Hpv vaccine

Author: Prof. Dr. med. Peter Altmeyer

Last updated on: 10.02.2021

Synonym(s)

Cervarix; Gardasil

Definition
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Vaccines against infections with human papilloma viruses (HPV 6, 11, 16, 18) approved for the first time in the EU at the end of 2006. The vaccine consists of aggregates of the viral structural protein (capsid protein) L1, also known as "virus like paticles". They do not contain DNA and are not oncogenic.

Spectrum of action
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The effect of Gardasil was evaluated in 4 placebo-controlled, randomized phase II and III trials involving a total of 20,541 women aged 16-26 years. HPV testing, cervical smear and detection by PCR technique were used to evaluate HPV 6, 11, 16 and 18 associated lesions. According to the previous findings, no dysplastic cervical lesions due to HPV 16, 18 induced infections were detected in all the subjects. Condylomata acuminata, commonly caused by HPV 6, 11, occurred in only 1 woman in the Gardasil vaccinated group (91 cases in the placebo group).

Evidence of efficacy of Cervarix was provided in women aged v. 15-25 LY after vaccination with Cervarix. The effect is based on the immunogenicity of the vaccine in girls and women aged 10-25 years.

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Field of application/use
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Worldwide about 70% of all cervical cancers are caused by HPV 16, 18, 90% of all condyloma acuminata are caused by HPV 6, 11 Gardasil is said to protect against the development of cervical and vulvar carcinomas or condyloma acuminata. The vaccine can be administered to children and adolescents aged 9 to 15 years and women aged 16 and over. Studies on the prevention of HPV-induced venereal diseases in homosexual men have not yet been completed.

Individual case reports on the success of Gardasil in disseminated extragenital infection with human papilloma viruses are remarkable (Wisekmann L et al. 2018).

Indication
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Prevention of high-grade cervical dysplasia (CIN 2/3), cervical carcinomas, high-grade dysplastic lesions of the vulva (VIN 2/3) and external genital warts (condylomata acuminata) caused by types 6, 11, 16 and 18 of human papilloma virus (HPV).

Dosage and method of use
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The basic immunization consists of 3 single doses (0.5 ml i.m. each in month 1, 3, 6). If the vaccination schedule differs, the 2nd dose should be administered at the earliest one month after the first dose and the third at the earliest 3 months after the 2nd dose.

Undesirable effects
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Common: pyrexia, local skin reactions (redness, pain, swelling).

Less frequent: urticaria, pruritus, bronchospasm.

Contraindication
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Allergies to the active substance or one of the components of the vaccine.

Preparations
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Gardasil; Cervarix

Note(s)
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The vaccine Gardasil is only approved in the USA for all girls and women aged 9-26 years. In Europe, on the other hand, it can also be used in boys between 9-15 years of age. Currently, HPV vaccination for boys is still off-label use (an injection of 0.5 ml costs about 160 euros).

Patientinformation
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After breast cancer, cervical cancer is the second most common cause of cancer death among young women in Germany. Cervical cancer is often caused by HPV viruses. According to current findings, Gardasil protects women who have not yet been infected with the HPV type present in the vaccine. Therefore, the indication seems to be given especially to young girls who are not yet sexually active. The efficacy of Gardasil in women with existing or previous HPV infection has not yet been sufficiently proven. However, vaccination with Gardasil is not a substitute for routine cervical cancer screening!

Literature
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Petry KU (2007) What does HPV vaccination mean for gynaecological cancer screening. dermatologist 58: 501-506
Speck LM (2006) Vaccines for the prevention of human papillomavirus infections. Skin Therapy Lett 11: 1-3
WiskemannL et al (2018) Extragenital, disseminated infection with human papilloma viruses. Dermatologist 69: 245-248