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Cancer Vaccine

9-valent HPV vaccine for Cervical Neoplasia

Phase 2
Waitlist Available
Led By Alessandro D Santin, MD
Research Sponsored by Yale University
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 between weeks 20 and 24 (approximately week 22)
Awards & highlights

Study Summary

This trial is testing whether imiquimod or imiquimod + 9-valent HPV vaccine can treat CIN 2/3.

Eligible Conditions
  • Cervical Neoplasia
  • Cervical Dysplasia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between weeks 20 and 24 (approximately week 22)
This trial's timeline: 3 weeks for screening, Varies for treatment, and between weeks 20 and 24 (approximately week 22) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Objective Response
Secondary outcome measures
Incidence of HPV Clearance

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: imiquimod + 9-valent HPV vaccineExperimental Treatment2 Interventions
Participants randomized to the imiquimod + 9-valent HPV vaccine group will receive instruction on imiquimod self application (16 week course) at the baseline visit. In addition, all women (regardless of age) will be administered a dose of the HPV vaccine on day of enrollment (regardless of previous HPV vaccination history). Women previously unvaccinated will receive an additional booster dose at 8 weeks.
Group II: imiquimod onlyActive Control1 Intervention
Participants randomized to the imiquimod only group will receive instruction on imiquimod self application (16 week course) at the baseline visit.
Group III: observation only (control)Active Control1 Intervention
Participants randomized to the control group will only be observed and will receive no intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
9-valent HPV vaccine
2016
Completed Phase 3
~410
Imiquimod
2005
Completed Phase 4
~2260

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,846 Previous Clinical Trials
2,736,345 Total Patients Enrolled
Alessandro D Santin, MDPrincipal InvestigatorYale University School of Medicine Department of Obstetrics, Gynecology & Reproductive Sciences, Division of Gynecologic Oncology
Sangini S Sheth, MD, MPHPrincipal InvestigatorYale University School of Medicine Department of Obstetrics, Gynecology & Reproductive Sciences, Division of Gynecologic Specialties

Media Library

9-valent HPV vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT02864147 — Phase 2
Cervical Neoplasia Research Study Groups: imiquimod + 9-valent HPV vaccine, imiquimod only, observation only (control)
Cervical Neoplasia Clinical Trial 2023: 9-valent HPV vaccine Highlights & Side Effects. Trial Name: NCT02864147 — Phase 2
9-valent HPV vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02864147 — Phase 2

Frequently Asked Questions

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

Is the 9-valent HPV vaccine used to prevent cancer or treat it?

"The 9-valent HPV vaccine is not only used to treat scalp structure, but also other conditions such as condylomata acuminata, superficial basal cell carcinoma, and warts on the face."

Answered by AI

What is the FDA's stance on 9-valent HPV vaccine?

"The 9-valent HPV vaccine is currently in Phase 2 clinical trials. While there is some data supporting its safety, more needs to be collected regarding efficacy before it can receive a higher score."

Answered by AI

How many individuals are receiving treatment through this study?

"Unfortunately, this study is no longer seeking participants. The trial was first advertised on July 1st 2016 but the most recent update occurred on August 5th 2022. However, there are 50 other trials recruiting patients with cervical intraepithelial neoplasia and 23 studies for 9-valent HPV vaccine that you may be eligible for."

Answered by AI

Is this research project looking for new participants at the moment?

"No, this particular study is no longer enrolling patients. According to the latest update on 8/5/2022, this trial is now closed. However, if you are still interested in participating in a clinical trial, there are 50 trials for cervical intraepithelial neoplasia and 23 9-valent HPV vaccine studies that are presently looking for patients."

Answered by AI

What are the most similar previous studies to this 9-valent HPV vaccine clinical trial?

"23 clinical trials for 9-valent HPV vaccines are ongoing and 6 of them have reached Phase 3. Many of the trials taking place in Texas, with Houston having the most active research sites. However, there are a total of 90 locations across the United States conducting these HPV vaccine studies"

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Smilow Cancer Hospital at Yale New Haven
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Smilow Cancer Hospital at Yale New Haven: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3)
2016. "Treatment of High-Grade Pre-Neoplastic Cervical Lesions (CIN 2/3)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02864147.
~15 spots leftby Apr 2025
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