Spotlight on the 9-valent HPV vaccine

Abstract

Starting in 2006, vaccination against human papillomavirus (HPV) has been progressively implemented in most developed countries. Two vaccines have been successfully used, a bivalent vaccine targeting HPV-related cancers (bHPV) and a quadrivalent vaccine (qHPV) targeting both HPV-related cancers and genital warts. Between December 2014 and June 2015, a new nonavalent HPV vaccine (9vHPV) was granted marketing authorization in the USA and Europe. The 9vHPV was developed from the qHPV and includes five additional HPV types that should increase the level of protection toward HPV-related cancers. Efficacy and/or immunogenicity of 9vHPV has been assessed in eight clinical studies. The 9vHPV vaccine induced a very robust immune response against all vaccine types, with seroconversion rates close to 100%. The safety profile of 9vHPV is comparable to that of qHPV. Local reactions, especially swelling, have been more frequently reported after 9vHPV than qHPV, and this slightly increases when the 9vHPV is coadministered with other vaccines. The additional coverage offered by the 9vHPV may prevent a significant proportion of HPV-related cancers (variable between 8% and 18%) depending on the local distribution of high-risk HPV types in the population. It is impossible, at present, to anticipate the actual impact of the wide use of the 9vHPV in comparison with the bHPV or the qHPV, since it depends on many variables including duration of protection, potential cross-protection toward nonvaccine types, and herd immunity effect.

Keywords: cervical cancer; genital warts; head and neck cancer; human papillomavirus vaccine; immunogenicity; vaccine safety.

Figure 1

Strategy followed to assess immunogenicity and efficacy of 9vHPV in premarketing clinical studies. Abbreviation: HPV, human papillomavirus.

Figure 2

Comparison of immune responses (GMT) between 9vHPV and qHPV vaccine for HPV types 6, 11, 16, and 18 in 9–15 year old girls and 16–26 year old women and men. Abbreviations: GMT, geometric mean titer; HPV, human papillomavirus.

Figure 3

Comparison of immune responses (GMT) at month 7 after 9vHPV vaccination to HPV types 31, 33, 45, 52, and 58 in 9–15 year old girls and boys, and 16–26 year old women and men. Abbreviations: GMT, geometric mean titer; HPV, human papillomavirus; M, male; F, female.

Figure 4

Comparison of immune responses (GMT) at month 7 after 9vHPV vaccination in 16–26 year old women that received or not previous vaccination with qHPV. Abbreviation: GMT, geometric mean titer.

Figure 5

Frequency of vaccine-related systemic adverse events (systemic adverse events included fever, headache, fatigue, nausea, dizziness, oropharyngeal or abdominal pain, myalgia, diarrhea) after 9vHPV and qHPV vaccination (reference citation number).

Figure 6

Estimated percentage of cervical cancers attributable to HPV types included in the qHPV and 9vHPV, in North America, Europe, Australia, and worldwide. Note: Data from Zhai and Tumban. Abbreviation: HPV, human papillomavirus.