NCT00696709

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 50 Years – 59 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
BIOLOGICAL	Comparator: V212	0.65 mL subcutaneous injection of heat-treated Varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered \~30 days apart
BIOLOGICAL	Comparator: Placebo	Placebo; 4-dose regimen administered \~30 days apart.

Timeline

• Start date: 2008-12-12
• Primary completion: 2009-11-16
• Completion: 2009-11-16
• First posted: 2008-06-13
• Last updated: 2019-11-08
• Results posted: 2019-11-08