Jun. 01, 2014

Testing the HPV Vaccine

By Jenny Thorn Palter

If you knew you were at increased risk of developing a particular form of cancer, and there was a vaccine that could help prevent it, wouldn’t you want to receive it?

Yet for people with lupus, in some cases, vaccines can trigger a lupus flare. Or perhaps the vaccine may not be effective for those with a compromised immune system. A drug manufacturer would have to take additional time and expense to study the safety and effectiveness of vaccines specifically for people with complex immune system diseases, such as lupus.

Sometimes it takes a person with a passion to accept this kind of challenge. Rheumatologist Patricia Dhar, M.D., at Wayne State University School of Medicine in Detroit, is that kind of person.

Guarding against HPV

The human papillomavirus, or HPV, can cause cervical, vulvar, vaginal, and anal cancers; precancerous lesions; and genital warts. There are many cancer-causing types of HPV; types 16 and 18 cause 70 percent of cases of cervical cancer, while types 6 and 11 cause 90 percent of cases of genital warts. The Gardasil® vaccine—called a “quadrivalent vaccine” because it protects against four HPV types (6, 11, 16, and 18)—was approved by the Food and Drug Administration in 2006 for girls and young women ages 9 to 26 and boys and young men ages 9 to 26.

Dhar and her colleagues have published data showing that women with lupus are at increased risk for both cervical dysplasia and cervical cancer. They believe this is due to persistent infection with HPV. “By age 50, 80 percent of women have been exposed to HPV,” Dhar says.

“If you receive the vaccine before being infected, when HPV ‘comes into the house,’ you already have an army [to fight it],” Dhar says. “But HPV is difficult to get rid of completely because some virus particles remain in the basal layer of the tissue, so there is always a ­reservoir of the virus in the body.”

The virus has the ability to hide in the cervical tissue cells, where it quietly reproduces, she explains. The longer the virus persists in cervical tissue, the greater its ability to cause transformation of the cells to cervical cancer. Gardasil boosts production of the antibodies that attach, or bind, to HPV so that the immune system can get rid of the virus.

Investigator-initiated research

Without data on how the vaccine works in lupus, Dhar knew physicians couldn’t be sure whether to recommend Gardasil to their patients. She decided to submit her own “investigator-initiated” study to Gardasil’s manufacturer, pharmaceutical giant Merck. It was reviewed and approved; Merck also agreed to provide the vaccine for the participants.

Dhar worked directly with the scientist responsible for worldwide clinical development of Gardasil, Alfred Saah, M.D., who is an internal medicine physician with a background in infectious diseases.

“It is deemed to be safe for people with lupus to be vaccinated, and it is recommended that they receive the normal types of vaccines that exist,” Saah says. “But there is always a concern that a vaccine will cause a flare. So the first question Dr. Dhar is investigating is, ‘Do certain things in lupus flare when the person uses Gardasil?’ The second issue, beyond safety, is, ‘How do people with lupus respond to this vaccine?’ ”

Saah stresses that the vaccine does not take the place of routine Pap testing, and both he and Dhar strongly recommend that women continue to have regular Pap tests.

“The Pap test protects against any type of ‘breakthrough’ from an inadequate response to the vaccine,” Saah says, “and also [allows] women to protect themselves against the types of HPV that are not in the vaccine.”


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