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HPV vaccination programme - What about boys?

The Mouth Cancer Foundation, while welcoming the government’s introduction of a human papilloma virus (HPV) immunisation programme for girls aged 12 - 13 years of age against cervical cancer, is concerned that boys are not being vaccinated.

This decision follows the advice of the Joint Committee on Vaccination and Immunisation (JCVI) which, based on a detailed review of evidence surrounding HPV vaccination, did not consider it to be cost-effective in preventing cervical cancer.

But according to an article recently published in the British Journal of Cancer, researchers from Finland using mathematical models of human papillomavirus (HPV) type 16 virus infection to determine the optimal age to vaccinate individuals as well as different approaches to introducing the vaccine into the general population concluded that:
  • Vaccination generates the greatest long-term benefit when administered prior to the first sexual contact.
  • Vaccination of males as well as females has a greater impact when administered at an early age.
While males cannot get HPV-linked cervical cancer, they make up half of the equation when it comes to spreading the sexually transmitted virus. This is a viral infectious process, and the majority of the time it is passed through heterosexual contact. Men can pass on the virus to their sexual partners, so it makes sense to vaccinate boys against HPV, and it would also protect them from throat cancer as the virus is also a leading cause of throat cancer, which affects both sexes.

The MCF is concerned that the JCVI may not have given due consideration to the vaccine's cost-effectiveness in preventing anal and throat cancers, plus genital warts, among boys.

Recent mounting evidence is confirming that infection with HPV via oral sex is by far the leading cause of throat cancer. This threat of throat cancer is especially troubling because doctors traditionally only look for these malignancies in long-time smokers and drinkers. And while girls and women typically see a gynecologist for their Pap smear to look for cervical cancer, not many boys and men are going to go to a doctor and ask them to look at their throat.

Historically, at least 25% of those diagnosed with mouth cancers are non-smokers. The other 75% of those diagnosed have used tobacco in some form during their lifetimes. But today the research into the relationship of HPV and mouth cancers gives us clues as to the origin of cancer in those 25% of diagnosed individuals who did not smoke, and also into changing behaviors both in tobacco use and sexual practices. The age standardised incidence of oral cancer in British males stayed at around 7 per 100,000 males between 1975 and 1989, but since then, the rate has steadily increased to reach 9.8 per 100,000 in 2004, an increase of 40% since 1989. While female oral cancer rates have remained significantly lower than male rates, their incidence trends have been similar with an average increase of 2.5% each year since 1989.

Given the decline of tobacco use over the last ten years, (the historic primary cause of the disease) and the increasing rate of incidence of oral cancers, particularly those of the posterior mouth, it is likely that the ‘75% – 25%’ statement which has been made by everyone is no longer an accurate representation of the situation. There have been large increases in the incidence of oral cancer diagnosed in men in their 40s and 50s whose rates have doubled from 3.6 to 8.8 per 100,000 for men aged 40-49 and from 11.5 to 24.9 for men aged 50-59. These rising trends of oral cancer in young and middle-aged men, particularly of cancer of the tongue, have also been reported in other European countries and the USA. This increase in a cancer that is often difficult to treat and sometimes debilitating and disfiguring, is alarming.

In general it appears that HPV positive tumors occur most frequently in a younger group of individuals than tobacco related malignancies. They also occur more in white males, and in non smokers. The rising incidence and mortality rates in young and middle-aged adults is incontrovertible. There has been debate over the causes of this increase but in recent years, there has been mounting epidemiologic and experimental evidence of a role for human papillomavirus (HPV) as the etiologic agent of a subset of head and neck cancers. The association is strongest for oropharyngeal cancers, especially those of the tonsil. The HPV group is the fastest growing segment of the oral cancer population.

The Oral Cancer Foundation (our sister organisation in the U.S.) strongly believe that in a younger population of non smoking mouth cancer patients, that HPV will present itself as the dominant causative factor. We both believe that since the historic definition of those who need to be screened is now changed by this newly defined HPV etiology, and no longer valid, it is NOT POSSIBLE to definitively know who is at risk for the development of the disease, and who is not. Simply stated, today ANYONE OLD ENOUGH TO HAVE ENGAGED IN SEXUAL BEHAVIOURS WHICH ARE CAPABLE OF TRANSFERING THIS VERY UBIQUITOUS VIRUS ARE AT RISK. For this reason we are concerned that boys are not being vaccinated.

