What is HPV?

Human papillomavirus (HPV) infection is a sexually transmitted disease associated with genital warts as well as a pre-disposition to cancer of the cervix in females. There are over 100 types of HPV but only 13 of them are known to cause cancer. The others are harmless or cause genital warts. Most HPV infections clear up by themselves, but in some people the infection can last a long time. HPV infects the cells of the surface of the cervix (the neck of the womb) where it can stay for many years without you knowing. The HPV virus can damage these cells leading to changes in their appearance. Over time, these changes can develop into cervical cancer.

Vaccination

All girls aged between 12 and 17 should be offered vaccination (Cervarix) via a NHS programme by August 2009. It is likely to be done in schools. The manufacturer of Cervarix, GlaxoSmithKline, said it should prevent 70% of cases.

There was some controversy over the decision to select Cervarix over another vaccine, Gardasil. Some experts said Gardasil would have been a better option because it targets four strains of HPV - two responsible for cervical cancer (16 and 18) and two causing the less serious condition of genital warts ( 6 and 11).

Gardasil is used by the majority of vaccination programmes worldwide.

Smear testing will continue - as most women will not enjoy the protection of the vaccine, and cancers can still emerge even in vaccinated women.

What is Gardasil?

Gardasil is a recombinant (artificially manufactured) HPV vaccine approved for use in the EU. The license approval covers use in females aged 9 to 26 years for the prevention of cervical cancer, high-grade cervical or vulvar dysplasias/ precancers as well as external genital warts (condylomata acuminate) caused by HPV types 6, 11, 16 and 18. These are the commonest (but not the only) viruses associated with cancer of the cervix which kills thousands of women in the UK every year. HPV vaccination provides the best protection against HPV infection that is available for persons having unprotected sexual intercourse with a previously infected partner. The results of the infection are not always obvious, so unless the two partners are both virgins or abstinence is complete, vaccination is advised. Vaccinated persons are NOT protected against other forms of sexually transmitted infection and barrier methods such as condoms are still advised for both heterosexual and homosexual intercourse.

Note that HPV vaccination does not eliminate the need for regular cervical smear checks as (a) the infection may have been already acquired, and (b) not all viruses causing cancer are covered. Protection against the 4 type of virus lasts for at least 5 years after completing the full course which consists of three doses by intramuscular injection in the upper arm - usually given at 0, 2 and 6 months. Alternative schedules are possible but it is recommended there should be at least 1 month between the first and the second dose, and at least 3 months between the second and the third, and all doses should be given within one year.

Potential Side Effects

Side effects are very uncommon as this is NOT a live vaccine; they usually consist of no more than some redness and soreness at the site of the injection which lasts a few days. Very occasionally an allergic reaction may follow such as hives or urticaria. However, HPV vaccine should NOT be used in people who may be hypersensitive (allergic) to the active substance or any of the other ingredients; if a patient shows signs of an allergy after a dose of the vaccine, (s)he should not receive further doses of the vaccine. Vaccination should be postponed in patients who are ill with a high fever, also patients who are pregnant, as safety in pregnancy has not been fully assessed; however, vaccination is not contraindicated in breast feeding women. The vaccine may be given with Hep B vaccines but has not been cleared for co-administration with other vaccines.

In patients who are HIV positive or immuno-compromised for other reasons (e.g. taking strong arthritis medications such as methotrexate), the normal immune reaction may not be sufficient to prevent subsequent infection in spite of a full course. So although immunisation is not contraindicated in such individuals, it is wise not to assume full protection and repeat courses may be necessary.

Pricing Information

Each Gardasil injection costs £140 per dose (normal course three doses at 0, 2 and 6 months).

Further Information

For further information about Gardasil, see the Gardasil patient information leaflet and the Electronic Medicines Compendium entry for Gardasil.