2023-09-15 17:10:29
The nonavalent recombinant HPV vaccine protects against the types of HPV that cause approximately 90% of cervical cancers and has a high level of immunogenicity for the 9 serotypes contained in the vaccine, reducing the global incidence of cancers and HPV-related diseases. These are the efficacy data published in ‘Pediatrics’, relating to a Long Term Follower Up (LTFU) study, released by Msd (known as Merck & Co. in the United States and Canada). Results resulting from a 10-year peer review of the study which was conducted from 2009 to 2021 in 13 countries and 5 continents. In girls and boys who received a 3-dose regimen of 9-valent recombinant vaccine for the human papilloma virus (HPV) between the ages of 9 and 15 – reports MSD – the immunogenicity was maintained and did not no cases of HPV-related pathology, neoplasia or genital warts developed.
“These data – says Eliav Barr, Senior Vice President, head of global clinical development of MSD and medical director of Merck Research Laboratories – highlight the importance of the 9-valent recombinant vaccine in the long-term prevention of some HPV-related cancers and diseases HPV-related cancers and diseases represent a significant public health problem. These important study findings serve as a reminder that we must do all we can to expand and catch up vaccination rates globally to help protect the population from HPV-related cancers”.
The long-term follow-up data – explains a note – evaluated immune responses, cases of persistent infection and disease (where the virus is not eliminated) and the safety profile in girls and boys aged between 9 and 15 years for 10 years after administration of the third dose of the 9-valent vaccine. In response to the primary objective of immunogenicity, the results showed robust antibody responses to the HPV types present in the vaccine, 10 years after the third dose, in boys and girls. Overall, 100% of participants were HIV positive (cLIA method) at month 7 and 81-98% remained HIV positive at month 126. With the most sensitive method (IgG-LIA), 95-100% of subjects were HIV positive at month 126. For all HPV types included in the 9-valent vaccine, an antibody peak was recorded around month 7 and decreased significantly between months 7 and 12, then more gradually in the following months up to month 126 .
Regarding the secondary objective of the study, the incidence of persistent infections and diseases related to the HPV types covered by the vaccine, among the girls there were no cases of high-grade disease of the HPV types targeted by the vaccine – cervical intraepithelial neoplasia, adenocarcinoma in situ, vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia – and some tumors (cervical, vulvar, vaginal) or external genital warts were not observed. In boys, no cases of disease were observed in the types of HPV targeted by the vaccine (penile intraepithelial neoplasia), penile/perineal/perianal cancer and external genital warts.
During the study – we read in the note – no serious adverse events or deaths related to the nonavalent recombinant vaccine were reported. The most common reasons for LTFU study discontinuation were due to participant withdrawal or loss to follow-up.
HPV – reminds Msd – is by far the most frequent sexually transmitted infection and there is a high potential for infection in the majority of sexually active males and females throughout their lives. Although most infections regress spontaneously, in case of persistence and chronicity the infection can evolve over time into a precancerous lesion and cancer. Globally, cervical cancer is the fourth most common cancer in women. There is no way to know which people with HPV will develop cancer or other health problems. With the exception of cervical cancer, there is no routine recommended screening for HPV-related cancers.
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