HPV Vaccine Shown to Prevent Genital Warts in Men
Recent results of a Phase III clinical trial involving Gardasil, a vaccine against four strains of human papillomavirus (HPV), indicate that the vaccine may help prevent genital warts in boys and men. Results of the study, funded by Merck, the manufacturer of Gardasil, were presented earlier this month at the annual meeting of the European Research Organization on Genital Infection and Neoplasia (EUROGIN).
Currently in the U.S., Gardasil is only approved for use in for girls and women aged 9-26. Yet while the vaccine provides protection against two strains of HPV associated with 70 percent of cervical cancer in females, it also protects against strains of HPV that cause genital warts that HPV Newseffect both males and females. The study evaluated approximately 4000 males between 16 through 23 years of age. Study participants received either three doses of Gardasil at regular intervals or a placebo. All participants were followed for 36 months. At the time of vaccination, participants had no evidence of genital lesions, no history of genital warts and five or fewer lifetime sexual partners.
Participants who were vaccinated with Gardasil were approximately 90 percent less likely to develop genital warts than those that received a placebo. No study participants experienced any serious side effects related to vaccination. Merck intends to submit a supplemental Biologics License Application for Gardasil to the FDA by the end of 2008 for the use of the vaccine in boys and men ages 9 to 26 for the prevention of genital warts.
ASHA’s fact sheet on HPV vaccines addresses some of the most common questions about Gardasil and other vaccines in development. ASHA’s website also offers recent data on the safety of Gardasil.
Filed under Advocacy, Buzz, Gardasil, Genital Warts, HPV, Vaccines | Comment (0)The Next Herpes Cure & David Knipe
This is an interesting YouTube video about Herpes Vaccines, the next Herpes Cure and the research going on down in Florida by David Knipe.
We do need to come together and figure this out. This discussion has been going on for far too long. Don’t you think?
Filed under Buzz, Herpes, Vaccines, Videos | Comment (0)There might be a vaccine for Chlamydia in 2010
Scientists in Australia are one step closer to discovering a vaccine for the common sexually-transmitted infection, chlamydia. A team from Queensland University of Technology and Harvard Medical School has already identified proteins that are able to protect against chlamydia and plan to breed mice with these immune fighting cells.
These cells, known as T-cells will be specifically directed to protect against the mouse strain of chlamydia. In doing so, they’ll be able to learn about what is involved in protecting mice against chlamydia infection and then duplicate those responses with vaccines.
“We’ve been testing these proteins as part of animal trials…and we think we’ve got the answer. It is possible that within three to five years we’ll be finished the animal trials and be looking at clinical trials in humans,” said Professor Peter Timms, from QUT’s Institute of Health and Biomedical Innovation (IHBI).
With 3 million new cases per year, Chlamydia is the most commonly reported STI in the U.S., especially among teens and young adults. The infection can be particularly dangerous for women, as many experience few or no symptoms and are unaware of their infection. Left untreated, chlamydia can cause serious complications and irreversible damage, including infertility.
Talk about Sexually Transmitted Diseases
Filed under Buzz, Chlamydia, Vaccines, std testing | Comment (0)Everything you ever wanted to know about Gardasil and more
Gardasil Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Read this information with care before you or your child gets Gardasil. You or your child will need 3 doses of the vaccine. It is important to read this leaflet when you receive each dose. This leaflet does not take the place of talking with your health care professional about Gardasil.
(As you can see I picked up the leaflet from my doc’s office, came home, and then I copied it to my blog so that you guys could get access to the information. Not all doc’s offices have this information so I felt it would be a good idea to share it with you.)
What is Gardasil and what is it used for?
Gardasil is a vaccine (injection/shot) that helps protect against the following diseases caused by Human Papillomavirus (HPV) Types in the vaccine (6, 11, 16, and 18):
- Cervical cancer (cancer of the lower end of the uterus or womb)
- Abnormal and precancerous cervical lesions
- Abnormal and precancerous vaginal lesions
- Abnormal and precancerous vulvar lesions
- Genital warts
Gardasil helps prevent these diseases - but it will not treat them. You or your child cannot get these diseases from Gardasil.
