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The VIVA Trial

The VIVA Trial

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, physical exams, and blood draws. Participants may receive biopsies at the pre-cancerous lesion site.

Participant Eligibility

Participant Eligibility
• Between the ages of 27- 69 at enrollment
• 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, except the ANCHOR study
▪ Women only: Currently pregnant

Contact

Sarah Taylor
(866) 352-9525

Additional Study Details

Full Study Title
HPV Vaccine to Interrupt Progression of Vulvar and Anal Neoplasia (VIVA) Trial: A Randomized, Double-Blind, Placebo-Controlled Trial

Study ID: 9790
Start Date: 01/09/2019
End Date: 06/01/2020

Investigator(s)
Margaret M. Madeleine, PhD
Anna Wald, MD, MPH
Constance Mao, MD
Jeffrey Schouten, MD
Verena Grieco, MD

Accepts Healthy Volunteers?
Yes

Study Site(s)

University of Washington Virology Research Clinic

908 Jefferson St. 11NJ1166
Seattle, Washington 98104



Interested?

Use the link below to send a message to the study coordinator, or call the number above to speak directly with a study representative.

I am interested in this research study.

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