vaccine

FDA approves Gardasil 9, the HPV vaccine, to prevent head-and-neck cancer

Source: www.statnews.com
Author: Matthew Herper

For the past decade, evidence has suggested that Gardasil, the HPV vaccine, could stem an epidemic of throat cancer. But it has also never received approval from the Food and Drug Administration for that use — and it was unclear if it ever would.

Charles Rex Arbogast/AP

On Friday, the agency granted that approval, clearing the latest version of the vaccine, Gardasil 9, to prevent a cancer that affects 13,500 Americans annually. The decision was announced by Gardasil’s maker, Merck.

The decision doesn’t change recommendations about who should get the vaccine, which is already recommended for females and males ages 9 through 45 to prevent cervical, vulvar, vaginal, and anal cancer as well as genital warts. But cancers of the head and neck — mainly those of the tonsils and throat — have been left off the list.

It’s a striking omission, because head and neck cancer, mostly cancer of the throat, is the most common malignancy caused by HPV, the human papilloma virus, in the U.S. According to the Centers for Disease Control and Prevention, there are 35,000 cases of HPV-related cancer in the U.S. annually. On top of the 13,500 cases in the throat, 10,900 are cases of cervical cancer.

“That’s excellent news,” said Stewart Lyman, a pharmaceutical consultant whose doctors discovered a tumor in his throat in 2016. It was removed surgically, and was caused by HPV. “To have this extended to head and neck cancer is really very helpful for helping to inform the public that this serious disease, which has significant morbidity and mortality associated with it, can be prevented with the vaccine,” Lyman said.

Marshall Posner, the director of head and neck medical oncology at the Tisch Cancer Institute, said the approval is “a good thing for the FDA to do” and that he would be “thrilled” if head and neck cancer cases could be reduced through vaccination in coming decades. He said he has “every expectation” that an HPV vaccine would reduce cancer rates.

The original version of the Gardasil vaccine was approved in 2006 for girls and women between the ages of 9 and 26 based on data from clinical trials showing that the vaccine, by preventing HPV infection, could also prevent precancerous cervical lesions. But such lesions don’t exist in head and neck cancer, and it was not clear how to prove the vaccine’s efficacy.

Maura Gillison, now a professor at M.D. Anderson Cancer Center, first connected a subset of head-and-neck cancers to HPV in 1999. But then she and other epidemiologists noticed something: The number of head and neck cancers was rising rapidly, and HPV seemed to be a culprit. What’s more, these sexually transmitted cases seemed different — and somewhat easier to treat. The most common victims were middle-aged men who had contracted the virus decades before.

The FDA is granting what’s known as an accelerated approval, meaning that the decision is contingent on the production of more data and is based on what’s known as a “surrogate endpoint” — an indication that a medicine works that is not foolproof. In this case, the FDA is approving the drug based on data on preventing anogenital infection. In February, Merck began a study of 6,000 men that will test whether patients who receive the vaccine are less likely to get persistent HPV infections in their throats.

Adding another disease to the approval does impact what Merck can say to doctors and patients about HPV and head and neck cancer. “It’s something that was missing in the label,” said Alain Luxembourg, director, clinical research, Merck Research Laboratories. “It is something missing in the conversation between patients and doctors.”

Otis Brawley, an oncology and epidemiology professor at Johns Hopkins University, said that while he is usually opposed to surrogate endpoints, in this case he is comfortable with the decision. “There’s already enough reasons to vaccinate for HPV in men,” he said, adding that doing so broadly might make it possible to eradicate the virus, and the cancers it causes.

For Gillison, who spotted the emergence of HPV throat cancer, it came too late. She pushed Merck to do a study, and said that the one that started in February is coming “10 years plus after when it would have really mattered.” She also thinks that the real reason for the decision is the weight of epidemiologic evidence that she and others produced.

“The fact of the matter is that this approval probably has little whatsoever to do with the anal data per se,” Gillison wrote via text message. “It is because the FDA is made more comfortable with inference because of all the data that has been generated regarding the relationship between oral HPV infection and HPV vaccination outside of vaccine trials in the last 10 years.”

What parents need to know about the HPV vaccine

Source: www.news-medical.net
Author: University of Chicago Medical Center, reviewed by Kate Anderton, B.Sc. (Editor)

The vaccine that prevents infection from human papillomavirus (HPV) is nothing short of a medical marvel. “It’s one of the most effective vaccines we have against any disease or infection. And it prevents cancer,” said Andrea Loberg, MD, clinical associate of obstetrics and gynecology.

