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% [...]

What Farrah Fawcett can teach us about anal cancer

Source: health.usnews.com/blogs Author: Deborah Kotz As much as I think celebrities should be afforded their privacy—like the rest of us—when they're battling life-threatening diseases, I sometimes blog about their conditions because I see them as teaching moments. Farrah Fawcett is in the news today with reports that she's been hospitalized for complications of anal cancer. She was first diagnosed with anal cancer in 2006. Speculation was running wild that she was "close to dying," but the latest reports say she's suffering from a blood clot that resulted from an "alternative" cancer treatment she had in Germany to fight the cancer's recurrence. Anal cancer is one of those cancers no one likes to talk about because it's, well, anal cancer. But we really should discuss it as much as, say, cervical cancer. Both are predominately caused by the sexually transmitted human papillomavirus. In fact, a 2004 study of 6,000 anal cancer patients (the majority of whom were women) found that 73 percent of the patients tested positive for the strain HPV-16, one of the strains that the Gardasil vaccine protects against. What's worrisome is that unlike cervical cancer, which has dropped dramatically since the advent of the Pap smear, anal cancer is on the rise. Incidence rates over the past 30 years have jumped by 78 percent in women and 160 percent in men, probably because more people now have more sexual partners and more people have anal sex (both among heterosexuals and gay men), says Lisa Johnson, a cancer epidemiologist [...]

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 [...]

Noted Hopkins scientist says research indicates need for effective HPV vaccine for women and men and a simple HPV screening test

Source: www.hopkinskimmelcancercenter.org/news Author: press release A call to explore a broader use of HPV (human papillomavirus) vaccines and the validation of a simple oral screening test for HPV-caused oral cancers are reported in two studies by a Johns Hopkins Kimmel Cancer Center investigator. Leading HPV expert Maura Gillison, M.D., Ph.D., the first to identify HPV infection as the cause of certain oral cancers and who identified multiple sex partners as the most important risk factor for these cancers, reports her latest work in the November 3, 2008, journal Clinical Cancer Research and in a Centers for Disease Control and Prevention (CDC) monograph. The CDC report on HPV-associated cancers appears on line November 3 and in the November 15, 2008, supplement edition of Cancer. In the CDC report, believed to be the first and most comprehensive assessment of HPV-associated cancer data in the United States, investigators analyzed cancer registry data from 1998-2003 and found 25,000 cancer cases each year occurred at cancer sites associated with HPV infection. In additional analysis, Gillison and colleagues at the National Cancer Institute identified HPV infection as the underlying cause of approximately 20,000 of these cancers. Gillison and team found approximately 20,000 cases of cancer in the United States each year are caused by HPV infection. Oral cancers are the second most common type of HPV-associated cancers and are increasing in incidence in the U.S., particularly among men. Add to that anal, penile, vaginal, and vulvar cancers that are also linked to HPV infection, and Gillison [...]

Drugmaker Merck seeks Gardasil approval for boys

Source: www.forbes.com Author: Linda A. Johnson Drugmaker Merck & Co. has asked federal regulators to approve use in males for its vaccine against the human papillomavirus, which causes cervical and other sexually transmitted cancers. The application was submitted in late December, Merck spokeswoman Amy Rose said Tuesday. It was long planned as part of Whitehouse Station, N.J.-based Merck's strategy to increase the market for Gardasil. It prevents infection with the sexually transmitted virus and thus cancers of the genital organs. Gardasil, launched in 2006 for girls and young women, quickly became one of Merck's top-selling vaccines, thanks to aggressive marketing and attempts to get states to require girls to get the vaccine as a requirement for school attendance. However, it is one of the priciest vaccines on the market, typically costing $360 for a three-dose regimen. Gardasil had 2007 sales of $1.5 billion, but sales began slowing in the second half of 2008, after a government-funded Harvard study concluded it was cost-effective for girls but not for women in their 20s. The U.S. Food and Drug Administration has two months to decide whether the application for use in males meets its standards. Reviews can then take 10 months or more. The application includes research data from a Merck study including about 4,000 males, ages 16 to 26; Gardasil prevented 90 percent of cases of penile cancer and genital warts caused by the four common virus strains targeted by the vaccine. The agency approved use of Gardasil in females ages 9 [...]

Wart virus caused 25,000 cancers in 5 years – CDC

Source: www.reuters.com Author: Reporting by Maggie Fox, editing by Will Dunham and Philip Barbara The human wart virus HPV caused 25,000 cases of cancer in the United States between 1998 and 2003, including not only cervical cancer but also anal and mouth cancers, the U.S. Centers for Disease Control and Prevention reported on Monday. The study suggests a broad need for screening both men and women for human papillomavirus, or HPV, another team of researchers, who did a similar survey, said. HPV includes about 100 different viruses, and they are the leading cause of cervical cancer. The viruses, transmitted sexually and by skin-to-skin contact, can also cause anal and penile cancers, as well as cancers of the mouth and throat. HPV also causes common warts. Both Merck and Co. and GlaxoSmithKline make vaccines against some of the strains of HPV most strongly linked with cervical cancer. They are recommended for girls and young women who have not begun sexual activity. "This gives us baseline data to measure the impact of HPV vaccine and cervical cancer screening programs in reducing the incidence of cervical cancer and other HPV-associated cancers and precancers," the CDC's Dr. Mona Saraiya, who led the study, said in a statement. Dr. Maura Gillison of Johns Hopkins University in Baltimore, who has studied the link between HPV and oral cancers, said the findings suggest a wider use of the cervical cancer vaccines may be justified. "Currently available HPV vaccines have the potential to reduce the rates of HPV-associated [...]

