A Phase II Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients with Autoimmune Disease

Phase 2

Completed

Conditions: shingles
skin laesions
10003816

Registration Number: NL-OMON37443

Lead Sponsor: Merck Sharp & Dohme (MSD)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

1. Patient is >=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.
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 >=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.
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: >=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 >=30 days prior to enrollment.
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 >=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.
9. Patient is able to read, understand and complete questionnaires and diaries.
10. All female patients of childbearing potential (as defined under Criterion #11) must
have a negative serum or urine pregnancy test (sensitive to 25IU beta human
chorionic gonadotropin [β-hCG]) prior to each vaccine dose.
11. Patient is highly unlikely to conceive during the time period starting 2 weeks prior to
enrollment through 6 months from the last vaccination dose, as indicated by at least one yes answer to the following questions:
- Patient is male.
- Patient is a female who agrees to remain abstinent or use (or have their partner use) adequate contraception during the time period starting 2 weeks prior to enrollment through 6 months from the last vaccination dose. Note that simultaneous use of two reliable forms of contraception is recommended.
- Patient is a female who is not of reproductive potential.

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 >=50 mg/day for >=30 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.
12. Patient has immunoglobulin or any blood products administered or scheduled in the period from 3 months prior to Visit 1 through 28 days Postdose 4.
13. Patient is unlikely to adhere to the study procedures or attend study visits.
14. Any other reason that in the opinion of the investigator might interfere with the evaluation required by the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to determine whether V212 is immunogenic when<br /><br>administered to adult patients with autoimmune disease and to assess the safety<br /><br>and tolerability of V212 in adult patients with autoimmune disease.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N.A.</p><br>

Related Trials