Pre-teens and teens who are vaccinated against HPV can be spared some of the deadliest, most disfiguring and hard-to-treat cancers-;those of the cervix, vagina, vulva, penis, anus, mouth and throat. Over 90% of cancers caused by HPV can be prevented-;29,000 cases of cancer per year-;with the HPV vaccine.

Concerns about sexual promiscuity
To some parents, however, the HPV vaccine may be an uncomfortable reminder that their child will be moving into adulthood and may choose to express his or her sexuality. HPV is transmitted by oral, vaginal and anal sex and other intimate skin-to-skin contact, and it is extremely prevalent; about 80% of people will be exposed to the virus in their lifetime.

Condoms reduce but don’t eliminate the risk of HPV infections because the virus lives in both oral and genital tissues. Condoms do not cover the entire genital area of either gender. Nor are same-sex female partners protected from contracting the virus, which often causes no symptoms until precancerous lesions or cancer show up years later. “It’s hard for parents to think about our kids becoming sexually active, but we also want them to have fulfilling lives,” said Truehart, whose own two teenagers have received the HPV vaccine. “We want to make sure they are protected before they start having sex.”

The recommended age for receiving the HPV vaccine is 11 or 12, when children are also scheduled to receive the Tdap vaccine (tetanus, diphtheria and pertussis) and the meningitis vaccine. But the two-dose vaccine-;the second dose is given six to 12 months after the first-;can be given to children as young as nine. Teens older than 15 and men and women need three doses of the vaccine to develop an immunity against HPV.

“Pre-teens have a more robust response to the vaccine and generate enough antibodies to protect against HPV after two immunizations, whereas older kids and adults need three doses to get the same immune response,” said Truehart. Another reason not to delay getting the HPV vaccine: an older teen may not want to wait six months or more to be fully immunized against HPV once he or she is on the verge of becoming sexually active. “It’s important for kids to be immunized before they are exposed to HPV,” Truehart said.

Not just for girls
When the U.S. Food and Drug Administration approved the HPV vaccine in 2006, it was recommended for girls and women to protect against cervical cancer. Three years later, the vaccine was approved for boys and men, based on evidence that males are also susceptible to HPV-related cancers. “Cancers caused by HPV affect women and men in equal numbers,” said Loberg. “Each year, there are approximately 10,800 cases of cervical cancer diagnosed in women, and 9,600 cases of head and neck cancer diagnosed in men.” And while there is a screening test for cervical cancer to catch and treat it early, there are no such screening tests for any of the other HPV-related cancers. And because most HPV infections are asymptomatic, people may be unwittingly transmitting the infection to their sexual partners.

HPV also causes genital warts which, although not harmful in most people, can be embarrassing and unsightly. In some cases, however, genital warts can be extremely painful and may even require surgery to remove them. For people with autoimmune disorders or who take medications that compromise their immune system, genital warts can be very difficult to manage, said Loberg. Out of more than 150 strains of HPV, the vaccine targets the most prevalent and harmful ones: two strains that cause genital warts and seven strains that cause various types of cancer.

No serious side effects
Despite HPV being the most common sexually transmitted infection, HPV-related cancers are relatively uncommon because in about 90% of people exposed to HPV, their immune systems clear the virus from their bodies before it causes cancer or precancer. “But we don’t know which individuals will develop a persistent infection, so why take that gamble when cancer can be the consequence?” said Loberg.

When parents ask whether the HPV vaccine is safe, Loberg’s ready answer is that “it’s incredibly safe.” More than 270 million doses of the HPV vaccine have been distributed worldwide since 2006, and there have been no serious side effects. One study that examined data from more than 56 million doses of HPV vaccine administered in the U.S. found that some girls became dizzy or fainted 15 minutes after receiving the vaccine. “That is the only side effect that we see,” other than mild side effects typical of other vaccines, such as fever, headache, and pain and redness at the injection site, said Loberg.

Pediatricians and primary care providers should be recommending the HPV vaccine for children, but if not, parents should bring it up.

“There is absolutely no downside to getting the HPV vaccine, and the upside is preventing your child from getting a deadly or disfiguring cancer,” she said.

January, 2020|Oral Cancer News|

Single dose of HPV vaccine may be as effective as three

Source: www.laboratoryequipment.com
Author: Michelle Taylor, Editor-in-Chief

More than a decade after the introduction of a vaccine that has been proven to stave off 90 percent of human papillomavirus-caused cancers, only half of U.S. adolescents have completed the 3-shot series. While part of that can be attributed to adolescents and adults who question the validity of the vaccine, the majority is due to unawareness of or forgetting the need for additional doses, lack of insurance and non-frequent contact with the medical system.

