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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01527383
First received: January 16, 2012
Last updated: March 7, 2014
Last verified: March 2014

January 16, 2012
March 7, 2014
February 2012
February 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • Geometric mean fold rise in varciella-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 ]
Complete list of historical versions of study NCT01527383 on ClinicalTrials.gov Archive Site
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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

This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of V212 when administered to adults with autoimmune disease.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Herpes Zoster
  • 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
  • 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.
  • Experimental: V212
    Intervention: Biological: V212
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
354
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01527383
V212-009
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP