Wednesday, Jan. 17, 11 a.m.

HPV Vaccine

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Dr. Richard Schlegel
Chair, Georgetown University Medical Center's Department of Pathology
Wednesday, January 17, 2007; 11:00 AM

Dr. Richard Schlegel's research helped lead to the development of Gardasil, a vaccine for human papillomavirus (HPV), a sexually transmitted virus that can cause genital warts and cervical cancer. The D.C. Council is currently considering a bill that would require girls to receive the HPV vaccine before the start of sixth grade.

Schlegel was online Wednesday, Jan. 17 at 11 a.m. to discuss the vaccine and the virus.

A transcript follows.

Schlegel is chair of the Georgetown University Medical Center's Department of Pathology, and has spent much of his career working on HPV research. Cervical cancer develops from certain strains of HPV, which affects both men and women. Gardasil blocks the two strains of HPV responsible for about 70 percent of cervical cancer cases. The FDA recommends the vaccine for females between the ages of nine and 26 to prevent cervical cancer.

Schlegel is now working on second- and third-generation vaccines to prevent HPV and decrease the incidence of cervical cancer in the developing world.

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Dr. Richard Schlegel: As an introduction, I am the Chair of Pathology of Georgetown and have been working on papillomaviruses for approximately 25 years. We are very interested in studying the interaction of this virus with humans and how it promotes cancer. Our laboratory studies include vaccine development as well as potential new drug therapies.

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Washington, D.C.: Two years ago I was diagnosed with the cervical cancer strain of HPV. After the colopscopy, it never developed into anything and my gynecologist gave me the all-clear. When I recently asked about the vaccine, she recommended against it, saying that I already had the antibodies and it was unnecessary. If this true? If you already have HPV, should you get Gardasil?

Dr. Richard Schlegel: Cervical caner

Dr. Richard Schlegel: Cervical cancer is caused by approximately a dozen different types of human papillomaviruses. You most likely were infected by only 1 type and the vaccine currently covers two types most frequently involved in cancer. So vaccination would give you the benefit of protecting against this other HPV type.

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Washington, D.C.: Three days ago, I asked a prominent pediatrician in Los Angeles if she recommended the vaccine and if so, when?

She enthusiastically endorsed the vaccine but said that she is cautioning parents to wait to vaccinate until the age of 14. Why would this be a better option than sixth grade or 11 years of age?

Dr. Richard Schlegel: No, immunizing at age 11 would certainly be the most beneficial. There isn't any difference known between vaccinating at age 11 or 14. The earlier the better.

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U St., Washington, D.C. :1. If HPV is sexually transmitted, why not also immunize boys/men and stop viral transmission from that source as well?

2. HPV seems linked to cervical cancer in women -- and seems to be a primary reason for the urgency of the campaign. Is there evidence that HPV is also linked to other diseases in men? Which would argue for immunizing them as well?

Dr. Richard Schlegel: Eventually the vaccination will probably be extended to boys. They certainly are infected by the virus and these infections can, with low frequency, lead to cancer of the penis. Also, the virus can be transmitted in genital/anal contact in homosexual men.

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Washington, D.C.: How soon can we expect second- and third-generation HPV vaccines?

Dr. Richard Schlegel: The upcoming HPV second and third generation are currently in the early clinical trial phases. I would anticipate that in 5-7 years there might be new formulations available. Also, both Merck and GSK and currently improving their vaccines to cover more of the HPV types involved in cancer and these might be available sooner.

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Washington, D.C.: About two years ago, I found out I had HPV and then had to have surgery to remove pre-cancerous cells. I had only been with two partners in my lifetime, and always used condoms.

So even if you are responsible, you can contract HPV. While I was lucky and no longer have HPV, it was an extremely difficult time for me, very scary experience. I'll make sure my children receive the vaccine.

Dr. Richard Schlegel: Unfortunately, condoms are not particularly effective in preventing the transmission of HPV. The virus is found in genital cells not covered by the condom.

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Washington, D.C.: Did you always know you wanted to study HPV, or did you start out doing something completely different?

Dr. Richard Schlegel: I started studying a cow papillomavirus in 1982 in order to study how viruses can induce abnormal growth of cells. Once HPV has been isolated from cervical cancer, we switched to studying the human virus and developed assays to study the transforming activity of these viruses in the laboratory. This eventually led to our interest in devising ways to inhibit these virus infections.

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Washington, D.C.: I see the news focus of today's chat is on the District of Columbia. But I was curious what implications your vaccine has for the health of individuals in developing countries. Are there many steps that need to occur to get the vaccine to these places? Is it difficult?

Dr. Richard Schlegel: Cervicalcancer is a critical health issue in developing countries and, in fact, is the second most common cause of cancer deaths in women worldwide. The current HPV vaccine will have an enormous impact and has the potential to save nearly 250,000 women every year. At Georgetown, we are involved in an international research cooperative to develop a more stable and cost-effective vaccine which will make this vaccination procedure afffordable in these countries.

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Muncie, Ind.: My 19-year-old daughter had the first shot right after Thanksgiving and the second shot after Christmas. I know that she is due for the third shot at the end of June, but she may be in another state for the summer. How important is it to have the third shot within 6 months of the second? It is difficult to find providers? Are there plans to widen distribution of the vaccine?

