vaccine

HPV vaccines: Research on safety, racial disparities in vaccination rates and male participation

Source: journalistsresource.us1.list-manage.com
Author: staff

Since it became available in the United States in 2006, the Human Papillomavirus (HPV) vaccine has been a source of debate, with proponents lauding it as a substantial gain in the fight against cancer, and opponents concerned with its implications for sexual activity among youth. With the U.S. Food and Drug Administration’s recent approval of Gardasil-9 — a vaccine that protects against nine of the most common strains of HPV that account for approximately 90 percent of cervical, vulvar, vaginal and anal cancers — there is both a renewed interest and concern that calls for a nuanced and comprehensive review of the science.

HPV is the most common sexually transmitted infection in the United States, with nearly all sexually active men and women believed to contract at least one form of it during their lifetime. According to the U.S. Centers for Disease Control and Prevention (CDC), an estimated 79 million Americans have HPV, and about 14 million become newly infected annually. While most infections clear the body within two years, some can persist and result in genital warts, cervical cancer or other types of cancers in men and women. Of the many HPV strains that exist, HPV types 16 and 18 have been identified as high risk, accounting for about 70 percent of all cervical cancer, as well as a large proportion of other HPV-related cancers.

While cervical cancer was previously a leading cause of death among women in the U.S., death rates declined substantially after the introduction of the Pap test in the 1950s. Nevertheless, according to the CDC, more than 12,000 women in the U.S. are diagnosed with cervical cancer each year, and more than 4,000 die from it. Public discourse around HPV tends to focus on the health of women because they disproportionately bear the burden of its health consequences. However, men also face substantial risk, particularly as it relates to oral and anal cancers.

Although screening procedures are in place for early detection of cervical cancer, there are no comparable strategies to identify HPV-related cancer in its early stages for men. Consequently, the administration of a vaccine to prevent infection and transmission presents an important line of protection. Currently, the HPV vaccine is administered over a course of three injections, which must be completed within six months to confer full protection. A 2012 review of clinical trials of HPV vaccines shows that vaccines designed to protect against two or four of the most common strains have very high efficacy rates, ranging between 90 percent and 100 percent. For that reason, large public health efforts have focused on improving vaccination rates before boys and girls become sexually active.

Today, both the CDC and American Academy of Pediatrics recommend routine vaccination against HPV for all 11-year-olds and 12-year-olds in the U.S. Although the early age of vaccination has been a source of public debate, medical recommendations are based partly on evidence that shows that antibody responses are highest during this age period. Also, it is a good idea to vaccinate adolescents before they come into contact with the virus as the vaccine is not effective against HPV types that already have been acquired. Despite such recommendations from medical professionals, vaccination completion rates remain low — 40 percent for girls and 20 percent for boys in 2014. That is substantially lower than the vaccination rate for tetanus, diphtheria, and pertussis and the vaccination rate for meningitis among members of the same age group.

Below are a series of studies that will help journalists understand and explain this important health topic from a variety of angles, including vaccine safety and racial and gender disparities in vaccination rates. Beat reporters can find related reports and statistics from organizations such as the CDC, National Cancer Institute and World Health Organization.

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Barriers to vaccination

“Reasons for Not Vaccinating Adolescents: National Immunization Survey of Teens, 2008-2010”
Darden, P.M.; et al. Pediatrics, April 2013, Vol. 131. doi: 10.1542/peds.2012-2384.

Summary: Using data from the National Immunization Survey of Teens, researchers found that parental intentions to not vaccinate for HPV increased from 39.8 percent in 2008 to 43.9 percent in 2010. The most commonly cited reasons for not vaccinating were “not recommended/needed,” “not sexually active,” and “safety concerns/side effects.” Vaccine safety concerns increased from 4.5 percent in 2008 to 16.4 percent in 2010.

“Barriers to Human Papillomavirus Vaccination Among US Adolescents: A Systematic Review of the Literature”
Holman, D.M.; et al. JAMA Pediatrics, January 2014, Vol. 168. doi: 10.1001/jamapediatrics.2013.2752.

Summary: “Health care professionals cited financial concerns and parental attitudes and concerns as barriers to providing the HPV vaccine to patients. Parents often reported needing more information before vaccinating their children. Concerns about the vaccine’s effect on sexual behavior, low perceived risk of HPV infection, social influences, irregular preventive care, and vaccine cost were also identified as potential barriers among parents.”

Vaccine safety

“Adverse Events Following Immunization in Ontario’s Female School-Based HPV Program”
Harris, T.; Williams, D.M.; Feiurek, J.; Scott, T.; Deeks, S.L. Vaccine, January 2014, Vol. 32. doi: 10.1016/j.vaccine.2014.01.004.

Summary: After a school-based HPV vaccination program was implemented among eighth grade girls in Ontario, Canada, researchers analyzed reports of adverse events following immunization over the following four years. From 2007 to 2011, nearly 700,000 HPV vaccine doses were administered and 133 confirmed cases of adverse events were reported. The most commonly reported side effects included allergic reactions (25 percent), rashes (22 percent), reactions at the injection site (20 percent), and non-specific “other events” (26 percent). Ten serious cases were identified, which included two cases of anaphylaxis, two seizures, one thrombocytopenia, and one death, which was concluded by the coroner to be due to a previously undiagnosed cardiac condition. Ultimately, the researchers conclude that the findings are in line with existing evidence on the safety profile of the HPV vaccine, and no new safety concerns were identified.

“Safety of Human Papillomavirus Vaccines: A Review”
Macartney, K.K.; Chiu, C.; Georgousakis, M.; Brotherton, J.M.L. Drug Safety, June 2013, Vol. 36. doi: 10.1007/s40264-013-0039-5.

Abstract: “Both vaccines are associated with relatively high rates of injection site reactions, particularly pain, but this is usually of short duration and resolves spontaneously. Systemic reactions have generally been mild and self-limited. Post vaccination syncope has occurred, but can be avoided with appropriate care. Serious vaccine-attributable adverse events, such as anaphylaxis, are rare, and although not recommended for use in pregnancy, abnormal pregnancy outcomes following inadvertent administration do not appear to be associated with vaccination. HPV vaccines are used in a three-dose schedule predominantly in adolescent females: as such, case reports linking vaccination with a range of new onset chronic conditions, including autoimmune diseases, have been made. However, well-conducted population-based studies show no association between HPV vaccine and a range of such conditions.”

Disparities in vaccination rates

“Racial/Ethnic and Poverty Disparities in Human Papillomavirus Vaccination Completion”
Niccolai, L.M.; Mehta, N.R.; Hadler, J.L. American Journal of Preventive Medicine, October 2011, Vol. 41. doi: 10.1016/j.amepre.2011.06.032.

Abstract: “Data from the 2008-2009 National Immunization Survey-Teen for girls aged 13-17 years who received at least one dose of HPV vaccine (n=7606) were analyzed in 2010-2011. During this 2-year period, 55 percent of adolescent girls who initiated vaccination completed the three-dose series. Completion was significantly higher in 2009 (60 percent) compared to 2008 (48 percent; p<0.001). After controlling for covariates, adolescents who were black or Hispanic were significantly less likely to complete vaccination than whites. Adolescents living below the federal poverty level were significantly less likely to complete vaccination than adolescents with household incomes >$75,000.”

“Social Inequalities in Adolescent Human Papillomavirus (HPV) Vaccination: A Test of Fundamental Cause Theory”
Polonijo, A.N.; Carpiano, R.M. Social Science & Medicine, April 2013, Vol. 82. doi: 10.1016/j.socscimed.2012.12.020.

Abstract: “Analyses of 2008, 2009, and 2010 United States National Immunization Survey-Teen data (n = 41,358) reveal disparities particularly for vaccine knowledge and receipt of a health professional recommendation. While parental knowledge is a prerequisite to adolescent vaccine uptake, low socioeconomic status (SES) and racial/ethnic minority parents have significantly lower odds of knowing about the vaccine. Receipt of a health professional’s recommendation to vaccinate is strongly associated with vaccine uptake, however the odds of receiving a recommendation are negatively associated with low SES and black racial/ethnic status.”

“Sociodemographic Differences in Human Papillomavirus Vaccine Initiation by Adolescent Males”
Agawu, A.; et al. Journal of Adolescent Health, November 2015, Vol. 57. doi: 10.1016/j.jadohealth.2015.07.002.

Summary: Researchers studied patterns of HPV vaccination among a sample of 58,757 adolescent males between the ages of 11 and 18 in a large primary care network. Results showed that African American males with private health insurance were twice as likely to initiate vaccination than White males with private insurance, while African American males on Medicaid were nearly three times more likely. Similar trends were observed among Hispanic males. The authors conclude that, “although the true mechanism underlying these differences remains unknown, potential candidates include provider recommendation patterns and differential vaccine acceptance within these groups.”

HPV vaccine and young males

“HPV Vaccination Coverage of Male Adolescents in the United States”
Lu, P.J.; et al. Pediatrics, October 2015, Vol. 136. doi: 10.1542/peds.2015-1631.

Summary: Researchers used data from the 2013 National Immunization Survey-Teen to investigate trends in HPV vaccination of adolescent boys. Findings revealed low rates of both vaccine uptake (34.6 percent) and completion (13.9 percent), however African American and Hispanic males were more likely to receive the vaccine than their White peers. In order to improve vaccination coverage, the authors conclude that a comprehensive approach is needed which includes physicians regularly assessing their patient’s vaccination status, educating doctors about current HPV vaccine recommendations as well as information on vaccine efficacy and safety, reducing costs, and improving health communication strategies to dispel misinformation about the vaccine.

“Longitudinal Predictors of Human Papillomavirus Vaccination Among a National Sample of Adolescent Males”
Reiter, P.L.; et al. American Journal of Public Health, August 2013, Vol. 103. doi: 10.2105/AJPH.2012.301189.

Abstract: “In fall 2010 and 2011, a national sample of parents with sons aged 11 to 17 years (n = 327) and their sons (n = 228) completed online surveys to identify predictors of HPV vaccination. Only 2 percent of sons had received any doses of HPV vaccine at baseline, with an increase to 8 percent by follow-up. About 55 percent of parents who had ever received a doctor’s recommendation to get their sons HPV vaccine did vaccinate between baseline and follow-up, compared with only 1 percent of parents without a recommendation. Willingness to get sons the HPV vaccine decreased from baseline to follow-up among both parents and sons.”

“Acceptability of Human Papillomavirus Vaccine for Males: A Review of the Literature”
Liddon, N.; Hood, J.; Wynn, B.A.; Markowitz, L.E. Journal of Adolescent Health, February 2010, Vol. 46. doi:10.1016/j.jadohealth.2009.11.199.

Abstract: “Among mothers of sons, support of HPV vaccination varied widely from 12 percent to 100 percent, depending on the mother’s ethnicity and type of vaccine, but was generally high for a vaccine that would protect against both genital warts and cervical cancer. Health providers’ intention to recommend HPV vaccine to male patients varied by patient age but was high (82 percent-92 percent) for older adolescent patients. A preference to vaccinate females over males was reported in a majority of studies among parents and health care providers. Messages about cervical cancer prevention for female partners did not resonate among adult males or parents. Future acceptability studies might incorporate more recent data on HPV-related disease, HPV vaccines, and cost-effectiveness data to provide more current information on vaccine acceptability.”

“Parents’ Decisions About HPV Vaccine for Sons: The Importance of Protecting Sons’ Future Female Partners”
Schuler, C.L.; DeSousa, N.S.; Coyne-Beasley, T. Journal of Community Health, October 2014, Vol. 39. doi: 10.1007/s10900-014-9859-1.

Abstract: “76 percent of parents reported vaccine decisions for sons were likely to be influenced by preventing HPV transmission from sons to their female partners. Parents likely to be influenced by female partner protection in vaccine decisions had greater intention to vaccinate sons than their counterparts (adjusted odds ratio 2.54). Because parents likely to consider female partners had increased intention to vaccinate sons, future efforts to improve vaccine uptake in boys should explore the benefits of highlighting potential female partner protection, as this concept may resonate with many parents.”

January, 2016|Oral Cancer News|

Multisite HPV16/18 Vaccine Efficacy Against Cervical, Anal, and Oral HPV Infection

Source: www.oxfordjournal.com
Authors: Daniel Bleacher, Aimee Kreimer, Mark Schiffman, Rolando Herrero, Ana Cecilia Rodriguez, Douglas Lowy, Carolina Porras, John Schiller, Wim Quint, Silvia Jiminez, Mahboobeh Safaeian, Linda Struijk, John Scchussler, Allan Hildesheim, Paula Gonzalez

 

Background: Previous Costa Rica Vaccine Trial (CVT) reports separately demonstrated vaccine efficacy against HPV16 and HPV18 (HPV16/18) infections at the cervical, anal, and oral regions; however, the combined overall multisite efficacy (protection at all three sites) and vaccine efficacy among women infected with HPV16 or HPV18 prior to vaccination are less known.

Methods: Women age 18 to 25 years from the CVT were randomly assigned to the HPV16/18 vaccine (Cervarix) or a hepatitis A vaccine. Cervical, oral, and anal specimens were collected at the four-year follow-up visit from 4186 women. Multisite and single-site vaccine efficacies (VEs) and 95% confidence intervals (CIs) were computed for one-time detection of point prevalent HPV16/18 in the cervical, anal, and oral regions four years after vaccination. All statistical tests were two-sided.

Results: The multisite woman-level vaccine efficacy was highest among “naïve” women (HPV16/18 seronegative and cervical HPV high-risk DNA negative at vaccination) (vaccine efficacy = 83.5%, 95% CI = 72.1% to 90.8%). Multisite woman-level vaccine efficacy was also demonstrated among women with evidence of a pre-enrollment HPV16 or HPV18 infection (seropositive for HPV16 and/or HPV18 but cervical HPV16/18 DNA negative at vaccination) (vaccine efficacy = 57.8%, 95% CI = 34.4% to 73.4%), but not in those with cervical HPV16 and/or HPV18 DNA at vaccination (anal/oral HPV16/18 VE = 25.3%, 95% CI = -40.4% to 61.1%). Concordant HPV16/18 infections at two or three sites were also less common in HPV16/18-infected women in the HPV vaccine vs control arm (7.4% vs 30.4%, P < .001).

Conclusions: This study found high multisite vaccine efficacy among “naïve” women and also suggests the vaccine may provide protection against HPV16/18 infections at one or more anatomic sites among some women infected with these types prior to HPV16/18 vaccination.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

October, 2015|Oral Cancer News|

Research Leader Discusses FDA-Funded Immunotherapy for Head and Neck Cancer

 
Source: www.onclive.com
Author: Gina Columbus
 
Brett-Miles
Brett Miles, MD, DDS

 

The investigational immunotherapy axalimogene filolisbac (ADXS11-001) has emerged as a potentially practice-changing agent in the treatment of HPV-related oropharyngeal cancer.

Shown to generate T cells directed against a cancer antigen and neutralize suppressor regulatory T cells and myeloid-derived suppressor cells that protect the tumor microenvironment from an immunologic attack and contribute to tumor growth, ADXS11-001 is the first of its kind—a therapeutic vaccine for the disease.

The agent is being examined in an ongoing phase II trial, which was reported as one of 18 recipients of research grants recently awarded by the FDA’s Office of Orphan Product Development. The grants, given to sites for product development in rare diseases, total more than $19 million. The ADXS11-001 grant provides collaborating researchers from Baylor College of Medicine and the Icahn School of Medicine at Mount Sinai with more than $1.1 million over 3 years.

