A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Adults With Autoimmune Disease (V212-009)
This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of V212 when administered to adults with autoimmune disease.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Phase II Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients With Autoimmune Disease|
- Geometric mean fold rise in varicella-zoster virus (VZV) antibody response as measured by glycoprotein enzyme-linked immunosorbent assay (gpELISA) [ Time Frame: Approximately 28 days postdose 4 ] [ Designated as safety issue: No ]
- Geometric mean fold rise in the VZV-specific immune responses measured by VZV interferon-gamma (IFN-g) ELISPOT [ Time Frame: Approximately 28 days postdose 4 ] [ Designated as safety issue: No ]
- Incidence of serious adverse events [ Time Frame: Through 28 days postdose 4 ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2012|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
V212 viral antigen for Herpes Zoster (HZ), 0.5 mL subcutaneous injection per dose, in a 4-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Other Name: Inactivated VZV vaccine
|Placebo Comparator: Placebo||
Vaccine stabilizer for V212 with no virus antigen, 0.5 mL subcutaneous per dose, in a 4-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and immunogenicity of V212 vaccine in adults with autoimmune disease, including patients with rheumatoid arthritis, psoriatic arthritis, psoriasis, inflammatory bowel disease, systemic lupus erythematosus, multiple sclerosis, and other similar diseases.