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Subjective sexual well-being refers to the cognitive and emotional evaluation of an individual's sexuality. This study examined subjective sexual well-being, explored its various aspects, examined predictors across different cultures, and investigated its possible associations with overall happiness and selected correlates, including sexual dysfunction. Data were drawn from the Global Study of Sexual Attitudes and Behaviors, a survey of 27,500 men and women aged 40-80 years in 29 countries. The cross-national variation of four aspects of sexual well-being (the emotional and physical satisfaction of sexual relationships, satisfaction with sexual health or function, and the importance of sex in one's life) was explored using cluster analysis, and relationships among sexual well-being, general happiness, and various correlates were examined using ordinary least squares regression and ordered logistic regression. Results from the cluster analysis identified three clusters: a gender-equal regime and two male-centered regimes. Despite this cultural variation, the predictors of subjective sexual well-being were found to be largely consistent across world regions. KEY WORDS: subjective well-being; sexual function; happiness; gender roles; cross-national.

: ObjectivesTo measure the prevalence of erectile dysfunction (ED) in community-based populations in Brazil, Italy, Japan, and Malaysia and to study its association with the demographic characteristics, medical conditions, and health-related behavior.: MethodsIn each country, a random sample of approximately 600 men aged 40 to 70 years was interviewed using a standardized questionnaire. All the data were self-reported. ED was assessed by the participants’ “ability to attain and maintain an erection satisfactory for sexual intercourse,” and the men were classified as not having ED if they answered “always” and as having mild, moderate, or complete ED if they answered “usually,” “sometimes,” or “never,” respectively.: ResultsThe age-adjusted prevalence of moderate or complete ED was 34% in Japan, 22% in Malaysia, 17% in Italy, and 15% in Brazil. The overall age-specific prevalence of moderate or complete ED was 9% for men aged 40 to 44 years, 12% for 45 to 49 years, 18% for 50 to 54 years, 29% for 55 to 59 years, 38% for 60 to 64 years, and 54% for those 65 to 70 years. The increased risk of ED was associated with diabetes, heart disease, lower urinary tract symptoms, heavy smoking, and depression and increased by 10% per year of age. It was inversely associated with education, physical activity, and alcohol drinking.: ConclusionsED is an international problem, the prevalence and severity of which increases with age. Despite national variations in prevalence, uniform associations were found between ED and medical conditions and lifestyle habits. [Copyright &y& Elsevier]

Background: Active immunization with the BNT162b2 vaccine (Pfizer-BioNTech) has been a critical mitigation tool against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during the coronavirus disease 2019 (Covid-19) pandemic. In light of reports of waning protection occurring 6 months after the primary two-dose vaccine series, data are needed on the safety and efficacy of offering a third (booster) dose in persons 16 years of age or older., Methods: In this ongoing, placebo-controlled, randomized, phase 3 trial, we assigned participants who had received two 30-μg doses of the BNT162b2 vaccine at least 6 months earlier to be injected with a third dose of the BNT162b2 vaccine or with placebo. We assessed vaccine safety and efficacy against Covid-19 starting 7 days after the third dose., Results: A total of 5081 participants received a third BNT162b2 dose and 5044 received placebo. The median interval between dose 2 and dose 3 was 10.8 months in the vaccine group and 10.7 months in the placebo group; the median follow-up was 2.5 months. Local and systemic reactogenicity events from the third dose were generally of low grade. No new safety signals were identified, and no cases of myocarditis or pericarditis were reported. Among the participants without evidence of previous SARS-CoV-2 infection who could be evaluated, Covid-19 with onset at least 7 days after dose 3 was observed in 6 participants in the vaccine group and in 123 participants in the placebo group, which corresponded to a relative vaccine efficacy of 95.3% (95% confidence interval, 89.5 to 98.3)., Conclusions: A third dose of the BNT162b2 vaccine administered a median of 10.8 months after the second dose provided 95.3% efficacy against Covid-19 as compared with two doses of the BNT162b2 vaccine during a median follow-up of 2.5 months. (Funded by BioNTech and Pfizer; C4591031 ClinicalTrials.gov number, NCT04955626.)., (Copyright © 2022 Massachusetts Medical Society.)