What other key information about Gardasil should I know?
- Vaccination does not substitute for routine cervical cancer screening. Females who receive Gardasil should continue cervical cancer screening.
- As with all vaccines, Gardasil may not fully protect everyone who gets the vaccine.
- Gardasil will NOT protect against diseases due to non-vaccine HPV types. There are more than 100 HPV types; Gardasil helps protect against 4 types (6, 11, 16, and 18). These 4 types have been selected for Gardasil because they cause approximately 70% of cervical cancers and 90% of genital warts.
- This vaccine will not protect you against HPV types to which you may have already been exposed.
- Gardasil also will not protect against other diseases that are not caused by HPV.
- Gardasil works best when given before you or your child has any contact with certain types of HPV (i.e., HPV types 6, 11, 16, and 18).
Who can receive Gardasil?
Gardasil is for girls and women 9 through 26 years of age. See “Who should not receive Gardasil?” below.
Who should not receive Gardasil?
Anyone who:
- is allergic to any of the ingredients in the vaccine. A list of ingredients can be found at the end of this leaflet.
- has an allergic reaction after getting a dose of the vaccine.
What should I tell my health care professional before I am vaccinated or my child is vaccinated with Gardasil?
It is very important to tell your health care professional if you or your child:
- has had an allergic reaction to the vaccine.
- has a bleeding disorder and cannot receive injections in the arm.
- has a weakened immune system, for example, due to a genetic defect or HIV infection.
- is pregnant or is planning to get pregnant. Gardasil is not recommended for use in pregnant women.
- has any illness with a fever more than 100 degrees F (37.8 degrees C).
- takes or plans to take any medicines, even those you can buy over the counter.
Your health care professional will decide if you or your child should receive the vaccine.
How is Gardasil given?
Gardasil is given as an infection. You or your child will receive 3 doses of the vaccine. Ideally the doses are given as:
- First dose: at a date you and your health care professional choose.
- Second dose: 2 months after the first dose.
- Third dose: 6 months after the first dose.
Make sure that you are your child gets all 3 doses. This allows you or your child to get the full benefits of Gardasil. If you or your child misses a dose, your health care professional will decide when to give the missed dose.
What are the possible side effects of Gardasil?
As with all vaccines, there may be some side effects with Gardasil. Gardasil has been shown to be generally well tolerated in women and girls as young as 9 years of age.
The most commonly reported side effects included:
- pain, swelling, itching, and redness at the injection site.
- fever.
Difficulty breathing (bronchospasm) has been reported very rarely. If you or your child has any unusual or sever symptoms after receiving Gardasil, contact your health care professional right away. For a more complete list of side effects, ask your health care professional.
What are the ingredients in Gardasil?
The main ingredients are purified inactive proteins that come from HPV Types 6, 11, 16, and 18. It also contains amorphous aluminum hydroxyphosphate sulfate, sodium chloride, L-histidine, polysorbate 80, sodium borate, and water for infection.
What are cervical cancer, precancerous lesions, and genital warts?
Cancer of the cervix is a serious disease that can be life-threatening. This disease is caused by certain HPV types that can cause the cells in the lining of the cervix to change from normal to precancerous lesions. If these are not treated, they can turn cancerous.
Genital warts are caused by certain types of HPV. They often appear as skin-colored growths. They are found on the inside or outside of the genitals. They can hurt, itch, bleed, and cause discomfort. These lesions are usually not precancerous. Sometimes, it takes multiple treatments to eliminate these lesions.
What is Human Papillomavirus (HPV)?
HPV is a common virus. In 2005, the Centers for Disease Control and Prevention (CDC) estimated that 20 million people in the United States had this virus. There are many different types of HPV; some cause no harm. Other can cause diseases of the genital area. For most people the virus goes away on its own. When the virus does not go away it can develop into cervical cancer, precancerous lesions, or genital warts, depending on the HPV type. See “What other key information about Gardasil should I know?”