It is hoped that the new cervical cancer vaccines approved for use in pre sexual individuals for the prevention of cervical cancer being developed and marketed by Merck and GlaxoSmithKline, will have a positive collateral impact in the world of head and neck / mouth cancers in the next couple of decades, as these young, vaccinated individuals do not develop HPV related malignancies in sites far removed from the cervix.

The Mouth Cancer Foundation is a strong supporter of the use of the vaccines, and encourages their use in young males as well as females in the U.K.

References:

Question:
Should girls be vaccinated?

Choices:
Yes
No

Question:
Should boys be vaccinated?

Choices:
Yes
No

 


Disclaimer: Please see your own dentist/doctor for a proper diagnosis as my words should not, in any circumstances, be taken as dental/medical advice.

"If you see what is small as it sees itself, and accept what is weak for what strength it has, and use what is dim for the light it gives, then all will go well. This is called Acting Naturally."
Lao-Tsu, Tao Teh King
 
Posts: 3893 | Location: St Luke's Hospital, Bradford and Pinderfields Hospital, Wakefield | Registered: 14 December 2002Reply With QuoteReport This Post
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Edited to allow addition of new link to replace dead link above for: government’s introduction of a human papilloma virus (HPV) immunisation programme for girls aged 12 - 13 years of age against cervical cancer
------------------------------------------------
The Mouth Cancer Foundation and NALC have started a petition to the Prime Minister to widen the planned HPV vaccination programme to include both sexes.

Please support it by going the HPV petition site. To sign the petition, you will need to give your name, address and email on the form provided. Once you have signed the petition, you will receive an email asking you to confirm that you wish to add your name to the petition by clicking a link. Once you have done this, your name will be added to the petition.

Thank you for your support.

Best wishes

Vinod

--
Dr Vinod K Joshi
Founder & Chief Executive
Mouth Cancer Foundation

This message has been edited. Last edited by: Dr Vinod K Joshi,


Disclaimer: Please see your own dentist/doctor for a proper diagnosis as my words should not, in any circumstances, be taken as dental/medical advice.

"If you see what is small as it sees itself, and accept what is weak for what strength it has, and use what is dim for the light it gives, then all will go well. This is called Acting Naturally."
Lao-Tsu, Tao Teh King
 
Posts: 3893 | Location: St Luke's Hospital, Bradford and Pinderfields Hospital, Wakefield | Registered: 14 December 2002Reply With QuoteReport This Post
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I thought that in one of the articles I had read the trials had only been carried out for girls. Does anybody know if the vaccine has had its safety testing completed for girls and boys?

Jenni
 
Posts: 248 | Location: Perranporth, Cornwall | Registered: 13 October 2006Reply With QuoteReport This Post
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Drinking And Smoking Don't Boost HPV-related Cancer Risk


quote:
New Brown University research, however, shows that alcohol and tobacco use doesn’t further increase the risk of contracting head and neck cancers for people infected with HPV16. This finding, published in the Journal of the National Cancer Institute, is the strongest evidence to date that these major cancers have two distinct causes — and may represent two distinct classes of cancer — and would require different prevention and treatment strategies.

Karl Kelsey, M.D., a Brown professor of community health and pathology and laboratory medicine and the director of the Center for Environmental Health and Technology, said the research has public health policy implications.

While the Centers for Disease Control and Prevention recommends that girls and young women receive the HPV vaccine to prevent cervical cancer — HPV16 causes about half of all cervical cancer cases — boys and men cannot get the vaccine. An estimated 20 million Americans are currently infected with genital HPV and 50 to 75 percent of sexually active men and women are infected with HPV at some point in their lives, according to the National Institutes of Health.

“Our current HPV vaccine recommendations should change,” Kelsey said. “Head and neck cancers, regardless of their cause, are predominantly male diseases. If boys and men received the HPV vaccine, a lot of these cancers could be prevented.”


Ref: Brown University (2007, November 27). Drinking And Smoking Don't Boost HPV-related Cancer Risk. ScienceDaily. Retrieved November 28, 2007, from http://www.sciencedaily.com/releases/2007/11/071127164933.htm


Disclaimer: Please see your own dentist/doctor for a proper diagnosis as my words should not, in any circumstances, be taken as dental/medical advice.

