Long-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: Interim analysis after 8 years of follow-up.

BACKGROUND: The nine-valent human papillomavirus (9vHPV) vaccine protects against infection and disease related to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. The pivotal 36-month Phase III immunogenicity study of 9vHPV vaccine in 9- to 15-year-old girls and boys was extended to assess long-term immunogenicity and effectiveness through approximately 10 years after vaccination. We describe results of an interim analysis based on approximately 8 years of follow-up after vaccination. METHODS: Participants aged 9-15 years who received three doses of 9vHPV vaccine (at day 1, month 2, and month 6) in the base study and consented to follow-up were enrolled in the long-term follow-up study extension (N = 1272 [females, n = 971; males, n = 301]). Serum was collected at months 66 and 90 to assess antibody responses. For effectiveness analysis, genital swabs were collected (to assess HPV DNA by polymerase chain reaction [PCR]) and external genital examination was conducted (to detect external genital lesions) every 6 months starting when the participant reached 16 years of age. Cervical cytology tests were conducted annually when female participants reached 21 years of age; participants with cytological abnormalities were triaged to colposcopy based on a protocol-specified algorithm. External genital and cervical biopsies of abnormal lesions were performed, and histological diagnoses were adjudicated by a pathology panel. Specimens were tested by PCR to detect HPV DNA. RESULTS: Geometric mean titers for each 9vHPV vaccine HPV type peaked around month 7 and gradually decreased through month 90. Seropositivity rates remained >90% through month 90 for each of the 9vHPV vaccine types by HPV immunoglobulin Luminex Immunoassay. No cases of HPV6/11/16/18/31/33/45/52/58-related high-grade intraepithelial neoplasia or genital warts were observed in the per-protocol population (n = 1107) based on a maximum follow-up of 8.2 years (median 7.6 years) post-Dose 3. Incidence rates of HPV6/11/16/18/31/33/45/52/58-related 6-month persistent infection in females and males were 49.2 and 37.3 per 10,000 person-years, respectively, which were within ranges expected in vaccinated cohorts. There were no vaccine-related SAEs or deaths during the period covered by this interim analysis. CONCLUSIONS: The 9vHPV vaccine provided sustained immunogenicity and durable effectiveness through approximately 7 and 8 years, respectively, following vaccination of girls and boys aged 9-15 years.

Human papillomavirus genotype detection in recurrent respiratory papillomatosis (RRP) in Colombia.

BACKGROUND: Knowledge on human papillomavirus (HPV) genotype distribution in recurrent respiratory papillomatosis (RRP) is essential to assess the impact of HPV vaccine. It is provided information for Colombia. METHODS: In all, 189 RRP primary cases diagnosed between 1985 and 2009 were identified from 5 pathology laboratories of Cali and Medellin, Colombia. HPV DNA testing in 129 cases that fulfilled inclusion criteria (available paraffin blocks, amplifiable DNA, and confirmed histologic diagnosis of RRP) was performed by the SPF-10/LiPA25 assay (version 1). RESULTS: Of all cases 36.1% were juvenile (<12 years old) and a majority of adults were males (p = .09); 95% of cases were HPV positive. HPV 6, 11, and 16 contributed to 69%, 27.1%, and 7.8% of all HPV positive cases. Twelve cases (9.3%) showed multiple infections; 8 of these were HPV 6 or 11 positive. CONCLUSIONS: HPV prophylactic vaccine including HPV 6 and 11 may have a major impact against RRP.

El estado del arte en las infecciones producidas por el virus del papiloma humano / State-of-the-art of infections produced by human papillomavirus

La infección anogenital por el virus del papiloma humano (VPH) es la infección de transmisión sexual mas frecuente en todo el mundo. En los humanos se han identificado alrededor de 100 genotipos de los cuales unos 40 infectan la región ano-genital. Los 15 genotipos de alto riesgo, son causa necesaria del cßncer cervical y han sido implicados como agentes carcinogénicos de la vulva, vagina, pene, ano y región orofaríngea. Los VPH de bajo riesgo producen las verrugas genitales (condilomas) y la papilomatosis respiratoria recurrente en hombres y mujeres. Se calcula que unas 300 millones de mujeres en el mundo portan la infección por VPH. El advenimiento de las vacunas profilßcticas contra el VPH representa una estrategia prometedora en la prevención de las enfermedades relacionadas con este virus.

