Merck & Co, Inc.

No abstract

BackgroundA 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.MethodsEfficacy, 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.ResultsThe 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.ConclusionsThe 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.

Background: COVID–19 is still a challenge, both with regard to its treatment and to the actual efficacy of the vaccines available to date, especially with the emergence of new variants. We evaluated the efficacy of the measles–mumps–rubella (MMR) vaccine in preventing SARS–CoV–2 infection and severity of COVID–19 in health workers. Methods: This analysis includes data from one ongoing blinded, randomized, placebo–controlled trial with participants aged 18–60 years were randomly assigned to receive the MMR vaccine or a placebo. The primary efficacy analysis included all participants with a positive nasopharyngeal RT–PCR test since their inclusion. Results: The MMR vaccine did not prevent the SARS–CoV–2 infection. Participants in the MMR group, compared with those in the placebo group, had a 48% risk reduction in symptomatic COVID–19 (RR = 0.52; 95% CI: 0.33-0.83; p=0.004) and a 76% risk reduction in COVID–19 treatment (RR = 0.24; 95% CI: 0.06-0.88; p = 0.020) with one dose and a 51% risk reduction in COVID–19 symptoms (RR = 0.49; 95% CI: 0.31 – 0.78; p = 0.001) and a 78% risk reduction in COVID–19 treatment (RR = 0.22; 95% CI: 0.06-0.82; p = 0.015) with two doses. Conclusions: This interim analysis of an ongoing clinical trial suggests that compared with a placebo, the vaccine reduces the risk of COVID–19 symptoms and reduces the need for COVID–19 treatment.

Introduction: HPV infection is the most prevalent sexually transmitted disease worldwide. The disease induced by this virus is dependent on several other factors that affect the host. The main factor is immunosuppression, mainly associated with HIV infection. Objective: research the presence of HPV infection (HPV DNA) in a group of HIV positive women and compare it with the HIV negative women group; analyse the prevalence of viral groups of oncogenic high-risk, low-risk; the relation between these findings to socioeconomic, demographic and behavioural characteristics, as well as variables related to HIV infection, such as CD4 level, viral load and HAART use. Methods: a total of 20 HIV positive and 99 HIV negative women were enrolled in a crosssectional and descriptive study, where genital samples were analysed by the hybrid capture method for detection of HPV DNA. Other data from charts and from a questionnaire have been collected from the patients. Results: the prevalence of HPV infection was 70% among the HIV positive group, and 21.2% among the HIV negative group. High-risk HPV was found in 71.4% of HPV positive cases of both groups, and both viral types were found in 35.7% of HIV positive women. HPV infection was associated with age above 35 years, low education level, CD4 between 200 to 500 cells/mm 3 , and HAART use in HIV positive women. Other variables studied did not show any association with HPV infection. Conclusion: the prevalence of HPV was about 3.3 times higher among HIV positive women, and high-risk HPV types were the most prevalent virus.

To determine the relationship between human papillomavirus (HPV) and endometrial carcinogenesis by comparing data from women with endometrial carcinoma to those of women with normal endometrial tissue. The survey was conducted for 100 women (50 with endometrial carcinoma and 50 with normal endometrial tissue) through HPV-DNA testing of paraffin-embedded endometrial tissue sections by polymerase chain reaction. Age, cigarette consumption, squamous differentiation and tumor grade, endometrium trophism, and HPV types detected in endometrial tissues were studied. HPV estimated odds ratio was similar in endometrial carcinoma and in normal endometrial tissue. The presence of HPV was not associated with age, tobacco abuse, endometrial histology status, squamous differentiation, or tumoral grade. DNA sequences of HPV types 16 and 18 were the most frequently detected in both groups. An association between HPV and endometrial carcinoma was not observed.

Introduction:Human papillomavirus (HPV) is the most commonly diagnosed sexually transmitted infection worldwide. It is estimated that 70% of cervical cancer cases are related to high-risk HPV 16 and 18 types; and 90% of genital warts to HPV 6 and 11. Despite its prevalence and significant associated morbidity, the knowledge about the infection and its prevention remain limited. Objective: To evaluate the knowledge about HPV, its relation to cervical cancer and genital warts and the HPV vaccine among students of The Federal University of Santa Catarina and employees of local health units in the city of Florianópolis, Santa Catarina, Brazil. Methods: A descriptive cross-sectional analysis with 136 college students from the health care area or not and 77 employees from local health units, assessed through questionnaires including demographic data, lifestyle habits, characteristics of HPV infection and HPV vaccine. Data were analyzed using IBM software programs SPSS 20.0 and Epi Info 6.04, and the possible associations between variables were tested using the χ 2 test. Results: 94,3% of participants reported knowledge about HPV, and 77,93% about HPV vaccine. HPV was identified as causing cervical cancer by 67,86% of the subjects in school, 55,22% of individuals from higher education without training in health and 94,91% of individuals with training in health. Only 3,75% of the respondents received the vaccine, despite 90,61% saying that would allow their child to receive it. Conclusion: Knowledge about HPV infection, its consequences and prevention, both in people in school and in higher education is still very limited. Keywords: Papillomaviridae; Papillomavirus vaccines; Papillomavirus infections; public health. RESUMO Introdução:O papilomavírus humano (HPV) é a infecção sexualmente transmissível mais diagnosticada em todo o mundo. Estima-se que 70% dos casos de câncer cervical estejam relacionados aos tipos de HPV de alto risco 16 e 18 e 90% das verrugas genitais aos tipos 6 e 11. A despeito de sua grande incidência e da importante morbidade associada, o conhecimento sobre a infecção e sobre suas formas de prevenção permanecem limitados. Objetivo: Avaliar o conhecimento sobre o HPV, sua relação com o câncer de colo de útero e verrugas genitais e sobre a vacina contra o HPV, entre estudantes da Universidade Federal de Santa Catarina e funcionários de unidades locais de saúde do município de Florianópolis. Métodos: Trata-se de um estudo transversal e descritivo, no qual 136 universitários da área da saúde ou não e 77 funcionários de unidades locais de saúde foram avaliados através de questionários incluindo dados demográficos, hábitos de vida, características da infecção pelo HPV e da vacina contra o HPV. Os dados foram analisados com o uso dos programas IBM Software SPSS 20.0 e Epi Info 6.04 e as possíveis associações entre as variáveis foram verificadas com o teste do χ 2 . Resultados: 94,3% dos participantes afirmaram conhecimento sobre o HPV e 77,93% sobre a vacina contra o HPV. O HPV foi identificado co...

Background: This exploratory analysis was conducted to characterize the level of HPV types 6/11 antibodies in peripartum maternal blood and in cord blood of infants born to women who received 9-valent HPV (9vHPV) vaccine or quadrivalent HPV (qHPV) vaccine in a pivotal efficacy study (V503-001, NCT 00543543). Methods: A total of 21 mother-infant pairs had evaluable HPV 6/11 results available for analysis. HPV6/ 11 antibodies were assessed using competitive Luminex immunoassay. The distribution of the ratios of infant to mother anti-HPV antibodies (i.e., infant-anti-HPV/mother-anti-HPV) was summarized. Results: All mothers and infants were seropositive to HPV 6 and HPV 11. Anti-HPV 6/11 geometric mean titers (GMTs) in peripartum maternal blood and in cord blood of infant born to study participants were highly correlated. A 100% of infants born to seropositive mothers were also seropositive. The GMT ratios of peripartum maternal blood vs. those in cord blood were HPV 6: 1.23 [0.43, 3.49] and HPV 11: 1.29 [0.54, 3.07] in the 9vHPV vaccine group and HPV 6: 1.33 [0.41, 4.29] and HPV 11: 1.19 [0.45, 3.13] in the qHPV vaccine group, respectively. Conclusions: These results indicate that antibodies induced by the 9vHPV vaccine cross the placenta, which could potentially be beneficial against HPV6/11 infection and related disease such as recurrent respiratory papillomatosis.