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AzTrials

Papillomavirus VaccinesPhase 4NCT03350698

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

A Phase 4 study testing Gardasil-9 in people with Papillomavirus Vaccines, run by Eastern Virginia Medical School at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 27 to 69 yearsHealthy volunteers can take part
Conditions the study is for
Papillomavirus Vaccines
What is being tested?
Gardasil-9
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
6 Apr 2018to 30 Dec 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 27 to 69 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • • 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

Who cannot join

  • • 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

Trial locations and contacts

1 site in 1 country.

Craig H Derkay, MD contact

757-668-9842

craig.derkay@chkd.org

Laura Stone, RN contact

757-388-6238

stonelj@evms.edu

United States1 site, 1 recruiting

  • EVMS Otolaryngology

    Norfolk, Virginia, 23507

    Laura Stone, BSN, 757-388-6238, stonelj@evms.edu

    Craig Derkay, MD, Craig.derkay@chkd.org

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
Gardasil-9
Keywords
Human papilloma virus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gardasil-9Biological

    3 vaccine series

Study groups in NCT03350698
Study groupRoleWhat they receive
active drugExperimentalHuman Papilloma virus ,Gardasil, 9 valent vaccine
Receives: Biological: Gardasil-9

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: baseline and 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2017
  2. Study start6 Apr 2018
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective Single-Subject Experimental Design
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03350698
Sponsor's protocol ID
17-09-FB-0176
Status last verified
Feb 2023
First submitted
10 Nov 2017
Last updated
21 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Gardasil-9 in people with Papillomavirus Vaccines, run by Eastern Virginia Medical School at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Craig H Derkay, MD (757-668-9842, craig.derkay@chkd.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

# of participants with elevated HPV antibody titers from baseline to 7 months (time frame: baseline and 7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03350698, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.

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