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

Last updated: February 16, 2023
Sponsor: Eastern Virginia Medical School
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03350698
17-09-FB-0176
  • Ages 27-69
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • • Actively practicing attending surgeon in the field of Otolaryngology, GeneralSurgery, Urology, or Obstetrics-Gynecology employed by EVMS or credentialed by CHKDand/or SNGH. or

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

Exclusion

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

Study Design

Total Participants: 100
Study Start date:
April 06, 2018
Estimated Completion Date:
December 30, 2023

Study 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.

Connect with a study center

  • EVMS Otolaryngology

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

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