NCT03350698

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

April 6, 2018

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

5.7 years

First QC Date

November 10, 2017

Last Update Submit

February 16, 2023

Conditions

Papillomavirus Vaccines

Keywords

Human papilloma virus

Outcome Measures

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

    baseline and 7 months

Study Arms (1)

active drug

EXPERIMENTAL

Human Papilloma virus ,Gardasil, 9 valent vaccine

Biological: Gardasil-9

Interventions

Gardasil-9BIOLOGICAL

3 vaccine series

active drug

Eligibility Criteria

Age27 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Current residents of EVMS Otolaryngology, General Surgery, Urology, or Obstetrics-Gynecology programs

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EVMS Otolaryngology

Norfolk, Virginia, 23507, United States

RECRUITING

Related Publications (11)

  • 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.

    PMID: 20451455BACKGROUND

  • 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.

    PMID: 12571259BACKGROUND

  • 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.

    PMID: 1662265BACKGROUND

  • 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.

    PMID: 21798893BACKGROUND

  • 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.

    PMID: 1660719BACKGROUND

  • 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.

    PMID: 14634897BACKGROUND

  • 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.

    PMID: 27068425BACKGROUND

  • 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.

    PMID: 25483701BACKGROUND

  • 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.

    PMID: 12836624BACKGROUND

  • 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.

    PMID: 22588197BACKGROUND

  • 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.

    PMID: 12374535BACKGROUND

Related Links

Study Officials

  • Craig H Derkay, MD

    Eastern Virginia Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Craig H Derkay, MD

CONTACT

757-668-9842craig.derkay@chkd.org

Laura Stone, RN

CONTACT

757-388-6238stonelj@evms.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Prospective Single-Subject Experimental Design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 10, 2017

First Posted

November 22, 2017

Study Start

April 6, 2018

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)