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

NCT01527383 | Completed Phase 2 Results

• 2 other identifiers: V212-0092011-002313-11
• Study Type: interventional
• Target: 354
• Locations: 0 countries
• Sites: N/A

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

Keywords

Shingles

Outcome Measures

Primary Outcomes (3)

• Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA)

  Serum samples were tested for antibody response using a gpELISA. The GMFR is response at approximately 28 days postdose 4 / response predose on Day 1.

  Baseline and ~28 days after Vaccination 4 (~Day 118)

• GMFR in VZV Antibody Response Measured by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay

  Serum samples were tested for activity using a VZV ELISPOT assay. The assay detects IFN-γ-secreting, VZV-specific cells from peripheral blood mononuclear cells (PBMCs). The unit of measure of the assay is ELISPOT cell count / 10\^6 PBMCs, and is expressed as geometric mean count (GMC). The GMFR is GMC at \~28 days after Vaccination 4 / GMC predose on Day 1.

  Baseline and ~28 days after Vaccination 4 (~Day 118)

• Percentage of Participants With a Serious Adverse Event

  A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants with one or more SAE was assessed.

  Up to ~28 days after Vaccination 4 (~Day 118)

Secondary Outcomes (3)

• Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card

  Up to Day 5 after any vaccination

• Percentage of Participants With a Systemic Adverse Event Prompted on the Vaccination Report Card

  Up to ~28 days after Vaccination 4 (~Day 118)

• Percentage of Participants With Elevated Temperature Prompted on the Vaccination Report Card

  Up to ~28 days after Vaccination 4 (~Day 118)

Study Arms (2)

V212

EXPERIMENTAL

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.

Biological: V212

Placebo

PLACEBO COMPARATOR

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.

Biological: Placebo

Interventions

V212 BIOLOGICAL

V212 viral antigen for HZ

Also known as: Inactivated Varicella-Zoster (VZV) vaccine

V212

Placebo BIOLOGICAL

Placebo comparator to V212 vaccine

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 29126292 RESULT

MeSH Terms

Conditions

Herpes Zoster

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2012
• First Posted: February 7, 2012
• Study Start: February 21, 2012
• Primary Completion: February 26, 2013
• Study Completion: February 26, 2013
• Last Updated: January 14, 2019
• Results First Posted: January 14, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share