NCT03350698

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Eastern Virginia Medical School · Academic / Other
• Sex: All
• Age: 27 Years – 69 Years
• Healthy volunteers: Accepted

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

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.

Conditions

• Papillomavirus Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	Gardasil-9	3 vaccine series

Timeline

• Start date: 2018-04-06
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2017-11-22
• Last updated: 2023-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study