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

NCT ID: NCT01527383

Last Updated: 2019-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 354 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-21
• Study Completion Date: 2013-02-26

Brief Summary

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.

Conditions

Herpes Zoster

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

V212

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.

Group Type: EXPERIMENTAL

V212

Intervention Type: BIOLOGICAL

V212 viral antigen for HZ

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Placebo comparator to V212 vaccine

Interventions

V212

V212 viral antigen for HZ

Intervention Type: BIOLOGICAL

Placebo

Placebo comparator to V212 vaccine

Intervention Type: BIOLOGICAL

Other Intervention Names

Inactivated Varicella-Zoster (VZV) vaccine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Eberhardson M, Hall S, Papp KA, Sterling TM, Stek JE, Pang L, Zhao Y, Parrino J, Popmihajlov Z. Safety and Immunogenicity of Inactivated Varicella-Zoster Virus Vaccine in Adults With Autoimmune Disease: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Clin Infect Dis. 2017 Oct 1;65(7):1174-1182. doi: 10.1093/cid/cix484.

Reference Type: RESULT

PMID: 29126292 (View on PubMed)

Other Identifiers

V212-009

Identifier Type: OTHER

Identifier Source: secondary_id

2011-002313-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V212-009

Identifier Type: -

Identifier Source: org_study_id