Eligible patients for the phase II study are newly diagnosed with stage II to IV HPV16-positive oropharynx squamous cell carcinoma who are scheduled to receive ablative transoral robotic surgery.

In an interview with OncLive, the study’s surgical principal investigator, Brett Miles, MD, DDS, associate professor of Otolaryngology Head and Neck Surgery, co-chief, Division of Head and Neck Oncology, Icahn School of Medicine at Mount Sinai, discusses the potential of ADXS11-001 in HPV-associated head and neck cancer and other emerging therapies and treatment strategies.

OncLive: Congratulations on your study being awarded a research grant from the FDA. How does it feel to be selected and how will it help further the phase II research?

  1. Miles: Number one, the beauty of having this award is that it allows us to know that we are in line with what the FDA is interested in and, especially, what the National Institutes of Health (NIH) is interested in, in terms of immunotherapy for head and neck cancer. It gives a little bit of confirmation that our work is headed in the right direction from the standpoint of the major funding agencies.

    Certainly, having that NIH funding is actually going to allow us to propel this study along. We are getting some preliminary results that appear to be encouraging and we really need to confirm those results; this is going to allow us to do that. That is the most exciting part.

Can you provide an overview of ADXS11-001 and how it operates in the immune system?

This is a therapeutic vaccine for HPV-related head and neck cancer and other cancers that are HPV-related. It is contrasting to the preventative vaccines that are widely known, such as Gardasil, for example. Gardasil is a vaccine that if you have not been exposed to the virus, it allows your immune system to fight HPV infection before it happens. The concept behind ADXS11-001 is to allow your immune system to recognize and attack cells that have already been infected with HPV. Therefore, it is a therapeutic vaccine, not a preventative vaccine. It is the only one available for head and neck cancer at this time in a clinical trial.

This is an attenuated virus that is given to the patient in the form of two vaccines, and then it tricks the immune system into thinking that these cells are infected with the bacteria. However, what they are recognizing is the viral proteins. Therefore, they attack the cells that are infected with HPV. That is the theory.

We have administered it to several patients on the trial, and we just got some preliminary data back on the response, and we are seeing some definite changes in the immune system and in the cell surface markers in patients who have had the vaccine. We do not have quite enough data yet to interpret what those changes mean. In other words, we know the vaccine is causing some type of immune response; we are not sure if that vaccine is effectively killing tumor cells yet, and we have not confirmed what those T cells are doing. We are still gathering data for that. Hopefully, with the next batch of patients that we enroll, we will be able to tell if this is actually an effective therapy for this disease. That is kind of where we are right now.

How has the safety profile of ADXS11-001 been thus far?

Patients have been tolerating it quite well. In terms of toxicity, it is like an immunotherapy. Therefore, you may get rashes and low-grade fevers, kind of feeling like you have the flu, and some other things that are relatively standard with immunotherapies. Remember, anything that activates your immune system to a sufficient level to fight off a tumor infection is also going to cause some level of low-grade side effects. However, we have not seen any severe side effects or any major issues with it. We have seen some changes in blood pressure during the infusions, so we give the vaccine in the cancer center. It is two doses and you are supervised for several hours after administration of the vaccine. We have not seen any major toxicities with the vaccine, but the low-grade ones are relatively common. People know when their immune system has been activated, that’s for sure.

What other immunotherapy agents on the horizon do you see having promise in the treatment of head and neck cancer?

One other study, that we have not yet opened but we are going to do, is combining the ADXS11-001 vaccine with MEDI4736, a PD-L1 inhibitor. That study will be for patients who have metastatic or recurrent disease. This ought to be kind of interesting because then you are attacking the immune system from two different angles. It is going to compare ADXS11-001 monotherapy with the PD-L1 monotherapy with a third arm that has both agents combined. I am not sure when that trial is going to be open, but that is the one coming up on the horizon.

Aside from immunotherapy, what other treatment-related research in head and neck cancer are you interested in seeing the results of?

The other main trial is our robotic surgery trial, which is called a de-escalation trial. As you may be aware, patients with HPV-related head and neck cancer have a good prognosis. One of the problems is, when they get standard concurrent chemoradiotherapy, they have a lot of functional morbidity. We have an ongoing robotics trial that basically treats patients with robotic surgery upfront and then they get standard chemotherapy with a reduced dose of radiation, a reduced dose of radiation, or no radiation based on their pathology.

We are hoping to offer the same cure rate for these earlier-stage HPV-related cancers, but with a more functional long-term outcome by tailoring what the patient gets, based on the pathology report, after the minimally invasive robotic surgery. That is something we are currently accruing for, and we are really excited to see if our survival data is comparable, which we think it will be. Our functional outcomes, based on the data we have, should certainly be improved over standard therapy.

There was research presented at the 2015 ASCO Annual Meeting that showed that reducing radiation and chemotherapy dosage in low-risk HPV-associated oropharyngeal squamous cell carcinoma may prevent disease recurrence while still improving quality of life. Can you comment on this study?

Both of these studies are consistent with the prevailing thoughts on de-escalation of therapy in appropriately selected patients. When properly stratified, many patients can enjoy high rates of oncologic cure, with reduced long-term morbidity. It highlights the difficult balance between administering just enough therapy to cure the cancer, without permanently destroying the quality of life in terms of speech and swallowing.

