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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Herpes Zoster

Treatments: Biological: Placebo; Biological: V212

Study type: Interventional

Funder types: Industry

Identifiers

NCT01527383

2011-002313-11 (EudraCT Number)

V212-009 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 354 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 Tumor Necrosis factor (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-Cluster of Differentiation (CD) 20 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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354 participants in 2 patient groups, including a placebo group

V212

Experimental group

Description:

Participants receive V212 as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.

Treatment:

Biological: V212

Placebo

Placebo Comparator group

Description:

Participants receive placebo as a 0.5 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.

Treatment:

Biological: Placebo