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Occupational Exposure to Human Papilloma Virus (HPV) and Prophylactic Vaccination

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ClinicalTrials.gov Identifier: NCT03350698
Recruitment Status : Not yet recruiting
First Posted : November 22, 2017
Last Update Posted : February 1, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Craig Derkay M.D., Eastern Virginia Medical School

Study Description
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Brief Summary:
Currently there are no standards for healthcare worker vaccination with the HPV, Gardasil-9 vaccine. For health care workers, the CDC only recommends for vaccination against hepatitis B, influenza virus, Measles, Mumps and Rubella (MMR), Chickenpox (Varicella), Tetanus, Diptheria, and Pertussis (Tdap), and meninogococcal infections6

Condition or disease Intervention/treatment Phase
Papillomavirus Vaccines Biological: Gardasil-9 Phase 4

Detailed Description:

Initial antibody titers will be measured immediately prior to initial vaccination (month 0). This will entail a blood-draw sample (less than 1 teaspoon) that will be sent to FOCUS labs for evaluation. This will be paid for by funding received from Merck.

The three-dose vaccination schedule will be followed with injections at month 0, 2, and 6. Gardasil 9 dosing will be per the recommended and approved labeled guidelines. Post-vaccination titers would be measured at month 7, which is in alignment with the methods of previous studies. This will entail a blood-draw sample (less than 1 teaspoon) that will be sent to FOCUS labs for evaluation.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective Single-Subject Experimental Design
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Occupational Exposure to Human Papilloma Virus (HPV) and Prophylactic Vaccination (Version IV Dated 24Oct2017)
Estimated Study Start Date : February 27, 2018
Estimated Primary Completion Date : June 14, 2018
Estimated Study Completion Date : November 15, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: active drug
Human Papilloma virus ,Gardasil, 9 valent vaccine
 Biological: Gardasil-9
3 vaccine series


Outcome Measures
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Primary Outcome Measures :
  1. # of participants with elevated HPV antibody titers from baseline to 7 months [ Time Frame: baseline and 7 months ]
    baseline change at 7 months post vaccine series. The antibody titer laboratory test will be used to record the levels


Eligibility Criteria
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Ages Eligible for Study:   27 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • • Actively practicing attending surgeon in the field of Otolaryngology, General Surgery, Urology, or Obstetrics-Gynecology employed by EVMS or credentialed by CHKD and/or SNGH.

or

• Current residents of EVMS Otolaryngology, General Surgery, Urology, or Obstetrics-Gynecology programs

Exclusion Criteria:

  • • Age 26 or younger

    • Age over 69
    • Hypersensitivity to vaccine component
    • History of severe allergic or hypersensitivity reactions to yeast
    • History of previous HPV vaccination with 9 valent vaccine
    • Pregnant
    • Moderate or severe acute illness
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03350698


Contacts
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Contact: Craig H Derkay, MD 757-668-9842 craig.derkay@chkd.org
Contact: Laura Stone, RN 757-388-6238 stonelj@evms.edu

Sponsors and Collaborators
Eastern Virginia Medical School
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Craig H Derkay, MD Eastern Virginia Medical School
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
HPV fact sheet  This link exits the ClinicalTrials.gov site recommended vaccines for healthcare workers  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Craig Derkay M.D., Professor, Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT03350698     History of Changes
Other Study ID Numbers: 17-09-FB-0176
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Craig Derkay M.D., Eastern Virginia Medical School:
Human papilloma virus

Additional relevant MeSH terms:
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Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs