Clinical trial NCT03350698: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Papillomavirus Vaccines
Keywords: Human papilloma virus
Lead sponsor: Eastern Virginia Medical School
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2017-11-22
Enrollment: 100
Sex: ALL
Minimum age (years): 27
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective Single-Subject Experimental Design
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: # of participants with elevated HPV antibody titers from baseline to 7 months
timeFrame: baseline and 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: EVMS Otolaryngology
state: Virginia
Study officials:
affiliation: Eastern Virginia Medical School
name: Craig H Derkay, MD
role: PRINCIPAL_INVESTIGATOR
References:
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