18 Jun 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
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