But, a new study from researchers at the University of Texas Health Science Center at Houston, has revealed a single-dose regimen may be equally as effective as the current 2- to 3-dose system.

“Ensuring boys and girls receive their first dose is a big challenge in several countries and a majority of adolescents are not able to complete the recommended series due to a lack of intensive infrastructure needed to administer two or three doses,” said the paper’s senior author Ashish Deshmukh, assistant professor at UTHealth School of Public Health. “If ongoing clinical trials provide evidence regarding sustained benefits of a one-dose regimen, then implications of single-dose strategy could be substantial for reducing the burden of these cancers globally.”

Deshmukh’s study examined the difference in the prevalence of HPV infection in a total of 1620 women aged 18 to 26 of whom 1,004 were unvaccinated, 616 received at least 1 dose of HPV vaccine 106 received just 1 dose, 126 received 2 doses and 384 received 3 doses.

Compared with unvaccinated women who had a HPV infection (4-valent vaccine types [6,11,16 and 18]) prevalence of 12.5%, women who received at least one dose showed significantly less prevalence—2.4% for women with 1 dose, 5.1% for those with 2 doses and 3.1% for those who received all 3 doses.

According to the paper recently published in JAMA Network Open, there was no significant difference in prevalence for 1 dose versus 2 doses or 1 dose versus 3 doses. Additionally, differences were not statistically significant for cross protection (HPV types 31, 33, and 45), and other high-risk HPV types (HPV types 35, 39, 51, 52, 56, 58, 59, and 68).

Using a multivariable logistic regression model, the authors predicted the probability of HPV infection (types 6, 11, 16, 18) to be higher in unvaccinated women (7.4%) compared with women who received 1 dose (2.3%), 2 doses (5.7), or 3 doses (3.1%).

According to the CDC, 34,800 new cancer diagnoses are linked to human papillomavirus (HPV) annually. The virus is thought to account for more than 90% of all cervical and anal cancers, more than 60% of all penile cancers, and approximately 70% of all oral cancers. While the study authors stressed it is too early for people to rely on a single dose for protection against these cancers, they are encouraged by the results of their research.

“The current HPV vaccine dosing regimen can be cumbersome for people to understand. If one dose is proven effective in trials, the vaccine regimen will be simplified,” said lead author Kalyani Sonawane, also an assistant professor at UTHealth School of Public Health. “This will help improve the coverage rate among adolescents that are currently below the Healthy People 2020 goal and possibly will also increase the momentum of uptake in the newly approved age group.”

January, 2020|Oral Cancer News|

Health department official on HPV vaccine: “What are we waiting for?”

Source: www.mynews13.com
Author: Rebecca Turco

Despite studies from the CDC showing the effectiveness of the HPV vaccine at preventing certain types of cancer, some parents are still hesitant to get their children vaccinated.

  • 92% of almost 35,000 cancers could be prevented by vaccine
  • Doctor: Some parents may think vaccine promotes sexual behavior
  • County Health Departments offer HPV vaccine for free

Dr. Raul Pino, the interim administrator of the Orange County Health Department, wants to change that.

Among the estimated 34,800 cancers probably caused by the human papilloma virus between 2012 and 2016, an estimated 92% could be prevented by the vaccine, according to the Centers for Disease Control and Prevention.

“We have a vaccine that prevents some type of cancers, and now we’re questioning if we should take the vaccine,” he said. “It will not only prevent penile cancer or vaginal cancer or cervical cancer, but also oral, esophagus and tonsils.

“So what are we waiting for?”

Pino thinks some parents might be hesitant because of the widely spread, but disproven, belief that vaccines are linked to autism. Then, there are other parents who think giving their child the vaccine is promoting sexual behavior. HPV is the most common sexually transmitted infection.

“The reality is, I think what the parents have to present to themselves in this debate, is what is the paramount objective here?” Pino said. “Is the paramount objective to offer protection to the individual, or is the paramount objective to prevent the behavior?”

Officials recommended that children receive the multi-dose HPV vaccine years before becoming sexually active, anywhere from 9 to 12 years old. A little more than half of teens, 51 percent, received all recommended doses of the vaccine last year, according to the CDC.

The HPV vaccine is not a required immunization for students in Florida. County health departments offer the vaccine for free.

October, 2019|Oral Cancer News|

Does HPV vaccine reduce HIV-positive men oral cancer risks?

Source: www.precisionvaccinations.com
Author: Don Ward Hackett, Fact checked by Robert Carlson, MD & Danielle Reiter, RN

Does the HPV vaccine protect against oral infections?

