Safety, Tolerability, and Immunogenicity of a Booster Dose of Zoster Vaccine, Live (V211-029)
Condition: Herpes Zoster; Varicella-zoster Vaccine
MeSH terms: Herpes Zoster
Intervention: Zoster Vaccine, Live
Intervention description: Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 600.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Shingles; Vaccine

Summary:

      This study was conducted to obtain safety and immunogenicity data after a booster dose of
      Zoster Vaccine, Live administered ≥10 years following an initial dose. This information was
      compared to similar information obtained after Zoster Vaccine, Live administration to
      age-matched and younger participants who received their first dose of Zoster Vaccine, Live.
      The study was designed to determine: 1) whether a booster dose of Zoster Vaccine, Live in
      participants ≥70 years of age induces an antibody response that is noninferior to that of a
      first dose of Zoster Vaccine, Live in participants matched for age; 2) whether a booster dose
      of Zoster Vaccine, Live induces an acceptable rise in the level of varicella-zoster virus
      (VZV) antibodies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All Groups:

               -  Must not have a fever of ≥100.4° F on the day of vaccination

               -  Any underlying chronic illness must be in stable condition

               -  History of varicella or residence in a VZV-endemic area for ≥30 years

          -  Group 1:

               -  70 years of age or older

               -  Took part in the Shingles Prevention Study (SPS) (V211-004, NCT00007501) and
                  received a single dose of Zoster Vaccine, Live ≥10 years prior to enrollment in
                  this study

          -  Group 2:

               -  70 years of age or older

          -  Group 3:

               -  60 to 69 years of age

          -  Group 4:

               -  50 to 59 years of age

        Exclusion Criteria:

          -  All Groups:

               -  History of hypersensitivity reaction to any vaccine component or an
                  anaphylactic/anaphylactoid reaction to neomycin

               -  Prior history of herpes zoster

               -  Pregnant or breast-feeding, or expecting to conceive within the duration of the
                  study

               -  Has been treated with immunoglobulin or any blood products, other than autologous
                  (self-donated) blood transfusion, in the 5 months prior to vaccination

               -  Received any other vaccine within 4 weeks prevaccination

               -  On immunosuppressive therapy

               -  Has known or suspected immune dysfunction

               -  Is taking any non-topical antiviral therapy with activity against herpesviruses,
                  including, but not limited to acyclovir, famciclovir, valacyclovir, and
                  ganciclovir.

          -  Groups 2, 3, and 4:

               -  Has previously received any varicella or zoster vaccine