Occupational Exposure to Human Papilloma Virus (HPV) and Prophylactic Vaccination
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ClinicalTrials.gov Identifier: NCT03350698 |
Recruitment Status :
Recruiting
First Posted : November 22, 2017
Last Update Posted : February 2, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Papillomavirus Vaccines | Biological: Gardasil-9 | Phase 4 |
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 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 |

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

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Ages Eligible for Study: | 27 Years to 69 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

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
Contact: Craig H Derkay, MD | 757-668-9842 | craig.derkay@chkd.org | |
Contact: Laura Stone, RN | 757-388-6238 | stonelj@evms.edu |
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 |
Principal Investigator: | Craig H Derkay, MD | Eastern Virginia Medical School |
Publications:
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 |
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 |
Human papilloma virus |
Papilloma Neoplasms, Squamous Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |