Herpes Zoster Clinical Trial
Official title:
A Double-Blind, Randomized, Placebo Controlled, Parallel Group Study to Evaluate Biomarkers of Immunity to Varicella Zoster Virus Following Immunization With V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine or With ZOSTAVAX in Healthy Volunteers
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.
All eligible participants, regardless of treatment group, were administered three injections of the varicella antigen (VZV Skin Test reagent), 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. Reactions to the skin test were assessed by the same examiner for each participant to the greatest extent possible. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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