Background: BNT162b2 is a lipid nanoparticle-formulated, nucleoside-modified RNA vaccine encoding a prefusion-stabilized, membrane-anchored severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) full-length spike protein. BNT162b2 is highly efficacious against coronavirus disease 2019 (Covid-19) and is currently approved, conditionally approved, or authorized for emergency use worldwide. At the time of initial authorization, data beyond 2 months after vaccination were unavailable., Methods: In an ongoing, placebo-controlled, observer-blinded, multinational, pivotal efficacy trial, we randomly assigned 44,165 participants 16 years of age or older and 2264 participants 12 to 15 years of age to receive two 30-μg doses, at 21 days apart, of BNT162b2 or placebo. The trial end points were vaccine efficacy against laboratory-confirmed Covid-19 and safety, which were both evaluated through 6 months after vaccination., Results: BNT162b2 continued to be safe and have an acceptable adverse-event profile. Few participants had adverse events leading to withdrawal from the trial. Vaccine efficacy against Covid-19 was 91.3% (95% confidence interval [CI], 89.0 to 93.2) through 6 months of follow-up among the participants without evidence of previous SARS-CoV-2 infection who could be evaluated. There was a gradual decline in vaccine efficacy. Vaccine efficacy of 86 to 100% was seen across countries and in populations with diverse ages, sexes, race or ethnic groups, and risk factors for Covid-19 among participants without evidence of previous infection with SARS-CoV-2. Vaccine efficacy against severe disease was 96.7% (95% CI, 80.3 to 99.9). In South Africa, where the SARS-CoV-2 variant of concern B.1.351 (or beta) was predominant, a vaccine efficacy of 100% (95% CI, 53.5 to 100) was observed., Conclusions: Through 6 months of follow-up and despite a gradual decline in vaccine efficacy, BNT162b2 had a favorable safety profile and was highly efficacious in preventing Covid-19. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)., (Copyright © 2021 Massachusetts Medical Society.)

Background: The background incidence of viscerotropic- (VLD) and neurotropic-like disease (NLD) unrelated to immunization in dengue-endemic countries is currently unknown., Methods: This retrospective population-based analysis estimated crude and standardized incidences of VLD and NLD in twelve hospitals in Brazil (n = 3), Mexico (n = 3), and Malaysia (n = 6) over a 1-year period before the introduction of the tetravalent dengue vaccine. Catchment areas were estimated using publicly available population census information and administrative data. The denominator population for incidence rates was calculated, and sensitivity analyses assessed the impact of important assumptions., Results: Total cases adjudicated as definite VLD were 5, 57, and 56 in Brazil, Mexico, and Malaysia, respectively. Total cases adjudicated as definite NLD were 103, 29, and 26 in Brazil, Mexico, and Malaysia, respectively. Crude incidence rates of cases adjudicated as definite VLD in Brazil, Mexico, and Malaysia were 1.17, 2.60, and 1.48 per 100,000 person-years, respectively. Crude incidence rates of cases adjudicated as definite NLD in Brazil, Mexico, and Malaysia were 4.45, 1.32, and 0.69 per 100,000 person-years, respectively., Conclusions: Background incidence estimates of VLD and NLD obtained in Mexico, Brazil, and Malaysia could provide context for cases occurring after the introduction of the tetravalent dengue vaccine., (Copyright © 2019. Published by Elsevier Ltd.)

Objective: Examine whether glycaemic control varies according to sex and whether the latter plays a role in modifying factors associated with inadequate glycaemic control in patients with type 2 diabetes (T2D) in Brazil and Venezuela., Design, Setting and Participants: This was a cross-sectional, nationwide survey conducted in Brazil and Venezuela from February 2006 to June 2007 to obtain information about glycaemic control and its determinants in patients with diabetes mellitus attending outpatient clinics., Main Outcome Measures: Haemoglobin A1c (HbA1c) level was measured by liquid chromatography, and patients with HbA1c ≥7.0% (53 mmol/mol) were considered to have inadequate glycaemic control. The association of selected variables with glycaemic control was analysed by multivariate linear regression, using HbA1c as the dependent variable., Results: A total of 9418 patients with T2D were enrolled in Brazil (n=5692) and in Venezuela (n=3726). They included 6214 (66%) women and 3204 (34%) men. On average, HbA1c levels in women were 0.13 (95% CI 0.03 to 0.24; p=0.015) higher than in men, after adjusting for age, marital status, education, race, country, body mass index, duration of disease, complications, type of healthcare, adherence to diet, adherence to treatment and previous measurement of HbA1c. Sex modified the effect of some factors associated with glycaemic control in patients with T2D in our study, but had no noteworthy effect in others., Conclusions: Women with T2D had worse glycaemic control than men. Possible causes for poorer glycaemic control in women compared with men include differences in glucose homeostasis, treatment response and psychological factors. In addition, sex modified factors associated with glycaemic control, suggesting the need to develop specific treatment guidelines for men and women., Competing Interests: Competing interests: EDM reports having received grant support through his institution from Pfizer Inc., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: A 9-valent human papillomavirus (HPV6/11/16/18/31/33/45/52/58; 9vHPV) vaccine was developed to expand coverage of the previously developed quadrivalent (HPV6/11/16/18; qHPV) vaccine., Methods: Efficacy, immunogenicity, and safety outcomes were assessed in Latin American participants enrolled in 2 international studies of the 9vHPV vaccine, including a randomized, double-blinded, controlled with qHPV vaccine, efficacy, immunogenicity, and safety study in young women aged 16-26 years, and an immunogenicity and safety study in girls and boys aged 9-15 years. Participants (N=5312) received vaccination at Day 1, Month 2, and Month 6. Gynecological swabs were collected regularly in young women for cytological and HPV DNA testing. Serum was analyzed for HPV antibodies in all participants. Adverse events (AEs) were also monitored in all participants., Results: The 9vHPV vaccine prevented HPV 31-, 33-, 45-, 52-, and 58-related high-grade cervical, vulvar, and vaginal dysplasia with 92.3% efficacy (95% confidence interval 54.4, 99.6). Anti-HPV6, 11, 16, and 18 geometric mean titers at Month 7 were similar in the 9vHPV and qHPV vaccination groups. Anti-HPV antibody responses following vaccination were higher among girls and boys than in young women. Most (>99%) 9vHPV vaccine recipients seroconverted for all 9 HPV types at Month 7. Antibody responses to the 9 HPV types persisted over 5 years. The most common AEs were injection-site related, mostly of mild to moderate intensity., Conclusions: The 9vHPV vaccine is efficacious, immunogenic, and well tolerated in Latin American young women, girls, and boys. These data support 9vHPV vaccination programs in Latin America, a region with substantial cervical cancer burden., (Copyright © 2018 Merck Sharp & Dohme Corp., and The Authors. Published by Elsevier B.V. All rights reserved.)

Background: The immunogenicity profile of the 9-valent HPV (9vHPV) vaccine was evaluated across five phase III clinical studies conducted in girls and boys 9-15 years of age and young women 16-26 years of age. The effect of baseline characteristics of subjects on vaccine-induced HPV antibody responses was assessed., Methods: Immunogenicity data from 11,304 subjects who received ≥1 dose of 9vHPV vaccine in five Phase III studies were analyzed. Vaccine was administered as a 3-dose regimen. HPV antibody titers were assessed 1 month after dose 3 using a competitive Luminex immunoassay and summarized as geometric mean titers (GMTs). Covariates examined were age, gender, race, region of residence, and HPV serostatus and PCR status at day 1., Results: GMTs to all 9 vaccine HPV types decreased with age at vaccination initiation, and were otherwise generally similar among the demographic subgroups defined by gender, race and region of residence. For all subgroups defined by race or region of residence, GMTs were higher in girls and boys than in young women. Vaccination of subjects who were seropositive at day 1 to a vaccine HPV type resulted in higher GMTs to that type, compared with those in subjects who were seronegative for that type at day 1., Conclusions: 9vHPV vaccine immunogenicity was robust among subjects with differing baseline characteristics. It was generally comparable across subjects of different races and from different regions. Greater immunogenicity in girls and boys versus young women (the population used to establish 9vHPV vaccine efficacy in clinical studies) indicates that the anti-HPV responses generated by the vaccine in adolescents from all races or regions were sufficient to induce high-level protective efficacy. This immunogenicity profile supports a widespread 9vHPV vaccination program and early vaccination., (Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.)

Objectives: The overall safety profile of the 9-valent human papillomavirus (9vHPV) vaccine was evaluated across 7 Phase III studies, conducted in males and females (nonpregnant at entry), 9 to 26 years of age., Methods: Vaccination was administered as a 3-dose regimen at day 1, and months 2 and 6. More than 15 000 subjects received ≥1 dose of 9vHPV vaccine. In 2 of the studies, >7000 control subjects received ≥1 dose of quadrivalent HPV (qHPV) vaccine. Serious and nonserious adverse events (AEs) and new medical conditions were recorded throughout the study. Subjects testing positive for pregnancy at day 1 were not vaccinated; those who became pregnant after day 1 were discontinued from further vaccination until resolution of the pregnancy. Pregnancies detected after study start (n = 2950) were followed to outcome., Results: The most common AEs (≥5%) experienced by 9vHPV vaccine recipients were injection-site AEs (pain, swelling, erythema) and vaccine-related systemic AEs (headache, pyrexia). Injection-site AEs were more common in 9vHPV vaccine than qHPV vaccine recipients; most were mild-to-moderate in intensity. Discontinuations and vaccine-related serious AEs were rare (0.1% and <0.1%, respectively). Seven deaths were reported; none were considered vaccine related. The proportions of pregnancies with adverse outcome were within ranges reported in the general population., Conclusions: The 9vHPV vaccine was generally well tolerated in subjects aged 9 to 26 years with an AE profile similar to that of the qHPV vaccine; injection-site AEs were more common with 9vHPV vaccine. Its additional coverage and safety profile support widespread 9vHPV vaccination., (Copyright © 2016 by the American Academy of Pediatrics.)

Background: The investigational 9-valent viruslike particle vaccine against human papillomavirus (HPV) includes the HPV types in the quadrivalent HPV (qHPV) vaccine (6, 11, 16, and 18) and five additional oncogenic types (31, 33, 45, 52, and 58). Here we present the results of a study of the efficacy and immunogenicity of the 9vHPV vaccine in women 16 to 26 years of age., Methods: We performed a randomized, international, double-blind, phase 2b-3 study of the 9vHPV vaccine in 14,215 women. Participants received the 9vHPV vaccine or the qHPV vaccine in a series of three intramuscular injections on day 1 and at months 2 and 6. Serum was collected for analysis of antibody responses. Swabs of labial, vulvar, perineal, perianal, endocervical, and ectocervical tissue were obtained and used for HPV DNA testing, and liquid-based cytologic testing (Papanicolaou testing) was performed regularly. Tissue obtained by means of biopsy or as part of definitive therapy (including a loop electrosurgical excision procedure and conization) was tested for HPV., Results: The rate of high-grade cervical, vulvar, or vaginal disease irrespective of HPV type (i.e., disease caused by HPV types included in the 9vHPV vaccine and those not included) in the modified intention-to-treat population (which included participants with and those without prevalent infection or disease) was 14.0 per 1000 person-years in both vaccine groups. The rate of high-grade cervical, vulvar, or vaginal disease related to HPV-31, 33, 45, 52, and 58 in a prespecified per-protocol efficacy population (susceptible population) was 0.1 per 1000 person-years in the 9vHPV group and 1.6 per 1000 person-years in the qHPV group (efficacy of the 9vHPV vaccine, 96.7%; 95% confidence interval, 80.9 to 99.8). Antibody responses to HPV-6, 11, 16, and 18 were noninferior to those generated by the qHPV vaccine. Adverse events related to injection site were more common in the 9vHPV group than in the qHPV group., Conclusions: The 9vHPV vaccine prevented infection and disease related to HPV-31, 33, 45, 52, and 58 in a susceptible population and generated an antibody response to HPV-6, 11, 16, and 18 that was noninferior to that generated by the qHPV vaccine. The 9vHPV vaccine did not prevent infection and disease related to HPV types beyond the nine types covered by the vaccine. (Funded by Merck; ClinicalTrials.gov number, NCT00543543).

A 9-valent human papillomavirus (6/11/16/18/31/33/45/52/58) VLP (9vHPV) vaccine has recently been proven highly efficacious in preventing disease associated with vaccine HPV types in a pivotal Phase III study. The demonstration of lot-to-lot consistency to confirm the reliability of the manufacturing process is a regulatory requirement for vaccine licensure in the United States. A randomized trial was conducted to demonstrate that three lots of 9vHPV vaccine elicit equivalent antibody response for all 9 vaccine types. The study required thorough planning because it required success on 27 separate statistical comparisons. An innovative statistical approach was used taking into account between-lot variance for more conservative power calculations. The study demonstrated equivalence of three lots of 9vHPV vaccine for all 9 vaccine types.

Purpose: To examine the prevalence of lower urinary tract symptoms (LUTS) and the bother they impose in a population-based sample of adults in Brazil., Methods: A cross-sectional population-based survey was conducted between September 2006 and January 2007 in the city of Salvador, Brazil. Cluster samples of representative households were randomly selected for interviews. A structured questionnaire was administered to men and women aged 30 years or older by trained interviewers. Participants were asked about the presence of individual LUTS using current International Continence Society (ICS) definitions and rated their symptom bother. Those with overactive bladder (OAB) also responded the OAB-Validated 8 and the Patient Perception of Bladder Condition questionnaires., Results: Of 3,616 eligible subjects, 3,000 (83%) participated (1,500 men and 1,500 women). OAB was present in 5.1% of men and in 10% of the women, while the prevalence of any LUTS was 81.5 and 84.1%, respectively. The majority of subjects with OAB, 80% of men and 78% of women, reported some bother associated with their urgency symptoms. Overall, storage symptoms were more common than voiding or postmicturition symptoms. Women reported storage symptoms (76.4%) more frequently than men (67.7%), while the opposite was true for voiding (men 39.7%, women 33.7%) and postmicturition (men 30.9%, women 12.8%)., Conclusions: This is the largest population-based survey of LUTS in Brazil, using the 2002 ICS definitions. LUTS prevalence was high and increased with age among both genders in Brazil, whereas the rates of OAB were somewhat lower than previously reported. The high prevalence of urinary symptoms and the bother commonly associated with them highlight their importance to overall well-being.

A small number of HPV types are related to a majority of HPV-related neoplastic lesions in humans. High-risk types such as HPV 16 and 18 are most often implicated, although other oncogenic and non-oncogenic HPV types can cause disease in men. The efficacy of the quadrivalent HPV vaccine (qHPV) against external genital lesions and intra-anal disease related to HPV in men has been demonstrated. This report examines the vaccine's efficacy against disease due to 10 additional non-vaccine HPV types, as well as efficacy regardless of HPV detection. The data presented suggest that vaccinating males against HPV 6, 11, 16 and 18 protects them against most vaccine HPV-type related anogenital disease. However, significant efficacy against disease due to non-vaccine HPV types was not seen. In addition, the data do not provide any evidence that vaccination with qHPV vaccine will increase the likelihood of disease caused by non-vaccine types in the short term., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Human papillomavirus (HPV) infection can lead to significant disease in males, including anogenital warts, intraepithelial neoplasias, and several types of oral and anogenital cancers. The quadrivalent HPV (type 6/11/16/18) L1 virus-like particle (VLP) vaccine (qHPV vaccine; Gardasil) has recently been demonstrated to prevent persistent infection and associated disease related to vaccine HPV types in males. We report the overall immunogenicity results from a trial of the quadrivalent HPV vaccine in males. Overall, 3,463 heterosexual men and 602 men who had sex with men were enrolled into a randomized, placebo-controlled, double-blind safety, immunogenicity, and efficacy study. Serum samples were collected prior to vaccination at day 1 and at months 7, 24, and 36 postvaccination. Immunogenicity was evaluated with a multiplex, competitive Luminex immunoassay. Almost all subjects (97.4 to 99.2%) seroconverted for vaccine HPV types by month 7. At month 36, 88.9%, 94.0%, 97.9%, and 57.0% of subjects were still seropositive for HPV-6, -11, -16, and -18, respectively. For all vaccine HPV types, black subjects had significantly higher antibody titers at month 7 than did both Caucasian and Asian subjects. An anamnestic antibody response was seen in men seropositive before vaccination. The vaccine was highly immunogenic in males 16 to 23 years of age; responses were comparable to those observed in women. Furthermore, the immune responses were consistent with the established efficacy of the vaccine in the prevention of incident and persistent HPV infection, anogenital warts, and anal intraepithelial neoplasia.

