Efficacy, safety, and immunogenicity of a quadrivalent HPV vaccine in Japanese men: A randomized, Phase 3, placebo-controlled study

Mikamo, Hiroshige; Yamagishi, Yuka; Murata, Shinichi; Yokokawa, Ruriko; Han, Shi Rong; Wakana, Akira; Sawata, Miyuki; Tanaka, Yoshiyuki

doi:10.1016/j.vaccine.2019.01.069

Cited by 36 publications

(37 citation statements)

References 24 publications

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“…Since April 2013, HPV vaccinations have been recommended for girls aged 13 to 16 years in Japan; the aggressive recommendation of HPV vaccinations had been withheld for 10 weeks because adverse events, such as a long-term pain, numbness, and autoimmune diseases, had occurred in some vaccinated girls [28]. The efficacy and safety of HPV vaccination for Japanese males has been revealed in clinical trial recently [29]. Therefore, gender-neutral vaccination should be recommended in our society.…”

Section: Resultsmentioning

confidence: 99%

Prevalence, Genotype Distribution, and Predictors against HPV Infections Targeted by 2-, 4-, 9-Valent HPV Vaccines among Japanese Males

et al. 2020

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Objectives: Epidemiological reports of sexual life and human papilloma virus (HPV) infection among Japanese men are scarce, and the necessity of HPV vaccines for males is regarded as a controversial topic in Japan. The objective of this study is to determine the prevalence, genotype distribution, and risk factors against HPV infections targeted by bivalent (2v), quadrivalent (4v), and 9-valent (9v) HPV vaccines among Japanese male patients who visited our urological clinics. Material and Methods: The study population consisted of 798 males aged 20 to 95 years (mean ± standard deviation, 55.4 ± 19.5 years). We collected scraping samples from the glans penis using cotton swabs from all patients for genotyping of HPVs. We compared patients’ characteristics and detected HPV genotypes in order to determine the risk factors against HPV infections. Results: Of 798 participants, 198 participants (198/798; 24.8%) had at least one genotype of any HPV infection. The total number of detected HPV genotypes was 328. Of 328 genotypes, 30% (n = 99; 99/328) were 9v HPV genotypes. Most frequently detected types of high-risk HPV infection were type 52 (n = 40; 40/328; 12.2%). Number of lifetime sex partners (≥21) and present or history of sexually transmitted infections were found to be predictors of any HPV infection with adjusted odds ratios of 3.106 (95% confidence interval (CI), 1.593–6.509) and 1.894 (95% CI, 1.185–3.026), respectively. Age of sex initiation was a predictor of 2v and 4v HPV infections with adjusted odds ratios of 100 (95% CI, 1.013–25.673) and 2.676 (95% CI, 1.037–6.905), respectively. Number of lifetime sex partners (≥21) was a predictor of 9v HPVs with adjusted odds ratios of 2.397 (95% CI, 1.060–5.424). Conclusions: Approximately, a quarter of Japanese male patients who visited urological clinics were exposed to HPV. Moreover, from the perspective of our multivariate logistic regression analysis, some kinds of sexual behavior aggravate the risk of typical HPV genotypes infections.

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Section: Resultsmentioning

confidence: 99%

Prevalence, Genotype Distribution, and Predictors against HPV Infections Targeted by 2-, 4-, 9-Valent HPV Vaccines among Japanese Males

et al. 2020

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“…We included RCTs and time-trend ecological studies which assessed the effectiveness of the quadrivalent HPV vaccine in the frequency (incidence/prevalence) of GW. In the RCTs, HPV vaccines were administered only to females, except one RCT, where Japanese males were received HPV vaccine or placebo [16]. Similarly to most of included RCTs, only women were vaccinated in ecological studies, but the whole population were included because the researchers examined the indirect effect of the vaccine on men as wellexcept in one study [17], where only females were involved.…”

Section: Search Strategy and Selection Criteriamentioning

confidence: 99%

“…Altogether 8 randomised, double-blind, placebocontrolled studies were included in our final quantitative analysis [16,[20][21][22][23][24][25][26]. Healthy, non-pregnant women aged between 15 and 26 years with no history of abnormal Pap smear at enrolment were included in seven RCTs, who reported no more than 4 lifetime sexual partners except the Finnish women in Munoz's study [24] where this restriction was not applied.…”

