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HPV Vaccine for Health Care Workers

Phase 4
Recruiting
Led By Craig H Derkay, MD
Research Sponsored by Eastern Virginia Medical School
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 7 months
Awards & highlights

Study Summary

This trial is testing if the HPV, Gardasil-9 vaccine is effective for health care workers.

Who is the study for?
This trial is for actively practicing surgeons and current residents in Otolaryngology, General Surgery, Urology, or Obstetrics-Gynecology at EVMS or affiliated hospitals. It's not open to those under 26 or over 69 years old, pregnant individuals, people with moderate/severe acute illness, a history of severe yeast allergies, or previous HPV vaccination with the Gardasil-9 vaccine.Check my eligibility
What is being tested?
The study is testing the Gardasil-9 vaccine in healthcare workers who are at risk of occupational exposure to HPV. The goal is to establish if there should be a standard for vaccinating healthcare workers against HPV similar to other vaccinations recommended by the CDC.See study design
What are the potential side effects?
Possible side effects from the Gardasil-9 vaccine may include pain at injection site, swelling, redness, headaches, fever and nausea. Severe allergic reactions are rare but can occur in those sensitive to yeast or other vaccine components.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
# of participants with elevated HPV antibody titers from baseline to 7 months

Trial Design

1Treatment groups
Experimental Treatment
Group I: active drugExperimental Treatment1 Intervention
Human Papilloma virus ,Gardasil, 9 valent vaccine

Find a Location

Who is running the clinical trial?

Eastern Virginia Medical SchoolLead Sponsor
68 Previous Clinical Trials
10,303 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,557 Total Patients Enrolled
2 Trials studying Papillomavirus Vaccines
1,650 Patients Enrolled for Papillomavirus Vaccines
Craig H Derkay, MDPrincipal InvestigatorEastern Virginia Medical School

Media Library

Gardasil-9 Clinical Trial Eligibility Overview. Trial Name: NCT03350698 — Phase 4
Papillomavirus Vaccines Research Study Groups: active drug
Papillomavirus Vaccines Clinical Trial 2023: Gardasil-9 Highlights & Side Effects. Trial Name: NCT03350698 — Phase 4
Gardasil-9 2023 Treatment Timeline for Medical Study. Trial Name: NCT03350698 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do you accept individuals over 30 years old to participate in this trial?

"The upper and lower age boundaries for this trial are 27 and 69 respectively."

Answered by AI

Has the Food and Drug Administration granted authorization for Gardasil-9?

"Our assessment of the safety profile for Gardasil-9 is a 3, as this medication has already been approved and released to market in Phase 4 trials."

Answered by AI

In what contexts is Gardasil-9 typically prescribed?

"Gardasil-9 has been proven effective in treating infections caused by human papillomavirus type 58, 31 and any other HPV strain."

Answered by AI

Is my profile compatible with the requirements of this investigation?

"The requirements to be accepted into this trial are a prior papillomavirus vaccination and the participant must between 27-69 years old. Approximately 100 people will be welcomed onto the programme."

Answered by AI

To what extent is the clinical trial populated with participants?

"Affirmative. According to clinicaltrials.gov, this experiment is currently enrolling individuals and was first posted on April 6th 2018 before being updated most recently on February 16th 2023. The trial requires 100 volunteers from one site for participation."

Answered by AI

Is this research endeavor still looking for participants?

"Affirmative. Clinicaltrials.gov has indicated that this research initiative, which was initially posted on April 6th 2018 is still actively recruiting participants. One hundred individuals will be recruited from a single site."

Answered by AI

Has this investigation been previously undertaken before?

"At present, 31 active trials are underway for Gardasil-9 across 129 municipalities and 32 nations. Merck Sharp & Dohme Corp. initiated the first trial in 2002 which included 12167 patients and concluded its Phase 3 evaluation stage. 117 studies have been finished since then."

Answered by AI

Are there any other experiments that have examined the effects of Gardasil-9?

"Presently, 31 clinical trials are being conducted for Gardasil-9; 14 of these active studies have reached phase 3. Over two hundred and forty three research centres in Bangkok and Chang Wat Nonthaburi are contributing to the investigation into this treatment's efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Occupational Exposure to Human Papilloma Virus (HPV) and Prophylactic Vaccination
Craig Derkay M.D. 2018. "Occupational Exposure to Human Papilloma Virus (HPV) and Prophylactic Vaccination". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03350698.
~14 spots leftby Apr 2025
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