To expand the available panel of recombinant proteins that can be useful for identifying Leishmania-infected dogs and for diagnosing human visceral leishmaniasis (VL), we selected recombinant antigens from L. infantum, cDNA, and genomic libraries by using pools of serum samples from infected dogs and humans. The selected DNA fragments encoded homologs of a cytoplasmic heat-shock protein 70, a kinesin, a polyubiquitin, and two novel hypothetical proteins. Histidine-tagged recombinant proteins were produced after subcloning these DNA fragments and evaluated by using an enzyme-linked immunosorbent assays with panels of canine and human serum samples. The enzyme-linked immunosorbent assays with different recombinant proteins had different sensitivities (67.4-93.0% and 36.4-97.2%) and specificities (76.1-100% and 90.4-97.3%) when tested with serum samples from Leishmania-infected dogs and human patients with VL. Overall, no single recombinant antigen was sufficient to serodiagnosis all canine or human VL cases.

Background: The rate of anal cancer is increasing among both women and men, particularly men who have sex with men. Caused by infection with human papillomavirus (HPV), primarily HPV type 16 or 18, anal cancer is preceded by high-grade anal intraepithelial neoplasia (grade 2 or 3). We studied the safety and efficacy of quadrivalent HPV vaccine (qHPV) against anal intraepithelial neoplasia associated with HPV-6, 11, 16, or 18 infection in men who have sex with men., Methods: In a substudy of a larger double-blind study, we randomly assigned 602 healthy men who have sex with men, 16 to 26 years of age, to receive either qHPV or placebo. The primary efficacy objective was prevention of anal intraepithelial neoplasia or anal cancer related to infection with HPV-6, 11, 16, or 18. Efficacy analyses were performed in intention-to-treat and per-protocol efficacy populations. The rates of adverse events were documented., Results: Efficacy of the qHPV vaccine against anal intraepithelial neoplasia associated with HPV-6, 11, 16, or 18 was 50.3% (95% confidence interval [CI], 25.7 to 67.2) in the intention-to-treat population and 77.5% (95% CI, 39.6 to 93.3) in the per-protocol efficacy population; the corresponding efficacies against anal intraepithelial neoplasia associated with HPV of any type were 25.7% (95% CI, -1.1 to 45.6) and 54.9% (95% CI, 8.4 to 79.1), respectively. Rates of anal intraepithelial neoplasia per 100 person-years were 17.5 in the placebo group and 13.0 in the vaccine group in the intention-to-treat population and 8.9 in the placebo group and 4.0 in the vaccine group in the per-protocol efficacy population. The rate of grade 2 or 3 anal intraepithelial neoplasia related to infection with HPV-6, 11, 16, or 18 was reduced by 54.2% (95% CI, 18.0 to 75.3) in the intention-to-treat population and by 74.9% (95% CI, 8.8 to 95.4) in the per-protocol efficacy population. The corresponding risks of persistent anal infection with HPV-6, 11, 16, or 18 were reduced by 59.4% (95% CI, 43.0 to 71.4) and 94.9% (95% CI, 80.4 to 99.4), respectively. No vaccine-related serious adverse events were reported., Conclusions: Use of the qHPV vaccine reduced the rates of anal intraepithelial neoplasia, including of grade 2 or 3, among men who have sex with men. The vaccine had a favorable safety profile and may help to reduce the risk of anal cancer. (Funded by Merck and the National Institutes of Health; ClinicalTrials.gov number, NCT00090285.).

