A Study to Test the Safety and Antibody Response of V212 in Healthy Adults (V212-004)(COMPLETED)

A Phase I, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of V212 in Healthy Adults

The purpose of this study was to assess the safety and tolerability of gamma-irradiated varicella-zoster virus (VZV) vaccine A (Part 1) and gamma-irradiated VZV vaccine B and C (Part 2) and to determine if they were immunogenic when administered to healthy individuals, as measured by VZV-specific antibody responses by glycoprotein enzyme-linked immunosorbent assay (gpELISA). The primary hypothesis was that gamma-irradiated VZV vaccine A (Part 1) and gamma-irradiated VZV vaccine B and C (Part 2) would elicit an acceptable VZV-specific immune response. The secondary hypothesis for Part 1 of the study was that heat-treated VZV vaccine would elicit an acceptable VZV-specific immune response.

Inclusion Criteria:

• Must be 50 to 59 years of age
• No fever on vaccination days
• Must have had chickenpox or lived in an area where the chickenpox virus is prevalent for 30 or more years
• Females of child-bearing potential must use acceptable forms of birth control

Exclusion Criteria:

• Prior history of shingles
• Prior receipt of any chickenpox or shingles vaccine
• Pregnant or breastfeeding
• Received or expect to receive a live virus vaccine (such as measles, mumps, rubella) from 4 weeks before the first visit through the last visit
• Received or expect to receive an inactivated vaccine (such as tetanus or pneumonia) from 7 days before the first visit through the last visit
• Received immunoglobulin or blood products
• Receiving treatment that may weaken the immune system
• Have an immune system disorder