Immunogenicity and safety of a two-dose live attenuated varicella vaccine given to adults following autologous hematopoietic stem cell transplantation
J Sasadeusz, HM Prince, A Schwarer, J Szer, A Stork, HL Bock, M Povey, O Nicholson, BL Innis
Transplant Infectious Disease | WILEY-BLACKWELL | Published : 2014
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; NCT00792623). 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 (AEs) after each vaccine dose and serious adverse events (SAEs) (until 17.5 months post dose 2) were recorded. RESULT..View full abstract
This study was sponsored by GlaxoSmithKline Biologicals SA. GlaxoSmithKline Biologicals SA was involved in all stages of the study conduct and analysis and also funded all costs associated with the development and the publishing of the present manuscript. The authors had full access to the data and the corresponding author was responsible for submission of the publication.