The VIVA Trial

Cancer Epidemiology Research Cooperative (CERC)

The VIVA Trial

Vaccine to Interrupt Progression of Vulvar and Anal Neoplasia

Principal Investigators: Margaret M. Madeleine, PhD; Anna Wald, MD, MPH
Study Manager: Sarah Taylor

 

The VIVA Clinical Trial (Vaccine to Interrupt Progression of Vulvar and Anal Neoplasia) will test whether the Human Papillomavirus (HPV) vaccine can improve the health of people who have been previously diagnosed with pre-cancerous lesions.

We plan to enroll men and women in the Seattle area with a history of pre-cancerous lesions, who will be randomly assigned to receive either the Gardasil vaccine or a saline solution (placebo) vaccine.  Participants will be asked to come to the clinic for a total of 7 visits over 3 years.  All participants will receive a total of 3 injections in the arm (Enrollment, Month 2, and Month 6) and will complete questionnaires, and have physical exams, blood draws and biopsies at the pre-cancerous lesion site.

Participant Eligibility

  • Between the ages of 27- 69 at the time of enrollment of pre-cancerous lesions
  • 2 or more months since last therapy or treatment for pre-cancerous lesions

Exclusions

  • Prior history of invasive HPV-related anogenital cancer or oropharyngeal cancer 
  • Currently participating in an interventional research study related to HPV
  • Women only: Currently pregnant

Here is a link to a recent article about the VIVA Clinical Trial:

https://centernet.fredhutch.org/cn/n/2017/06/epidemiologists-receive-hpv-vaccine-grant.html

Additional Information about the VIVA Trial

What is the VIVA Clinical Trial?

The VIVA Clinical Trial will test whether the Human Papillomavirus (HPV) vaccine can improve the health of people who have been previously diagnosed with pre-cancerous lesions. This research is being conducted by scientists at the University of Washington and Fred Hutchinson Cancer Research Center. We will test whether the vaccine can help reduce additional lesions in patients who have not previously received the HPV vaccine.

Participants will be randomly assigned to the intervention or control groups. Participants in the intervention group will receive the active Gardasil vaccine. Participants in the control group will receive an inactive vaccine. We will compare these two groups in order to determine whether the Gardasil vaccine is an effective and safe treatment for reducing the progression of anal and vulvar lesions. Gardasil is an FDA-approved vaccine being tested for a new use. We don’t know if this will prevent recurrence.

 

How are participants assigned to the active vaccine and placebo groups?

Study participants will be randomly (like the flip of a coin) assigned by a computer to the active or placebo vaccine groups.

Who will be asked to participate?

We hope to enroll about 345 people who have been diagnosed with a pre-cancerous lesion. Our participants must be between age 27 and 69 at enrollment and live in the greater Seattle metropolitan area.

Is the information kept confidential?

We will keep the information participants give us strictly confidential. We only use names to contact participants and will not give this information to anyone else for any reason. Only the investigators and staff directly involved with this project have access to study data, which are protected by strict security measures.

 

What is asked of VIVA participants?

We will first determine an interested person’s potential eligibility by conducting a telephone interview that will take about 10 minutes. When someone is potentially eligible after the telephone interview, and interested in hearing more about the study, we will set up a screening visit at the UW Virology Research Clinic.

At the clinic screening visit we will explain the research requirements and activities and potential participants will be advised of any risks that could be associated with this trial. Potential participants will also have the opportunity to ask as many questions as they like.

Potential participants can decide to enroll in the trial after the screening visit if they are found to be eligible. When someone decides to enroll in the trial they will be randomly assigned to the intervention or control group. Participants will be asked to come to up to 6 more clinic visits in Seattle over 3 years. All participants will receive 3 injections in the arm with either the vaccine or placebo. All participants will also be asked to fill out questionnaires, have physical exams, blood draws and biopsies at the original lesion site.

Where is the UW Virology Research Clinic?

It is located at 9th and Jefferson in Seattle, near Harborview Medical Center.

 

Is participation voluntary?

Participation is completely voluntary. At the first clinic visit, potential participants can decide to enroll or not enroll in the trial, without consequences to them or their medical care. Participants also have the right to drop out of the trial at any time after enrollment.  

What is the active vaccine for the intervention group?

Participants randomly assigned to the intervention group will receive 3 injections of the licensed Human Papillomavirus (HPV) vaccine Gardasil.

What is the placebo vaccine for the control group?

Participants randomly assigned to the control group will receive 3 injections of the placebo vaccine which is a saline solution.

Our goal is to compare these two groups in order to determine whether the Gardasil vaccine is an effective and safe treatment for reducing the progression of pre-cancerous lesions.

When will participants find out if they are in the active vaccine or placebo group?

Participants and the research staff will not know who is assigned to the active vaccine and placebo groups until the end of the study. This information will be shared with participants when the Trial is complete.  At that time, participants who received the placebo vaccine will be offered Gardasil, free of charge.

 

Will participants be paid to participate in the Trial?

We will provide parking and up to $350 as a token of our appreciation for people who participate in the VIVA Trial.

 

How long does the VIVA Trial last?

Clinic visits take place over 3 years, with phone or email follow up for an additional year.

Funding for this study is provided by the National Cancer Institute.

Contact Information:

For more information about VIVA Trial contact the study manager or study clinic.

Clinic Location

Our clinic is located on the 11th floor of the Ninth and Jefferson Building at Harborview Medical Center and open Monday through Friday 8am to 5:30pm.

University of Washington Virology Research Clinic
908 Jefferson St, 11th floor, Seattle, WA 98104
206-520-4340 | vrc@uw.edu

For further information about this study, please contact the study  manager:

Sarah Taylor
(206) 667-4493
Toll free: 1-866-352-9525
sataylor@fredhutch.org

Further Information about this Trial Available at the Following:
CT.gov
University of Washington: Institute of Translational Health Sciences - The VIVA Trial
Fred Hutch Clinical Trials