Who is at risk for Human Papillomavirus?
In 2005, the CDC estimated that at least 50% of sexually active people catch HPV during their lifetime. A male or female of any age who takes part in any kind of sexual activity that involves genital contact is at risk. Many people who have HPV may not show any signs or symptoms. This means that they can pass on the virus to others and not know it.
Will Gardasil help me if I already have Human Papillomavirus?
You may benefit from Gardasil if you already have HPV. This is because most people are not infected with all four types of HPV contained in the vaccine. In clinical trails, individuals with current or past infection with one or more vaccine-related HPV types prior to vaccination were protected from disease caused by the remaining vaccine HPV types. Gardasil is not intended to be used for treatment for the above mentioned diseases. Talk to your health care professional for more information.
* This leaflet is a summary of information about Gardasil. If you would like more information, please talk to your health care professional or visit gardasil.com - This information was issued in June of 2006, Manufactured and Distributed by: MERCK & CO., INC., Whitehouse Station, NJ 08889, USA 96823 - This information is presented only for informational and educational reasons and should not take the place of your own doctor’s medical advice. Permission was granted to help spread the word about the HPV vaccine Gardasil.
Filed under Buzz, Cervical Cancer, Gardasil, Genital Warts, HIV | AIDS, Vaccines | Comment (1)Personal Rant about Alternatives, Prescriptions, HPV Vaccine and Conspiracy Theorists
I bring up the “alternative/natural” substances vs. “prescription” because there are a lot of conspiracy theorists that read my blog on a daily basis - so that was more for their benefit than strictly just for you.
How long should we have to wait before we figure out that vaccines save lives? Ten years, twenty years, thirty years of waiting before we can find out that it’s really ok to take the HPV vaccine and that as with all vaccines, there may be some side effects? We already know this, right? How long do you think it took for scientists to put together the HPV vaccine? Do you think that they just sat around in the board room, through it together without conducting years of testing before offering it up to the public?
So we miss out on the vaccine that has the potential to prevent two types of HPV that can cause cervical cancer. Why? Because of conspiracy theorists against any and all research that has been conducted within the pharmaceutical industry to try and save lives? Are you against the drug companies so much so that you would forgo vaccinating your children just to prove a point after all the years of research that has already been done on this? Does that not count at all or do we have to start over because it’s finally made it to the market?
Everything out there to treat any type of illness whether it be alternative or clinically proven has the potential to have side effects. When you go to pick up your medication at the pharmacy there is always a list of possible side effects that come with medications. The same thing goes for vaccines. When you vaccinate your children they send you home with a sheet of paper that tells you what to watch out for and what to do if your child develops any of the symptoms associated with that vaccine. Why would the HPV vaccine be any different?
I know that it’s different for some… because there are MANY that truly believe that vaccinating our daughters with the HPV vaccine essentially says to them that they can go out and have sex and won’t have to worry about two types of cancer or contracting any type of genital wart. Why is it that it’s ok to vaccinate but when you are vaccinating for the purpose of preventing a sexually transmitted disease people have a problem with that? The strange part is that this sexually transmitted disease happens to cause various strains of cervical cancer which happens to be one of the leading causes of death in women. I guess the three letters STD sorta trumps that then so that makes it bad. WHATEVER!!
So basically what you are saying is that it doesn’t matter how many years have gone into researching and developing this vaccine. It will never be good enough unless we wait another life time and millions of deaths later in order to know what we already know about the vaccine. Oh THAT makes perfect sense to me now… what I want to know is what your definition of a lifetime is? How long should we wait before we protect our kids from the four types of HPV that cause cervical cancer and genital warts?
Filed under Buzz, Cervical Cancer, Genital Warts, Vaccines, std testing | Comments (4)NEJM Report Finds HPV Test More Effective Than Pap in Determining Cervical Cancer Risk
GAITHERSBURG, Md. and HILDEN, Germany, Oct. 18 /PRNewswire-FirstCall/– The first randomized, controlled study in North America of HPV testing as a stand-alone screen concluded that it is almost 40 percent more accurate than traditional cytology (the Pap “smear”) in identifying women with advanced cervical disease, according to a report published today in The New England Journal of Medicine.