"If you see what is small as it sees itself, and accept what is weak for what strength it has, and use what is dim for the light it gives, then all will go well. This is called Acting Naturally."
Lao-Tsu, Tao Teh King
 
Posts: 3893 | Location: St Luke's Hospital, Bradford and Pinderfields Hospital, Wakefield | Registered: 14 December 2002Reply With QuoteReport This Post
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The full text PDF is freely available from the link immediately below:

Lack of Association of Alcohol and Tobacco with HPV16-Associated Head and Neck Cancer

Journal of the National Cancer Institute
Advance Access published online on November 27, 2007

Katie M. Applebaum, C. Sloane Furniss, Ariana Zeka, Marshall R. Posner, Judith F. Smith, Janine Bryan, Ellen A. Eisen, Edward S. Peters, Michael D. McClean, Karl T. Kelsey


Disclaimer: Please see your own dentist/doctor for a proper diagnosis as my words should not, in any circumstances, be taken as dental/medical advice.

"If you see what is small as it sees itself, and accept what is weak for what strength it has, and use what is dim for the light it gives, then all will go well. This is called Acting Naturally."
Lao-Tsu, Tao Teh King
 
Posts: 3893 | Location: St Luke's Hospital, Bradford and Pinderfields Hospital, Wakefield | Registered: 14 December 2002Reply With QuoteReport This Post
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HPV also blamed for oral cancer in men


BEIJING, Feb. 2 (Xinhuanet)--
quote:
Human papillomavirus, or HPV, the leading cause of cervical cancer in women, is also a major cause of oral cancer in men, according to a new study in the United States reported by media Saturday.

The sexually transmitted virus causing cancers of the mouth and upper throat is probably the result of an increase in oral sex and the decline in smoking, the study said.

The new study looked at more than 30 years of National Cancer Institute data on oral cancers. Researchers categorized about 46,000 cases, using a formula to divide them into those caused by HPV and those not connected to the virus.

They concluded the incidence rates for HPV-related oral cancers rose steadily in men from 1973 to 2004, becoming about as common as those from tobacco and alcohol.

However, the only available vaccine against HPV, made by Merck & Co. Inc., is currently given only to girls and young women.

Now Merck plans this year to ask government permission to offer the shot to boys.

In related research, Penn State University scientists reported that cigarette smoke may aggravate HPV and raise the risk of cervical cancer.

The HPV is the fastest growing sexually transmitted disease in the nation. Cervical cancer is a leading cause of cancer-related death in women in developing countries.

According to the American Cancer Society, it was estimated that 11,150 new cases and 3,670 deaths would be reported in the U.S. from cervical cancer in 2007.


Disclaimer: Please see your own dentist/doctor for a proper diagnosis as my words should not, in any circumstances, be taken as dental/medical advice.

"If you see what is small as it sees itself, and accept what is weak for what strength it has, and use what is dim for the light it gives, then all will go well. This is called Acting Naturally."
Lao-Tsu, Tao Teh King
 
Posts: 3893 | Location: St Luke's Hospital, Bradford and Pinderfields Hospital, Wakefield | Registered: 14 December 2002Reply With QuoteReport This Post
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Hmmm, So that's what caused it.
 
Posts: 582 | Location: Congleton, Cheshire | Registered: 29 March 2007Reply With QuoteReport This Post
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Going Down


Disclaimer: Please see your own dentist/doctor for a proper diagnosis as my words should not, in any circumstances, be taken as dental/medical advice.

"If you see what is small as it sees itself, and accept what is weak for what strength it has, and use what is dim for the light it gives, then all will go well. This is called Acting Naturally."
Lao-Tsu, Tao Teh King
 
Posts: 3893 | Location: St Luke's Hospital, Bradford and Pinderfields Hospital, Wakefield | Registered: 14 December 2002Reply With QuoteReport This Post
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Is it advisable / possible for the partner and (adult, sexually active) children of a (non-smoking & hardly drinking)relatively young oral cancer sufferer to get themselves checked out / vaccinated against HPV?
 
Posts: 16 | Location: N Staffs | Registered: 06 November 2006Reply With QuoteReport This Post
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Hello Joy

Yes it is possible to be tested for HPV. See:HPV Test.

The current vaccines,Gardasil and Cervarix, are preventative (rather than therapeutic) vaccines and so recommended for women who are 9 to 25 years old and have not contracted HPV. There is work being done on developing therapeutic vaccines but nothing to report yet.

Hope that helps.