Background: Prophylactic vaccination with a quadrivalent HPV (types 6, 11, 16, 18) vaccine (qHPV) has been shown to prevent infection with HPV 6/11/16/18 and associated disease in women and more recently, in men. Here we report on the safety and reactogenicity of the qHPV vaccine in males. A total of 4,065 healthy males aged 16-26 years were enrolled into a randomized, placebo-controlled, double-blind trial. Subjects were randomized 1:1 to receive qHPV vaccine or placebo at day 1, month 2, and month 6. Safety and tolerability were assessed via the collection of reported adverse experiences (AEs). All serious AEs (vaccine- or procedure-related or not) and all deaths occurring during the study were recorded. Safety analyses were conducted in all subjects who received at least one dose of vaccine or placebo. The proportion of subjects who reported at least one injection-site AE was higher in the qHPV vaccine group versus the placebo group (60.1% vs 53.7%, respectively), however most of these AEs were mild/moderate in intensity. The incidence of at least one systemic AE was comparable between the vaccine and placebo groups (31.7% vs 31.4%, respectively). There were no vaccine-related serious AEs or deaths. The occurrence of AEs did not increase with each successive injection, and among trial participants who were seropositive for at least one vaccine HPV type at enrollment, the profile of adverse events was similar to that of the entire study cohort. The qHPV vaccine was generally well tolerated in males aged 16-26 years and had a favorable safety profile.

Background: Infection with human papillomavirus (HPV) and diseases caused by HPV are common in boys and men. We report on the safety of a quadrivalent vaccine (active against HPV types 6, 11, 16, and 18) and on its efficacy in preventing the development of external genital lesions and anogenital HPV infection in boys and men., Methods: We enrolled 4065 healthy boys and men 16 to 26 years of age, from 18 countries in a randomized, placebo-controlled, double-blind trial. The primary efficacy objective was to show that the quadrivalent HPV vaccine reduced the incidence of external genital lesions related to HPV-6, 11, 16, or 18. Efficacy analyses were conducted in a per-protocol population, in which subjects received all three vaccinations and were negative for relevant HPV types at enrollment, and in an intention-to-treat population, in which subjects received vaccine or placebo, regardless of baseline HPV status., Results: In the intention-to-treat population, 36 external genital lesions were seen in the vaccine group as compared with 89 in the placebo group, for an observed efficacy of 60.2% (95% confidence interval [CI], 40.8 to 73.8); the efficacy was 65.5% (95% CI, 45.8 to 78.6) for lesions related to HPV-6, 11, 16, or 18. In the per-protocol population, efficacy against lesions related to HPV-6, 11, 16, or 18 was 90.4% (95% CI, 69.2 to 98.1). Efficacy with respect to persistent infection with HPV-6, 11, 16, or 18 and detection of related DNA at any time was 47.8% (95% CI, 36.0 to 57.6) and 27.1% (95% CI, 16.6 to 36.3), respectively, in the intention-to-treat population and 85.6% (97.5% CI, 73.4 to 92.9) and 44.7% (95% CI, 31.5 to 55.6) in the per-protocol population. Injection-site pain was significantly more frequent among subjects receiving quadrivalent HPV vaccine than among those receiving placebo (57% vs. 51%, P<0.001)., Conclusions: Quadrivalent HPV vaccine prevents infection with HPV-6, 11, 16, and 18 and the development of related external genital lesions in males 16 to 26 years of age. (Funded by Merck and others; ClinicalTrials.gov number, NCT00090285.).

Background: We examined the baseline prevalence of penile, scrotal, perineal/perianal, and intra-anal human papillomavirus (HPV) infection in human immunodeficiency virus (HIV)-seronegative men who have sex with men (MSM)., Methods: Data were analyzed from 602 MSM aged 16-27 years with ≤ 5 lifetime sexual partners. Serum samples were tested for antibodies to HPV6/11/16/18. Swab samples were collected separately from several anogenital areas for detection of HPV6/11/16/18/31/33/35/39/45/51/52/56/58/59 DNA., Results: The prevalence of any tested HPV type was 18.5% at the penis, 17.1% at the scrotum, 33.0% at the perineal/perianal region, 42.4% in the anal canal, and 48.0% at any site. Overall, 415 MSM (69.7%) were negative to HPV 6, 11, 16, and 18 at enrollment by both serology and DNA detection. Men residing in Europe and Latin America had significantly increased risk of HPV infection at external genital sites and the anal canal compared to men from Australia. Tobacco use and greater number of lifetime sexual partners was associated with higher HPV infection prevalence., Conclusions: The prevalence of HPV infection is high among young sexually active MSM, with the anal canal being the most common site of infection. Lifetime number of sexual partners was the most important modifiable risk factor for anogenital HPV infection.

Background: We examined the baseline prevalence of penile, scrotal, and perineal/perianal human papillomavirus (HPV) in heterosexual men (HM). We also evaluated baseline characteristics of HM to assess factors associated with prevalent HPV detection., Methods: We tested serum samples from 3463 HM aged 16-24 years with 1-5 lifetime female sexual partners for antibodies to HPV 6, 11, 16, and 18. We collected baseline swab specimens for the detection of DNA of HPV 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59 from 3 areas: penile, scrotal, and perineal/perianal. Risk factors for prevalent HPV DNA detection were evaluated., Results: The prevalence of any tested HPV type was 18.7% at the penis, 13.1% at the scrotum, 7.9% at the perineal/perianal region, and 21.0% at any site. Having >3 lifetime female sexual partners had the greatest impact on HPV prevalence: odds ratio (OR) 3.2 (95% confidence interval (CI) 2.1-4.9) for HPV 6, 11, 16, and 18; and OR 4.5 (95% CI 3.3-6.1) for all HPV types tested. HPV DNA detection was highest in Africa. Neither condom usage nor circumcision was associated with HPV DNA prevalence., Conclusion: Genital-HPV DNA detection is common in young, sexually active HM. We found HPV to be most prevalent in African men and least prevalent in men from the Asia-Pacific region. Increased numbers of sexual partners was an important risk factor for HPV DNA prevalence.

