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Completed

NCT Number: NCT00546819

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

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

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zoster Vaccine, Live

Biological

A single dose of 0.65 ml Zoster Vaccine, Live, injected subcutaneously on Day 1

Other names: V211

Comparator: Placebo

Biological

A single dose of 0.65 ml Placebo to ZOSTAVAX™ injected subcutaneously on Day 1.

Primary outcomes

  1. Number of Participants With Serious Adverse Events (SAE)

    Time frame: Up to 182 days postvaccination

    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.

Secondary outcomes

  1. Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibodies at 42 Days Postvaccination

    Time frame: 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).

  2. Geometric Mean Fold Rise (GMFR) of the VZV Antibody Response From Day 1 to Day 42 Postvaccination.

    Time frame: 42 days postvaccination

    The geometric mean fold rise (GMFR) of the VZV antibodies from Day 1 to Week 6 postvaccination.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Oct 19, 2007
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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