Anogenital human papillomavirus infection is the most frequent sexually transmitted disease. Around one hundred genotypes have been identified in humans, and 40 infect the genitalia and anal regions. Fifteen genotypes, classified as high-risk HPVs, are the necessary cause of cervical cancer and have been involved as carcinogenic agents for cancer of the vulva, vagina, anus, penis, and oropharyngeal cavity. Low-risk HPVs are the causative agents of genital warts, and recurrent respiratory papillomatosis in both men and women. The number of women harboring HPV-DNA worldwide is estimated to be 300 million. The recently introduced prophylactic HPV vaccines represent a hopeful strategy to prevent HPV infection and HPV-related diseases.

La vacuna contra el virus del papiloma humano: una gran arma para la prevención primaria del cßncer de cuello uterino / The human papillomavirus vaccine: A powerful tool for the primary prevention of cervical cancer

La vacuna profilßctica contra el virus del papiloma humano (VPH) constituye la herramienta de salud pública mßs promisoria para la prevención primaria de cßncer de cuello uterino. La vacunación de mujeres antes de haber adquirido la infección viral tiene un gran impacto en la prevención de lesiones pre- eoplßsicas y cßncer de cuello uterino. Las vacunas actuales no eliminan completamente el riesgo de cßncer de cérvix, por lo tanto las mujeres vacunadas como las que no alcancen a recibir la vacuna, se les debe seguir ofreciendo los programas de detección temprana. Las estrategias que incluyen la combinación de vacunación con alta cobertura de adolescentes y tamización con métodos mßs sensibles que la citología, tales como la prueba de VPH, pueden ser mßs costo-efectivas que las estrategias actualmente utilizadas. La inefectividad de los actuales programas de tamización en países latinoamericanos incluido Colombia, amerita su evaluación inmediata a la luz de la disponibilidad de nuevos métodos que son costo-efectivos en países en desarrollo tales como la prueba de VPH y la inspección visual y tratamiento inmediato para mujeres con dificultades de acceso oportuno al tratamiento.

Prophylactic human papillomavirus (HPV) vaccine is the most promissory public health tool for primary prevention of cervical cancer. Immunization of females before the acquisition of HPV infection has the greatest impact in preventing pre-neoplasic lesions and cervical cancer. Current HPV vaccines do not eliminate cervical cancer risk, therefore, screening should continue covering vaccinated as well as women that do not get the vaccine. The strategies that include combination of high-coverage vaccination of HPV-unexposed adolescents with screening using methods with higher sensitivity than cytology as HPV test may be more cost-effective than the strategies currently used. The cytology-based screening programs of Latin America countries including Colombia are very ineffective. The evidence in favor of the cost-effectiveness of other screening strategies such as HPV tests and visual inspection followed by immediate treatment for women with difficult access to health care services in developing countries warrants the immediate revision of the current strategies.

Impact of Helicobacter pylori infection on growth of children: a prospective cohort study.

OBJECTIVE: The aim of this study was to prospectively follow a cohort of children without Helicobacter pylori infection and to compare growth velocity in the children who become infected during follow-up with that of children who remained infection-free. METHODS: Three hundred forty-seven children in general good health, aged 12 to 60 months, who tested negative for H. pylori by the 13C-urea breath test, from three daycare centers in a lower-middle class borough of Cali, Colombia, were monitored for 2.5 years. Anthropometric measurements were performed every 2 months and breath tests every 4 months. Linear mixed models were used to analyze growth velocity in relation to onset of H. pylori infection. RESULTS: One hundred five (30.3%) children who were uninfected at the start of the study became infected during follow-up. Growth velocity in infected children was reduced by 0.042 +/- 0.014 cm/mo (P = 0.003) (approximately 0.5 cm/yr) after adjusting for age. The rate of deceleration in growth velocity was relatively constant over time. CONCLUSIONS: Among these lower-middle class children aged 12 to 60 months from a population with high prevalence of H. pylori infection, a new and sustained infection was followed by significant growth retardation.

