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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01527383
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : January 23, 2018
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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

Detailed Description:
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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Actual Study Start Date : February 21, 2012
Primary Completion Date : February 26, 2013
Study Completion Date : February 26, 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: V212 Biological: V212
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 Biological: 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 :
  1. 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 ]
  2. 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 ]
  3. Incidence of serious adverse events [ Time Frame: Through 28 days postdose 4 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed with an autoimmune disease
  • Clinically stable disease for at least 30 days before enrollment
  • Not likely to undergo hematopoietic stem cell transplantation during the study period
  • Receiving at least one parenteral or oral biologic agent, such as a TNF alpha inhibitor, or a parenteral or oral non-biologic therapy, at a stable dose for at least 3 months, with no planned or anticipated changes
  • History of varicella, antibodies to VZV, or residence for at least 30 years in a country with endemic VZV infection, or if participant is less than 30 years old, attended primary or secondary school in a country with endemic VZV infection

Exclusion Criteria:

  • Prior history of Herpes Zoster (shingles) within 1 year before enrollment
  • Prior varicella or zoster vaccine
  • Active central nervous system lupus erythematosus requiring therapeutic intervention within 90 days of enrollment
  • Prior or planned therapy containing rituximab or other anti-CD20 monoclonal antibodies from 3 months before enrollment through 28 days postdose 4
  • Systemic corticosteroid therapy, prednisone, or equivalent over 40 mg daily at the time of enrollment

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01527383     History of Changes
Other Study ID Numbers: V212-009
First Posted: February 7, 2012    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Keywords provided by Merck Sharp & Dohme Corp.:

Additional relevant MeSH terms:
Herpes Zoster
Autoimmune Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs