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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Herpes Zoster

Treatments: Biological: Comparator: Placebo; Biological: Zoster Vaccine, Live

Study type: Interventional

Funder types: Industry

Identifiers

NCT00546819

2006_557

V211-017

Details and patient eligibility

About

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

Enrollment: 309 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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309 participants in 2 patient groups, including a placebo group

ZOSTAVAX™

Experimental group

Description:

Participants administered ZOSTAVAX™ on Day 1.

Treatment:

Biological: Zoster Vaccine, Live

Placebo

Placebo Comparator group

Description:

Participants administered Placebo on Day 1.

Treatment:

Biological: Comparator: Placebo