2008-12-23T20:01:22-07:00December, 2008|Oral Cancer News|

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|

7 Facts you need to know about HPV and Gardasil

Source: www.usnews.com Author: Bernadine Healy M.D. As women—and soon men—gain access to the new Merck vaccine Gardasil, which targets the sexually transmitted human papillomavirus, the Centers for Disease Control and Prevention has stepped up efforts to identify the 25,000 or more cancers primarily associated with HPV that increase the burden of cancer in the United States each year. As reported in the November 15 supplement to the journal Cancer, the latest figures include 10,846 patients with invasive cancer of the cervix, followed by 7,360 with cancers of the mouth, particularly the tonsils and the back of the tongue. In addition, there are 3,018 cancers of the anus, 2,266 of the vulva, and 828 of the penis. To the CDC, these are baseline numbers to track the life-threatening consequences of HPV infection. To sexually active young people, this report should be a wake-up call. The hows and whys of catching contagious warts and cancer through sex should be part of every parent's birds-and-bees talk, every school's sex-ed curriculum, and—most of all—all young people's thinking about their own sexual vulnerability. Here are seven need-to-know facts: 1. Infected boys and men are silent carriers of HPV, spewing out their contagion in body fluids. With some strains, visible warts on the genitals bud off fresh virus. 2. Infected girls and young women (particularly vulnerable to infection because of a still-developing cervix) also shed abnormal cells bearing virus into Pap smears, tests that sexually active women should have yearly. The atypical cells usually clear in [...]

2008-11-18T03:34:59-07:00November, 2008|Oral Cancer News|

Public knowledge and attitudes towards Human Papilloma Virus (HPV) vaccination

Source: 7th Space (Johns Hopkins Medical Letter) Author: Charlotte Devereaux et al. Human Papilloma Virus (HPV) vaccine has undergone successful trials and has recently been approved for use for the primary prevention of cervical cancer. The aim of this study was to determine knowledge and attitudes towards HPV vaccination. Method: Semi-structured interview and questionnaire delivered in a street survey. Standardised HPV-related statements used to measure HPV knowledge and attitudes to vaccination. The setting was three different areas of Birmingham, to target a mix of social class and ethnicity. The sample population was composed of 16-54 year olds. Results: A total of 420 participants were recruited. Poor knowledge of HPV and its links with cervical cancer were observed. 81% had a knowledge score of zero. Knowledge about HPV was associated with different ethnic group and socio-economic group. The majority (88%) of participants were in favour of vaccination, with 83.6% indicating that they would allow a child under their care to be vaccinated. Conclusion: Initial responses to the proposed HPV vaccination within the UK public are favourable. However, knowledge levels are poor and media and health professional promotion are required to raise awareness. Authors: Charlotte Devereaux Walsh, Aradhana Gera, Meeraj Shah, Amit Sharma, Judy E Powell and Sue Wilson Source: BMC Public Health 2008, 8:368

Cervical cancer vaccine called safe

Source: www.washingtonpost.com Author: staff Gardasil, the two-year-old vaccine that's designed to prevent cervical cancer, is safe, U.S. officials said Wednesday. The U.S. Centers for Disease Control and Prevention's Immunization Safety Office said a study of 370,000 doses given to girls and young women over the past two years found no evidence that the vaccine causes an increased risk of blood clots or other serious conditions, Bloomberg News reported. The CDC, which recommends the vaccine for girls starting at ages 11 and 12, based its findings on statistics from the Vaccine Safety Datalink, which uses medical data to test hypotheses about vaccine safety, the news service said. "There were no associations found that suggested an elevated risk," said John Iskander, acting director for the Immunization Safety Office, toldBloomberg. Critics of the vaccine, including some groups that worry that the inoculation could promote promiscuity, have contended that Gardasil may not be safe and could give women a false sense of security about sexually transmitted diseases. Gardasil protects against four types of genital human papillomavirus, HPV, which is spread through sexual contact and can cause cervical cancer in women. The U.S. study covered 190,000 girls and young women who received at least one dose of the vaccine's three-shot regimen. The CDC researchers compared medical data on those girls who got the vaccine with data for girls and young women who received other vaccines or none. "The results are really reassuring," said Dr. Paul Offit, chief of the infectious diseases division at Children's Hospital [...]

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