A Phase II Randomized, Placebo-Controlled 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-ES
• Lead Sponsor: Merck Sharp & Dohme Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-01
• Study Completion: 2013-02-26
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

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

Inclusion Criteria

1. Patient is > or = to 18 years of age on the day of signing informed consent.
2. Patient has been diagnosed with an autoimmune disease, including but not limited to RA, PSA, PSO, IBD, SLE, MS, or other similar diseases (see Appendix 6.1 of protocol).
3. Patient is not likely to undergo HCT during the study period (through 28 days Postdose 4).
4. Patient must be on at least one biologic agent, such as a TNF alpha inhibitor, or a non-biologic therapy, at a stable dose for > or = to 3 months, with no planned or anticipated changes in treatment regimen at the time of enrollment. Treatment route of administration must be parenteral or oral; topical administration alone is not sufficient
(See Appendix 6.2 of protocol).
5. Minimum doses are required for the following treatments if taken as monotherapy:
5.1 methotrexate, >0.4 mg/Kg/week;
5.2 sulfasalazine, or mycophenolate mofetil: > or = to 2g/day;
5.3 azathioprine, >3.0 mg/Kg/day;
5.4 6-mercaptopurine, >1.5 mg/Kg/day;
5.5 prednisone or equivalent of >20 mg/day.
No minimum doses are required for patients receiving combination therapy including two or more non-biologic agents.
6. Patient has clinically stable disease for > or = to 30 days prior to enrollment. (Note: MS patient who has experienced a serious relapse [exacerbation] that affects their ability to carry out activities of daily living, should not be enrolled into the study until 4 to 6 weeks after the onset of the relapse.)
7. Patient understands the study procedures, alternative treatments available and risks involved with the study, and voluntarily agrees to participate by giving written informed consent. The patient may also provide consent for future biomedical research. However, the patient may participate in the main trial without participating in future biomedical research.
8. Patient has prior history of varicella, antibodies to VZV (documented prior to receipt of blood products), or residence (for ?> or = to 30 years) in a country with endemic VZV infection, or if participant is < 30 years old, attended primary or secondary school in a country with endemic VZV infection (See Section 3.2.8 for more details).
9. Patient is able to read, understand and complete questionnaires and diaries.

Read the rest inclusion criteria in the study protocol.

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

1. A history of allergic reaction to any vaccine component (including gelatin) or an anaphylactic/anaphylactoid reaction to neomycin (a history of contact dermatitis to neomycin is not a criterion for study exclusion).
2. Prior history of HZ within 1 year of enrollment.
3. Prior receipt of any varicella or zoster vaccine.
4. Patient has active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebritis or CNS vasculitis) requiring therapeutic intervention within 90 days of enrollment.
5. Patient is receiving or expected to receive therapy containing rituximab or any other anti-CD20 monoclonal antibodies at any time during the time period beginning
3 months prior to enrollment through 28 days Postdose 4.
6. Patient is receiving systemic corticosteroid therapy, prednisone or prednisone equivalent >40 mg/day at the time of enrollment.
7. Patient has received systemic prednisone or prednisone equivalent ?> or = to 50 mg/day for > or = to 0 days within 6 months of enrollment.
8. Patient has participated in a study of investigational drug or vaccine or received investigational products within 30 days prior to enrollment or is expected to receive an investigational product (other than the study vaccine) throughout the duration of the study.
9. Patient is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment through 6 months after last vaccination dose.
10. Any live virus vaccine administered or scheduled in the period from 4 weeks prior to Dose 1 through 28 days Postdose 4.
11. Any inactivated vaccine administered or scheduled within the period from 7 days prior to, through 7 days following, any dose of study vaccine.

Read the rest exclusion criteria in the study protocol.

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