Fred Hutch epidemiologists receive $2.5M grant for first-ever study of therapeutic use for HPV vaccine

Could the preventive vaccine also be a therapy for anogenital precancers?
Dr. Margaret Madeleine
Dr. Margaret Madeleine and colleagues plan to test whether the Gardasil 9 HPV vaccine could eliminate the recurrence of anogenital precancers after initial treatment. Fred Hutch file

The human papillomavirus, or HPV, can lead to a number of malignancies, including anal and vulvar cancer. But can the HPV vaccine be used as a treatment for anogenital precancers?

Dr. Margaret Madeleine, an epidemiologist with Fred Hutchinson Cancer Research Center’s Public Health Sciences Division, just received a five-year, $2.5 million grant from the National Cancer Institute to find out.  It is the first U.S.-based trial to test whether the preventive HPV vaccine could be also be used as a therapy for these precancers.

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“The HPV vaccine is totally effective and safe and is most effective for preventing HPV infection,” she said. “That’s the primary way to use the vaccine. This is a therapeutic use in people who’ve already been infected [with HPV] and has not been tested yet. It’s a new way to use the vaccine.”

According to Madeleine, people diagnosed with anal or vulvar in situ disease (or precancer) often experience recurrence after their initial treatment and have to undergo “incredibly invasive” surgeries to remove the new lesions.

She and her team plan to test whether the Gardasil 9 HPV vaccine could eliminate these recurrences by removing the HPV infection that drives the precancers.

Research by Fred Hutch’s Dr. Denise Galloway and colleagues laid the groundwork for the creation of the HPV vaccines Gardasil and Cervarix, which prevent HPV infection. Gardasil, approved in 2006 for use in the U.S., prevents the types of HPV that account for 70 percent of cervical cancers and 90 percent of genital warts. Gardasil 9, approved in early 2015, protects against 90 percent of cervical cancers as well as many cancers of the anus, penis, vulva, vagina and throat. Recommended for girls and boys starting at age 11 or 12, the HPV vaccine is currently in use only as a preventive.

Madeleine will work with Dr. Anna Wald, an epidemiologist with the Hutch’s Vaccine and Infectious Disease Division and medical director of the University of Washington Virology Research Clinic, to determine if the vaccine could also be used as a therapy. Their study will be a randomized, double-blind, placebo-controlled trial with two groups of patients, both of whom have been treated for an anogenital precancer but neither of whom have been vaccinated for HPV. One group will receive the Gardasil 9 HPV vaccine; the other group will receive a placebo.

The HPV Vaccine to Interrupt Progression of Vulvar and Anal Lesions trial, dubbed VIVA, will be conducted at Seattle’s Harborview Medical Center. Participants will be followed for three years.

Madeleine said earlier studies have shown that people with these types of precancers recur less often if they’ve had HPV vaccination or have natural antibodies to the virus.  

“We think it will keep new infections from growing into tumors,” she said. “The idea is to see within three years whether there’s a 50 percent decrease in recurrence.”

If there is, Madeleine said the trial will answer a key question.

“If we can rigorously test this idea,” she said. “It would be a really nice answer to a question that’s outstanding:  whether the vaccine has a therapeutic benefit.”

Diane Mapes is a staff writer at Fred Hutchinson Cancer Center. She has written extensively about health issues for NBC News, TODAY, CNN, MSN, Seattle Magazine and other publications. A breast cancer survivor, she blogs at and tweets @double_whammied. Email her at Just diagnosed and need information and resources? Visit our Patient Care page.

Read more about Fred Hutch achievements and accolades.

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