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▎ WuXi AppTec content team editors worldwide, there are about 70,000 cases of human papillomavirus (HVP) cancers every year, including penis, anus, oropharyngeal cancer and other head and neck cancers, which are more common in men
.
So, can men get HPV vaccine to prevent related infections? What is the efficacy and safety? A randomized, placebo-controlled Phase 3 trial aimed at men aged 16-26 to assess the effectiveness, immunogenicity, and safety of the quadrivalent HPV vaccine for men explored this
.
Recently, the test results were published in The Lancet Infectious Diseases, revealing to us that in men, the quadrivalent human papillomavirus (HPV) vaccine can prevent HPV 6, 11, 16 and 18 Related infections and lesions
.
Screenshot source: The Lancet Infectious Diseases This phase 3 trial lasted 10 years and is an international, multi-center, double-blind, randomized, placebo-controlled trial
.
Among them, basic research lasts for 3 years and is carried out in 71 centers in 18 countries and regions
.
Eligible participants are: heterosexual men (16-23 years old) or men who have sex with men (MSM; 16-26 years old)
.
In the pre-study screening, men who detected anogenital warts or genital lesions, suggesting that they were infected with non-HPV sexually transmitted diseases, or had a history of such diseases, were excluded
.
Participants were randomly assigned (1:1) to receive the quadrivalent HPV vaccine or placebo on the first day, the second month, and the sixth month.
A total of 3 doses of 0.
5 mL each were given
.
Image source: 123RF During the period from August 10, 2010 to April 3, 2017, the study conducted a 7-year open-label long-term follow-up extension study, involving 1803 participants, 46 in 16 countries/regions Centers
.
The criteria for participating in the long-term follow-up study are: Early vaccination group: In the basic study, 936 participants received one or more doses of the quadrivalent HPV vaccine, including 827 heterosexual men and 109 MSM
.
Supplemental vaccination group: At the end of the basic study, the placebo group had 867 participants who had received one or more doses of the quadrivalent HPV vaccine, including 739 heterosexual men and 128 MSM
.
The main efficacy endpoints of the study are: among all participants: the incidence of external genital warts related to HPV 6 or 11, and the incidence of external genital warts related to HPV 6, 11, 16 or 18; among the MSM population: and The incidence of anal intraepithelial neoplasia (including anal warts and flat lesions) and anal cancer associated with HPV 6, 11, 16, or 18
.
At the same time, safety assessments were conducted on all participants who received at least one dose of the vaccine
.
▲The incidence of HPV-related external genital and anal diseases of the 16-26-year-old vaccinated men who participated in the long-term follow-up study, whether they were vaccinated early (936 people) or supplementary vaccinations (867 people), decreased (Source: Reference [2]) After the third dose of the quadrivalent HPV vaccine, the median follow-up time of participants in the early vaccination group was 9.
5 years, and the median follow-up time of participants in the revaccination group was 4.
7 years
.
Compared with the placebo group in the basic research, the participants in the early vaccine group with long-term follow-up had much lower incidences of multiple HPV-related: the incidence of external genital warts related to HPV 6 or 11 was per 10,000 person-years 0.
0 (95% CI 0.
0 –8.
7) and 137.
3 (83.
9 – 212.
1); external genital disease related to HPV 6, 11, 16 or 18, the incidence rate per 10,000 person-years is 0.
0 (0.
0-7.
7) and 140.
4 (89.
0) -210.
7); Anal intraepithelial neoplasia or anal cancer related to HPV 6, and only MSM with HPV 11, 16 or 18 has an annual incidence of 20.
5 (0.
5-114.
4) and 906.
2 (553.
5-1399.
5) per 10,000 persons
.
Compared with before the quadrivalent HPV vaccine (that is, during the basic research period), during the long-term follow-up period, participants in the revaccination group also had fewer associated lesions
.
There are no new reports of external genital warts related to HPV 6 or 11 or external genital lesions related to HPV 6, 11, 16 or 18; anal intraepithelial neoplasia or anal cancer related to HPV 6, 11, 16 or 18 The incidence is low
.
In terms of safety, no serious adverse events related to the vaccine have been reported
.
Studies have shown that the quadrivalent HPV vaccine can provide long-lasting protection against anogenital diseases related to HPV 6, 11, 16 and 18, and is safe and reliable
.
Therefore, men can prevent HPV infection by vaccinating the quadrivalent HPV vaccine, or revaccinating (previously vaccinated)
.
Related reading "The Lancet-Infectious Diseases": HPV vaccine for men, related infections reduced by 52%-76%, early HPV vaccine, 87% reduction of cervical cancer! The latest research of "The Lancet" hand in the transcript! "The Lancet" sub-published 850,000 data: Will HPV vaccine increase the risk of other diseases? How effective is the HPV vaccine given to "overage"? The latest consensus of China's application experts: All your doubts are given here for girls of the right age to get HPV vaccine, and China will reduce 90% of cervical cancer in the future! The International Agency for Cancer Research emphasizes the benefit of key population reference materials[1] deMartel C, Georges D, Bray F, Ferlay J, Clifford GM.
Global burden of cancerattributable to infections in 2018: a worldwide incidence analysis.
Lancet GlobHealth 2020; 8: e180 –90.
[2] Stephen E Goldstone, Anna R Giuliano,Joel M Palefsky, et al.
,(2021).
Efficacy, immunogenicity, and safety of aquadrivalent HPV vaccine in men: results of an open-label, long-term extensionof a randomised, placebo-controlled, phase 3 trial.
The Lancet InfectiousDiseases.
DOI: https://doi.
org/10.
1016/S1473-3099(21)00327-3 Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health Research progress
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a recommended treatment plan
.