Introduction: Accurate estimates of prevalence/incidence are important in understanding the true burden of male and female sexual dysfunction and in identifying risk factors for prevention efforts. This is the summary of the report by the International Consultation Committee for Sexual Medicine on Definitions/Epidemiology/Risk Factors for Sexual Dysfunction., Aim: The main aim of this article is to provide a general overview of the definitions of sexual dysfunction for men and women, the incidence and prevalence rates, and a description of the risk factors identified in large population-based studies., Methods: Literature regarding definitions, descriptive and analytical epidemiology of sexual dysfunction in men and women were selected using evidence-based criteria. For descriptive epidemiological studies, a Prins score of 10 or higher was utilized to identify population-based studies with adequately stringent criteria. This report represents the opinions of eight experts from five countries developed in a consensus process and encompassing a detailed literature review over a 2-year period., Main Outcome Measures: The study aims to provide state-of-the-art prevalence and incidence rates reported for each dysfunction and stratified by age and gender. Expert opinion was based on the grading of evidence-based medical literature, widespread internal committee discussion, public presentation, and debate., Results: A wealth of information is presented on erectile dysfunction, its development through time, and its correlates. The field is still in need of more epidemiological studies on the other men's sexual dysfunction and on all women's sexual dysfunctions., Conclusions: A review of the currently available evidence from epidemiological studies is provided.

Objective: To evaluate a possible correlation between the International Prostate Symptom Score (IPSS) and the Sexual Health Inventory for Men (SHIM) in an unselected population of men presenting to a clinic, as lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) are highly prevalent in ageing men, and recent largely community-based epidemiological studies reported a close association between ED and LUTS., Patients and Methods: This was a cross-sectional study in an unselected consecutive sample of 118 men aged >40 years attending a urology clinic; the reason for consulting was not ascertained. While in the waiting room the men were asked to participate in the study and on agreement were given the IPSS and the SHIM to complete., Results: The mean (range) age of the participants was 61.7 (45-82) years. Overall, 19 (16%) and 47 (40%) of the men reported having moderate or severe LUTS, respectively. Erectile problems were also common, the prevalence of moderate ED was 11% and complete ED 29%. The Pearson correlation coefficient between the IPSS and the SHIM was - 0.32 (P < 0.001)., Conclusion: There was a close correlation between the IPSS and SHIM in this unselected population of men, adding evidence favouring a close association between LUTS and ED.

Introduction: Although there is considerable interest in the prevalence and impact of sexual problems worldwide, to date only male erectile dysfunction has been studied systematically in Asian countries., Aim: To study the prevalence of sexual problems and associated help-seeking patterns, among mature adults in Korea and to compare the results with those obtained in other Southeast Asian and East Asian countries., Methods: As part of the Global Study of Sexual Attitudes and Behaviors (GSSAB), a survey was conducted in Korea during 2001 and 2002. Sampling was based on an intercept methodology and 1,200 individuals (600 men and 600 women) aged 40-80 years completed the survey out of 3,691 eligible subjects (response rate of 32.5%)., Main Outcome Measures: General health, relationships, and sexual behaviors, attitudes, and beliefs., Results: Ninety-one percent of men and 71% of women had engaged in sexual intercourse during the 12 months preceding the interview. Early ejaculation (33%) and erectile difficulties (32%) were the sexual problems most frequently reported by Korean men; these conditions were more common in Korea than in other Asian regions. Increasing age, physical inactivity, smoking, and prostate disease were significant correlates of erectile difficulties. The sexual problems most frequently reported by women in Korea were lack of sexual pleasure (37%) and inability to reach orgasm (31%). Only 2% of men and women in Korea had talked to a medical doctor about their sexual problems., Conclusions: Middle-aged and older adults in Korea regard sex as an important part of life and report continued sexual activity. Several sexual problems are highly prevalent in this population, but very few individuals seek medical help for these disorders. This is largely due to believing that the problem is not serious, not being bothered by the problem, difficulties regarding access to or affordability of medical care, and/or a lack of awareness of available treatments.

Objectives: To study sexual activity, the prevalence of sexual difficulties and related help-seeking behaviors, among mature adults in Canada., Materials and Methods: A telephone survey (random digit dialed) was conducted in Canada in 2001 to 2002. Interviews were based on a standardized questionnaire, including demographics, general health, relationships, and sexual behaviors, attitudes and beliefs. The survey was completed by a total of 1007 individuals (500 men and 507 women) aged 40 to 80 years in Canada., Results: Overall, 83% of men and 71% of women had engaged in sexual intercourse during the 12 months preceding the interview, and 42% of men and 36% of women engaged in sexual intercourse more than once a week. Early ejaculation (23%) and erectile difficulties (16%) were the sexual problems most frequently reported by men. The sexual problems most frequently reported by women were a lack of sexual interest (30%) and lubrication difficulties (24%). Older age (60 to 80 years compared with 40 to 49 years) and diagnoses of depression and diabetes were all significant predictors of erectile difficulties in men. More than 75% of men and women had sought no help for their sexual problem(s) from a health professional., Conclusions: Many middle aged and older adults in Canada report continued sexual interest and activity. Although a number of sexual problems are highly prevalent in this population, few individuals seek medical help for these problems. This may be partly because they are not sufficiently bothered by the problem or do not think that it is serious.

