HPV Vaccine

HPV vaccination is a standard vaccination (regular vaccination) for girls/women and boys/men. The dead vaccine contains purified, recombinant L1 proteins from the capsid of the papillomavirus types. Human papillomaviruses (HPV) are responsible for infections of the skin or mucosa. In addition, it has been proven that the virus, especially the high-risk types 16 and 18 of the HP virus, are an important factor in the development of cervical carcinoma (cervical cancer) and condylomata acuminata (genital warts). These high-risk groups are the cause of approximately 70% of all invasive cervical cancers and more than 50% of high-grade cervical intraepithelial neoplasms (CIN 2/3). HPV vaccination has been available against the two high-risk types for some time. Vaccines achieve greater than 90% efficacy in preventing HPV 16- or 18-associated CIN 2+ (CIN = cervical intraepithelial neoplasia = precursor to invasive cervical carcinoma) in women (who were HPV 16 and/or 18 negative before vaccination). There is now an HVP vaccine that is effective against nine virus types (6, 11, 16, 18, 31, 33, 45, 52, 58) (nine-way HPV vaccine). The following are the recommendations of the Standing Commission on Vaccination (STIKO) at the Robert Koch Institute on HPV vaccination:

Indications (areas of application)

  • Lack of or incomplete basic immunization (see below).
  • Women who have not received vaccination against HPV at the recommended time (9-14 years) may also benefit from vaccination against HPV; the same applies to men
  • Conclusive data on the success of vaccinating boys/men to prevent transmission are not available.
  • Life partners of persons with genital warts.
  • Persons with sexually transmitted diseases such as HIV.
  • Women after surviving infection with the HP virus, to avoid reinfection.

Note: In 2018, the Standing Commission on Vaccination (STIKO) also issued a recommendation on HPV vaccination for boys.

Contraindications

  • Individuals with acute illnesses requiring treatment.

Implementation

  • Basic immunization:
    • Girls: Age 9-13 (Gardasil) or 9-14 years (Cervarix, Gardasil9) with 2 doses 6 months apart to prevent infection with the pathogens.
    • Boys: Age 9-14 years, to avoid infection with the pathogens.
  • For catch-up vaccination
    • Girls: Age > 13 years or > 14 years, or with a vaccination interval of < 6 or < 5 months between the 1st and 2nd doses, a 3rd vaccine dose is required (note information in the technical information).
    • Boys: Age 17 years
  • The full vaccination series should be completed before the first sexual intercourse.

Note: “Women and men older than 17 years who have not received vaccination against HPV may also benefit from vaccination against HPV, but the effectiveness of vaccination is reduced in non-HPV-naive individuals.” Note: In addition to the Cervarix and Gardasil vaccines, the nine-valent HPV vaccine Gardasil 9 has been available on the German market since April 2016. All three vaccines can be used to achieve the vaccination goal of reducing cervical cancer and its precursors. An initiated vaccination series should be completed with the same HPV vaccine, if possible.

Efficacy

  • The active agent against nine virus types (6, 11, 16, 18, 31, 33, 45, 52, 58) showed a comparable seroconversion rate to the tetravalent agent (vaccine efficacy between 96 and 97.1%).
  • The tetravalent agent against HPV 6, 11, 16 and 18 shows a 98% efficacy; for the tetravalent placebo-controlled immunogenicity long-term data of about 4 years available (as of 2012).
  • The bivalent agent against HPV 16 and 18 shows 91% efficacy against incident infections, 95% efficacy against persistent infections, and 90% efficacy against HPV 16-, 18-associated CIN.
  • In long-term follow-up, there is no evidence to date of a decline in vaccine protection after vaccination against HPV 16 and 18 (as of 2014).
  • The HPV vaccine Cervarix (bivalent vaccine against HPV types 16 and 18) may achieve good vaccine protection after only a single dose: vaccine efficacy against HPV-16/18 infections was 77.0% (95% CI 74.7-79.1) with three doses, 76.0% (62.0-85.3) with two doses, and 85.7% (70.7-93.7) with one dose. For incidence HPV-31/33/45 infections, efficacy was 59.7% (56.0-63.0) with three doses, 37.7% (12.4-55.9) with two doses, and 36.6% (-5.4 to 62.2) with one dose.
  • A recent analysis of data from the Finnish Cancer Registry showed that in women vaccinated against HPV, there was not a single invasive carcinoma per 65,656 women per year. In contrast, among unvaccinated women, ten HPV-associated invasive malignancies developed per 124,245 women per year; this corresponds to a rate of eight diseases per 100,000 women per year: eight cervical carcinomas (6.4 diseases per 100. 000 women per year), one oropharyngeal carcinoma (cancer of the oral pharynx; 0.8 diseases per 100,000 women per year), and one vulvar carcinoma (cancer of the vulva; cancer of the female external genital organs; 0.8 diseases per 100,000 women per year).
  • Cochrane Review: In girls and women aged 15 to 26 years who are vaccinated against human papillomavirus HPV 16 and HPV 18, the risk of the dangerous precursor of cervical carcinoma CIN2+ (CIN = cervical intraepithelial neoplasia) decreases from 164 per 10. 000 to 2 per 10,000. For the precursor CIN3+, the risk decreased from 70 to 0 per 10,000. Furthermore, the meta-analysis demonstrated that HVP vaccination was not associated with increased risks of serious adverse events.
  • Data from a meta-analysis on the efficacy of human papillomavirus (HPV) vaccination over an 8-year period demonstrated that HPV vaccination programs significantly reduced not only HPV infections but also precancerous cervical lesions of the CIN2+ level.
  • Based on Swedish registry data, it was demonstrated that women and girls who had been vaccinated in time to age thirty were approximately 90% less likely to develop cervical cancer than those who had not been vaccinated.

Possible side effects / vaccination reactions

  • No side effects have been reported to date, except for minor local side effects such as redness, swelling, and pain at the injection site.
  • Men: Based on reports of adverse effects secondary to vaccination received through the Vaccine Adverse Event Reporting System in the United States between January 1, 2006, and September 30, 2018, 5,493 reports of adverse effects secondary to HPV vaccination were evaluated. The three most common adverse effects in men-compared with other vaccines-were syncope (brief loss of consciousness; n=701, odds ratio: 2.85), loss of consciousness (n=425, OR: 2.79), and falls (n=272, OR: 3.54).

Despite the vaccination, regular cancer screening by a gynecologist should not be omitted, as the vaccination cannot produce complete protection against cervical cancer. Cancer screening note: HPV-based screening (HPV testing) provides 60% to 70% greater protection against invasive cervical cancer compared with cytology. Further references

  • The Saxon Vaccination Commission (SIKO) already recommended HPV vaccination of boys in 2012. Furthermore, the commission of the S3 guideline “Vaccination prevention of HPV-associated neoplasms” (www.hpv-impfleitlinie.de) has justified the vaccination of boys.
  • A population-based study in Denmark was able to show that accidental HPV vaccination during pregnancy did not result in increased miscarriages, stillbirths, preterm births, severe birth defects, or the birth of children who were too small or too light for their gestational age (SGA) at birth.
  • An epidemiologic study (population-based retrospective cohort study) cannot confirm the suspicion of increased autoimmune disease in young girls following human papillomavirus (HPV) vaccination; likewise, there is no statistically significant increased risk of primary ovarian insufficiency (POI; ovarian dysfunction) after HPV vaccination.