Clinical trial NCT01527383: A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Adults With Autoimmune Disease (V212-009)
Official title: A Phase II Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients With Autoimmune Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Herpes Zoster
Keywords: Shingles
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-02-07
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA)
timeFrame: Baseline and ~28 days after Vaccination 4 (~Day 118)
measure: GMFR in VZV Antibody Response Measured by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay
timeFrame: Baseline and ~28 days after Vaccination 4 (~Day 118)
measure: Percentage of Participants With a Serious Adverse Event
timeFrame: Up to ~28 days after Vaccination 4 (~Day 118)
Secondary outcomes:
measure: Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card
timeFrame: Up to Day 5 after any vaccination
measure: Percentage of Participants With a Systemic Adverse Event Prompted on the Vaccination Report Card
timeFrame: Up to ~28 days after Vaccination 4 (~Day 118)
measure: Percentage of Participants With Elevated Temperature Prompted on the Vaccination Report Card
timeFrame: Up to ~28 days after Vaccination 4 (~Day 118)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.