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Immunogenicity and safety of a two‐dose live attenuated varicella vaccine given to adults following autologous hematopoietic stem cell transplantation
Author(s) -
Sasadeusz J.,
Prince H.M.,
Schwarer A.,
Szer J.,
Stork A.,
Bock H.L.,
Povey M.,
Nicholson O.,
Innis B.L.
Publication year - 2014
Publication title -
transplant infectious disease
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.69
H-Index - 67
eISSN - 1399-3062
pISSN - 1398-2273
DOI - 10.1111/tid.12295
Subject(s) - immunogenicity , medicine , hematopoietic stem cell transplantation , immunology , hematopoietic stem cell , stem cell , varicella vaccine , chickenpox vaccine , transplantation , attenuated vaccine , virology , haematopoiesis , antibody , immunization , biology , biochemistry , virulence , gene , genetics
Background Immunogenicity and safety of varicella vaccine ( Varilrix ™ [Oka‐ RIT ]; GlaxoSmithKline Vaccines) in adults who had undergone autologous hematopoietic stem cell transplantation ( HSCT ) were assessed (September 2003 to September 2007; NCT 00792623). Methods Two Oka‐ RIT doses were given at 4.5 and 6.5 months post transplantation. Humoral immune responses were assessed using an immunofluorescence assay (anti‐varicella zoster virus [ VZV ] antibody; cutoff 1:4) after each vaccine dose. Solicited local (8 day) and general (43 day), unsolicited (until day 43) adverse events ( AE s) after each vaccine dose and serious adverse events ( SAE s) (until 17.5 months post dose 2) were recorded. Results Of 45 patients, 19 were included in the according to protocol cohort for immunogenicity; 15 patients had pre‐ and post‐vaccination serum samples positive for anti‐ VZV antibodies. Vaccine responses (anti‐ VZV antibody titer ≥1:4 in seronegative patients, and ≥4‐fold increase in anti‐ VZV antibody titer in seropositive patients) were elicited by only 2 patients 2 months post dose 1, and by a single patient 1.5 months post dose 2. Although no major safety signals were detected, any and Grade 3 solicited AE s that were causally related to vaccination were reported by 44.8% and 10.3% patients, respectively. During the 43‐day follow‐up period, 3 patients developed varicella‐like rash (1 vaccine‐type VZV ). Beyond 43 days, herpes zoster was reported in 2 patients and wild‐type varicella infection in 2 patients (1 was breakthrough infection). Four non‐fatal SAE s were reported by patients and considered causally unrelated to vaccination. Conclusion Oka‐ RIT was poorly immunogenic but safe when given to adults up to 6 months post autologous HSCT , and alternative strategies are required to prevent VZV ‐associated complications in these populations.