Dr. Richard Schlegel: No, the timing of the final booster is not critical. I would arrange it to be compatible with schedule (i.e. at the end of the summer).

Hopefully the vaccine will be available widely very soon. It is certainly available in many states right now and in many college health centers.

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Baltimore: Is sex the only way HPV is transmitted?

Dr. Richard Schlegel: Although sex is the most common mechanism for transmitting the papillomavirus, it is not the only way. For example, during birth, babies can be infected in their airway by passing through the birth canal of an infected mother. Also, the papillomaviruses that infect our hands and feet are transmitted by contact with infected surfaces. However, with regard to cervical cancer, sex is basic mechanism of infection.

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Washington, D.C.: I have heard that you can't get the vaccine after the age of 25. I'm a 24 year old woman. If I get the first one of the series now, will I be able to finish it even after I turn 25 in a few months? Is it even accurate that there is an age limit?

Dr. Richard Schlegel: This is a great question. The reason for recommending the age limit is that this is the time at which most women will be exposed to the virus. However, women older than 26 can certainly gain benefit from vaccination, especially if they have had limited sexual contact. Women older than 26 have a very good immune system and will respond well to the vaccine.

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Gaithersburg, Md.: How long does the vaccine last? I've heard vague reports that it's good for five years but nothing concrete.

Dr. Richard Schlegel: Currently, the vaccine is known to last AT LEAST 5 years. However, with continuing followup, we may find that it last for much longer. We really don't know the limit right now.

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Georgetown, D.C.: Are there other cancers that are triggered by HPV?

Dr. Richard Schlegel: Yes, papillomaviruses are also involved in oral cancers and anal cancers, such as the cancer that Farah Fawcett currently has. Overall, then, the HPV vaccines are going anticipated to prevent these malignancies as well.

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Durham, N.C.: Has there been any research done on the possible therapeutic benefits of the vaccine being given to an individual already infected with one of the high-risk strains of HPV?

Dr. Richard Schlegel: This is a very controversial question. I think it is safe to say that our information is incomplete at the current time. It appears from the ongoing clinical trials that the vaccine does not have a significant effect on established infections (probably of recent onset). However, the effect of the vaccine on long-term, persistent infection in not known. There is very limited data in animal studies that vaccination might be beneficial for such persistent infections. However, these are animal studies and would certainly need to be verified in human trials.

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Washington, D.C.: Dr. Schlegel,

I am so pleased that you are here to talk about your research. This is a lifesaving vaccine and you have done so much for public health!

Will there be a vaccine for men at any point? Is any of your research geared toward that?

Thanks for your time.

Dr. Richard Schlegel: The same vaccine that is availabe for women will probably be offered to men in the future. Clinical trials are evaluating this procedure. It certainly offers the best way to prevent transmission.

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Charlottesville, Va.: I was diagnosed with a strain of HPV that does not cause cervical cancer. Can or should I still get the vaccine?

Dr. Richard Schlegel: Yes, you should definitely get vaccinated, because the vaccine will cover the high-risk papillomaviruses. Being infected with the lower-risk types of HPV does not interfere with this vaccination.

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Ashburn, Va.: I have a thirteen year old daughter and I would really like to get the HPV vaccine for her. I am a cancer survivor myself, and if there's a way to spare her any of that pain, I want to make it happen. When she had her annual physical last summer, I asked about the vaccine and was told that they didn't carry it and didn't know where to get it. They suggested the county board of health, but they had no information either. So I tried searching the Web to find information on where it was available and couldn't find any. Can you please direct me to information on how to obtain the vaccine for my daughter? If this vaccine is as important as I understand it to be, why is it so hard to find out how to get it for my child?

Dr. Richard Schlegel: I would suggest you call your local medical board-- each city has one-- and they should be able to direct you to a place to get the vaccine. THis is important-- you should keep trying.

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Washington, D.C.: I'm 33 years old and my Doctor said that I'm too old for the vaccine. Is this true? Or should I receive it anyway? I don't have HPV.

Dr. Richard Schlegel: As I said before, this is a great question. The reason for recommending the age limit is that this is the time at which most women will be exposed to the virus. However, women older than 26 can certainly gain benefit from vaccination, especially if they have had limited sexual contact. Women older than 26 have a very good immune system and will respond well to the vaccine.

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Takoma Park, Md.: Dr. Schlegel

The vaccine does not prevent all types of HPV, including the more serious and fast moving types. Do you think the vaccine will give folks a false sense of security?

Dr. Richard Schlegel: Actually, the current Merck and GlaxoSmithKline vaccines cover the most frequent and serious HPV types that cause cancer. However, both of these companies are modifying their vaccines to cover more HPV types and these vaccines should be available in the next five years.

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Washington, D.C.: How useful is this drug in preventing rectal cancer in men? Can it be helpful if administered post-exposure to HPV?

Dr. Richard Schlegel: It is anticipated that the HPV vaccines will also have a dramatic effect on preventing rectal cancers in men. However, clinical trials are incomplete at this time.

