Join the fight against cervical cancer

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Join the fight against cervical cancer
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Volunteers needed for the PATRICIA clinical trial

• 13,000 volunteers are needed worldwide for a
  4-year global clinical trial
• This clinical trial aims to prove the safety and
  effectiveness of a new investigational cervical
  cancer vaccine
• If you are aged 1525 years, healthy and not
  pregnant, you can volunteer for this clinical
  trial

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Why clinical trials are needed

• Scientists first carry out laboratory tests to
  discover the general properties of a potential
  new medicine
• Small-scale clinical trials are then performed
  to see whether the new medicine is safe and
  effective enough to be used in people
• Lastly, clinical trials involving large numbers
  of people are carried out to confirm the safety
  and effectiveness of the medicine in real-life
  use

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Why join this clinical trial?

• Infection with certain types of human
  papillomavirus (HPV) can cause cervical cancer
• This clinical trial will test a new vaccine that
  might protect against infections with some types
  of HPV
• If the vaccine works it should reduce your
  chances of getting cervical cancer later in life
• By helping to test how well the vaccine works,
  youll also be helping women in the future

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What is HPV?

• HPV can infect the skin and genitals in men and
  women
• In women, certain types of HPV can infect the
  cervix (at the entrance to the womb)
• Over time, infection with some high-risk HPV
  types can lead to cervical cancer

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The cervix

• The cervix is the opening to the uterus (womb)
• It connects the uterus to the vagina
• Cervical cancers develop here

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HPV types

• There are more than 200 types of HPV
  approximately 30 can infect the cervix
• Cervical HPV types can be split into
• high-risk (cancer-causing) types (types 16, 18,
  31, 33, 45 and others)
• low-risk types (types 6, 11 and others)
• Infections with high-risk types may last longer
  (persistent infection) than infections with
  low-risk types
• HPV 16 and HPV 18 are two high-risk types of HPV
  and cause more than 70 of all cervical cancers

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HPV 16 and HPV 18

• HPV 16 and HPV 18 are two high-risk types of HPV
  and cause more than 70 of all cervical cancers

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About HPV infections

• Approximately 75 of sexually active women will
  have a cervical HPV infection at some point in
  their life
• Women may not be aware of having a cervical HPV
  infection because infections rarely cause
  obvious symptoms
• Most infections (more than 80) clear up by
  themselves, usually after a few months
• If infection persists, women are at risk of
  developing cervical cancer

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What is cervical cancer?

• Cervical cancer is the fifth most common cause of
  death from cancer in women and is the primary
  cause in developing countries
• Every year there are
• 470,000 new cases of cervical cancer
• 190,000 deaths from cervical cancer
• HPV infection is the cause of cervical cancer

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Cases of cervical cancer worldwide
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Cervical cancer development

• An infection that does not go away over time is
  considered persistent
• Persistent infections can cause your bodys
  cells to form abnormally
• If abnormal cells are not killed by your bodys
  defenses they can turn into pre-cancer cells
• Most pre-cancer cells are killed by your bodys
  defenses if they are not, they might progress
  to cervical cancer

Normal
Mild (CIN 1)
Moderate (CIN 2)
Severe (CIN 3)
Cancer
Image sourced from www.gynaesurgeon.co.uk/smear/s
mear1.htm
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How cervical cancer iscurrently treated by
doctors

• Abnormal cells are detected by cytology
  screening(Pap smear testing)
• The cervix might then be inspected visually with
  an instrument called a colposcope this
  procedure is called colposcopy
• Abnormal cells, or lesions, caught in these
  early stages, can be treated by removing the
  abnormal cells in a procedure called a biopsy or
  by other methods

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Can a vaccine help?

• Currently, HPV infection cannot be prevented
• A vaccine that prevents persistent infection with
  HPV will protect against subsequent development
  of cervical cancer
• Additional advantages
• fewer Pap smears
• fewer cervical exams
• less anxiety

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PATRICIA clinical trial vaccine

• The PATRICIA clinical trial vaccine targets two
  types of HPV infection HPV 16 and HPV 18
• This vaccine contains man-made virus-like
  particles (VLPs) that look just like HPV 16 and
  HPV 18
• Unlike the real HPV 16 and HPV 18 viruses, the
  VLPs are empty shells they cannot infect you
• VLPs are made using the latest technology and are
  believed to be both safe and effective

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PATRICIA clinical trial vaccine

• In previous clinical trials
• the vaccine has been shown to produce a strong
  immune response
• the vaccine has been shown to prevent infection
  with HPV 16 and HPV 18
• the vaccine was well tolerated (only mild
  discomfort at injection site)

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How the new vaccine works

• The bodys immune system responds to the VLPs as
  it would to the real HPV 16 and HPV 18 viruses
  producing antibodies and other defences
• These defences protect against infection with HPV
  16 and HPV 18, resulting in lasting immunity
• Women in a small pilot clinical trial who were
  given the vaccine developed immunity to
  persistent infection with HPV 16 and HPV 18
• Doctors believe this could prevent the majority
  of them developing cervical cancer later in life

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Aims of this clinical trial

• This clinical trial aims to prove that the new
  HPV vaccine
• can prevent persistent HPV infections
• can prevent the development of pre-cancer cells
  onthe cervix
• can create a strong immune response in all women
• is safe for use in young women worldwide

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Why a worldwide clinical trial?

