Why have they given me this informative leaflet?
They have given you this leaflet to inform you that healthy women between 18 and 45 years of age are needed to participate in two studies designed to evaluate the effectiveness of two vaccines against a virus of sexual transmission called Virus of the Human Wart (VPH). One study is aimed to women between 18 and 25 and the other to women between 24 and 45.

Why are these two studies carried out?
The objective of the studies is to determine if the administration of these vaccines produces antibodies (the organism’s own defences) capable of preventing: (1) the infection by VPH, (2) genital warts, (3) abnormal cytology (Papanicolau), and (4) the uterus neck cancer.

What is the VPH?
VPH are the first letters of “Virus of the Human Wart”. The infection by VPH is an infection of sexual transmission. This means that this virus is acquired and is infected through sexual intercourse. The infection by VPH is the most frequent venereal illness in sexually active young women and affects mainly the neck of uterus, but also to the vulva, the vagina, and the anus.

Who can be infected with the VPH?
Any person that has had or still has sexual intercourse can be infected with the VPH. The conducts that enlarge the risk of infection are: (1) to have initiated the first sexual relations at an early age; (2) to have or to have had several sexual couples; (3) to have sexual intercourse with people that have or have had several sexual couples. It is necessary to be aware of the fact that a monogamous woman can also contract the infection by VPH.

What illnesses does the VPH produce?
Many types of VPH exist. The ones called low risk VPH are the cause of genital warts or condilomas. The high risk VPH can cause wounds to the neck of the uterus (abnormal cytology) that can evolve to cancer. This cancer can be serious. There is not still an efficient treatment that cures the infection by VPH. The present strategy to prevent the uterus neck cancer falls in the premature detection and treatment of pre-cancerigenic wounds produced by the VPH. It is highly probable that the vaccination against the VPH happens in a not very distant future together with an efficient strategy to prevent the uterus neck cancer.

How does a woman know that she has the VPH?
It is impossible to know when a person has acquired the VPH. The virus may be present in the genital mucous membrane for months or years without being declared. At present there is a test that detects the presence of infection by VPH in the cervix. The presence of genital warts or an abnormal cytology (Papanicolau) are the first signs of infection by VPH.

What do the two studies of vaccination against the VPH of ICO consist of?
The Institut Català d'Oncologia (ICO) is a leader centre in the research on the VPH and the uterus neck cancer. Since the infections by VPH cannot be cured, medical and scientists study strategies to prevent the population from being infected and developing these illnesses. One of the strategies consists of the vaccination. The vaccine is a type of medicine that stimulates and enlarges the bodies’ own defences to fight the virus when this enters the organism. The majority of us are already vaccinated against several infectious illnesses, as for example, measles, mumps, chicken pox or the virus of the B hepatitis. At present ICO participates in two international studies that evaluate the utility of two vaccines against the VPH. The vaccine aimed to adult women (24 to 45 years old) has the potential to prevent the infection by 4 types of VPH: two that cause genital warts and two that cause uterus neck cancer. The vaccine aimed to young women (18 to 25 years old) has the potential to prevent the infection by the 2 types of VPH that cause the uterus neck cancer.

Are these vaccines safe?
The two vaccines used in this study do not contain active virus and therefore it is totally impossible to be infected with the VPH from its administration. These vaccines are in a very advanced phase of development. Prior studies in thousands and thousands of women around the world, including women of the campus of Bellvitge, have shown that the two vaccines are very safe and have a large capacity to prevent the infection. The medical team that will assist you during the study in which you participate has a great experience in the field of the vaccination against the VPH.

Who can participate in these studies?
Any healthy woman between 18 and 45 who is not pregnant nor plans to be during the 7-8 months that the phase of vaccination lasts can participate. After the last vaccine, although she continues in the study, there is no problem in being pregnant.

What does participating in these studies imply?

The women from 18 to 25 years will receive randomly either the vaccine against 2 types of VPH or the vaccine against the Virus of the Hepatitis A (VHA). The vaccine against the VHA is a vaccine already marketed, which since 1996 all the 12-year-old children in Catalonia receive systematically. This study lasts 48 months and implies a total of 10 visits.

The women from 24 to 45 years old will be administered randomly either the vaccine against 4 types of VPH or a “placebo”, an equal product in appearance to the vaccine but that does not contain the active principles of the vaccine against the VPH. This study lasts 36 months and implies a total of 9 visits.

All the participants will receive general physical examinations and regular gynaecological revisions during the time that each one of the studies lasts.

In case of detecting some anomaly in the neck of the uterus or some treatable venereal illness, the study will cover its treatment.

At the end of the study, those women that have not received the vaccine against the VPH will be able to receive it, if they want to, free of cost.

Your participation in these studies is completely voluntary. At any moment you will be able to stop participating in the study and this will not imply changes in your habitual health assistance.

All your medical and personal data will be treated with the strictest confidentiality. Your name will be separated from your data since the start of the study in such a way that non-authorized people will not be able to link the name with your personal information.

Why is it important that you participate in these studies?
The uterus neck cancer is the responsible for the premature death of thousands of women everywhere in the world. If you participate in one of these studies you will help doctors and researchers to get to know a way to prevent the infection by the VPH and the illnesses that this virus produces. Therefore, your participation will contribute to prevent the uterus neck cancer in the world.

Which are the benefits of participating in these studies?

You will contribute actively in the research for the prevention of two illnesses that affect women’s health: the genital warts and the uterus neck cancer.

How to participate in one of these two studies or to receive more information:
Get in contact with us. We are at the Service of Epidemiology and Cancer Register of the Institut Català d'Oncologia (ICO):