ZOSTAVAX™ in Patients on Chronic/Maintenance Corticosteroids (V211-017) (COMPLETED)

Study Overview
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Brief Summary
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The purpose of the study was to assess the safety, tolerability, and immunogenicity of ZOSTAVAX™ in patients receiving chronic/maintenance corticosteroids.

Official Title
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A Phase IIb Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Zoster Vaccine Live (Oka/Merck) in Patients on Chronic/Maintenance Corticosteroids

Conditions
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Herpes Zoster

Intervention / Treatment
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* Biological: Zoster Vaccine, Live
* Biological: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Varicella-history positive, herpes zoster (HZ)-history negative patients 60 years of age and older receiving chronic/maintenance systemic corticosteroid therapy at a daily dose of 5 to 20 mg of prednisone or equivalent for at least the 2 weeks immediately prior to enrollment and expected to continue to receive a daily dose of 5 to 20 mg of prednisone or equivalent for the 6-week primary safety follow-up period (dose may vary within this range during the 6-week postvaccination period) All females enrolling must be postmenopausal Exclusion Criteria: Patients with a history of hypersensitivity reaction to gelatin or neomycin Prior receipt of varicella or zoster vaccine; prior history of herpes zoster Immune globulin and/or blood products given within 5 months prior to or expected within the 6-week postvaccination period Receipt of any live virus vaccinations within 1 month or receipt of any inactivated vaccinations within 7 days prior to enrollment Known immune deficiency that is caused by a medical condition Any use in the 8 weeks prior to vaccination or for 6 weeks after vaccination other medications which may suppress the immune system including methotrexate, corticosteroids at a daily dose greater than 20 mg of prednisone or equivalent, agents used to treat cancer, or medications which alter the level of the immune response used to treat arthritis or other illnesses Concomitant use of antiviral therapy A history of alcohol abuse or recreational drug use

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZOSTAVAX™<br>Participants administered ZOSTAVAX™ on Day 1. | Biological: Zoster Vaccine, Live<br>* A single dose of 0.65 ml Zoster Vaccine, Live, injected subcutaneously on Day 1<br>* Other names: V211;|
| Placebo Comparator: Placebo<br>Participants administered Placebo on Day 1. | Biological: Comparator: Placebo<br>* A single dose of 0.65 ml Placebo to ZOSTAVAX™ injected subcutaneously on Day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Serious Adverse Events (SAE) | A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement. | Up to 182 days postvaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibodies at 42 Days Postvaccination | The Geometric Mean Titer (GMT) of VZV antibodies in participants' serum samples was assessed by a glycoprotein enzyme-linked immunosorbent assay (gpELISA). | 42 days postvaccination | 
| Geometric Mean Fold Rise (GMFR) of the VZV Antibody Response From Day 1 to Day 42 Postvaccination. | The geometric mean fold rise (GMFR) of the VZV antibodies from Day 1 to Week 6 postvaccination. | 42 days postvaccination |