If you need guidance on treatment plans, please go to a regular hospital for treatment
.
.
So, can men get HPV vaccine to prevent related infections? What is the efficacy and safety? A randomized, placebo-controlled Phase 3 trial aimed at men aged 16-26 to assess the effectiveness, immunogenicity, and safety of the quadrivalent HPV vaccine for men explored this
.
Recently, the test results were published in The Lancet Infectious Diseases, revealing to us that in men, the quadrivalent human papillomavirus (HPV) vaccine can prevent HPV 6, 11, 16 and 18 Related infections and lesions
.
Screenshot source: The Lancet Infectious Diseases This phase 3 trial lasted 10 years and is an international, multi-center, double-blind, randomized, placebo-controlled trial
.
Among them, basic research lasts for 3 years and is carried out in 71 centers in 18 countries and regions
.
Eligible participants are: heterosexual men (16-23 years old) or men who have sex with men (MSM; 16-26 years old)
.
In the pre-study screening, men who detected anogenital warts or genital lesions, suggesting that they were infected with non-HPV sexually transmitted diseases, or had a history of such diseases, were excluded
.
Participants were randomly assigned (1:1) to receive the quadrivalent HPV vaccine or placebo on the first day, the second month, and the sixth month.
A total of 3 doses of 0.
5 mL each were given
.
Image source: 123RF During the period from August 10, 2010 to April 3, 2017, the study conducted a 7-year open-label long-term follow-up extension study, involving 1803 participants, 46 in 16 countries/regions Centers
.
The criteria for participating in the long-term follow-up study are: Early vaccination group: In the basic study, 936 participants received one or more doses of the quadrivalent HPV vaccine, including 827 heterosexual men and 109 MSM
.
Supplemental vaccination group: At the end of the basic study, the placebo group had 867 participants who had received one or more doses of the quadrivalent HPV vaccine, including 739 heterosexual men and 128 MSM
.
The main efficacy endpoints of the study are: among all participants: the incidence of external genital warts related to HPV 6 or 11, and the incidence of external genital warts related to HPV 6, 11, 16 or 18; among the MSM population: and The incidence of anal intraepithelial neoplasia (including anal warts and flat lesions) and anal cancer associated with HPV 6, 11, 16, or 18
.
At the same time, safety assessments were conducted on all participants who received at least one dose of the vaccine
.
▲The incidence of HPV-related external genital and anal diseases of the 16-26-year-old vaccinated men who participated in the long-term follow-up study, whether they were vaccinated early (936 people) or supplementary vaccinations (867 people), decreased (Source: Reference [2]) After the third dose of the quadrivalent HPV vaccine, the median follow-up time of participants in the early vaccination group was 9.
5 years, and the median follow-up time of participants in the revaccination group was 4.
7 years
.
Compared with the placebo group in the basic research, the participants in the early vaccine group with long-term follow-up had much lower incidences of multiple HPV-related: the incidence of external genital warts related to HPV 6 or 11 was per 10,000 person-years 0.
0 (95% CI 0.
0 –8.
7) and 137.
3 (83.
9 – 212.
1); external genital disease related to HPV 6, 11, 16 or 18, the incidence rate per 10,000 person-years is 0.
0 (0.
0-7.
7) and 140.
4 (89.
0) -210.
7); Anal intraepithelial neoplasia or anal cancer related to HPV 6, and only MSM with HPV 11, 16 or 18 has an annual incidence of 20.
5 (0.
5-114.
4) and 906.
2 (553.
5-1399.
5) per 10,000 persons
.
Compared with before the quadrivalent HPV vaccine (that is, during the basic research period), during the long-term follow-up period, participants in the revaccination group also had fewer associated lesions
.
There are no new reports of external genital warts related to HPV 6 or 11 or external genital lesions related to HPV 6, 11, 16 or 18; anal intraepithelial neoplasia or anal cancer related to HPV 6, 11, 16 or 18 The incidence is low
.
In terms of safety, no serious adverse events related to the vaccine have been reported
.
Studies have shown that the quadrivalent HPV vaccine can provide long-lasting protection against anogenital diseases related to HPV 6, 11, 16 and 18, and is safe and reliable
.
Therefore, men can prevent HPV infection by vaccinating the quadrivalent HPV vaccine, or revaccinating (previously vaccinated)
.
Related reading "The Lancet-Infectious Diseases": HPV vaccine for men, related infections reduced by 52%-76%, early HPV vaccine, 87% reduction of cervical cancer! The latest research of "The Lancet" hand in the transcript! "The Lancet" sub-published 850,000 data: Will HPV vaccine increase the risk of other diseases? How effective is the HPV vaccine given to "overage"? The latest consensus of China's application experts: All your doubts are given here for girls of the right age to get HPV vaccine, and China will reduce 90% of cervical cancer in the future! The International Agency for Cancer Research emphasizes the benefit of key population reference materials[1] deMartel C, Georges D, Bray F, Ferlay J, Clifford GM.
Global burden of cancerattributable to infections in 2018: a worldwide incidence analysis.
Lancet GlobHealth 2020; 8: e180 –90.
[2] Stephen E Goldstone, Anna R Giuliano,Joel M Palefsky, et al.
,(2021).
Efficacy, immunogenicity, and safety of aquadrivalent HPV vaccine in men: results of an open-label, long-term extensionof a randomised, placebo-controlled, phase 3 trial.
The Lancet InfectiousDiseases.
DOI: https://doi.
org/10.
1016/S1473-3099(21)00327-3 Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health Research progress
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a recommended treatment plan
.
If you need guidance on treatment plans, please go to a regular hospital for treatment
.