Best wishes
Vinod Coffee


Disclaimer: Please see your own dentist/doctor for a proper diagnosis as my words should not, in any circumstances, be taken as dental/medical advice.

"If you see what is small as it sees itself, and accept what is weak for what strength it has, and use what is dim for the light it gives, then all will go well. This is called Acting Naturally."
Lao-Tsu, Tao Teh King
 
Posts: 3893 | Location: St Luke's Hospital, Bradford and Pinderfields Hospital, Wakefield | Registered: 14 December 2002Reply With QuoteReport This Post
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Oral sex a factor in oral cancer increase
3rd March 2008
quote:
The cases of oral cancer caused by a virus transmitted during oral sex appear to have increased drastically over the last 30 years, according to a study by US researchers.

The number of tongue, mouth and throat cancers due to the sexually transmitted human papilloma virus (HPV), which can also cause cervical cancer in women, rose by about a third from 1973 to 2004, say researchers.

The team – led by Maura Gillison at Johns Hopkins University in Baltimore, Maryland, US – studied trends in oral cancers recorded by US National Cancer Institute registries.

Earlier work had established a link between certain strains of the common sexually transmitted virus and oral cancer.

The latest study, which looked at nearly 46,000 cases, is the first to quantify an increase in mouth and throat cancers due to sexual activity.

‘What we do know is that the prevalence of HPV is high, particularly among young people and this shouldn't be a surprise given that, since the sexual revolution, people have been having more sexual partners,' a New Scientist article quoted Lesley Walker, director of cancer information at Cancer Research UK.

The rise was largest among young white males, suggesting this group is more likely to have oral sex at a younger age now than it was 20 years ago, says Gillison's team.

Although, oral cancers linked to HPV infection have risen, the study notes the incidence of oral cancers in parts of the mouth or throat not linked to HPV infection remained constant until 1982, and then started to decline.

Gillison called for a need to consider giving boys the HPV vaccine, to protect them from the disease.

A Merck vaccine is presently licensed for use in young women and girls to protect them against the most common cervical cancer-causing strains of HPV.

‘We need to start having a discussion about those cancers other than cervical cancer that may be affected in a positive way by the vaccine,' Gillison said.

The study is published in the journal of Clinical Oncology.

The Mouth Cancer Foundation and NALC have started a petition to the Prime Minister to widen the planned HPV vaccination programme to include both sexes.

Please support it by going the HPV petition site. To sign the petition, you will need to give your name, address and email on the form provided. Once you have signed the petition, you will receive an email asking you to confirm that you wish to add your name to the petition by clicking a link. Once you have done this, your name will be added to the petition.

Thank you for your support.

This message has been edited. Last edited by: Dr Vinod K Joshi,


Disclaimer: Please see your own dentist/doctor for a proper diagnosis as my words should not, in any circumstances, be taken as dental/medical advice.

"If you see what is small as it sees itself, and accept what is weak for what strength it has, and use what is dim for the light it gives, then all will go well. This is called Acting Naturally."
Lao-Tsu, Tao Teh King
 
Posts: 3893 | Location: St Luke's Hospital, Bradford and Pinderfields Hospital, Wakefield | Registered: 14 December 2002Reply With QuoteReport This Post
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Hi Dr Joshi
We have had the cervical cancer vaccinations for young girls free of charge to girls from about the age of 13 (I think ~ doesn't affect me so I don't know the age range for sure) for about 12 months (I think ~ again, it's been one hell of a year so not too sure).
Just this last week there has been television reports about adverse effects of Gardasil. I didn't pay too much attention to the programme other than to notice one woman in particular filmed having seizures which were attributed to the drug.
There are always those opposed to any vaccination, I know but hope those responsible are able to get the figures out into the public about the ratios of those who have had reactions and those who have not, weighing up the risks vs benefits etc. If males are going to benefit as well, I hope it is made available to them.
Mind you, I suspect there would not be the general support in the community if the vaccine is promoted as offering protection from a condition (as bad as it may be), associated with oral sex. That would cause a lot of heads to become firmly ensconsed in the sand I suspect.
Cheers
Deborah
 
Posts: 743 | Location: Willaston, South Australia, Australia | Registered: 09 July 2007Reply With QuoteReport This Post
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Dr. Joshi,

I am very interested in this, as I have 3 boys and I have head and neck cancer. I have been preaching to everyone to have the HPV injection even if you are over 25. To not have it is just insane. Anything to protect yourself against this awful cancer. But my question is this, I am in the US and was wondering if you know where I can go to see about boys getting vaccinated here in the states.

