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

NCT00546819 | Completed Phase 2 Results

• 2 other identifiers: V211-0172006_557
• Study Type: interventional
• Target: 309
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Herpes Zoster

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  42 days postvaccination

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

  42 days postvaccination

Study Arms (2)

ZOSTAVAX™

EXPERIMENTAL

Participants administered ZOSTAVAX™ on Day 1.

Biological: Zoster Vaccine, Live

Placebo

PLACEBO COMPARATOR

Participants administered Placebo on Day 1.

Biological: Comparator: Placebo

Interventions

Zoster Vaccine, Live BIOLOGICAL

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

Also known as: V211

ZOSTAVAX™

Comparator: Placebo BIOLOGICAL

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

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Varicella-history positive, herpes zoster (HZ)-history negative patients
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Russell AF, Parrino J, Fisher CL Jr, Spieler W, Stek JE, Coll KE, Su SC, Xu J, Li X, Schlienger K, Silber JL. Safety, tolerability, and immunogenicity of zoster vaccine in subjects on chronic/maintenance corticosteroids. Vaccine. 2015 Jun 17;33(27):3129-34. doi: 10.1016/j.vaccine.2015.04.090. Epub 2015 May 8.

  PMID: 25964168 RESULT

MeSH Terms

Conditions

Herpes Zoster

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Chickenpox Vaccine; Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2007
• First Posted: October 19, 2007
• Study Start: October 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 12, 2017
• Results First Posted: August 15, 2011

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share