The investigational immunotherapy axalimogene filolisbac (ADXS11-001) has emerged as a potentially practice-changing agent in the treatment of HPV-related oropharyngeal cancer.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

September, 2015|Oral Cancer News|

Vaccine law should cover HPV cancers

Source: www.sacbee.com
Author: Brandon Brown

Vaccines are the most effective way to prevent infectious diseases. Gov. Jerry Brown rightly signed a law that requires, starting July 1, 2016, that all children enrolled in public or private schools or day care be vaccinated against whooping cough, measles, polio and other diseases, regardless of parents’ religious or personal beliefs. But frustratingly, the California mandate does not include the vaccine to protect against cervical, anal and oral cancers, and genital warts.

HPV vaccines have been around for 10 years. Three types exist, with the newest providing the highest protection against chronic infection and precancerous conditions among boys and girls. Despite the recommendations of major health groups, national data show only 57 percent of adolescent females and 35 percent of males received at least one dose of the three-dose HPV vaccine series in 2013. HPV vaccine has the lowest completion rate of any vaccine in the United States.

There may be several explanations for this. One is the short time that providers have available to stress the need for early vaccination during a normal medical visit, much less to address parents’ concerns about implicitly sanctioning sexual activity. But the vaccine is linked to age rather than sexual activity, and postponing it until after boys and girls start having sex decreases its effectiveness.

Another reason for low vaccination rates is that it requires tremendous work, including training health care providers on how to promote HPV vaccine as a cancer-prevention tool similar to hepatitis B vaccine, which has a similar route of transmission. With hepatitis B, sex is not part of the discussion, and HPV should be treated the same way.

We must applaud Rhode Island for recently joining Washington, D.C., and Virginia for incorporating all vaccines recommended by pediatricians and the Centers for Disease Control and Prevention, including HPV, into their school immunization regulations.

More than 14 million HPV infections occur annually in the United States. With such a sobering statistic, no sound justification can be made for HPV vaccines to be treated differently than other recommended vaccines. It’s time for solutions instead of excuses.

Author: Brandon Brown is an assistant professor at the University of California, Riverside, School of Medicine.

September, 2015|Oral Cancer News|

An HPV-E6/E7 immunotherapy plus PD-1 checkpoint inhibition results in tumor regression and reduction in PD-L1 expression

Source: www.nature.com
Author: A E Rice, Y E Latchman, J P Balint, J H Lee, E S Gabitzsch and F R Jones
 

We have investigated if immunotherapy against human papilloma virus (HPV) using a viral gene delivery platform to immunize against HPV 16 genes E6 and E7 (Ad5 [E1-, E2b-]-E6/E7) combined with programmed death-ligand 1 (PD-1) blockade could increase therapeutic effect as compared to the vaccine alone. Ad5 [E1-, E2b-]-E6/E7 as a single agent induced HPV-E6/E7 cell-mediated immunity. Immunotherapy using Ad5 [E1-, E2b-]-E6/E7 resulted in clearance of small tumors and an overall survival benefit in mice with larger established tumors. When immunotherapy was combined with immune checkpoint blockade, an increased level of anti-tumor activity against large tumors was observed. Analysis of the tumor microenvironment in Ad5 [E1-, E2b-]-E6/E7 treated mice revealed elevated CD8+ tumor infiltrating lymphocytes (TILs); however, we observed induction of suppressive mechanisms such as programmed death-ligand 1 (PD-L1) expression on tumor cells and an increase in PD-1+ TILs. When Ad5 [E1-, E2b-]-E6/E7 immunotherapy was combined with anti-PD-1 antibody, we observed CD8+ TILs at the same level but a reduction in tumor PD-L1 expression on tumor cells and reduced PD-1+ TILs providing a mechanism by which combination therapy favors a tumor clearance state and a rationale for pairing antigen-specific vaccines with checkpoint inhibitors in future clinical trials.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

September, 2015|Oral Cancer News|

HPV vaccine now free for ‘at-risk’ boys and men under 26

Source: www.vancitybuzz.com
Author: Jill Slattery

vaccine

The government of B.C. announced this week the HPV vaccine for human papilloma virus will now be available free of charge to boys and men under age 26 who classify as ‘at-risk’.

Beginning in September, the free HPV vaccine program currently only available to young women will become available to men who have sex with males or who are “street-involved”.

“Providing the vaccine for all girls protects heterosexual boys as well, but leaves at-risk boys and young men unprotected. This change will address that gap,” said the province in a media release.

“The human papilloma virus is the most common sexually transmitted infection,” said Health Minister Terry Lake. “It can lead to serious health problems and could develop into an HPV-related cancer. Our vaccination program will help protect all young British Columbians from cancers and other diseases caused by HPV infection.”

HPV can be contracted by having sex with another person infected by the virus. According to the Centers for Disease Control and Prevention (CDC), HPV is “spread easily during anal or vaginal sex, and it can also be spread through oral sex or other close skin-to-skin touching during sex. HPV can be spread even when an infected person has no visible signs or symptoms.”

While HPV may cause little to no symptoms in some, it can lead to genital warts and certain kinds of cancer. In men, oropharyngeal cancers (cancers at the back of the throat) are the most common.