The study, which involved more than 10,000 Canadian women age 30-69, found that the HPV test’s sensitivity — its ability to accurately identify women with pre-cancerous cervical cells or cancer — was 94.6 percent, compared to 55.4 percent for the Pap. HPV (humanpapilloma virus) is the primary cause of cervical cancer.
This seminal study used QIAGEN’s Hybrid Capture(R) 2 High-Risk HPV DNA test — the only such test that is both CE-marked in Europe and approved by the U.S. Food and Drug Administration(1). The molecular diagnostic test was developed by Digene Corp., now part of QIAGEN N.V. (Nasdaq: QGEN; Frankfurt, Prime Standard: QIA). The performance of QIAGEN’s HPV test has been validated in studies that included more than 300,000 women.
“We already knew before conducting this study that the sensitivity of the Pap left a lot to be desired,” stated one of the study’s authors, Eduardo Franco, DrPH, of Montreal’s McGill University, in a news announcement. “However, 55.4 percent accuracy is only slightly above chance. Flipping a coin gives you 50 percent.”
Participants in the Canadian Cervical Cancer Screening Trial (CCCaST) were randomly assigned to a “focus on Pap” or “focus on HPV” screening group, although for ethical reasons, both groups received both tests. In this study, conventional cytology was used. Recent analyses have found that the newer “liquid-based” cytology does not significantly improve the ability to detect disease. All CCCaST participants who tested positive on either the Pap or HPV test were referred for a follow-up biopsy. In addition to the HPV test’s greater sensitivity, the study found that its specificity — the likelihood that women with positive results actually have disease — was only slightly less than the Pap’s (94.1 percent vs. 96.8 percent).
HPV testing for routine cervical cancer prevention is currently most widely practiced in the United States, where it is approved for use along with a Pap in women age 30 and over. Under the currently recommended guidelines, screening that includes HPV testing may be performed at longer intervals than when the Pap is used alone. However, the authors of the NEJM report concluded that co-testing “only marginally improved sensitivity compared with HPV testing alone.”
The conclusions of CCCaST reinforce a growing number of other studies showing greater sensitivity for HPV testing and suggesting its use as the primary, front-line screen — with the Pap reserved for follow-up evaluation. (2) For example, most recently, the Oct. 4 issue of The Lancet reported on a trial involving more than 17,000 women in the Netherlands. The study, led by Professor Chris Meijer of VU Medical Centre in Amsterdam, concluded that HPV DNA testing detects pre-cancerous cervical cells earlier than the traditional Pap, thus allowing longer intervals between screenings. This is an important feature for health authorities working to control costs — particularly those in developing countries, where a variety of obstacles make it difficult for women to access regular medical care.
Medical experts agree that the most effective approach to cervical cancer prevention combines HPV vaccines for girls and young women with screening of older women.
“We believe that a shift from cellular to viral (screening) tests, coupled with education and vaccination, will contribute to more efficient control of cervical cancer,” the authors stated in the NEJM report.
Filed under Buzz, Cervical Cancer, HIV | AIDS, Vaccines, std testing | Comments (2)HIV Vaccine Study Suspended
The trial of a much-anticipated new HIV vaccine was suspended last week, following a review by an independent monitoring board that deemed the vaccine ineffective. The suspension of the phase II clinical trial of Merck & Co.’s investigational HIV vaccine (V520), in development for a decade, marks a setback in the global effort to combat the worldwide HIV epidemic.
The trial, called STEP, was an international phase II “test of concept” trial in uninfected volunteers at high risk for acquiring HIV infection. It intended to test both whether the vaccine would help prevent the occurrence of new HIV infections as well as reduce the amount of virus in those who developed infection. The trial enrolled 3,000 HIV-negative volunteers from areas of North and South America, the Caribbean, and Australia between 18 and 45 years of age. A planned interim efficacy analysis conducted in approximately 1,500 volunteers revealed the disappointing results.
