A Study to Evaluate Immunity to Varicella Zoster Virus After Immunization With V212 Vaccine or Zostavax (V212-003)
Condition: Herpes Zoster
MeSH terms: Herpes Zoster; Chickenpox
Intervention: V212; Comparator: Zostavax™; Comparator: Placebo; VZV Skin Test; Saline
Intervention description: Two doses of 0.65 mL V212 subcutaneous injection administered at Day 1 and Day 31; Two doses of 0.65 mL Zostavax™ subcutaneous injection administered at Day 1 and Day 31; Two doses of 0.65 mL subcutaneous injection of placebo administered at Day 1 and Day 31; Three intradermal injections of the 0.1 ml varicella antigen (VZV Skin Test reagent) were administered, once at baseline before the first vaccination, a second time before the second vaccination, and a third time approximately 14 days after the second vaccination.; One intradermal injection of the 0.1 ml saline was administered at the time of the baseline VZV skin test prior to the first vaccination. Saline and VZV skin test reagents were administered on opposite arms.
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A study in two parts (Part A and Part B) to evaluate the responsiveness of various biomarkers
      of immunity to Varicella-Zoster Virus (VZV) following repeated immunizations with heat
      treated VZV vaccine V212 or with Zostavax™.

      The enrollment of participants into this study was conducted in 2 parts, Part A and Part B.
      The first 42 eligible participants were enrolled into Part A of the study. In Part A, the
      reaction of the VZV skin test at baseline was evaluated at both 48 and 72 hours post
      administration of the VZV skin test reagent and saline (in opposite arms), with 2 examiners
      performing the reading at each timepoint; all subsequent skin test readings in Part A were
      performed at 48 hours post administration. After all skin test reactions were obtained at
      baseline for the 42 subjects in Part A, an interim analysis was performed (1) to assess the
      frequency of baseline negative skin tests in order to confirm that the planned sample size
      (N=120) was adequate for an evaluation of the effect of vaccination on the VZV Skin Test, and
      (2) to assess the frequency of baseline positive skin tests at 72 hours relative to 48 hours
      (post administration) in order to determine the preferred time for evaluation of the skin
      test reaction.

      The interim analysis from Part A confirmed the study sample size, an additional 78 subjects
      were enrolled into Part B to achieve the planned sample size (N=120). The study procedures
      for Part B of the study were identical to those in Part A with the following exceptions: (1)
      baseline skin test readings were performed only once, at either 48 or 72 hours (post
      administration) to accommodate the scheduling of clinic visits, and (2) only one examiner was
      needed for the skin test reading at baseline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has prior history of Varicella

          -  Female participants are of non-childbearing potential

        Exclusion Criteria:

          -  Participant has had a hypersensitivity reaction to any vaccine component

          -  Participant has a prior history of Herpes Zoster

          -  Participant has received any Varicella or Zoster vaccine including Zostavax

          -  Participant has a history of immunosuppression caused by disease, corticosteroids,
             cancer therapy or organ transplant

          -  Participant has an active cancer

          -  Participant has received or will receive a live virus vaccine or an inactivated virus
             vaccine 4 weeks prior to participating in study (with the exception of influenza
             vaccine)

          -  Participant is not bed-ridden or homebound