A Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients with Autoimmune Disease

Phase 1

• Conditions: Prevention of herpes zoster in adults with autoimmune disease; MedDRA version: 14.1Level: PTClassification code 10019974Term: Herpes zosterSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-002313-11-BE
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-02
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

Patient is =18 years of age with an autoimmune disease, has clinically stable disease for =30 days prior to enrollment, is receiving treatment with at least one biologic agent or non-biologic therapy at a stable dose for =3 months, has a prior history of varicella, antibodies to VZV, or residence in a country with endemic VZV infection for =30 years (if patient is <30 years old, attended primary or secondary school in a country with endemic VZV infection), is not likely to undergo hematopoietic cell transplant, and is highly unlikely to conceive during the time period starting 2 weeks prior to enrollment through 6 months from the last vaccination dose.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 204
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 136

Exclusion Criteria

Patient has a history of herpes zoster within 1 year of enrollment, has a history of receipt of any varicella or zoster vaccine, has or will receive treatment with any anti-CD20 monoclonal antibody within the time period from 3 months prior to enrollment through 28 days following the last dose of study vaccine, is likely to receive any live virus vaccine during the period from 4 weeks prior to enrollment through 28 days following the last dose of study vaccine, or is likely to receive any inactivated vaccine during the period from 7 days prior to, through 7 days following, any dose of study vaccine.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1) To determine whether V212 is immunogenic when administered to adult patients with autoimmune disease. <br>2) To assess the safety and tolerability of V212 in adult patients with autoimmune disease.;Secondary Objective: None;Primary end point(s): The primary immunogenicity endpoint is the GMFR of the VZV-specific immune responses from prevaccination to ~28 days Postdose 4.;Timepoint(s) of evaluation of this end point: Day 1 (prior to Dose 1) and Visit 5 (28 days Postdose 4 [+7 days])

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None