Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03350698
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : February 2, 2021
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Craig Derkay M.D., Eastern Virginia Medical School

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Papillomavirus Vaccines Biological: Gardasil-9 Phase 4

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective Single-Subject Experimental Design
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Occupational Exposure to Human Papilloma Virus (HPV) and Prophylactic Vaccination (Version IV Dated 24Oct2017)
Actual Study Start Date : April 6, 2018
Estimated Primary Completion Date : June 14, 2021
Estimated Study Completion Date : November 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: active drug
Human Papilloma virus ,Gardasil, 9 valent vaccine
 Biological: Gardasil-9
3 vaccine series


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. # of participants with elevated HPV antibody titers from baseline to 7 months [ Time Frame: baseline and 7 months ]
    baseline change at 7 months post vaccine series. The antibody titer laboratory test will be used to record the levels


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   27 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03350698


Contacts
Layout table for location contacts
Contact: Craig H Derkay, MD 757-668-9842 craig.derkay@chkd.org
Contact: Laura Stone, RN 757-388-6238 stonelj@evms.edu

Locations
Layout table for location information
United States, Virginia
EVMS Otolaryngology Recruiting
Norfolk, Virginia, United States, 23507
Contact: Laura Stone, BSN    757-388-6238    stonelj@evms.edu   
Contact: Craig Derkay, MD       Craig.derkay@chkd.org   
Sponsors and Collaborators
Eastern Virginia Medical School
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Principal Investigator: Craig H Derkay, MD Eastern Virginia Medical School
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: Craig Derkay M.D., Professor, Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT03350698    
Other Study ID Numbers: 17-09-FB-0176
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Craig Derkay M.D., Eastern Virginia Medical School:
Human papilloma virus
Additional relevant MeSH terms:
Layout table for MeSH terms
Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms