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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Occupational Exposure to Human Papilloma Virus (HPV) and Prophylactic Vaccination (Version IV Dated 24Oct2017)

Conditions
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Papillomavirus Vaccines

Intervention / Treatment
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* Biological: Gardasil-9


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 27 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective Single-Subject Experimental Design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active drug<br>Human Papilloma virus ,Gardasil, 9 valent vaccine | Biological: Gardasil-9<br>* 3 vaccine series<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| # 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 | baseline and 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human papilloma virus