That’s the question a new National Cancer Institutes (NCI) funded clinical trial of the Gardasil 9 vaccine hopes to answer.

This extensive study will determine whether the Gardasil 9 vaccine can prevent persistent oral HPV infections among men who are Human Immunodeficiency Virus (HIV) positive, said the NCI online on October 8, 2019.

Oral HPV infections and HPV-related oral cancers are common in men and among HIV-positive individuals.

Gardasil 9 is the most recent formulation of the Human Papolivirus (HPV) vaccine, which covers 5 additional cancer-causing HPV types. There are over 100 types of HPV.

“We are hoping that if we show the efficacy of the vaccine, that vaccinating both males and females will ultimately reverse” the rising incidence of HPV-related oropharyngeal cancers, said one of the trial’s lead investigators, Anna Giuliano, Ph.D., of Moffitt Cancer Center.

The trial is one of several within the US–Latin American–Caribbean Clinical Trials Network (ULACNet), an NCI-led effort to reduce the burden of HPV-related cancers in HIV-positive individuals.

This new study intends to build relevant insights upon a June 2017 study found that vaccination against HPV may sharply reduce oral HPV infections that are a major risk factor for oropharyngeal cancer, a type of head and neck cancer, says the NCI.

The 2017 study found that the prevalence of oral infection with 4 HPV types, including two high-risk, or cancer-causing, types, was 88 percent lower in those who reported receiving at least 1-dose of an HPV vaccine, than in those who said they were not vaccinated.

The ULACNet international collaborative research network brings together institutions in the United States and counterparts in low- and middle-income countries (LMICs) in the Latin American and the Caribbean (LAC) region.

Funded in Fall 2019 via a U54 Partnership Centers Cooperative Agreement mechanism, ULACNet comprises of 3 Partnership Centers, each collaboratively conducting a multidisciplinary Clinical Trials Program supported via an infrastructure of an Administrative and Coordinating Core, a Data Management and Statistical Core, and a Central Laboratory Core.

ULACNet investigators collaborate with the NCI to design and conduct clinical trials on three key scientific areas across the continuum of prevention interventions for HPV-related cancers in people living with HIV, including:

  • optimizing dosing and delivery and evaluating new indications for HPV prophylactic vaccines
  • evaluating new biomarkers and technologies for improving the accuracy of cervical and anogenital cancer screening and triage
  • evaluating novel non-excisional treatments for HPV-related precancerous lesions

Outcomes of ULACNet clinical trials are expected to influence the development of clinical practice guidelines to improve preventive clinical care and reduce the burden of highly preventable HPV-related cancers in people living with HIV.

The three ULACNet Partnership Centers include the following collaborations between institutions in the United States and partners in Mexico, Puerto Rico, Brazil, Peru, and the Dominican Republic:

  • University of California, San Francisco (UCSF) in San Francisco, CA (PI: Joel Palefsky, MD) in partnership with University of Puerto Rico in San Juan, Puerto Rico (PI: Anna Patricia Ortiz, PhD, MPH) and National Institute of Public Health (INSP) in Cuernavaca, Morelos, Mexico (PI: Jorge Salmeron, MD, DSc)
  • Weill Medical College of Cornell University in New York, NY (PI: Timothy Wilkin, MD, MS) in partnership with Moffitt Cancer Center, in Tampa, FL (PI: Anna Giuliano, PhD, MPH), University of Sao Paulo in Sao Paulo, Brazil (PI: Luisa Villa, PhD), National Institute of Public Health (INSP) in Cuernavaca, Morelos, Mexico (PI: Eduardo Lazcano-Ponce, MD, PhD), and the University of Puerto Rico in San Juan, Puerto Rico (PI: Jorge Santana-Bagur, MD)
  • Fred Hutchinson Cancer Research Center in Seattle, WA (PIs: Margaret Madeleine, PhD, MPH, and Ann Duerr, MD, PhD) in partnership with Asociacion Civil Via Libre in Lima, Peru (PI: Robinson Cabello, MD), National Institute of Infectious Diseases Evandro Chagas-Oswaldo Cruz Foundation (FIOCRUZ) in Rio de Janeiro, Brazil (PI: Beatriz Grinsztejn, MD, PhD), PATH in Seattle, WA (PI: Silvia de Sanjose, MD, PhD), and Instituto Dermatologico Dominicano y Cirugia de Piel (IDCP) in Santo Domingo, Dominican Republic (PI: Yeycy Donastorg, MD).

For more information about this important clinical trial, please contact the ULACNet Program Director is Vikrant Sahasrabuddhe, MBBS, DrPH in the NCI Division of Cancer Prevention.

