Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial

Goldstone, Stephen E.; Giuliano, Anna R.; Palefsky, Joel M.; Lazcano‐Ponce, Eduardo; Penny, Mary E.; Cabello, Robinson; Moreira, Edson Duarte; Baraldi, Ezio; Jessen, Heiko; Ferenczy, Alex; Kurman, Robert J.; Ronnett, Brigitte M.; Stoler, Mark H.; Bautista, Oliver; Das, Rituparna; Group, Thomas; Luxembourg, Alain; Zhou, Hanhan; Saah, Alfred J.

doi:10.1016/s1473-3099(21)00327-3

Cited by 62 publications

(70 citation statements)

References 34 publications

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“…12–15 Several studies have shown that HPV vaccination effectively prevents preventing anal, penile, and oral HPV infection in MSM. 16–18 The HPV vaccine is promoted only in women in most countries. Therefore, MSM who do not receive indirect protection from vaccination can only be protected by being vaccinated.…”

Section: Introductionmentioning

confidence: 99%

Factors influencing HPV vaccination willingness among men who have sex with men in China: a structural equation modeling analysis

Pan

Lin

et al. 2022

Human Vaccines & Immunotherapeutics

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Men who have sex with men (MSM) are at high risk of infection with human papillomavirus (HPV). Some countries have incorporated MSM into their HPV vaccination strategies. The acceptance of the HPV vaccine is an important factor affecting vaccine promotion in MSM. This study aims to analyze the factors influencing HPV vaccination willingness among MSM in China. Non-probability sampling was used to recruit MSM in China in June 2021. The information collected included demographic characteristics, HPV knowledge, attitude, behavior, history of sexually transmitted diseases (STDs), and HPV vaccination intention. A structural equation model was used to analyze the data based on the theory of knowledge-attitude-behavior. Among 889 participants, 736 (82.79%) of the MSM were willing to receive the HPV vaccine. The results of the structural equation model showed that knowledge, attitude, behavior, and STD history influenced the vaccination intention, of which knowledge (total effect of .36) and attitude (total effect of .31) had the greatest influence. Since most MSM in China were willing to be vaccinated against HPV, they should be considered for inclusion in the HPV vaccination program. Enhancing HPV awareness and improving risk awareness may be useful in increasing the vaccination willingness of MSM in China.

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Section: Introductionmentioning

confidence: 99%

Factors influencing HPV vaccination willingness among men who have sex with men in China: a structural equation modeling analysis

Pan

Lin

et al. 2022

Human Vaccines & Immunotherapeutics

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“…NCT00090285 trial [47] is an open-label, long-term follow-up extension multicentre study conducted at 46 centers in 16 countries. After the P020 and P020-11 trial [46,59], participants who had received at least one dose of the 4-valent HPV vaccine in the previous study were defined as the early vaccination group.…”

Section: Menmentioning

confidence: 99%

Long-Term Effects of Human Papillomavirus Vaccination in Clinical Trials and Real-World Data: A Systematic Review

et al. 2022

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The preventive effect of HPV vaccines against anogenital and oropharyngeal cancers has been proven in both clinical trials and real-world data. We reviewed the published evidence about the long-term efficacy and effectiveness of the HPV vaccine in available papers of clinical trials and real-world data. As far as we searched, the longest period of preventive effect for the bivalent, 4-valent, and 9-valent vaccine were 11 years in the Costa Rica trial, 14 years in the FUTURE II, and 8 years in the LTFU extension study of V503-002 and the Scandinavian study, respectively. The sustained clinical effect during the observation period was longest for the 4-valent vaccine. In real-world data, the longest observation period of the vaccine effectiveness was 12 years in an Australian study for the 4-valent vaccine. On the other hand, the longest period of long-term persistence of HPV vaccine-induced seropositivity was 14 years in FUTURE II for the 4-valent vaccine. For the bivalent vaccine, additional long-term follow-up studies may not have been planned due to the launch of the 4-valent and 9-valent vaccines. In some studies of the 9-valent vaccine, the results have not yet been published because of the short observation period. The additional results are expected in the future. In a national immunization program, most girls and boys are inoculated with HPV vaccine by the time puberty begins; thus, it is important to monitor the vaccine effect at least until the sexually active period in their 20s and 30s.

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“…This follow-up study of a 3-year international, randomised trial of the quadrivalent human papillomavirus (HPV) vaccine investigated the durability of protection in men aged 16-26 years at the time of vaccination. 4 Ten years on, compared with placebo, there were no new HPV 6-related or HPV 11-related cases of external genital warts (0.0 incidence per 10 000 personyears (95% CI 0.0 to 8.7) vs 137.3 (95% CI 83.9 to 212.1)), or external genital lesions related to HPV 6, 11, 16 or 18 (0.0 (95% CI 0.0 to 7.7) vs 140.4 (95% CI 89.0 to 210.7)). Among men who have sex with men, the incidence of anal intraepithelial neoplasia or anal cancer related to HPV 6, 11, 16 or 18 was 20.5 (0.5-114.4) vs 906.2 (553.5-1399.5).…”

Section: Quadrivalent Hpv Vaccine Offers Long-term Protection From Di...mentioning

confidence: 99%

Research news in clinical context

Tan¹,

Daskalopoulou

Thomson-Glover

2022

Sex Transm Infect

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Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial

Cited by 62 publications

References 34 publications

Factors influencing HPV vaccination willingness among men who have sex with men in China: a structural equation modeling analysis

Factors influencing HPV vaccination willingness among men who have sex with men in China: a structural equation modeling analysis

Long-Term Effects of Human Papillomavirus Vaccination in Clinical Trials and Real-World Data: A Systematic Review

Research news in clinical context

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