Leann
 
Posts: 64 | Location: Aiken SC, USA | Registered: 19 August 2006Reply With QuoteReport This Post
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Finally, there seems to be some coverage on this topic. It's a start. This is from today's New York Times (May 13, 2008).

"Oral Cancer in Men Associated With HPV"

Here's link, that I hope will work:
http://www.nytimes.com/2008/05/13/health/13canc.html?ex...ink&exprod=permalink

(If I should just embed the text, please let me know.)

Susan
 
Posts: 32 | Location: USA | Registered: 10 January 2008Reply With QuoteReport This Post
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From Medscape Medical News, 14/07/2009
quote:
Final Analysis Shows HPV Vaccine Is Effective and Safe
by Roxanne Nelson

July 14, 2009 — The final results of a large phase 3 trial have confirmed that a bivalent vaccine is highly effective at protecting against human papillomavirus (HPV) types 16 and 18. Licensed under the name Cervarix and manufactured by GlaxoSmithKline, the vaccine was effective at providing protection against cervical intraepithelial neoplasia grade 2+ (CIN2+) lesions associated with HPV-16 and HPV-18, as well as lesions that were associated with nonvaccine types HPV-31, HPV-33, and HPV-45.

These 5 HPV types are responsible for about 82% of all cervical cancers, researchers say, in a report published online July 7 in the Lancet.

This is 1 of 2 vaccines against HPV that are now commercially available, the other being Gardasil (Merck). At present, only Gardasil is marketed in the United States, while Cervarix is awaiting approval there. But both vaccines are marketed in many other countries worldwide, including most of Europe.

The 2 vaccines also differ in the range of HPV subtypes they target — Cervarix is active against HPV 16 and 18, while Gardasil is active against HPV 6, 11, 16, and 18.

But even though both HPV vaccines appear to be effective at reducing precancerous lesions and have the potential to substantially reduce the incidence of cervical cancer, current approaches are too limited, argue the authors of an accompanying editorial.

Cannot Be Limited to Women

The only efficient way to control the spread of HPV is to "vaccinate the other half of the sexually active population: boys and men," write the editorialists, Karin Michels, PhD, from Harvard Medical School, in Boston, Massachusetts, and Harald zur Hausen, DSc, MD, from the German Cancer Research Center, in Heidelberg, Germany. Dr. zur Hausen was awarded the 2008 Nobel Prize in Physiology or Medicine for his discovery of human papilloma viruses causing cervical cancer.

The primary public-health goal of immunization programs is to halt the spread of infection and ultimately disease, and the current targets for the HPV vaccines are girls and young women who have not yet become sexually active. But while this program will reduce cervical-cancer incidence in a couple of decades, they note, "this subgroup of the population at risk is too small to limit the spread of the virus."

The editorialists point out that infection with oncogenic HPV types goes beyond cervical cancer, as they are also a primary cause of anal cancer and contribute to a substantial proportion of penile, oropharyngeal, and tonsillar cancers, all of which are predominant in men.

"Women have shouldered responsibility for contraception since its inception," they write. "The goal to eradicate sexually transmitted carcinogenic viruses can be jointly carried by women and men and could be accomplished within a few decades."

Lead author of the latest study, Jorma Paavonen, MD, a professor of obstetrics and gynecology at the University of Helsinki, in Finland, agrees. "Vaccinating both girls and boys is important to produce so-called herd immunity, which protects the population as a whole and may ultimately lead to eradication of the high-risk oncogenic HPV types."

He added that there is an ongoing randomized phase 4 community trial in Finland that is evaluating the HPV vaccine in both sexes, and more than 30,000 participants have already been enrolled.

Latest Results

The latest results, from a 3-year follow-up of women participating in the Papilloma Trial Against Cancer in Young Adults (PATRICIA), show the vaccine to be highly immunogenic, generally well tolerated, and effective against HPV-16 or HPV-18 infections and associated precancerous lesions, the researchers note.

Efficacy against CIN2+ associated with HPV types 16 and 18 was 92.9% (96.1% CI, 79.9% – 98.3%) in the primary analysis and 98.1% (95% CI, 88.4% – 100%) in an additional analysis, in which probable causality to HPV type was assigned in lesions infected with multiple oncogenic types.