Adolescentes y embarazo: salud y nutrición / Adolescents and pregnancy: health and nutrition

Intoducción: Para 1995, en Colombia, la tasa de fecundidad (número anual de nacimientos por mil mujeres) en adolescentes se estimó 71 por mil, con una tasa de escolaridad del 72 por mil. En estudios realizados en países similares al nuestro, las madres adolescentes tuvieron una mayor prevalencia de prematurez y recién nacidos bajos de peso comparadas con madres adultas. Otros estudios han mostrado una posible competencia por nutrientes entre la madre adolescente en proceso de crecimiento y el producto de la concepción que da como resultado recién nacidos bajos de peso. Métodos: se incluyeron 180 adolescentes embarazadas sanas de 13 a 17 años de edad y 131 adolescentes no-embarazadas controles. Además como grupo control de lagunas variables, se estudiaron 53 mujeres adultas embarazadas. En ellas se obtuvieron datos sociodemográficos, antropométricos, nutricionales y de salud al ingreso al estudio, semana 13 de gestación, y posteriormente en dos rondas más a la semana 23 y 35. Se midió la velocidad de crecimiento al corto plazo para correlacionarlo con el peso del recién nacido. Resultados: no se encontró desnutrición significante en la población estudiada. La ganancia de peso durante el embarazo fue adecuada y comparable con las normas establecidas por la OMS para Colombia. La mayoría de las adolescentes (85 por ciento) crecieron durante el embarazo y el peso de recién nacido fue adecuado y comparable con el peso de los recién nacidos de adolescentes que no crecieron y con las mujeres adultas. El 21 por ciento de las adolescentes embarazadas tenían valores de ferritina < 12 µg/l y el 7 por ciento tenían valores de ácido fólico menores de 5 ng/ml. Conclusiones: Las adolescentes embarazadas de una extensa comunidad deprimida de la ciudad de Cali se comportan de una manera un poco diferente desde el punto de vista de salud y nutrición comparadas con adolescentes de comunidades similares en países como Colombia. No encontramos una competencia evidente por nutrientes entre la madre y el feto, ni una prevalencia significante de recién nacidos bajos de peso

La desnutricion marginal y el desarrollo intelectual en escolares calenos / Marginal malnutrition and intelectual development in school students from Cali

Se trato de demostrar si la desnutricion marginal, la escolaridad de la madre, el numero de ninos en la familia y el orden de nacimiento se relacionaban con el desarrollo mental en un grupo seleccionado de 99 estudiantes varones en escuelas publicas (edades 6 a 16 anos) de barrios de familias con bajos ingresos de Cali, Colombia. Los ninos se clasificaron de acuerdo con su edad y estado nutricional segun los estandares de Rueda-Williamson para ninos colombianos. El grupo normal se compuso de varones cuyo peso estaba entre 95 y 110% del peso normal esperado para edad y estatura; el grupo de bajo peso lo formaron varones cuyo peso era menos de 95% del estandar para edad y estatura. El desarrollo intelectual se midio con la prueba de dibujo de Goodenough-Harris y la prueba de matrices progresivas de Raven. Se encontro una tendencia consistente de menor desempeno en el grupo de bajo peso, y las diferenicas llegaron a ser estadisticamente significativas en la prueba de dibujos de Goodenough-Harris. No se encontraron asociaciones entre el desarrollo mental y la escolaridad de la madre, el numero de hijos en la familia y el orden de nacimiento