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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03350698

Enrollment

100

Registered

2017-11-22

Start date

2018-04-06

Completion date

2023-12-30

Last updated

2023-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Papillomavirus Vaccines

Keywords

Human papilloma virus

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.

Interventions

BIOLOGICALGardasil-9

3 vaccine series

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Intervention model description

Prospective Single-Subject Experimental Design

Eligibility

Sex/Gender

ALL

Age

27 Years to 69 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
# 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

Countries

United States

Contacts

Primary ContactCraig H Derkay, MD

craig.derkay@chkd.org757-668-9842

Backup ContactLaura Stone, RN

stonelj@evms.edu757-388-6238

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026