Section: Characteristics Of the Included Studiesmentioning

confidence: 99%

“…The total number of enrolled women was 20,416 in the vaccinated group and 20,279 in the placebo group. In the Japanese RCT [16] 561 males were in the vaccinated group and 562 males were received placebo. The mean age of the participants is shown in Table 1.…”

Section: Characteristics Of the Included Studiesmentioning

confidence: 99%

“…By achieving high vaccination coverage (> 80%) in girls, the risk of HPV infection for boys can also be reduced and its elimination could also be achieved [12]. Moreover, the quadrivalent vaccine has also been found to be highly effective in preventing genital lesions associated with infection with HPV 6,11,16,or 18 in men [13]. Therefore, several countries, such as the United States of America (USA), Australia, Switzerland, Austria, and Canada, have started to vaccinate boys as well as the quadrivalent vaccination prevents genital cancers and GW in both males and females.…”

Section: Introductionmentioning

confidence: 99%

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The quadrivalent HPV vaccine is protective against genital warts: a meta-analysis

et al. 2020

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Background: The quadrivalent human papillomavirus (HPV) vaccine has been assumed to give protection against genital warts (GW) as well as cervical cancer. Our main question was whether HPV vaccine has any effects on the prevention of GW reported in randomised controlled clinical trials (RCTs) and time-trend analyses. Methods: This meta-analysis was performed according to the PRISMA guidelines using the PICO format. We searched in three electronic databases (PubMed, Embase, Cochrane Trials), and assessed heterogeneity using the Q-test and Isquared statistics, meta-regression was also performed. Odds ratios (OR) and their confidence intervals (CI) were calculated. The sensitivity was tested by leave-one-out method. We evaluated the presence of publication bias using the funnel plot graph and the Copas selection model. The strength of evidence was assessed using the GRADE approach. Results: Eight RCTs (per-protocol populations) and eight time-trend ecological studies were included in this meta-analysis. A significant reduction (pooled OR = 0.03, 95% CI: 0.01-0.09; I-squared = 53.6%) of GW in young women was recorded in RCTs, and in time-trend analyses both in young women (pooled OR = 0.36, CI 95% = 0.26-0.51; I-squared = 98.2%), and in young men (pooled OR = 0.69, 95% CI = 0.61-0.78; I-squared = 92.7%). In subgroup analysis, a significant reduction of the number of GW events was observed especially in women under 21 years (pooled OR = 0.33, 95% CI = 0.17-0.63). Leave-one-out analysis showed that similar results could be obtained after excluding one study, meta-regression did not show significant difference. Conclusions: Prophylactic, quadrivalent HPV vaccination can prevent GW in healthy women and men, therefore, it should be included in routine immunization programme.

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Headache After Vaccination: An Update on Recent Clinical Trials and Real-World Reporting

Garces

Cocores

Goadsby

et al. 2022

Curr Pain Headache Rep

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Purpose of Review The aim of this review is to characterize headache as a vaccine adverse event (VAE) in clinical trials. Recent Findings Of the recent phase III vaccine RCTs (non-COVID-19), 53 studies reported on headache (13 infectious agents). The median rate (interquartile range) of headache was 15.6% ( IQR : 9.6–37.6%). Of these, 24.5% of the RCTs reported headache greater in the vaccine group compared to the placebo/control group. In the herpes zoster vaccination trials, headache was more common in all active groups: median rate 33.9% ( IQR : 29.7–40.5%) as compared to placebo: median rate 17.7% ( IQR : 15.4–23.8%). Influenza and HPV vaccination trials were the 2nd and 3rd most common to have headache as a VAE. Of the 6 widely distributed COVID-19 vaccinations, median rate of post-vaccination headache was 39% ( IQR : 28–50%). Summary Headache is a common VAE in vaccine trials. Standardized grading methods, predictors of persistence, and treatment regimens are warranted.

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Efficacy, safety, and immunogenicity of a quadrivalent HPV vaccine in Japanese men: A randomized, Phase 3, placebo-controlled study

Cited by 36 publications

References 24 publications

Prevalence, Genotype Distribution, and Predictors against HPV Infections Targeted by 2-, 4-, 9-Valent HPV Vaccines among Japanese Males

Prevalence, Genotype Distribution, and Predictors against HPV Infections Targeted by 2-, 4-, 9-Valent HPV Vaccines among Japanese Males

The quadrivalent HPV vaccine is protective against genital warts: a meta-analysis

Headache After Vaccination: An Update on Recent Clinical Trials and Real-World Reporting

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