• If approved, this vaccine against cervical
  cancer is likely to be used worldwide
• This clinical trial will enable investigators to
  study the vaccine in women from
• a range of ethnic groups, from different
  countries
• countries with different economic conditions
  andlevels of healthcare provision
• Only a global clinical trial can prove that the
  vaccine is effective and has a good safety
  profile in such a wide range of different people
  and situations

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Why are so many people needed?

• 13,000 healthy young women in 14 countries
  worldwide will be enrolled in this clinical trial
• These women will represent a wide range of races
  and cultures, the aim being to show whether or
  not the vaccine is suitable for worldwide use
• Governments insist that large-scale clinical
  trials like this must be carried out before they
  will grant licences for the use of new medicines

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Can you volunteer?

• If you are aged 1525 years, healthy and not
  pregnant, you can volunteer for this clinical
  trial
• You should avoid pregnancy during the first 8
  months of the clinical trial the vaccination
  period
• This means you should either use effective
  contraception or abstain from sex

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If you volunteer for the PATRICIA clinical trial

• You will be given three doses of the new HPV
  vaccine or a control hepatitis A vaccine for
  comparison
• The clinical trial is double-blind neither
  you nor the investigators will know which vaccine
  you have been given until the end of the clinical
  trial, to avoid any risk of bias
• You will also receive gynaecological care and
  regular medical tests and check-ups free of
  charge

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Why you should volunteer for the PATRICIA
clinical trial

• By the end of the clinical trial, you should be
  immune to infection with either HPV 16 and HPV 18
  or hepatitis A virus if the vaccines are as
  effective as shown by other clinical trials
• Doctors believe that if you become immune to
  infection with HPV 16 and HPV 18, your risk of
  developing cervical cancer should be dramatically
  reduced

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Summary of what is involvedfor volunteers

• Ten visits to the clinical trial center during
  the 4 years of the clinical trial
• Three doses of the HPV vaccine or the control
  vaccine
• Three to seven blood tests
• A gynaecological examination every year
• Cervical smear every 6 months
• Colposcopy if any abnormal cells are found in the
  cervical smear

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What the PATRICIA clinical trial also involves

• You will be asked to record
• any side-effects of the vaccinations
• any illnesses or medical emergencies that you
  have during the 4 years of the clinical trial
• You will be asked to report if you become
  pregnant
• You will be interviewed when you join the
  clinical trial and then once a year for the 4
  years of the clinical trial
• This interview will cover a range of personal
  information, such as your sex life and smoking
  habits
• All information will be kept strictly private and
  confidential

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Cervical smear what will happen?

• A cervical smear will be collected every 6 months
  
• The cervical smear will be checked for infection
  with HPV 16 and HPV 18. Most women will remain
  negative.
• The doctors will also look for
• infection with other HPV types
• presence of abnormal cervical cells, which may
  require colposcopy
• infection with chlamydia and gonorrhoea, two
  common sexually transmitted infections (STIs)

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Cervical smear what happens next?

• Most women will remain negative
• However, if you have any abnormal results from
  screening, you will be given more examinations
  and treatment free of charge
• This may involve
• coming back in a few months for another test
• having a test to see if HPV infection is causing
  the abnormal results
• coming back for a colposcopy and/or biopsy

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Colposcopy and biopsy

• Colposcopy is the visual inspection of the cervix
  if the doctors decide from this that detailed
  examination is needed, they will perform a biopsy
• In a biopsy, a sample of tissue is taken from the
  cervix to look at any abnormal cells in more
  detail

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Image sourced from http//www.gynaesurgeon.co.uk/o
perations/colposcopy1.htm
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What are the risks of participating?

• You might experience some side-effects from the
  the new vaccine, including
• fever, headache, loss of appetite, nausea,
  diarrhea, sleeplessness, fatigue, allergic
  reactions, soreness, tenderness and swelling at
  the injection site
• You might experience some discomfort associated
  with some of the procedures involved in the
  clinical trial

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What are the benefits?

• All volunteers will receive gynaecological care
  during the 4-year course of the clinical trial
• All volunteers will receive screening for
  chlamydia and gonorrhea, which can cause illness
  and infertility
• Women who receive the HPV vaccine may be
  protected against HPV 16 and HPV 18 infection and
  consequent development of cervical cancer
• Women who receive the control hepatitis A vaccine
  will be offered the HPV vaccine at the end of the
  clinical trial, if the HPV vaccine is shown to
  work effectively

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Summary

• As a volunteer for this clinical trial
• You could help reduce the risk of HPV infection
  and cervical cancer for millions of women in the
  future
• You will receive gynaecological care for 4 years
• You could be among the first to receive a vaccine
  that aims to provide protection against HPV 16
  and HPV 18 infection and reduce the risk of
  cervical cancer

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Any questions?

• Please feel free to ask the doctor(s) or staff
  running this clinical trial in your area if you
  have any questions on
• HPV and HPV infections
• cervical cancer
• the vaccine
• the clinical trial center
• the medical examinations involved in the clinical
  trial
• the various tests involved in the clinical trial
• when the clinical trial will start in your area
• whether you can volunteer for the clinical trial

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Your local clinical trial doctor

• Michael C. Caldwell, MPH, MD
• Commissioner of Health
• Dutchess County Department of Health
• [phone]