“In general, HPV is thought to be responsible for more than 90% of anal and cervical cancers, about 70% of vaginal and vulvar cancers, and more than 60% of penile cancers,” reports the CDC.

“It is clear that some men are more at risk for HPV related cancers than are others,” said Dr. Perry Kendall, B.C.’s provincial health officer. “As most of these infections are vaccine-preventable, extending B.C.’s HPV immunization program to this at-risk demographic is a cost-effective way to provide protection to the people who need it most.”

Men who have sex with other men carry a disproportionately high chance of contracting HPV.

The provincial HPV vaccine program uses the Gardasil vaccine, protecting from HPV types 16 and 18 that cause 70% of cervical cancers, 80% of anal cancers and other cancers of the mouth, throat, penis, vagina and vulva. It also protects against infection from HPV types 6 and 11 that cause about 90% of cases of genital warts.

Hey, Ontario — boys deserve protection from HPV, too

Source: news.nationalpost.com
Author: Robyn Urback

For years now, groups including the Canadian Medical Association, the Canadian Cancer Society and the National Advisory Committee on Immunization have been petitioning the Ontario government to cover the cost of the HPV vaccine for boys. Since 2007, the province has paid to immunize girls against the common sexually transmitted infection — which is known to cause cervical, vaginal and other cancers in women, and mouth and throat cancers in men — but boys still have to shell out around $400 or more for three doses (though recent studies show that two doses may be sufficient) of the demonstrably effective, safe vaccine.

HPV Vaccinations Back In Spotlight After Perry Joins Presidential Race

Alberta and Prince Edward Island already cover the cost of the immunizations for both boys and girls, and so too will Nova Scotia as of this coming fall. And there’s good reason for that: doctors say that the rates of oral cancers among men have risen dramatically over the past several years, with HPV present in about two-thirds of cases. The good news is that the survival rate of these HPV-positive cancers is about 80 per cent; the bad news is that there can be lifelong effects, including problems with swallowing, hearing, tasting and in extreme cases, dependence on a feeding tube.

But here’s more good news: we know the HPV vaccine works. In the U.S., for example, it has been shown to reduce the rates of infection among 14- to 19-year-old girls by more than 56 per cent since it was introduced in 2007, and there are indications it might be similarly successful among boys. So with such obvious benefits, why would Ontario choose to leave half of its young population exposed?

Money. Obviously. According to a statement released by the Ministry of Health a couple of weeks ago, the province has put off expanding its vaccination program to boys in order to evaluate “economic and societal factors.”

There’s no question that these vaccines don’t come cheap, but they certainly don’t cost as much as treating a patient with oropharyngeal cancer, and indeed there may long-term savings — anywhere from $8 million to $28 million per year, as a recent study has shown. Furthermore, the immunization program in Ontario now depends on the notion of “herd” immunity, whereby the spread of the infection is contained if a large enough proportion of the population is inoculated. That means, essentially, that 15-year-old boys in Ontario today are left to either trust that the girls around them have been vaccinated, or to fork over the money in order to protect themselves. (This also leaves boys who might contract the virus from other boys completely exposed to the infection).

It is true that the prevalence of throat cancers among men in Ontario is still relatively low, but according to a 2011 study published in the Journal of Clinical Oncology, if trends continue the way the are, the rates of HPV-positive oropharyngeal cancer in the U.S. will surpass that of cervical cancer by the year 2020. It’s also likely that the cost of the vaccine will come down over the next few years (indeed, it used to be prohibitively expensive at more than $500 for a full course), especially as old patents expire and new versions of the vaccine become available. But here’s the most compelling reason why Ontario should expand its HPV vaccination: boys deserve to be protected from a cancer-causing infection, too. Alberta, Nova Scotia and PEI get that; it’s a shame Ontario still needs to think it over.

Single Dose of HPV-16/18 Vaccine Looks to Be Sufficient

Source: www.medscape.com
Author: Jenni Laidman
 

A single dose of a vaccine against human papillomavirus (HPV) may prevent cervical cancer as effectively as the standard three-dose regimen, researchers concluded after analyzing the combined results of two large vaccine trials. The HPV vaccine in these studies was Cervarix (GlaxoSmithKline), which is effective against HPV strains 16/18.

If randomized controlled trials ultimately support the result of this post hoc analysis, it could broaden protection against cervical cancer in areas of the world where vaccination programs are hardest to administer and where cervical cancer is disproportionately burdensome, the study authors say.

“Even if you ignore the expense, the feasibility of implementing and getting back to individuals for a second and third dose is quite challenging, especially in places where there is no infrastructure,” coauthor Cosette Wheeler, PhD, Regents Professor, Pathology and Obstetrics and Gynecology, University of New Mexico Health Sciences Center in Albuquerque, told Medscape Medical News.

The studies are published online June 10 in the Lancet Oncology.

The possibility of a single-dose HPV vaccine is “a huge public health win,” coauthor Aimée R. Kreimer, PhD, Investigator, Division of Cancer Epidemiology & Genetics, National Cancer Institute, Bethesda, Maryland, told Medscape Medical News. “Even if one dose protects only against HPV types included in the vaccine formulation, if we vaccinated most girls, we would have the chance to reduce cervical cancer by around 75%.”