References:
US-Latin American-Caribbean Clinical Trials Network (ULACNet) for Prevention of HPV-related Cancers in People Living with HIV
HPV Vaccine May Provide Men with “Herd Immunity” against Oral HPV Infections
HPV Vaccination Linked to Decreased Oral HPV Infections
HPV-Related Cancer Prevention and Control Programs at Community-Based HIV/AIDS Service Organizations: Implications for Future

October, 2019|Oral Cancer News|

HPV ‘Herd Immunity’ Is on the Rise Among Adults

Source: www.webmd.com
Author: Dennis Thompson, HealthDay Reporter

The United States could be approaching a state of herd immunity against human papillomavirus (HPV), a virus linked to several cancers.

Oral HPV infections declined by 37% among unvaccinated 18- to 59-year-old men between 2009 and 2016, according to a Sept. 10 report in the Journal of the American Medical Association.

That included a decline in infections of HPV16, the strain found in more than 9 out of 10 cases of head and neck cancer related to the virus, said senior researcher Dr. Maura Gillison, a professor of medicine at MD Anderson Cancer Center in Houston.

Researchers say men are benefitting from increased HPV vaccination rates among American women, who receive the vaccine to prevent virus-caused cervical cancer.

“In contrast to cervical cancers, we have no means by which to screen for HPV-positive head and neck cancers,” Gillison said. “The vaccine is our best hope for prevention.”

HPV vaccination has been recommended for girls since 2006 and for boys since 2011. The virus has been linked to cancers of the cervix, penis, anus, mouth and throat.

Vaccination rates among boys and girls are steadily rising, according to the U.S. Centers for Disease Control and Prevention.

About half of teens were up to date on the HPV vaccine in 2017, and two-thirds of 13- to 17-year-olds had received the first dose to start the series. On average, the percentage of teens who started the HPV vaccine series rose by 5 percentage points each year between 2013 and 2017, the CDC says.

“At least 75% vaccine coverage of boys and girls would be necessary to eradicate HPV16, the HPV type that is most likely to lead to cancer development,” Gillison said.

But vaccination rates have lagged among males.

To see if males are receiving some protection from greater HVP vaccination among females, Gillison and her colleagues reviewed U.S. federal health survey data gathered between 2009 and 2016.

They found that by 2016, about 15% of women and 6% of men had received the vaccine.

Despite lower vaccination rates among males, oral HPV infections declined from 2.7% to 1.6% in men between 2009 and 2016.

Interestingly, prevention of oral HPV infections and the head and neck cancers they cause is not listed as a reason to get the vaccine, Gillison said. No clinical trials have been undertaken to show that the HPV vaccine could prevent such cancers.

The decrease in HPV infections among the unvaccinated men is consistent with a decline in genital HPV infections among unvaccinated women between 2004 and 2014, the researchers noted.

“This study demonstrates that even with suboptimal uptake of the HPV vaccine, important gains are being made in herd immunity against oral HPV types included in the vaccine,” said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security in Baltimore. He was not involved with the study.

“Oral HPV infection is a major factor in the development of head and neck cancer, and this vaccine has the potential to be game-changing as more individuals are vaccinated,” Adalja said.

HPV-positive head and neck cancers are the most rapidly rising cancers in the United States among men under age 60, Gillison said.

She called on doctors to use the data from this and other studies to promote HPV vaccination.

“I can guarantee that all of my patients diagnosed with HPV-positive head and neck cancer would exchange two or three shots for three months of toxic cancer therapy in a heartbeat,” she said.

“The HPV vaccine, together with the hepatitis B vaccine, are the two most important advances in the history of cancer prevention, period,” Gillison concluded.

September, 2019|Oral Cancer News|

Which HPV vaccination schedule is best: 1, 2 or 3 doses?

Source: www.precisionvaccinations.com
Author: Don Ward Hackett

A new cervical cancer prevention study of women first offered Human Papillomavirus (HPV) vaccine found that 1-dose of quadrivalent HPV vaccine was as effective as 3-doses at preventing histologically confirmed, high–grade cervical lesions.

This Australian study’s finding published online on July 15, 2019, supports the hypothesis that the 1-dose HPV vaccination schedule may be a viable strategy when working towards the global elimination of cervical cancer.

These researchers said ‘If one dose could prevent precancerous cervical lesions, then global cervical cancer prevention would be greatly facilitated.’

This is an important goal since about 90 percent of cervical cancer cases are caused by HPV. This study included 250,648 women in Australia with 19.5 percent unvaccinated, 69.8 percent had received 3-doses, 7.3 percent 2-doses, and 3.4 percent just 1-dose of the HPV vaccine.

