NCT01527383

A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Adults With Autoimmune Disease (V212-009)

A Phase II Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients With Autoimmune Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 354 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a study to evaluate the safety and immunogenicity of V212 vaccine in adults with autoimmune disease, including participants with rheumatoid arthritis, psoriatic arthritis, psoriasis, inflammatory bowel disease, systemic lupus erythematosus, multiple sclerosis, and other similar diseases. The primary hypothesis is that vaccination with V212 vaccine will elicit significant VZV-specific immune responses at approximately 28 days after vaccination 4. The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is \>1.0.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
BIOLOGICAL	V212	V212 viral antigen for HZ
BIOLOGICAL	Placebo	Placebo comparator to V212 vaccine

Timeline

• Start date: 2012-02-21
• Primary completion: 2013-02-26
• Completion: 2013-02-26
• First posted: 2012-02-07
• Last updated: 2019-01-14
• Results posted: 2019-01-14