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

Phase 4

Recruiting

• Conditions: Papillomavirus Vaccines
• Interventions: Biological: Gardasil-9

• Registration Number: NCT03350698
• Lead Sponsor: Eastern Virginia Medical School

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.

Study Timeline

• Study First Submitted: 2017-11-10
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-22
• Study Start: 2018-04-06
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-21
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
active drug	Gardasil-9	Human Papilloma virus ,Gardasil, 9 valent vaccine

Primary Outcome Measures

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

Trial Locations

Locations (1)

EVMS Otolaryngology; 🇺🇸 Norfolk, Virginia, United States