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Cancer Vaccine

Recombinant Human Papillomavirus Nonavalent Vaccine for Vulvar Intraepithelial Neoplasia

Phase 4

Waitlist Available

Led By Anna Wald

Research Sponsored by Fred Hutchinson Cancer Research Center

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 up to month 36

Awards & highlights

Study Summary

This trial looks at how well the HPV vaccine works in preventing vulvar or anal cancer in patients with high-grade pre-cancerous lesions.

Eligible Conditions

Anal Intraepithelial Neoplasia
Vulvar Intraepithelial Neoplasia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to month 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to month 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Persistent High-risk Infection Among Vaccine Compared With Placebo Recipients

Secondary outcome measures

HPV Antibody Level

Incidence of Adverse Events (AEs) Via Solicited Vaccine Reactogenicity by Arm

Time to Recurrence of Anogenital High Grade Squamous Intraepithelial Lesion (HSIL)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (recombinant human papillomavirus nonavalent vaccine)Experimental Treatment3 Interventions

Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months.

Group II: Arm II (placebo)Placebo Group3 Interventions

Patients receive placebo IM at baseline, 2 months, and 6 months.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor

443 Previous Clinical Trials

148,184 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,925,945 Total Patients Enrolled

Fred Hutchinson Cancer CenterLead Sponsor

556 Previous Clinical Trials

1,343,207 Total Patients Enrolled

Frequently Asked Questions

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

How many participants are being included in the experimental research?

"This medical study is no longer actively seeking volunteers. It was initially posted on August 1st 2017 and received its last update October 18th 2022. However, there are 2394 studies for vulva related conditions that are still recruiting as well as 32 trials for the Recombinant Human Papillomavirus Nonavalent Vaccine which require participants."

Answered by AI

Is there still capacity to enroll participants in this trial?

"According to information available on the clinicaltrials.gov website, this medical trial is not accepting new participants at present; it was originally posted in August 2017 and last edited in October 2022. At the moment there are 2426 other trials actively searching for patients."

Answered by AI

Is this groundbreaking research the first of its kind?

"At present, there are 32 trials in progress for Recombinant Human Papillomavirus Nonavalent Vaccine located in 129 cities and 32 nations. Merck Sharp & Dohme Corp's first endeavour began back in 2002 with a Phase 3 drug approval stage impacting 12167 individuals; since then, 819 further experiments have been conducted."

Answered by AI

Does this research experiment accept individuals aged 25 and up?

"Eligibility for this clinical trial requires that prospective participants must be between 27 and 69 years old."

Answered by AI

To what illnesses is Recombinant Human Papillomavirus Nonavalent Vaccine typically prescribed?

"The recombinant human papillomavirus nonavalent vaccine is suitable to treat infections caused by HPV type 58, 31 and general infection attributed to the virus."

Answered by AI

Could you elucidate the potential risks associated with Recombinant Human Papillomavirus Nonavalent Vaccine?

"With a Phase 4 trial underway, the safety of Recombinant Human Papillomavirus Nonavalent Vaccine has been rated at 3 on our scale. This signifies that it is approved for use by patients with certain medical conditions."

Answered by AI

Has research been conducted to assess the efficacy of Recombinant Human Papillomavirus Nonavalent Vaccine?

"Currently, 32 trials of the Recombinant Human Papillomavirus Nonavalent Vaccine are ongoing with 16 in Phase 3. Bangkok and Chang Wat Nonthaburi host most of these studies but there exist 244 other testing sites around the world."

Answered by AI

Is it feasible to enroll in this investigation?

"This medical study seeks to enrol 188 individuals aged 27-69 suffering from vulva. To meet the criteria, they must reside near one of the participating clinics and be ready to attend 8 visits over a 3 year period. In addition, those selected will need to sign records release forms as well as provide acknowledgement that no treatment has been administered for HSIL in the past two months or more."

Answered by AI