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

Herpes Zoster Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00546819
• Other study ID #: V211-017
• Secondary ID: 2006_557
• Status: Completed
• Phase: Phase 2
• First received: October 17, 2007
• Last updated: February 2, 2016
• Start date: October 2007
• Est. completion date: August 2010

Study information

• Verified date: February 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 309
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

Biological:
• Zoster Vaccine, Live
A single dose of 0.65 ml Zoster Vaccine, Live, injected subcutaneously on Day 1
• Comparator: Placebo
A single dose of 0.65 ml Placebo to ZOSTAVAX™ injected subcutaneously on Day 1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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):3129-3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No