This study’s limitations include some degree of under–linkage and inaccurate data linkage because Australia does not have a unique national identifier, which impacts the classifications of vaccinated women as unvaccinated.

Additionally, these researchers said ‘we believe that these data support decision-makers to consider how a 1-dose HPV vaccination schedule, or a planned schedule with a 3–5 year interval between doses, could reduce vaccine demand globally, which currently exceeds vaccine supply.’

But the Gardasil 9 vaccine manufacturer appears to be resolving this supply/demand imbalance. During July 2019, Merck said it is spending $1.68 billion, opening 2 new Gardasil production plants, and adding 525 related jobs.

To clarify the Gardasil 9 vaccine dosing schedule, the Centers for Disease Control and Prevention (CDC) publish the following information:

Who should still receive a 3-dose schedule?
The CDC continues to recommend a 3-dose schedule for persons starting the HPV vaccination series on or after the 15th birthday, and for persons with certain immunocompromising conditions. The 2nd vaccine dose should be given 1–2 months after the 1st dose, and the 3rd dose, should be given 6 months after the first dose.

Who should receive just 2-doses?
Two doses of the HPV vaccine are recommended for all boys and girls at ages 11-12; the vaccine can be given as early as age 9. If you wait until they’re older, they may need three doses instead of two.

In the USA, HPV vaccines have been licensed for use among women since 2006 and among men since 2010.

HPV infections are so common that nearly all men and women will get at least one type of HPV at some point in their lives. Nearly 80 million Americans are currently infected with some type of HPV, says the CDC. About 14 million Americans, including teens, become infected each year. HPV is spread through intimate skin-to-skin contact. You can get HPV by having vaginal, anal, or oral sex with someone who has the virus.

Cervical cancer is the only type of HPV cancer with a recommended screening test. The other types of HPV cancer may not be detected until they cause health problems. HPV vaccination helps prevent these cancers by preventing infections that cause these cancers, says the CDC. HPV vaccines, like any medicine, can cause side effects, which you are encouraged to report to the CDC or a healthcare provider.

August, 2019|Oral Cancer News|

Updated HPV vaccine recommendations follow big HPV infection drops shown in new study

Source: www.forbes.com
Author: Tara Haelle

A vial of the human papillomavirus (HPV) vaccine Gardasil. (AP Photo/Charles Rex Arbogast)

Adults up to age 45 are now recommended to discuss with their doctors getting the human papillomavirus (HPV) vaccine, which prevents 3% of all cancer in women and 2% of all cancer in men—an estimated 34,000 cancers a year in the U.S. Following confirmation from the director of the Centers for Disease Control and Prevention (CDC), the recommendations also extend the age in men from age 21 to age 26, the same as in women.

The decision from the CDC’s Advisory Committee on Immunization Practices (ACIP) July 26 came the same day The Lancet published the largest study to date on the vaccine’s effectiveness. The meta-analysis of 65 studies found drops of 31%-83% of HPV infections and genital warts in men and women, depending on age and diagnosis.

HPV is responsible for nearly all cervical cancer, over 90% of anal cancer, 70% of oral, throat and neck cancers and over 60% of penile cancer. Though HPV is primarily transmitted through sexual contact, non-sexual transmission occurs as well.

Previously, the HPV vaccine had been recommended for females and males in a series of two doses up to age 14 or three doses up to age 26 in women and age 21 in men. Men ages 22-26 could also get the vaccine.

ACIP’s unanimous vote to extend the recommendation to age 26 in men corresponds to evidence showing the vaccine’s substantial benefits for men. In fact, research shows men to be up to six times more likely than women to develop an oral infection with the highest risk strain of HPV.

ACIP’s 10-4 vote regarding adults ages 27-45 who haven’t received the HPV vaccine emphasizes shared decision-making with their providers. The HPV vaccine is not licensed by the FDA for adults older than 45 since data on its effectiveness does not exist for this age group.

The “decision from ACIP emphasizes what the data has shown—that the HPV vaccine is safe and effective for use in patients ages 27 to 45, and that use of the vaccine in this age group should be the result of shared decision-making between patients and their trusted physicians,” Christopher M. Zahn, M.D., vice president of Practice Activities at the American College of Obstetricians and Gynecologists (ACOG) said in a statement.

“Obstetrician-gynecologists are encouraged to discuss with their patients ages 27 to 45 the potential benefits of HPV vaccination, addressing the reduced efficacy compared to vaccination within the younger target age range as well as the reduced risk of high-grade disease and cervical cancer,” Zahn said, adding getting the vaccine at the recommended age of 11-12 years offers the most benefit.

