A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Adults With Autoimmune Disease (V212-009)
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|ClinicalTrials.gov Identifier: NCT01527383|
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : January 23, 2018
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of V212 when administered to adults with autoimmune disease.
|Condition or disease||Intervention/treatment||Phase|
|Herpes Zoster||Biological: V212 Biological: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||354 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Phase II Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients With Autoimmune Disease|
|Actual Study Start Date :||February 21, 2012|
|Actual Primary Completion Date :||February 26, 2013|
|Actual Study Completion Date :||February 26, 2013|
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.
Primary Outcome Measures :
- 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 ]
- 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 ]
- Incidence of serious adverse events [ Time Frame: Through 28 days postdose 4 ]
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