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

Primary Purpose

Papillomavirus Vaccines

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Gardasil-9
Sponsored by
Eastern Virginia Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Papillomavirus Vaccines focused on measuring Human papilloma virus

Eligibility Criteria

27 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • EVMS OtolaryngologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

active drug

Arm Description

Human Papilloma virus ,Gardasil, 9 valent vaccine

Outcomes

Primary Outcome Measures

# of participants with elevated HPV antibody titers from baseline to 7 months
baseline change at 7 months post vaccine series. The antibody titer laboratory test will be used to record the levels

Secondary Outcome Measures

Full Information

First Posted
November 10, 2017
Last Updated
February 16, 2023
Sponsor
Eastern Virginia Medical School
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03350698
Brief Title
Occupational Exposure to Human Papilloma Virus (HPV) and Prophylactic Vaccination
Official Title
Occupational Exposure to Human Papilloma Virus (HPV) and Prophylactic Vaccination (Version IV Dated 24Oct2017)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2018 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Virginia Medical School
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Papillomavirus Vaccines
Keywords
Human papilloma virus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Prospective Single-Subject Experimental Design
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active drug
Arm Type
Experimental
Arm Description
Human Papilloma virus ,Gardasil, 9 valent vaccine
Intervention Type
Biological
Intervention Name(s)
Gardasil-9
Intervention Description
3 vaccine series
Primary Outcome Measure Information:
Title
# of participants with elevated HPV antibody titers from baseline to 7 months
Description
baseline change at 7 months post vaccine series. The antibody titer laboratory test will be used to record the levels
Time Frame
baseline and 7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
27 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Craig H Derkay, MD
Phone
757-668-9842
Email
craig.derkay@chkd.org
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Stone, RN
Phone
757-388-6238
Email
stonelj@evms.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig H Derkay, MD
Organizational Affiliation
Eastern Virginia Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
EVMS Otolaryngology
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Stone, BSN
Phone
757-388-6238
Email
stonelj@evms.edu
First Name & Middle Initial & Last Name & Degree
Craig Derkay, MD
Email
Craig.derkay@chkd.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20451455
Citation
Marur S, D'Souza G, Westra WH, Forastiere AA. HPV-associated head and neck cancer: a virus-related cancer epidemic. Lancet Oncol. 2010 Aug;11(8):781-9. doi: 10.1016/S1470-2045(10)70017-6. Epub 2010 May 5.
Results Reference
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PubMed Identifier
12571259
Citation
Munoz N, Bosch FX, de Sanjose S, Herrero R, Castellsague X, Shah KV, Snijders PJ, Meijer CJ; International Agency for Research on Cancer Multicenter Cervical Cancer Study Group. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med. 2003 Feb 6;348(6):518-27. doi: 10.1056/NEJMoa021641.
Results Reference
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PubMed Identifier
1662265
Citation
Dickens P, Srivastava G, Loke SL, Larkin S. Human papillomavirus 6, 11, and 16 in laryngeal papillomas. J Pathol. 1991 Nov;165(3):243-6. doi: 10.1002/path.1711650308.
Results Reference
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PubMed Identifier
21798893
Citation
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Results Reference
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PubMed Identifier
1660719
Citation
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Results Reference
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PubMed Identifier
14634897
Citation
Calero L, Brusis T. [Laryngeal papillomatosis - first recognition in Germany as an occupational disease in an operating room nurse]. Laryngorhinootologie. 2003 Nov;82(11):790-3. doi: 10.1055/s-2003-44546. German.
Results Reference
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PubMed Identifier
27068425
Citation
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Results Reference
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PubMed Identifier
25483701
Citation
Einstein MH, Takacs P, Chatterjee A, Sperling RS, Chakhtoura N, Blatter MM, Lalezari J, David MP, Lin L, Struyf F, Dubin G; HPV-010 Study Group. Comparison of long-term immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years: end-of-study analysis of a Phase III randomized trial. Hum Vaccin Immunother. 2014;10(12):3435-45. doi: 10.4161/hv.36121.
Results Reference
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PubMed Identifier
12836624
Citation
Sehulster L, Chinn RY; CDC; HICPAC. Guidelines for environmental infection control in health-care facilities. Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC). MMWR Recomm Rep. 2003 Jun 6;52(RR-10):1-42.
Results Reference
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PubMed Identifier
22588197
Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Links:
URL
http://www.cdc.gov/std/hpv/stdfact-hpv.htm
Description
HPV fact sheet
URL
http://www.cdc.gov/vaccines/adults/rec-vac/hcw.html
Description
recommended vaccines for healthcare workers

Learn more about this trial

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

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