To study sexual activity, the prevalence of sexual dysfunction and related help-seeking behaviours among mature adults in Spain, a telephone survey was conducted in Spain in 2001-2002. This was completed by 750 men and 750 women aged 40-80 years. Eighty-eight percent of men and 66% of women had engaged in sexual intercourse during the 12 months preceding the interview. Early ejaculation (31%) and lack of sexual interest (17%) were the most common male sexual problems. A lack of sexual interest (36%) and an inability to reach orgasm (28%) were the most common female sexual problems. Approximately 80% of men and women with a sexual problem had not sought help from a health professional. Many men and women in Spain report continued sexual interest and activity into middle age and beyond. Although a number of sexual problems are highly prevalent, few people seek medical help.

The Global Study of Sexual Attitudes and Behaviors was a survey of 27,500 men and women aged 40 to 80 years in 29 countries. Here we report the sexual activity, the prevalence of sexual problems and related help-seeking behaviour among subjects in Germany. A telephone survey was conducted in 2001 and 2002, using a standardised questionnaire covering demographics, general health, relationships, and sexual behaviours, attitudes and beliefs. A total of 1,500 individuals in Germany (750 men and 750 women) completed the survey. Eighty-six percent of men and 66% of women had engaged in sexual intercourse during the year preceding the interview. The most common male sexual problems were early ejaculation (15%), a lack of sexual interest, erectile dysfunction and non-pleasurable sex (each 8%). The most common female sexual problems were a lack of sexual interest (18%), non-pleasurable sex (14%) and lubrication difficulties (13%). Most sexual problems were less common among men and women in Germany than in other European regions. Increasing age was a significant predictor of a lack of sexual interest and erectile difficulties in men. Only 18% of men and 15% of women had talked to a doctor about their sexual problem(s). In conclusion, many middle-aged and older German adults reported continued sexual interest and activity. Overall, sexual problems were less prevalent in Germany compared with other European regions. Of those who experienced sexual problems, however, few had sought medical help. This was often due to a lack of perception of a problem.

Background: Depression and erectile dysfunction (ED) have a complex and bi-directional relationship. We examined the relationships between erectile dysfunction and depressive symptoms or diagnosed depression, sexual activity and sexual satisfaction., Methods: A population survey of men aged 40-70 years was carried out in Brazil, Italy, Japan and Malaysia in 1997-1998. A questionnaire was used to collect life style, sexual behaviors and medical data. Depressive symptoms were assessed using the Center for Epidemiologic Studies Depression Scale. ED was classified as moderate or complete if the men reported they were "sometimes" or "never" able to achieve and maintain an erection satisfactory for sexual intercourse. Only men with a sexual partner and not taking psychoactive drugs were considered., Results: Diagnosed depression was reported by 2.0% of the men, depressive symptoms by 21.0%. The prevalence of moderate or complete ED was 17.8%. Sexual satisfaction related to the frequency of sexual intercourse and inversely related to depressive symptoms. Depressive symptoms were positively associated with being single (odds ratio [OR] 1.7), widowed, separated or divorced (OR 2.2), moderate or complete ED (1.8), heart disease (1.6) and smoking (1.6), and negatively associated with age, physical activity and frequency of sexual intercourse., Limitations: Cross-sectional studies cannot establish a temporal cause-effect relationship. However, the confirmation of known associations reassures about the validity of the original findings., Conclusions: The findings suggest that depressive symptoms are linked to ED by the mediation of decreased sexual activity and the dissatisfaction generated by the inability to have a healthy sexual life.

Despite the wealth of information on the prevalence and correlates of canine Leishmania infection (CLI), data on its incidence are still sparse, and little is known regarding risk factors for CLI. We studied a cohort of dogs in an urban area in Brazil to determine whether incidence varied with age, breed, and environmental characteristics. The mean follow-up was 1.5 years, and the crude incidence rate was 11.8 cases/100 dog-years (95% confidence interval [CI] = 8.6-15.6). In the multivariate analysis, short fur was the strongest predictor of CLI (relative risk [RR] = 9.4). In addition, our data indicate that raising pigs (RR = 4.1), chickens (RR = 3.3), or other livestock (RR = 2.6) significantly increased the risk of CLI. Thus, suggesting control measures directed towards modifying the environmental factors favoring contact between vectors, reservoirs, and susceptible humans, such as proximity to pigpens or hen houses. Furthermore, conventional control programs of insecticidal spraying of human dwellings should also apply insecticide in and around animal sheds.