search
Back to results

Increasing Use of the Vaccine Against Herpes Zoster/Shingles at NYULMC and Bellevue Hospital

Primary Purpose

Herpes Zoster

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Choosing to receive the vaccine
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Herpes Zoster

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 60 years of age or older
  • Absence of evidence of immune compromise in the medical record
  • Ability to speak and read English, Spanish or Chinese and give informed consent

Exclusion Criteria:

  • Vulnerable patients, including the cognitively impaired, prisoners and employee
  • FDA contraindications for Zostavax vaccine

Sites / Locations

  • Bellevue Hospital
  • NYU Langone Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Subjects who received the vaccine

Subjects who declined the vaccine

Arm Description

Patients in this arm were eligible for the herpes zoster vaccine and chose to receive it.

Outcomes

Primary Outcome Measures

Answers to Survey Questions
All enrolled patients completed a survey of baseline characteristics, eligibility for the herpes zoster vaccine, and attitudes regarding herpes zoster vaccination. The survey results from patients who agreed to receive the herpes zoster vaccine were compared to the results of patients who declined to be vaccinated.

Secondary Outcome Measures

Full Information

First Posted
November 18, 2011
Last Updated
August 7, 2013
Sponsor
NYU Langone Health
Collaborators
Merck Sharp & Dohme LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT01483378
Brief Title
Increasing Use of the Vaccine Against Herpes Zoster/Shingles at NYULMC and Bellevue Hospital
Official Title
Increasing Use of the Vaccine Against Herpes Zoster/Shingles at NYULMC and Bellevue Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine if vaccination rate of eligible patients at a major urban public hospital will increase by having ophthalmologists screen patients for eligibility and a nurse administer the vaccine in the General Eye Clinic.
Detailed Description
Patient vaccination behaviors will be assessed after 100 doses of the Zostavax vaccine are provided to underserved patients screened by ophthalmologists at the General Eye Clinic at a public hospital that does not normally provide the vaccine. A nurse will be at the clinic to administer the vaccine. Patients will be contacted by phone 1 month later and seen within 3 months in the Eye Clinic to determine whether there were any side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects who received the vaccine
Arm Type
Other
Arm Description
Patients in this arm were eligible for the herpes zoster vaccine and chose to receive it.
Arm Title
Subjects who declined the vaccine
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Choosing to receive the vaccine
Primary Outcome Measure Information:
Title
Answers to Survey Questions
Description
All enrolled patients completed a survey of baseline characteristics, eligibility for the herpes zoster vaccine, and attitudes regarding herpes zoster vaccination. The survey results from patients who agreed to receive the herpes zoster vaccine were compared to the results of patients who declined to be vaccinated.
Time Frame
January 9, 2012 to February 12, 2012

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 60 years of age or older Absence of evidence of immune compromise in the medical record Ability to speak and read English, Spanish or Chinese and give informed consent Exclusion Criteria: Vulnerable patients, including the cognitively impaired, prisoners and employee FDA contraindications for Zostavax vaccine
Facility Information:
Facility Name
Bellevue Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21788078
Citation
Ghaznawi N, Virdi A, Dayan A, Hammersmith KM, Rapuano CJ, Laibson PR, Cohen EJ. Herpes zoster ophthalmicus: comparison of disease in patients 60 years and older versus younger than 60 years. Ophthalmology. 2011 Nov;118(11):2242-50. doi: 10.1016/j.ophtha.2011.04.002. Epub 2011 Jul 23.
Results Reference
background
PubMed Identifier
19909942
Citation
Hu AY, Strauss EC, Holland GN, Chan MF, Yu F, Margolis TP. Late varicella-zoster virus dendriform keratitis in patients with histories of herpes zoster ophthalmicus. Am J Ophthalmol. 2010 Feb;149(2):214-220.e3. doi: 10.1016/j.ajo.2009.08.030. Epub 2009 Nov 11.
Results Reference
background
PubMed Identifier
20439573
Citation
Hurley LP, Lindley MC, Harpaz R, Stokley S, Daley MF, Crane LA, Dong F, Beaty BL, Tan L, Babbel C, Dickinson LM, Kempe A. Barriers to the use of herpes zoster vaccine. Ann Intern Med. 2010 May 4;152(9):555-60. doi: 10.7326/0003-4819-152-9-201005040-00005.
Results Reference
background
PubMed Identifier
21238856
Citation
Lu PJ, Euler GL, Harpaz R. Herpes zoster vaccination among adults aged 60 years and older, in the U.S., 2008. Am J Prev Med. 2011 Feb;40(2):e1-6. doi: 10.1016/j.amepre.2010.10.012.
Results Reference
background
PubMed Identifier
15930418
Citation
Oxman MN, Levin MJ, Johnson GR, Schmader KE, Straus SE, Gelb LD, Arbeit RD, Simberkoff MS, Gershon AA, Davis LE, Weinberg A, Boardman KD, Williams HM, Zhang JH, Peduzzi PN, Beisel CE, Morrison VA, Guatelli JC, Brooks PA, Kauffman CA, Pachucki CT, Neuzil KM, Betts RF, Wright PF, Griffin MR, Brunell P, Soto NE, Marques AR, Keay SK, Goodman RP, Cotton DJ, Gnann JW Jr, Loutit J, Holodniy M, Keitel WA, Crawford GE, Yeh SS, Lobo Z, Toney JF, Greenberg RN, Keller PM, Harbecke R, Hayward AR, Irwin MR, Kyriakides TC, Chan CY, Chan IS, Wang WW, Annunziato PW, Silber JL; Shingles Prevention Study Group. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med. 2005 Jun 2;352(22):2271-84. doi: 10.1056/NEJMoa051016.
Results Reference
background
PubMed Identifier
20178416
Citation
Rimland D, Moanna A. Increasing incidence of herpes zoster among Veterans. Clin Infect Dis. 2010 Apr 1;50(7):1000-5. doi: 10.1086/651078.
Results Reference
background
Citation
Kaufman HE (ed) Herpes zoster ophthalmicus: preventing ocular complications through vaccination. Ophthalmology 2008; 115:S1-38
Results Reference
background
PubMed Identifier
23394910
Citation
Jung JJ, Elkin ZP, Li X, Goldberg JD, Edell AR, Cohen MN, Chen KC, Perskin MH, Park L, Cohen EJ. Increasing use of the vaccine against zoster through recommendation and administration by ophthalmologists at a city hospital. Am J Ophthalmol. 2013 May;155(5):787-95. doi: 10.1016/j.ajo.2012.11.022. Epub 2013 Feb 6.
Results Reference
derived

Learn more about this trial

Increasing Use of the Vaccine Against Herpes Zoster/Shingles at NYULMC and Bellevue Hospital

We'll reach out to this number within 24 hrs