HPV vaccine studied for first time in men

Source: www.sciencedaily.com Author: staff A vaccine designed to protect against the most common causes of genital warts and cervical and penile cancer is now being evaluated in young men. The Medical College of Georgia is a site for the first international study of a vaccine that protects against four strains of human papillomavirus in men age 16 to 23. “It’s a great opportunity for men to protect themselves from developing genital warts and penile cancer,” says Dr. Daron G. Ferris, a principal investigator on the study who directs the MCG Gynecologic Cancer Prevention Center. “It’s also a great way for men to protect their sexual partners from developing warts as well as cervical cancer, lower genital tract cancers and precancerous changes of the cervix.” MCG also is studying the vaccine in boys and girls age 10 to 15 and is still enrolling women age 15 to 45 in several other studies. “We are interested in looking at the efficacy of this vaccine in populations that will become target populations, should the Food and Drug Administration approve the vaccine,” Dr. Ferris says. MCG was the largest site in North America for the study in women age 15 to 25 of a vaccine for HPV types 16 and 18, the two most common causes of cervical and penile cancer. That vaccine was reported 100 percent effective at preventing the persistent HPV infections that cause cervical cancer in the Nov. 13 issue of the British journal, The Lancet. This newest study in men [...]

Giving Gardasil to boys not worth the cost?

Source: HealthDay.com Author: Steven Reinberg But other experts dispute finding, and say young men need protection from STDs THURSDAY, Oct. 8 (HealthDay News) -- The cost of giving boys the human papillomavirus (HPV) vaccine would outweigh any health benefit, researchers say. Last month, a U.S. Food and Drug Administration panel recommended expanding use of the Gardasil vaccine to males aged 9 to 26 to protect them from genital warts, but the cost effectiveness of such a program was unclear at the time. But researchers from the Harvard School of Public Health conducted such an analysis comparing a girls-only vaccination program with a co-ed vaccination program. Currently, Gardasil is approved for girls aged 9 and over to protect them from cervical cancer. "This study found that while vaccine coverage and efficacy are high in girls, including boys in an HPV vaccination program generally exceeds what the U.S. typically considers good value for money," said lead researcher Jane Kim, an assistant professor of health decision science. The report is published in the Oct. 9 online edition of the British Medical Journal. Vaccination was considered a good value if cost-effectiveness ratios ranged from $50,000 to $100,000 per quality-adjusted life year, meaning the cost of the vaccine vs. the number of added years someone would gain by getting the vaccine. Assuming 75 percent coverage and lifelong protection, the researchers found routine vaccination of 12-year-old girls was a good value at less than $50,000 per quality-adjusted life year. However, adding preadolescent boys increased the cost-effectiveness ratio [...]

2009-10-12T11:54:27-07:00October, 2009|Oral Cancer News|

HPV vaccine debate shifts to boys

Source: Buffalo News Author: Henry L. Davis New questions arise as cancer tied to HPV is rising in men Parents who face the dilemma of whether to protect their young daughters with a vaccine aimed at a sexually transmitted infection that causes cervical cancer now face a new question: Should they do the same for their sons? As evidence mounts of a rising number of other cancers linked to the human papillomavirus, or HPV, a debate has intensified over whether to give the vaccine to males. Advocates say vaccinating boys and men can prevent them from passing on the virus to their sexual partners. Critics still question the long-term safety and effectiveness of Merck & Co.’s Gardasil, despite studies indicating that its risks and lasting power are within the range of other vaccines. But a newer wrinkle in the debate is the discovery in recent years that oral HPV infections — most likely acquired from oral sex with multiple partners—significantly increase the risk of head and neck cancers. The rate of oral cancers is rising so steadily, especially in men, that, if the trend continues, there may be more oral cancers in the United States caused by HPV in 10 years than by tobacco or alcohol, a major study concluded last year. “We should be investing our care and dollars in preventing HPV infection instead of treating the cancers,” said Dr. Thom Loree of Roswell Park Cancer Institute. Physicians at the cancer center have begun publicly touting the benefits of [...]

