The value of the Gardasil vaccine for Human Papilloma Virus is widely associated with children and adolescents, but a study initiated by Wayne State University School of Medicine Associate Professor of Medicine J. Patricia Dhar, M.D. '82, shows that women with lupus up to age 50 - a high-risk population for HPV - could also benefit by making them less susceptible to developing HPV-related pre-cancerous cells and cervical cancer, also known as neoplasia.

Dr. Dhar, a rheumatologist and the principal investigator of the WSU Lupus Database, previously showed that cervical neoplasia is increased in women with lupus.

Lupus patients also have increased susceptibility to skin cancer, lymphoma and cervical cancer, she said. The study findings may translate to other autoimmune diseases as well, including rheumatoid arthritis and scleroderma, and could be beneficial to transplant, HIV/AIDS and other immunosuppressed groups, she said.

"We can catch things early, before they develop into cancer. This vaccine will prevent the pre-cancer of the cervix. We monitor lupus patients more closely for cervical cancer than the general population. We want to give them a defense so they don't get a virus that predisposes them to pre-cancer," she said. "Because once you get this bug, it is really hard to get rid of. The HPV vaccine is not a live vaccine so you cannot get an infection from the vaccine."

HPV is so common that nearly all sexually active people will get it at some point, according to the U.S. Centers for Disease Control and Prevention. While there are many types, some cause cervical and other cancers.

"When HPV infection persists, that's when it can transform the tissue into neoplasia. In healthy women, the antibodies made from a previous HPV infection are low-level and may not protect a woman from getting another infection. The vaccine, however, causes production of very high levels of antibodies against HPV and these antibodies prevent the virus from binding to the cervix and causing an infection," she said. "My group has shown that HPV infection of the cervix can become latent and never really go away. It is important because it is not something primary doctors that treat lupus think about when they treat these patients."

The outcome of this first Phase I study to evaluate the safety and immunogenicity of the quadrivalent HPV vaccine made by Gardasil in women with systemic lupus erythematosus, or SLE, was published in the May 9 issue of the journal Vaccine.

"I don't think primary care physicians realize patients with lupus are at a higher risk for HPV diseases and cervical neoplasia. We don't see lupus patients getting vaccinated. I don't think the patients are aware of this or think about it, and I don't think the primary care docs are aware or think of it," Dr. Dhar said. "Now we've shown that it is safe and effective. It should be part of their health prevention, because they are at risk lifelong for HPV-related disease."

The researchers administered the qHPV vaccine at the standard dosing schedule to 34 women 18 to 50 years old with mild to moderate SLE and minimally active or inactive SLE, with no adverse events related to the vaccine reported. The study team included WSU's Distinguished Professor Robert Sokol, M.D.; Lynnette Essenmacher, M.P.H.; Ardella Magee and the late Joel Ager Jr., Ph.D.

The study was supported in part by a research grant from the Investigator-Initiated Studies Program of Merck, Sharp & Dohme Corp., which also provided the vaccines. Dr. Dhar provided the protocol.