That’s the exciting part, Dr Wheeler added. “If we’re able to achieve success with one dose, or frankly even with two doses, that makes the possibility for worldwide prevention much greater.”

HPV type 16 is the leading cause of cervical cancer, responsible for about 50% of all cases, and HPV 18 is the second-largest cause, at 20%.The authors note that this research was carried out with Cervarix, and it is unclear whether the results would also apply to the other HPV vaccine that is available, Gardasil (Merck & Co.), which is active against several more HPV strains and is the product that is commonly used in the United States. Whether results of this trial have any bearing on Gardasil will depend on what’s driving the strong immune response to Cervarix, the authors suggest. Cervarix carries a proprietary adjuvant, which may be responsible for the immune response.

Surprise Over Efficacy Findings

The idea of the current post hoc analysis arose from results in the large randomized controlled Costa Rica Vaccine Trial, in which about 20% of participants received fewer than three doses of HPV-16/18 vaccine. “We were surprised to observe that efficacy was the same regardless of the number of doses received,” Dr Kreimer told Medscape Medical News.

That led to the post hoc analysis of the immunization results from the Costa Rica Vaccine Trial combined with results from the only other large phase 3, double-blind, randomized trial of HPV-16/18, for a total of more than 14,000 participants, ages 15 to 25 years, including about 7000 control subjects. The second trial, called PATRICIA (Papilloma Trial Against Cancer in Young Adults), took place in 14 countries. The analysis found that 4 years after vaccination, women who received the required three vaccine doses and women who received fewer than three doses — usually due to pregnancy or a colposcopy referral — were equally protected against HPV-16/18. Further, the analysis showed a potential benefit of cross-protection against closely related HPV strains 31/35/45 among women whose two doses were 6 months apart — a benefit previously seen only with three doses.

Four-year vaccine efficacy against HPV-16/18 in the combined analysis was 77% for the 13,296 (6634 case, 6662 control) women in the three-dose group, 76% for the 549 (273 case, 276 control) women in the two-dose group, and 85.7% for the 238 (138 case, 100 control) women in the single-dose group. Efficacy against the closely related HPV-31/33/35 was 59.7% for three doses, 37.7% for two doses, and 36.6% for one dose. When data for the two doses were analyzed according to dosing regimen, the cross-protective efficacy was 10.1% for those who received their second dose 1 month after the first and 68.1% for those who received the second dose at 6 months.

Antibody concentrations for two doses given 6 months apart were very close to concentrations for three doses, the research showed. One-dose vaccination titers at 6 to 48 months were lower than those for two or three doses, “but the titers were stable and several times higher than those identified for natural immunity,” the researchers write. “We can now infer that these lower, vaccine-induced antibody titers provide as strong HPV prevention as the titers from two or three doses, at least in the short term.”

Just how long these vaccines will provide protection still needs to be determined. “We know with three doses we can see the protection going out toward 10 years, and we hope that maybe the protection is lifelong,” commented Dr Wheeler. “That does not mean that we know we will never need a booster. And that doesn’t mean if we give less than three doses that we know about the longevity or durability of that protection. So that’s another piece of the puzzle.”

Although these results cannot be applied to Gardasil, Dr Wheeler notes that studies looking at Gardisil antibody titers after two doses look promising.

In an accompanying comment, Julia M.L. Brotherton, Medical Director, National HPV Vaccination Program Register, VCS Registries, East Melbourne, Victoria, Australia, commented: “These data suggest that one dose of bivalent HPV vaccine might be adequate to protect against HPV-16 and HPV-18 persistent infections and, therefore, probably disease. HPV-16 and HPV-18 cause more than 70% of cervical cancers and the vast majority of HPV-related cancers at other anatomic sites. If this finding is confirmed, it opens up a great opportunity to extend the reach of protection using HPV vaccines to more people than we would have previously thought possible.”

Four authors of the study are GSK employees and own shares and stock options in the company. Other researchers had financial or advisory relationships GSK, Roche Molecular Systems, Merck, and Sanofi Pasteur MSD. Dr Brotherton notes that she has been an investigator for investigator-initiated HPV epidemiology research grants partially funded by bioCSL/Merck, but this did not involve financial compensation.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

Three things you might not know about HPV

Source: www.huffingtonpost.ca
Author: Sunnybrook Health Sciences Centre

April 26 to May 2 is National Immunization Awareness week in Canada. One immunization known for raising a lot of questions is the Human Papillomavirus (HPV) vaccination, provided free of charge in Ontario to girls in grades 8-12, and following provincial schedules across the country.

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While there is lots of information online, at school and at the doctor’s office about HPV, there is still a lot of confusion about what it may mean for your loved ones. Dr. Nancy Durand, gynecologist at Sunnybrook, explains three little-known facts about HPV.

1) HPV causes cancer in men, too
When Michael Douglas candidly revealed his oral cancer was caused by HPV, many people expressed surprise.

Even though HPV has traditionally been thought of as a disease that affects women and mainly causes cervical cancer, men are actually at higher risk of being diagnosed with certain types of HPV-positive cancers than women.

“It’s not well understood why men are at higher risk for HPV-positive oral cancer, but it does point out that vaccination in men is even more important than we may have previously thought,” says Dr. Durand. Physicians are learning more and more that HPV can also cause other cancers in both women and men, such as anal cancers and head & neck cancers (cancers of the base of the tongue, tonsils and soft palate).