The vaccine did not prevent infection. In volunteers who received at least one dose of the three-dose vaccine series, 24 cases of HIV infection were observed in the 741 volunteers who received vaccine, while 21 cases of HIV infection were observed in the 762 participants in the placebo group. In the subgroup who had received at least two vaccinations and who were HIV negative for at least the first 12 weeks of the trial, 19 cases of HIV infection were observed in the 672 volunteers who received vaccine and 11 cases were observed in the 691 volunteers who received placebo. In addition, the vaccine did not reduce the amount of virus in the bloodstream of those who became infected; HIV RNA levels approximately 8 to 12 weeks after diagnosis of infection were similar in the vaccine and the placebo arms.
Though the results are disappointing, researchers have stated that there are many other trial vaccines currently being tested, as well as some that are soon to go into testing. This is promising, due to the fact that different vaccines stimulate different types of immunity. “It isn’t the end of the line,” said Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition, a New York group advocating prevention. Merck’s data “aren’t the answers we wanted, but they will help improve our other vaccine candidates.”
This information brought to you by the American Social Health Association and presented strictly for educational purposes.
Filed under Advocacy, Buzz, HIV | AIDS, PID, Vaccines, std testing | Comments (2)Experimental AIDS Vaccine Failed to Work
It was a high-profile failure in the daunting quest to develop a vaccine to prevent AIDS. Merck’s vaccine was the farthest along, considered the most promising and was closely watched by experts in the field.
Officials at the company, based in Whitehouse Station, N.J., said 24 of 741 volunteers who got the vaccine in one segment of the experiment later became infected with HIV, the virus that causes AIDS. In a comparison group of volunteers who got dummy shots, 21 of 762 participants also became infected.
Could you imagine being a volunteer for a clinical trial such as this one, being HIV free, and at the announcement of the failure of the vaccine finding out that you now have HIV?
I realize that some were given dummy shots and others were not but that can’t be the best news to find out that you contracted HIV from experimental testing.
You’re not suppose to actually contract the viruses that these vaccines are supposed to keep you from getting. It’s all very disturbing to me. I am so disappointed about this setback for the HIV community.
Filed under Buzz, HIV | AIDS, Vaccines, std testing | Comments (3)Teen Sex vs. Cancer Prevention
The Chomsky’s have become advocates for the use of Gardasil, the vaccine for HPV or the Human Papillomavirus.
The Chomsky’s believe the vaccine could have prevented Caryn’s cancer.
They along with their doctor believe the vaccine should be widely used by girls and women across the country.
Dr. Rebecca Stern told CBS4 News, “I’ve seen a significant increase in the detection of HPV. I really think the vaccination is a medical breakthrough.”
Legislators in Florida tried to make the vaccine mandatory but that effort failed.
Some in the legislature argued the vaccine could promote sexual activity among girls and young women. ~ Interesting story at CBS4.com
If you take the time to read the entire story I think you will be fascinated. In a nutshell, Caryn is a cancer survivor who didn’t think she could have kids. Her mother steps in at age 59 and offers to have the couple’s baby through invitro fertilization. It’s an amazing story of love and sacrifice.
It’s unfortunate that the effort to make the vaccine mandatory failed because some argued that the vaccine would promote sexual activity. It’s one thing to say that the measure failed because they want the government to stay out of their medical choices. It’s a completely different ball game when somebody says it’s not going to be mandatory because they think it will encourage more teens to have sex.
Adults need to stop worrying about their teens having sex. No matter how much you talk to them and hope that they make good choices they are going to do what they want to do and if they are going to have sex they will find a way to have sex.
I’m so frustrated that somebody could place the possibility of teens having sex (which will never go away) above and beyond cancer prevention!
In any case, I’m thrilled that this couple were able to have children and that the twins have a Mom who is cancer free today!
See this post on Sexual Health Buzz
See this post on Domestic Divapalooza
Filed under Buzz, Cervical Cancer, Gardasil, Stories, Vaccines | Comment (0)
