PMID- 25272081
OWN - NLM
STAT- MEDLINE
DCOM- 20150827
LR  - 20141222
IS  - 1399-3062 (Electronic)
IS  - 1398-2273 (Linking)
VI  - 16
IP  - 6
DP  - 2014 Dec
TI  - Immunogenicity and safety of a two-dose live attenuated varicella vaccine given 
      to adults following autologous hematopoietic stem cell transplantation.
PG  - 1024-31
LID - 10.1111/tid.12295 [doi]
AB  - 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. 
      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 AEs 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 SAEs 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.
CI  - (c) 2014 GlaxoSmithKline Biologicals S. A. Transplant Infectious Diseases published 
      by John Wiley & Sons Ltd.
FAU - Sasadeusz, J
AU  - Sasadeusz J
AD  - Victorian Infectious Disease Service, Royal Melbourne Hospital, Melbourne, 
      Australia.
FAU - Prince, H M
AU  - Prince HM
FAU - Schwarer, A
AU  - Schwarer A
FAU - Szer, J
AU  - Szer J
FAU - Stork, A
AU  - Stork A
FAU - Bock, H L
AU  - Bock HL
FAU - Povey, M
AU  - Povey M
FAU - Nicholson, O
AU  - Nicholson O
FAU - Innis, B L
AU  - Innis BL
LA  - eng
SI  - ClinicalTrials.gov/NCT00792623
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20141001
PL  - Denmark
TA  - Transpl Infect Dis
JT  - Transplant infectious disease : an official journal of the Transplantation 
      Society
JID - 100883688
RN  - 0 (Antibodies, Viral)
RN  - 0 (Chickenpox Vaccine)
SB  - IM
MH  - Adult
MH  - Antibodies, Viral/blood
MH  - Chickenpox Vaccine/administration & dosage/adverse effects/*immunology
MH  - *Hematopoietic Stem Cell Transplantation
MH  - Herpesvirus 3, Human/immunology
MH  - Humans
MH  - Immunization Schedule
OTO - NOTNLM
OT  - immunogenicity
OT  - safety
OT  - transplantation
OT  - varicella vaccine
OT  - varicella zoster
EDAT- 2014/10/02 06:00
MHDA- 2015/08/28 06:00
CRDT- 2014/10/02 06:00
PHST- 2014/04/01 00:00 [received]
PHST- 2014/07/01 00:00 [revised]
PHST- 2014/08/18 00:00 [revised]
PHST- 2014/08/21 00:00 [accepted]
PHST- 2014/10/02 06:00 [entrez]
PHST- 2014/10/02 06:00 [pubmed]
PHST- 2015/08/28 06:00 [medline]
AID - 10.1111/tid.12295 [doi]
PST - ppublish
SO  - Transpl Infect Dis. 2014 Dec;16(6):1024-31. doi: 10.1111/tid.12295. Epub 2014 Oct 
      1.