CClinicalTrials.gg
Sign In
Status unknownNCT03350698Updated Feb 21, 2023

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

A Phase 4 interventional study of Gardasil-9 in Papillomavirus Vaccines, sponsored by Eastern Virginia Medical School. Status unknown at 1 site in United States. Open to participants aged 27 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-21.

Sponsored by Eastern Virginia Medical School · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
27 Years to 69 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Papillomavirus Vaccines

Browse trials for

Keywords

  • Human papilloma virus
03

Who can participate

Ages eligible
27 Years to 69 Years
Sexes eligible
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

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
04

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    active drug

    Human Papilloma virus ,Gardasil, 9 valent vaccine

    Biological: Gardasil-9

Interventions

  • BiologicalGardasil-9

    3 vaccine series

05

What researchers measure

Primary outcomes

  1. # of participants with elevated HPV antibody titers from baseline to 7 months

    baseline change at 7 months post vaccine series. The antibody titer laboratory test will be used to record the levels

    Time frame: baseline and 7 months

06

Study locations

1 of 1 sites recruiting
07

References and documents

Publications

  • Marur S, D'Souza G, Westra WH, Forastiere AA. HPV-associated head and neck cancer: a virus-related cancer epidemic. Lancet Oncol. 2010 Aug;11(8):781-9. doi: 10.1016/S1470-2045(10)70017-6. Epub 2010 May 5. PubMed 20451455 ↗
  • Munoz N, Bosch FX, de Sanjose S, Herrero R, Castellsague X, Shah KV, Snijders PJ, Meijer CJ; International Agency for Research on Cancer Multicenter Cervical Cancer Study Group. Epidemiologic classification of human papillomavirus types associated with cervical cancer. N Engl J Med. 2003 Feb 6;348(6):518-27. doi: 10.1056/NEJMoa021641. PubMed 12571259 ↗
  • Dickens P, Srivastava G, Loke SL, Larkin S. Human papillomavirus 6, 11, and 16 in laryngeal papillomas. J Pathol. 1991 Nov;165(3):243-6. doi: 10.1002/path.1711650308. PubMed 1662265 ↗
  • Stransky N, Egloff AM, Tward AD, Kostic AD, Cibulskis K, Sivachenko A, Kryukov GV, Lawrence MS, Sougnez C, McKenna A, Shefler E, Ramos AH, Stojanov P, Carter SL, Voet D, Cortes ML, Auclair D, Berger MF, Saksena G, Guiducci C, Onofrio RC, Parkin M, Romkes M, Weissfeld JL, Seethala RR, Wang L, Rangel-Escareno C, Fernandez-Lopez JC, Hidalgo-Miranda A, Melendez-Zajgla J, Winckler W, Ardlie K, Gabriel SB, Meyerson M, Lander ES, Getz G, Golub TR, Garraway LA, Grandis JR. The mutational landscape of head and neck squamous cell carcinoma. Science. 2011 Aug 26;333(6046):1157-60. doi: 10.1126/science.1208130. Epub 2011 Jul 28. PubMed 21798893 ↗
  • Hallmo P, Naess O. Laryngeal papillomatosis with human papillomavirus DNA contracted by a laser surgeon. Eur Arch Otorhinolaryngol. 1991;248(7):425-7. doi: 10.1007/BF01463570. PubMed 1660719 ↗
  • Calero L, Brusis T. [Laryngeal papillomatosis - first recognition in Germany as an occupational disease in an operating room nurse]. Laryngorhinootologie. 2003 Nov;82(11):790-3. doi: 10.1055/s-2003-44546. German. PubMed 14634897 ↗
  • Makiyama K, Hirai R, Matsuzaki H. Gardasil Vaccination for Recurrent Laryngeal Papillomatosis in Adult Men: First Report: Changes in HPV Antibody Titer. J Voice. 2017 Jan;31(1):104-106. doi: 10.1016/j.jvoice.2016.01.008. Epub 2016 Apr 8. PubMed 27068425 ↗
  • Einstein MH, Takacs P, Chatterjee A, Sperling RS, Chakhtoura N, Blatter MM, Lalezari J, David MP, Lin L, Struyf F, Dubin G; HPV-010 Study Group. Comparison of long-term immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years: end-of-study analysis of a Phase III randomized trial. Hum Vaccin Immunother. 2014;10(12):3435-45. doi: 10.4161/hv.36121. PubMed 25483701 ↗
  • Sehulster L, Chinn RY; CDC; HICPAC. Guidelines for environmental infection control in health-care facilities. Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC). MMWR Recomm Rep. 2003 Jun 6;52(RR-10):1-42. PubMed 12836624 ↗
  • Ilmarinen T, Auvinen E, Hiltunen-Back E, Ranki A, Aaltonen LM, Pitkaranta A. Transmission of human papillomavirus DNA from patient to surgical masks, gloves and oral mucosa of medical personnel during treatment of laryngeal papillomas and genital warts. Eur Arch Otorhinolaryngol. 2012 Nov;269(11):2367-71. doi: 10.1007/s00405-012-2049-9. Epub 2012 May 16. PubMed 22588197 ↗
  • Garden JM, O'Banion MK, Bakus AD, Olson C. Viral disease transmitted by laser-generated plume (aerosol). Arch Dermatol. 2002 Oct;138(10):1303-7. doi: 10.1001/archderm.138.10.1303. PubMed 12374535 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03350698
Lead sponsor
Eastern Virginia Medical School
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Craig Derkay M.D. (Professor, Eastern Virginia Medical School) — Principal investigator
First posted
Nov 22, 2017
Start date
Apr 6, 2018
Primary completion
Dec 30, 2023 (estimated)
Completion
Dec 30, 2023 (estimated)
Last update
Feb 21, 2023

Study contacts

Craig H Derkay, MD
Contact
craig.derkay@chkd.org
757-668-9842
Laura Stone, RN
Contact
stonelj@evms.edu
757-388-6238
Craig H Derkay, MD
principal investigator · Eastern Virginia Medical School

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Papilloma→

Other studies from this sponsor

Eastern Virginia Medical School

Start the discussion