The final analysis was event-driven, meaning that there were enough end points to show efficacy during this follow-up. "Also, the efficacy was even stronger when we used a CIN3+ end point, which is the immediate precursor of invasive cervical cancer," he told Medscape Oncology. "This and the Kaplan-Maier curves show that the efficacy gets stronger over time and does not wear off."

A total of 18,644 women between the ages of 15 and 25 years, residing in 14 countries, were included in PATRICIA. Participants were randomized to receive either the HPV vaccine or a control hepatitis-A vaccine. The analyses were conducted in several cohorts:

According-to-protocol cohort for efficacy (ATP-E), which consisted of women who met eligibility criteria, complied with the trial protocol, and received all 3 doses of study vaccine (vaccine=8093; control=8069).
Total vaccinated cohort (TVC), which included all women receiving at least 1 vaccine dose, regardless of their baseline HPV status; this represents the general population, including those who are sexually active (vaccine=9319, control=9325).
Total vaccinated cohort-naive (TVC-naive), consisting of women with no evidence of oncogenic HPV infection at baseline; this represents women before sexual debut (vaccine=5822; control=5819).
All of the participants received vaccinations at months 0, 1, and 6, and the mean follow-up was 34.9 months after the third dose. The primary-end-point analysis was conducted in the ATP-E cohort, in participants who were seronegative at month 0 and HPV DNA negative at months 0 and 6 for the HPV type considered in the analysis.

Efficacy Observed for Vaccine and Nonvaccine Oncogenic Types

At the final analysis, there were a total of 60 confirmed cases of CIN2+, of which 33 (55%) contained DNA from nonvaccine oncogenic HPV types in addition to HPV-16 or HPV-18. Within this group, 12 CIN3+ lesions containing HPV-16/18 DNA, including 3 cases of adenocarcinoma in situ, were detected. Only 2 of these cases were found in the vaccine group, while the other 10 were detected among the controls.

Neither this trial nor any of the other trials have shown any safety signals.
Vaccine efficacy against CIN2+, irrespective of HPV DNA in lesions, was 30.4% in the TVC and 70.2% in the TVC-naive groups. The researchers also noted that efficacy against CIN3+ was 33.4% in the TVC cohort and 87.0% in the TVC-naive cohort.

The efficacy against CIN2+ associated with 12 nonvaccine oncogenic types was 54.0% in the ATP-E group. Since several lesions were coinfected with HPV-16/18, a post hoc analysis was conducted excluding these lesions, showing an efficacy of 37.4% against CIN2+ lesions associated exclusively with nonvaccine types. These 2 analyses suggest that the true vaccine efficacy against CIN 2+ associated with 12 nonvaccine oncogenic HPV types is between 37% and 54%, the authors note.

The authors also observed that the vaccine substantially reduced the number of colposcopy referrals and cervical-excision procedures in both the TVC and TVC-naive cohorts.

In general, the safety profile was generally similar to that of the control vaccine. "Neither this trial nor any of the other trials have shown any safety signals," said Dr. Paavonen. "All existing evidence shows that the prophylactic HPV vaccine is safe."

The study was funded by GlaxoSmithKline Biologicals. Several of the study authors have reported financial relationships with GlaxoSmithKline and/or Merck; the disclosures are listed in the paper. The editorialists have disclosed no relevant financial relationships.

Lancet. Published online July 7, 2009.

Clinical Context

The HPV-16/18 vaccine adjuvanted with AS04 is effective in the prevention of HPV-16 or HPV-18 infections, as reported in the June 30, 2007, issue of The Lancet by Paavonen and colleagues. The results were based on data from the event-triggered interim analysis of the phase 3, randomized, double-blind, controlled PATRICIA study.

This event-driven final report of the PATRICIA data further assesses the efficacy of the HPV-16/18 vaccine in the prevention of CIN2+ and CIN3+ lesions associated with HPV-16/18 and nonvaccine oncogenic HPV types.