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Silver Spring, Md.: How does the vaccine work? Does it kill the virus? Stop it from replicating? Prevent it from attaching to whatever structure (I guess the cervix) it attaches to?

Dr. Richard Schlegel: When injected, the vaccine stimulates the production of antibodies. THese antibodies bind to the virus and prevent it from infecting our cells. You are correct in your statement that it will prevent attachment of the virus to cervical cells.

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Annapolis, Md.: I am a family physician, and I want to thank you for helping answer questions about this important vaccine.

The vaccine was not in great supply last summer, and many physicians were not stocking the vaccine until it was clear the insurance companies were going to cover it (it costs about $120/dose, not including ancillary fees, and it is a 3-shot series). Now that the vaccine is out and many if not all insurance companies are covering the vaccine, most family doctors and pediatricians are providing the vaccine. The parent in Ashburn, Va., should perhaps simply go back to the original physician who didn't have the vaccine last summer and ask again--they probably have it now. Just a thought.

Dr. Richard Schlegel: Good suggestion, thanks for your comment.

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Reston, Va.: What percentage of HPV cases actually develop into cervical cancer?

Dr. Richard Schlegel: Actually, the great majority of HPV infections resolve spontaneously within one year. Only a small percentage of women, much less than one percent, become persistently infected by the virus and have an increased chance of developing cervical cancer.

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Washington, D.C.: My doctor suggested that she did not support the vaccine, because in the future insurance companies might refuse to cover PAP/wellness examinations. Do you agree that this is possible?

Dr. Richard Schlegel: I don't believe that will happen. Health care groups realize that its going to be important to continue to perform pap tests in the future, since the vaccine will only cover 75 percent of cases.

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Nashville, Tenn.: I'm 23 and am very interested in getting the vaccine within the next month. But what happens when the newer vaccines that cover more strains of HPV come out? I don't see why I should wait for these, but should I get vaccinated again when they come around?

Dr. Richard Schlegel: I wouldn't suggest waiting for that, because those vaccines have not yet been developed and may not be for several years.

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Cleveland: You mentioned that women over 26 respond well to the vaccine because they have a strong immune system, but are there any risks associated for women younger than 26 who have a weakened immune system? Is it possible that, like a flu virus, you could actually contract HPV from this vaccine?

Dr. Richard Schlegel: It's important to recognize that the vaccine is non-infectious. THere is no live virus in this preparation, so it would not be dangerous to someone whose immune system might be somewhat weakened.

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Washington, D.C.: An earlier questioner commented that she no longer had HPV, but I don't believe this possible. Is it true that once you have it, it is always with you? And if true, what's the best way (if condoms are not effective) to limit transmission? Is there a "cure" being worked on?

Dr. Richard Schlegel: It's true that if someone is infected, they might develop a latent or persistent infection, and in most of these cases, that person will probably not be infectious because they don't have observable viral lesions. There are several trials evaluating therapies for these viruses, but none are available at this time.

But as I said before, most HPV cases will spontaneously resolve themselves without treatment.

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Washington, D.C.: My boyfriend's last partner tested postitive for HPV. How can he get tested?

Dr. Richard Schlegel: THere are methods of testing men by scraping the penile surface and detecting the virus by standard techniques, but, its not a standard clinical practice currently. There really isn't a standarized method for testing for the virus in men. If there is an observable lesion, it can certainly be biopsied and tested but if there are no symptoms, its difficult to test men.

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Bowling Green, Ky.: First, I feel compelled to ask for the sake of full disclosure - what financial interests do you currently have in companies producing or distributing this vaccine?

Second, what side effects are currently known or suspected as a potential result of this vaccination?

Dr. Richard Schlegel: The technology developed in my lab at GEorgetown was licensed commercially for the development of the vaccine.

Regarding side effects, there haven't been any serious side effects observed to date with the vaccine. Of those observed, pain and swelling at the site of the injection are the most common.

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New York, New York: Thanks for taking questions.

What is the difference between Cervarix and Gardisil? Are any vaccines effective against existing HPV infection? If a person is already infected with a particular strain of HPV, will a vaccine prevent infection with other strains of the virus?

Dr. Richard Schlegel: Gardasil is a tetravalent vaccine that covers four different HPV types that cause genital infection. Two of the types are HPV 16 and 18, which cause cervical cancer. Cervarix will cover HPV 16 and 18. As I said before, there isn't conclusive data on whether these vaccines will work on persistent infections. There is preliminary data suggesting that there is no significant effect on early onset infections.

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Washington, D.C.: How did your research impact the development of the HPV vaccine?

What future plans do you have?

Would you recommend the vaccine for your own family members?

Dr. Richard Schlegel: We are currently developing, with a grant from the Gates Foundation, second- and third-generation vaccines that are both therapeutic and prophylactic... and yes, both of my daughters, aged 20 and 22, are currently being vaccinated.

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Dr. Richard Schlegel: THanks to everyone who wrote in with their great questions today. Unfortunately, there were many questions I did not have time to answer.

If you are interested in learning more, you can learn more at the Center for Disease Control and Prevention website at http://www.cdc.gov

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