15μg HA/strain/dose) TIV. Injection-site and systemic reactions were documented after each vaccination and immune responses were measured before and after each vaccination.
[h=4]RESULTS:[/h] A total of 44 subjects were enrolled (25 in year 1 and 19 in year 2), with 15 in the SD group and 29 in the HD group. The median time to vaccination after transplantation was 7.9 months (range 6-106 months); median age was 50 years (range, 19.6-73 years); and 61% were male. No differences in demographic or lab data were noted between groups; however, the HD group had higher median baseline total IgG level (676 vs. 469 mg/dL, p=0.025). No differences in individual injection-site or systemic reactions were noted in the HD compared to the SD group; however, more events of any injection-site symptom combined were reported in the HD group. No serious adverse events were attributed to vaccination. Post-vaccination, the HD group had a higher percentage of individuals with titers >1:40 and a higher geometric mean titer (GMT) against the H3N2 strain compared to the SD group.
[h=4]CONCLUSION:[/h] HD and SD TIV were found to be safe and well tolerated in adult HCT recipients. However, the HD group had higher frequency of injection-site reactions, but the majority of the reactions were mild and resolved.. The HD group had a higher percentage of individuals with post-vaccination titer >1:40 and GMT for H3N2 antigen, indicating better immunogenicity. These data support the need for a phase II immunogenicity trial in HCT recipients.
Copyright ? 2015 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.
[h=4]KEYWORDS:[/h] and hematopoietic stem cell transplant; influenza; vaccination
PMID: 26705931 [PubMed - as supplied by publisher]
[h=1]Randomized, Double Blind, Study of the safety and Immunogenicity of Standard-Dose Trivalent Inactivated Influenza Vaccine versus High-Dose Trivalent Inactivated Influenza Vaccine in Adult Hematopoietic Stem Cell Transplant Patients.[/h] Halasa NB[SUP]1[/SUP], Savani BN[SUP]2[/SUP], Asokan I[SUP]3[/SUP], Kassim A[SUP]2[/SUP], Simons R[SUP]2[/SUP], Summers C[SUP]2[/SUP], Bourgeois J[SUP]2[/SUP], Clifton C[SUP]2[/SUP], Vaughan LA[SUP]2[/SUP], Lucid C[SUP]4[/SUP], Wang L[SUP]5[/SUP], Fonnesbeck C[SUP]5[/SUP], Jagasia M[SUP]2[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Hematopoietic stem cell transplantation (HCT) survivors are less likely to mount a strong immune response to trivalent inactivated influenza vaccine (TIV) when compared to matched, healthy controls.
[h=4]METHODS:[/h] High-dose (HD) or standard-dose (SD) TIV was given to adult HCT subjects 18 years or older at least six months post-transplant. Subjects were randomized 2:1 to receive either the HD (60μg hemagglutinin [HA]/strain/dose) or the SD (15μg HA/strain/dose) TIV. Injection-site and systemic reactions were documented after each vaccination and immune responses were measured before and after each vaccination.
[h=4]RESULTS:[/h] A total of 44 subjects were enrolled (25 in year 1 and 19 in year 2), with 15 in the SD group and 29 in the HD group. The median time to vaccination after transplantation was 7.9 months (range 6-106 months); median age was 50 years (range, 19.6-73 years); and 61% were male. No differences in demographic or lab data were noted between groups; however, the HD group had higher median baseline total IgG level (676 vs. 469 mg/dL, p=0.025). No differences in individual injection-site or systemic reactions were noted in the HD compared to the SD group; however, more events of any injection-site symptom combined were reported in the HD group. No serious adverse events were attributed to vaccination. Post-vaccination, the HD group had a higher percentage of individuals with titers >1:40 and a higher geometric mean titer (GMT) against the H3N2 strain compared to the SD group.
[h=4]CONCLUSION:[/h] HD and SD TIV were found to be safe and well tolerated in adult HCT recipients. However, the HD group had higher frequency of injection-site reactions, but the majority of the reactions were mild and resolved.. The HD group had a higher percentage of individuals with post-vaccination titer >1:40 and GMT for H3N2 antigen, indicating better immunogenicity. These data support the need for a phase II immunogenicity trial in HCT recipients.
Copyright ? 2015 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.
[h=4]KEYWORDS:[/h] and hematopoietic stem cell transplant; influenza; vaccination
PMID: 26705931 [PubMed - as supplied by publisher]