Study Highlights

18,644 women aged 15 to 25 years at time of first HPV vaccination were enrolled from 14 countries.
Inclusion criteria were no more than 6 lifetime sexual partners, contraceptive use during the vaccination period, and intact cervix.
Exclusion criteria were history of colposcopy, pregnancy, breast-feeding, chronic disease, or immunodeficiency.
Subjects were randomized to receive HPV-16/18 AS04-adjuvanted vaccine or control hepatitis A vaccine at 0, 1, and 6 months.
Cervical samples were collected every 6 months, and gynecologic and cytopathologic examinations were done every 12 months.
Blood samples for HPV-16 and HPV-18 antibodies were collected in all subjects at months 0, 7, and 24 and in a subset of women at months 6, 12, 36, and 48.
Testing was performed for HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.
CIN2+ was defined as CIN2, CIN3, adenocarcinoma in situ, or invasive carcinoma.
CIN3+ was defined as CIN3, adenocarcinoma in situ, or invasive carcinoma.
The TVC of 18,644 women (9319 vaccine; 9325 control) received at least 1 vaccination, had baseline and follow-up polymerase chain reaction or cytology sample, and represented general population including sexually active women.
The TVC for efficacy (TVC-E) of 18,525 women (9258 vaccine; 9267 control) received at least 1 vaccination, had baseline normal or low-grade cytology, and efficacy data.
The TVC-naive cohort of 11,641 women (5822 vaccine; 5819 control) received at least 1 vaccination, had baseline normal cytology results, negative oncogenic HPV results, efficacy data, and represented women before sexual debut.
The ATP-E of 16162 women (8093 vaccine; 8069 control) received 3 vaccinations, had baseline normal or low-grade cytology results, and efficacy data.
Mean follow-up period was 34.9 months for ATP-E group and 39.4 months for the TVC-E group.
60 CIN2+ cases occurred, including 33 with DNA from nonvaccine oncogenic HPV types plus HPV-16 or HPV-18 and 12 CIN3+ cases.
Primary analysis of ATP-E cohort showed that HPV vaccine efficacy was 92.9% (96.1% CI, 79.9% - 98.3%; P < .0001) in the prevention of CIN2+ associated with HPV-16 or HPV-18 DNA in the lesion.
Analysis of CIN2+ prevention with use of HPV assignment based on HPV DNA in lesion and preceding cytology results showed a vaccine efficacy of 98.1% for HPV-16 and HPV-18, 100% for HPV-16, and 92.3% for HPV-18.
For CIN3+ associated with HPV-16 and HPV-18, vaccine efficacy was 80% (96.1% CI, 0.3% - 98.1%; P = .0221).
For CIN2+ irrespective of HPV type, vaccine efficacy was 30.4% in the TVC cohort and 70.2% in the TVC-naive cohort.
For CIN3+ irrespective of HPV type, vaccine efficacy was 33.4% in the TVC cohort and 87.0% in the TVC-naive cohort.
For CIN2+ associated with nonvaccine oncogenic HPV types, the estimated vaccine efficacy was between 37% and 54%.
For CIN2+ associated with individual HPV types, vaccine efficacy was found for HPV-31 in the ATP-E, TVC-E, and TVC cohorts; for HPV-45 in the TVC-E and TVC cohorts; and for HPV-33 in TVC.
Vaccine efficacy for persistent infection and CIN2+ was noted for individual HPV types in some, but not all, cohorts:
HPV-31 for 6- and 12-month infections and CIN2+
HPV-33 for 6- and 12-month infections and CIN2+
HPV-45 for 6- and 12-month infections
HPV-58 for CIN2+
HPV-52 was not linked with vaccine efficacy.
Study limitations included possible underestimation of incidence of CIN2+ because of nonvaccine HPV types, which progress more slowly than HPV-16 and HPV-18.
Clinical Implications

The efficacy of HPV vaccine is 93% in the prevention of CIN2+ lesions associated with HPV-16 and HPV-18 and 98% in cases of probable causality to HPV-16 or HPV-18.
The efficacy of HPV vaccine is estimated to be 37% to 54% in the prevention of 12 nonvaccine oncogenic HPV types.



Medscape Medical News CME © 2009 MedscapeCME

Disclaimer

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This message has been edited. Last edited by: Dr Vinod K Joshi,


Disclaimer: Please see your own dentist/doctor for a proper diagnosis as my words should not, in any circumstances, be taken as dental/medical advice.

"If you see what is small as it sees itself, and accept what is weak for what strength it has, and use what is dim for the light it gives, then all will go well. This is called Acting Naturally."
Lao-Tsu, Tao Teh King
 
Posts: 3893 | Location: St Luke's Hospital, Bradford and Pinderfields Hospital, Wakefield | Registered: 14 December 2002Reply With QuoteReport This Post
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