This trial is concluded. This means the trial has been completed. The results of the trial are summarised in the 'results' section of this page. You cannot enrol in this trial.
About this trial
This ongoing study is evaluating the use of Gardasil in young men.
It hopes to demonstrate that the vaccine reduces the incidence of anogenital warts, penile/perianal/perineal intraepithelial neoplasia [PIN], penile/perianal/perineal cancer and Human Papilloma VirusA small infective organism which is incapable of reproducing outside a host cell. (HPV) infection in young men.
It also hopes to demonstrate that the vaccine can reduce the incidence of anal intraepithelial neoplasia (AIN) or anal cancer particularly in gay men.
Background information
Research conducted by the Kirby Institute at UNSW has shown that the annual incidence of anal cancer in Australia has increased by almost 50% in the last 20 years.
What’s more, the rate of increase has been twice as fast for men, about 20 times higher for gay men and even higher for those with HIV. In fact, overseas data suggests that up to one in a 1000 positive gay men per year may develop the disease.
More than 80% of anal cancer is caused by a type of human papillomavirus, HPV16, which is preventable by the currently available HPV vaccines (Gardasil or Cervarix) that are currently offered for free in Australia to girls and young women to prevent cervical cancer. The vaccines are most effective when given to children, before the start of sexual activity, but they are currently not funded for male vaccination.
AUGUST 2012 UPDATE
HPV vaccine extended to boys
In a world first, Australian schoolboys will be able to get the successful Gardasil vaccine, which will protect them from contracting the human papillomavirus (HPV) and from developing a range of cancers late in life. Starting next school year, the Gillard Government will fund the vaccine for 12- and 13-year-old boys through school-based programs under the National Immunisation Program. Year 9 boys will also be able to get the vaccine at school under a catch-up program for the next two years.
Minister for Health Tanya Plibersek said providing the HPV vaccine to boys would protect them and increase the effectiveness(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the standard procedure, Phase II clinical trials gauge efficacy, and Phase III trials confirm it. of the vaccination program for girls.
“Already the HPV vaccine has had an impact – significantly reducing the number of lesions that lead to cervical cancer amongst women in the vaccinated age group. It is estimated that a quarter of new infections will be avoided by extending the vaccine to boys,” said Ms Plibersek.
An Australian innovation, the vaccine protects against four important genotypes of the human papillomavirus (HPV). The HPV vaccination program for boys is expected to cost $21.1 million over four years. This will include an information campaign, a vaccine register and monitoring of adverse reactions.
| Official title: | An Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men
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| What is this trial studying? | Other |
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| Start date: | September 2004 This may be the proposed or expected start date for trials which have not yet started. |
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| How many participants will this trial enrol? | 4065 The exact number of participants may be lower or slightly higher than this. Some trials also have specific quotas for participants from each state, city or clinic. |
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| How long is this trial planned to go for? | Participants in this trial will be asked to follow the trial protocol for 5 years. Following the conclusion of the trial, participants will be followed up for a further 8 years. |
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| Links to further information: | |
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| Tags: | anal cancer, HPV |
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Who can enrol in this trial?
You may be eligible to participate in this trial if you meet the following criteria:
- At least 16 years old
- This trial is for men only
- Healthy males between the ages of 16 and 26 with no known history of genital warts
This is a summary of key inclusion and exclusion criteria for this trial. There may be other criteria which may exclude some people from participation in this trial. Some laboratory tests may also be required. Consult your doctor, or view the trial protocol or informed consent documentation to see the full range of exclusion and inclusion criteria.
Results:
Gardasil is now indicated for use in men aged up to 26 years for the prevention of external genital lesions and infection caused by HPV Types 6, 11, 16 and 18.
In this worldwide, multicentre trial in over 4000 males aged 16 through to 26, the efficacy(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the standard procedure, Phase II clinical trials gauge efficacy, and Phase III trials confirm it. of Gardasil against HPV 6/11/16/18 genital lesions (genital warts and perineal/perianal/penile intraepithelial neoplasia) was 90.4%.
Primary results can be found here: http://www.ncbi.nlm.nih.gov/pubmed/21288094?dopt=Abstract
Results for the subgroup of MSM can be found here: http://www.ncbi.nlm.nih.gov/pubmed/22029979?dopt=Abstract
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