A ninevalent HPV 6/11/16/18/31/33/45/52/58 vaccine was licensed in Europe in 2015 and has become available in 2016.
A review of the available data from the phase III trials and the current recommendations.
The ninevalent vaccine has been evaluated in more than 27000 study participants. All these protocols and study results are published and availale. The vaccine has been highly immunogenic in females and males from 9-26. The immunogenicity (and clinical efficacy) against HPV 6/11/16/18 is non- inferior to the quadrivalent HPV vaccine, the clinical efficacy against HPV 31/33/45/52/58 related disease and persistant infection is >96%. A 2dose schedule in girls/boys under the age of 15 has been is highly immunogenic and licensed by EMA and FDA. An administration in prior recipients of the quadrivalent vaccine is immunogenic and safe. The safety profile in general is favourable.
The ninevalent vaccine is licensed in Europe for males and females from the age of nine, under the age of 15 two doses with 6-12 months interval are sufficient. A study evaluating the immunogenicity in women up to the age of 45 is ongoing. The vaccine is safe, highly immunogenic in all evaluated populations and highly effective in preventing disease related to the nine HPV genotypes.
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