“Women’s decisions will also likely consider their individual circumstances, preferences, and concerns, and the role of the obstetrician-gynecologist is to provide unbiased information in a balanced, thorough way in order to aid that decision-making,” he said.

New research finds big drops in HPV-related infections

The new study found that HPV infections with strains 16 and 18 dropped 83% among girls ages 13-19 and by 66% among women ages 20-24 up to eight years after vaccination.

The HPV 16 and 18 strains in Gardasil cause 70 percent of all cervical, vaginal, vulvar and anal cancers. Gardasil 9 also protects against HPV 6 and 11, which cause 90% of genital warts, and against five other strains (31, 33, 45, 52, and 58). Together, the strains in Gardasil 9 represent 90% of HPV-related cancers.

HPV infections caused by HPV 21, 33 and 45 cut in half (54%) among vaccinated girls ages 15-19, according to the new research. Similarly, genital warts diagnoses fell by 67% in these girls and by 48% in boys of the same age. Older men (up to 24) and women (up to 29) also saw declines in genital warts by 31%-54%.

Rates of grade 2 cervical neoplasia, a precursor to cancer, also dropped by half (51%) in screened girls 15-19 and by 31% in women 20-24 years.

Cervical cancer can take up to 20 years to develop, so the vaccine, first approved in 2006, has not been available long enough for a sizable evidence base showing a reduction in cancer incidence. Dramatic declines in HPV infection rates, however, are expected to translate to similar declines in HPV-caused cancer rates, and immunity from the vaccine is long-lasting.

Multiple large reviews of the HPV vaccine have found it to be among the safest vaccines available. While the actual shot itself can be particularly painful, the only regularly reported side effects are pain, redness and soreness at the injection site and, in some teens, temporary fainting, which is common with many vaccines in adolescents. Among 13,000 people in the clinical trials for Gardasil 9, five people also reported fever, allergy to the vaccine, asthmatic crisis, headache and tonsillitis, though not all of these were determined to be caused by the vaccine.

The most effective way to reduce cervical cancer has been and remains regular screenings. However, screenings only detect early development of abnormal tissue that could become cancerous whereas the HPV vaccine prevents the viral infections that leads to those tissue abnormalities in the first place.

Since there is no current way to screen for throat/mouth/neck or anal cancer in women or men (or penile cancer in men), the HPV vaccine remains the only way to prevent those cancers.

Cancer ‘vaccine’ shown to be effective in small trial

Source: www.upi.com
Author: Dennis Thompson, HealthDay News

A new method of brewing a cancer vaccine inside a patient’s tumor could harness the power of the immune system to destroy the disease, researchers report.

Immune stimulants are injected directly into a tumor, which teaches the immune system to recognize and destroy all similar cancer cells throughout the body, said senior researcher Dr. Joshua Brody. He is director of the Lymphoma Immunotherapy Program at the Icahn School of Medicine at Mount Sinai in New York City.

“We’re injecting two immune stimulants right into one single tumor,” Brody said. “We inject one tumor and we see all of the other tumors just melt away.”

Eight out of 11 lymphoma patients in a small, early clinical trial experienced partial or complete destruction of the tumor that received the initial injection, according to the report published April 8 in the journal Nature Medicine.

The vaccine also halted overall cancer progression in six patients for three to 18 months, and caused significant regression or actual remission in three patients, the investigators found.

The results were solid enough that the research team is expanding its next clinical trial to include lymphoma, breast, and head and neck cancer patients, Brody said. That trial started in March.

Prior efforts at unleashing the immune system to fight cancer have focused on T-cells, which Brody calls the “soldiers” of the immune army because they directly attack harmful invaders in the body.

Drugs called checkpoint inhibitors help T-cells identify cancer cells as the bad guys and kill them off.

“We call them the ‘Jimmy Carter’ medicines because that’s what Jimmy got when he had very advanced-stage melanoma,” Brody said.

But the checkpoint inhibitors have typically only been able to help about one in five cancer patients significantly, “so there’s lots of room for improvement,” he added.

This new vaccine approach focuses on dendritic cells, which Brody calls the “generals” of the immune system’s army. Dendritic cells guide the response of T-cells to fight off invaders.

“We’re trying to mobilize these immune generals to tell the soldiers what to do,” Brody said.

Patients first received nine daily injections of an immune stimulant intended to “recruit” dendritic cells by teaching them how to recognize cancerous cells, the study authors said.

