Safety & Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Intervention: Herpes Zoster Vaccine 1437173A; Placebo vaccine (saline)
Intervention description: Different formulations of investigational vaccine (GSK 1437173A) administered in 2 or 3 doses intramuscularly.; 1 or 3 doses of Placebo (saline) injected intramuscularly.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vaccine; Safety; Herpes Zoster; Immunogenicity; Stem cell transplantation

Summary:

      The purpose of this observer-blind study is to evaluate the safety and immunogenicity of
      GlaxoSmithKline Biologicals' investigational Herpes Zoster vaccine GSK1437173A when
      administered as 2 doses or 3 doses to hematopoietic stem cell transplant (HCT) recipients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol;

          -  Male and female subjects at least 18 years old at the time of vaccination;

          -  Serological evidence of prior VZV infection for all subjects born in 1980 or later and
             for subjects born outside the US before 1980 in a tropical or sub-tropical region. No
             testing for serological evidence of prior VZV infection is required for US subjects
             born before 1980;

          -  Has undergone autologous HCT within the past 50-70 days for treatment of Hodgkin
             lymphoma, non-Hodgkin lymphoma (T or B cell), myeloma or acute myeloid leukemia, and
             there are no plans for additional HCTs

          -  Written informed consent obtained from the subject;

          -  If the subject is female, she must be of non-childbearing potential or if she is of
             childbearing potential, she must practice adequate contraception for 30 days prior to
             vaccination, have a negative pregnancy test and continue such precautions for 2 months
             after completion of the vaccination series.

        Exclusion Criteria:

          -  Use of any investigational non-registered product other than the study vaccine(s)
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period;

          -  Administration or planned administration of a vaccine that is not part of the study
             protocol since transplantation. However licensed non-replicating vaccines (i.e.
             inactivated and subunit vaccines, including inactivated and subunit influenza
             vaccines, with or without adjuvant) may be administered up to 8 days prior to dose 1;

          -  Administration of immunoglobulins since transplantation;

          -  Previous vaccination against varicella or HZ;

          -  History of HZ within the previous 12 months;

          -  Known exposure to VZV since transplantation;

          -  Evidence of active infection at the time of enrollment including a temperature of ≥
             37.5° C or any serious HCT-related complication;

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine;

          -  Hypersensitivity or intolerance to acyclovir or valacyclovir;

          -  Pregnant or lactating female.