Clinical trial

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

Name

17-09-FB-0176

Description

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 arms

Trial start

2018-04-06

Estimated PCD

2023-12-30

Trial end

2023-12-30

Status

Recruiting

Phase

Early phase I

Treatment

Gardasil-9

3 vaccine series

Arms:

active drug

Size

100

Primary endpoint

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

baseline and 7 months

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective Single-Subject Experimental Design', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-02-21

1 organization

1 product

1 indication

Organization

Eastern Virginia Medical School

Product

Gardasil-9

Indication

Human Papillomavirus Vaccines