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

Eastern Virginia Medical School (EVMS)

Status and phase: Enrolling; Phase 4

Conditions: Papillomavirus Vaccines

Treatments: Biological: Gardasil-9

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03350698

17-09-FB-0176

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 27 to 69 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

active drug

Experimental group

Description:

Human Papilloma virus ,Gardasil, 9 valent vaccine

Treatment:

Biological: Gardasil-9