CClinicalTrials.gg
CompletedNCT01483378Updated Aug 9, 2013Results posted

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

An interventional study of Choosing to receive the vaccine in Herpes Zoster, sponsored by NYU Langone Health. Completed at 2 sites in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-08-09.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
170
Allocation
Non-randomized
Ages
60 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Herpes Zoster
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In context

Herpes Simplex

305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.

This study's enrollment of 170 is above the median of 101 across 227 interventional studies indexed under Herpes Simplex.

Browse Herpes Simplex studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
170 participants (actual)

Study arms

  • Other
    Subjects who received the vaccine

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

    Other: Choosing to receive the vaccine

  • No intervention
    Subjects who declined the vaccine

Interventions

  • OtherChoosing to receive the vaccine
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: January 9, 2012 to February 12, 2012

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Results

Posted Aug 9, 2013

Participant flow

We prospectively recruited eligible patients from the Bellevue Eye clinic until 100 patients were prescribed and received the vaccine. Recruitment occurred from January 9, 2012 to February 12, 2012.

Participant flow — Overall Study
MilestonePatients Who Received the Herpes Zoster VaccinePatients Who Declined the Herpes Zoster Vaccine
Started10066
Completed10066
Not completed00

Outcome measures

PrimaryAnswers 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.

Time frame:
January 9, 2012 to February 12, 2012
Reported as:
Number · Percentage of responders
Answers to Survey Questions
Percentage of respondersPatients Who Received the Herpes Zoster VaccinePatients Who Declined the Herpes Zoster Vaccine
Subject reported receiving flu Vaccine last year89 (83 to 95)71.2 (60 to 82)
Reported would receive the vaccine if recommended98 (95 to 100)74 (64 to 85)

Adverse events

Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Subjects Who Received the Herpes Zoster Vaccine—0/100 (0%)11/100 (11%)
Subjects Who Declined the Herpes Zoster Vaccine———
Most frequent other events
Most frequent other events
EventSubjects Who Received the Herpes Zoster VaccineSubjects Who Declined the Herpes Zoster Vaccine
Injection Site ReactionSkin and subcutaneous tissue disorders11/100—

Baseline characteristics

170 patients were enrolled in the study, however 2 met FDA contraindications for herpes zoster vaccination and 2 already received the vaccine, so only 166 were included in the analysis.

Age Continuous
Age Continuous(years)Survey Participants
Age68 ± 15
Sex: Female, Male
Sex: Female, Male(Participants)Survey Participants
Female94
Male72
Region of Enrollment
Region of Enrollment(participants)Survey Participants
United States166
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Study locations

2 sites
  • Bellevue Hospital
    New York, New York 10016, United States
  • NYU Langone Medical Center
    New York, New York 10016, United States
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References and documents

Publications

  • 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. PubMed 21788078 ↗
  • 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. PubMed 19909942 ↗
  • 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. PubMed 20439573 ↗
  • 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. PubMed 21238856 ↗
  • 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. PubMed 15930418 ↗
  • 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. PubMed 20178416 ↗
  • Kaufman HE (ed) Herpes zoster ophthalmicus: preventing ocular complications through vaccination. Ophthalmology 2008; 115:S1-38
  • 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. PubMed 23394910 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01483378
Lead sponsor
NYU Langone Health
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Dec 1, 2011
Start date
Jan 2012
Primary completion
Feb 2012
Completion
Feb 2012
Results posted
Aug 9, 2013
Last update
Aug 9, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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