2) Not all HPV infections lead to cancer
You’ve probably read some of the (slightly scary) statistics about HPV: Three in four Canadians will get HPV in their lifetime. It can lead to a variety of cancers and cause genital warts, and there is no cure. But should this keep you up at night, worrying about the potentially deadly consequences of HPV?

Hardly, says Dr. Durand. “Most people who are infected with this virus will clear it — probably 80 per cent of people. It’s the other 20 per cent of people with a persistent infection who may be at risk of cancer, and it’s still only a very small percentage of those people who may go on to develop cancer,” she says.

Many people never even realize they’ve had an HPV infection, as there are usually no symptoms, and the infection often goes away on its own.

3) You’re never too old to get the HPV vaccine
What if you didn’t get the HPV vaccine back in middle school, and now you think it’s too late to get it?

“Regardless of your age and your onset of sexual activity, we can vaccinate both men and women, and we can see a reduction in disease,” says Dr. Durand.

It’s actually not too late — the vaccine can still be effective, even in adults who’ve already been sexually active. “Many people think vaccination can only be done before the onset of sexual activity. But regardless of your age and your onset of sexual activity, we can vaccinate both men and women, and we can see a reduction in disease,” says Dr. Durand.

Anyone, male or female, over the age of nine can be vaccinated. So, if you’ve put off getting the vaccine because you thought you were too old, it’s not too late!

Note: Co-authored by Sybil Millar, Communication Advisor at Sunnybrook Health Sciences Centre

April, 2015|Oral Cancer News|

Nova Scotia to include boys in HPV vaccination schedule

Source: www.theglobeandmail.com
Author: Kelly Grant, Health Reporter

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Boys in Nova Scotia will begin receiving free vaccinations against the human papillomavirus next fall, a move that makes the Maritime province only the third in Canada to extend public funding of the cancer-thwarting shot to all children, regardless of gender.

In the budget unveiled on Thursday, Nova Scotia’s Liberal government announced it would make the HPV vaccine available to Grade 7 boys as part of the regular school-based immunization program. The expansion is expected to cost $492,000 a year.

Every province in Canada already covers the HPV vaccine for girls in an effort to prevent genital warts and cervical cancer, both of which can be caused by some strains of the virus, which is transmitted through sex and skin-to-skin contact.

But in recent years, oncologists and major health organizations – including the Canadian Cancer Society and the National Advisory Committee on Immunization – have begun calling for HPV vaccinations for boys, too. Until this week, only Prince Edward Island and Alberta had heeded that call with a publicly funded program.

HPV can lead to cancers of the penis, anus, oral cavity and throat in men, as well as genital and anal warts.

“We have a vaccine. It can prevent cancers in men and women, so we want Canadians to be vaccinated against it, because we can actually prevent cancers from starting in the first place,” said Robert Nuttall, the assistant director of cancer control policy at the Canadian Cancer Society.

Nova Scotia’s decision to fund the vaccine for boys was especially important to one recently retired member of the provincial legislature. Gordie Gosse, who until last week represented the riding of Sydney-Whitney Pier in Cape Breton, was diagnosed nearly a year ago with Stage 4 throat cancer caused by HPV. The 59-year-old former speaker of the legislature had more than 12 hours of surgery to remove the tumour and reconstruct parts of his face, followed by chemotherapy and radiation.

“If I’d had the vaccine, I wouldn’t have had the cancer,” he said in an interview on Friday.

Mr. Gosse, a member of the opposition NDP, made it his final mission as an elected official to extend public funding of the HPV vaccine to boys, which, according to a spokesman for the province’s department of health, the Liberal government was already studying as part of its annual vaccine review.

When his private members’ bill on the male vaccine program passed second reading on April 1, Mr. Gosse figured the measure would be in the budget. He announced his retirement the next day. “I was quite ecstatic,” Mr. Gosse said.

The HPV vaccine is most effective when administered before a child or teen starts having sex.

However, provincial governments are wrestling with whether it is cost-effective to vaccinate boys as well as girls.

“Right now it’s [about] money,” said Eduardo Franco, chair of the department of oncology at McGill University in Montreal.

Dr. Franco pointed to an evaluation done in Quebec two years ago that found vaccinating boys would not be cost-effective, in part because men who sleep with women would benefit from the protection the vaccine provided to their female partners. But that leaves gay men vulnerable, Dr. Franco said.

“The solution is truly universal HPV vaccination,” he said. “No questions asked. We [should] just take it for granted that it’s part of the adolescent vaccine calender.”

Alberta’s Grade 5 HPV immunization program costs $11-million a year – $4-million for boys, $4-million for girls, plus an extra $3-million a year for a limited-time “catch-up” program for Grade 9 boys that ends in 2017.

But the overall HPV immunization program is expected to save an estimated $13.4-million a year down the road by preventing some cases of HPV-caused cancer, according to Alberta Health.

Ontario is reviewing its HPV immunization program, said David Jensen, a spokesman for the Ministry of Health and Long-Term Care.

“Various factors are being considered such as scientific evidence (e.g., burden of disease and vaccine effectiveness), economic and societal factors, as well as cost effectiveness and impact on the health system,” he said by e-mail.

April, 2015|Oral Cancer News|