The patients then received eight injections of a second stimulant that “activates” the dendritic cells, prompting them to instruct T-cells to hunt and destroy the now revealed cancer cells in the body.

Essentially, the method turns the injected tumor into a cancer vaccine factory, the researchers explained.

The approach differs from traditional vaccines for the flu or measles because those are preventive, teaching the body beforehand how to fight off an infectious disease, Brody pointed out.

This vaccine is therapeutic. “We’re trying to teach the immune system to get rid of the thing even after you’ve already got the problem,” he said.

Lab tests involving mice show that this vaccine approach could be at least three times more powerful if combined with checkpoint inhibitors, Brody added.

Because of this, patients in the new trial will receive both the vaccine and checkpoint inhibitors, the researchers said.

Susanna Greer, scientific director of clinical cancer research and immunology for the American Cancer Society, said that “priming” dendritic cells inside a person’s tumor to produce the best anti-tumor immune response “suggests a promising immunotherapy strategy.”

“Additional human studies are warranted to confirm these findings,” Greer said.

Dr. Catherine Diefenbach, director of clinical lymphoma at the NYU Langone Perlmutter Cancer Center in New York City, said the vaccine approach is “novel and extremely interesting,” and could help explain why checkpoint inhibitors usually don’t help patients with non-Hodgkin lymphoma.

However, she noted that really only three of the 11 patients in the initial clinical trial had truly meaningful responses to the vaccine.

“These are indolent lymphoma patients,” said Diefenbach, an expert for the American Society of Clinical Oncology. “The fact there was stable disease doesn’t really mean anything because these cancers don’t grow fast.”

April, 2019|Oral Cancer News|

HPV discovery raises hope for new cervical cancer treatments

Source: www.eurekalert.org
Author: press release – University of Virginia Health Syste

Researchers at the University of Virginia School of Medicine have made a discovery about human papillomavirus (HPV) that could lead to new treatments for cervical cancer and other cancers caused by the virus.

HPV is responsible for nearly all cases of cervical cancer and 95 percent of anal cancers. It is the most common sexually transmitted disease, infecting more than 79 million Americans. Most have no idea that are infected or that they could be spreading it.

“Human papillomavirus causes a lot of cancers. Literally thousands upon thousands of people get cervical cancer and die from it all over the world. Cancers of the mouth and anal cancers are also caused by human papillomaviruses,” said UVA researcher Anindya Dutta, PhD, of the UVA Cancer Center. “Now there’s a vaccine for HPV, so we’re hopeful the incidences will decrease. But that vaccine is not available all around the world, and because of religious sensitivity, not everybody is taking it. The vaccine is expensive, so I think the human papillomavirus cancers are here to stay. They’re not going to disappear. So we need new therapies.”

HPV and Cancer
HPV has been a stubborn foe for scientists, even though researchers have a solid grasp of how it causes cancer: by producing proteins that shut down healthy cells’ natural ability to prevent tumors. Blocking one of those proteins, called oncoprotein E6, seemed like an obvious solution, but decades of attempts to do so have proved unsuccessful.

Dutta and his colleagues, however, have found a new way forward. They have determined that the virus takes the help of a protein present in our cells, an enzyme called USP46, which becomes essential for HPV-induced tumor formation and growth. And USP46 enzyme promises to be very susceptible to drugs. Dutta calls it “eminently druggable.”

“It’s an enzyme, and because it’s an enzyme, it has a small pocket essential for its activity, and because drug companies are very good at producing small chemicals that will jam that pocket and make enzymes like USP46 inactive,” said Dutta, chairman of UVA’s Department of Biochemistry and Molecular Genetics. “So we are very excited by this possibility that by inactivating USP46 we’ll have a way to treat HPV-caused cancers.”

Curiously, HPV uses USP46 for an activity that is opposite to what the oncoprotein E6 was known to do. E6 has been known for more than two decades to recruit another cellular enzyme to degrade the cell’s tumor suppressor, while Dutta’s new finding shows that E6 uses USP46 to stabilize other cellular proteins and prevent them from being degraded. Both activities of E6 are critical to the growth of cancer.

The researchers note that enzyme USP46 is specific to HPV strains that cause cancer. It is not used by other strains of HPV that do not cause cancer, they report.

Notes:
(1) The researchers have published their findings in the scientific journal Molecular Cell. The team included Shashi Kiran, Ashraf Dar, Samarendra K. Singh, Kyung Yong Lee and Dutta. All are from UVA’s Department of Biochemistry and Molecular Genetics.

(2)The work was supported by the National Institutes of Health, grant R01 GM084465.

December, 2018|Oral Cancer News|