2009-07-15T13:04:17-07:00July, 2009|Oral Cancer News|

Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24-45 years: a randomised, double-blind trial

Source: The Lancet, Volume 373, Issue 9679, Pages 1949 - 1957, 6 June 2009 Author: Prof Nubia Muñoz MD et al. Background Although the peak incidence of human papillomavirus (HPV) infection occurs in most populations within 5—10 years of first sexual experience, all women remain at risk for acquisition of HPV infections. We tested the safety, immunogenicity, and efficacy of the quadrivalent HPV (types 6, 11, 16, 18) L1 virus-like-particle vaccine in women aged 24—45 years. Methods Women aged 24—45 years with no history of genital warts or cervical disease were enrolled from community health centres, academic health centres, and primary health-care providers into an ongoing multicentre, parallel, randomised, placebo-controlled, double-blind study. Participants were allocated by computer-generated schedule to receive quadrivalent HPV vaccine (n=1911) or placebo (n=1908) at day 1, and months 2 and 6. All study site investigators and personnel, study participants, monitors, and central laboratory personnel were blinded to treatment allocation. Coprimary efficacy endpoints were 6 months' or more duration of infection and cervical and external genital disease due to HPV 6, 11, 16, 18; and due to HPV 16 and 18 alone. Primary efficacy analyses were done in a per-protocol population, but intention-to-treat analyses were also undertaken. This study is registered with ClinicalTrials.gov, number NCT00090220. Findings 1910 women received at least one dose of vaccine and 1907 at least one dose of placebo. In the per-protocol population, efficacy against the first coprimary endpoint (disease or infection related to HPV 6, 11, 16, and 18) was 90·5% (95% [...]

A vaccine debate once focused on sex shifts as boys join the target market

Source: www.washingtonpost.com Author: Rob Stein When a vaccine designed to protect girls against a sexually transmitted virus arrived three years ago, the debate centered on one question: Would the shots make young girls more likely to have sex? Now the vaccine's maker is trying to get approval to sell the vaccine for boys, and the debate is focusing on something else entirely: Is it worth the money, and is it safe and effective enough? "We are still more worried about the promiscuity of girls than the promiscuity of boys," said Susan M. Reverby, a professor of women's studies and medical history at Wellesley College. "There's still that double standard." The shift in the discussion about Gardasil illustrates the complex interplay of political, economic, scientific, regulatory and social factors that increasingly influence decisions about new types of medical care. For the vaccine, the new dynamic reflects a strategic tack by Gardasil's critics, growing concern about health-care costs, fears about whether medical treatments are being vetted adequately and stubborn biases about gender, experts say. "There is the cost, the safety, the boys versus girls," said Susan F. Wood, a professor of public health at George Washington University. "These are some of the complexities that are going to have to be addressed one way or the other with this vaccine." Gardasil protects against the human papillomavirus, the most common sexually transmitted infection. HPV causes genital warts and, in women, can lead to cervical cancer -- a disease that strikes about 10,000 American women [...]

What to expect: HPV vaccine Gardasil for men

Source: www.vaccinerx.com Author: written by Vaccind Rx Daily Staff The four-type (6,11,16,18) human papillomavirus (HPV) vaccine Gardasil® is also effective in men according to the primary analysis from a pivotal phase III clinical study. In previously uninfected men aged 16 to 26 years*, Gardasil® prevented 90% (95%CI: 69, 98) of external genital lesions caused by HPV types 6, 11, 16 or 18. The data were presented this week at the congress of the European Research Organisation on Genital Infection and Neoplasia (EUROGIN) in Nice, France.1 The study was designed to determine the efficacy of Gardasil® in preventing HPV 6,11,16 or 18- related 'external genital lesions' a composite endpoint that included genital warts, penile / perineal / perianal lesions† (PIN, PIN2/3; potential pre-cursors to cancer) and penile / perineal / perianal cancer. In the study, Gardasil was 90.4% effective in reducing external genital lesions (3 cases in the vaccine group vs 31 cases in the placebo group; 95% CI:69.2, 98.1). All three cases observed in the HPV vaccinated group were of genital warts, resulting in a vaccine efficacy of 89.4% (95% CI [65.5, 97.9]) in preventing genital warts in men. There were no cases of penile / perineal / perianal lesions in the vaccinated group vs. 3 cases in the placebo group. There were no cases of penile / perineal / perianal cancer in either group. At the time of this analysis, the study had a mean duration of about 29 months. No HPV vaccine-related serious adverse events were reported. A [...]

2008-11-25T22:12:42-07:00November, 2008|Oral Cancer News|
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