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.

4-Valent Human Papillomavirus (4vHPV) Vaccine in Preadolescents and Adolescents After 10 Years.

OBJECTIVES: We describe the final 10-year data for the long-term follow-up study of the 4-valent human papillomavirus (4vHPV) vaccine in preadolescents and adolescents. METHODS: In the base study (V501-018), 1661 sexually inactive boys and girls received the 4vHPV vaccine (early vaccination group [EVG], managed for 9.9 years) or a placebo at day 1, month 2, and month 6. Thereafter, at month 30, the placebo group (catch-up vaccination group [CVG], managed for 7.4 years) received the 4vHPV vaccine by using the same dosing schedule. Long-term anti-HPV type 6, 11, 16, and 18 immune responses were assessed. Effectiveness was estimated by calculating the incidence rate of the primary endpoints (HPV types 6, 11, 16, and 18-related disease or persistent infection). RESULTS: For HPV types 6, 11, and 16, 89% to 96% of subjects remained seropositive through 10-years postvaccination. The preadolescents had 38% to 65% higher geometric mean titers at month 7, which remained 16% to 42% higher at 10 years compared with adolescents. No cases of HPV type 6, 11, 16, and 18-related diseases were observed. Ten subjects had a persistent infection of ≥6 months duration with vaccine-type HPV and 2 subjects had persistent infection for ≥12 months. No new serious adverse events were reported through 10 years. CONCLUSIONS: A 3-dose regimen of the 4vHPV vaccine was immunogenic, clinically effective, and generally well tolerated in preadolescents and adolescents during 10 years of follow-up. These long-term findings support efforts to vaccinate this population against HPV before exposure.

Giba carpiana, una patología frecuente / Carpal Boss a Frequent Pathology

Carpal boss o giba carpiana es una patología que se ha descrito desde hace más de 200 años; no obstante, a pesar de ser una entidad reconocida por mucho tiempo, su incidencia es desconocida y no se ha podido establecer su etiología. Se han propuesto varias teorías al respecto, como el proceso degenerativo de la articulación carpo-metacarpiana, o periostitis en la inserción del tendón del músculo extensor carpi radialis longus secundaria a trauma repetitivo, entre otros. Clínicamente, el paciente puede ser asintomático y el hallazgo puede resultar incidental; o puede ser sintomático, siendo el dolor el síntoma más común. En el examen físico, el médico puede sentir un abultamiento en la parte dorsal de la mano, que es más común en la mano dominante. Las imágenes ayudan a saber si el abultamiento es una lesión intra- o extra-ósea y, para tal efecto, se pueden utilizar radiografías, tomografía computarizada (TC) y resonancia magnética (RM). El ultrasonido es útil para ayudar en el diagnóstico diferencial. Algunos de los diagnósticos diferenciales tienen origen benigno, como el ganglión o el lipoma, pero también hay tumores y entidades pseudotumorales, como el tumor de células gigantes. El tratamiento puede ser médico o quirúrgico.

Carpal boss is a pathology that has been described for more than 200 years; nevertheless, despite being a condition recognized for a long time, its incidence and etiology are unknown. Several theories have been proposed, including degeneration of the carpometacarpal joint, and periostitis at the insertion of the tendon of extensor carpi radialis longus secondary to repetitive trauma, among others. Clinically, the patient may be asymptomatic and the finding may be incidental; or he/she may be symptomatic, pain being the most common symptom. On physical examination, the doctor may feel a lump on the back of the hand, which is more common in the dominant hand. Images help to clarify whether the lump is an intra- or extra-osseous lesion; for this purpose, radiography, CT and MR imaging can be used. Ultrasound is useful to aid differential diagnosis. Some of the differential diagnoses has benign origin, such as ganglion cyst or lipoma, but there are also tumors and tumor-like entities, such as giant cell tumor. Treatment may be medical or surgical.

A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women.

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).

Long-term study of a quadrivalent human papillomavirus vaccine.

BACKGROUND: We present a long-term safety, immunogenicity, and effectiveness study of a quadrivalent human papillomavirus (HPV4) vaccine. METHODS: Sexually naive boys and girls aged 9 to 15 years (N = 1781) were assigned (2:1) to receive HPV4 vaccine or saline placebo at day 1 and months 2 and 6. At month 30, the placebo group (n = 482) received HPV4 vaccine following the same regimen and both cohorts were followed through month 96. Subjects ≥ 16 years were eligible for effectiveness evaluations. The primary objective was to evaluate the long-term anti-HPV6/11/16/18 serological levels. The secondary objective was to estimate vaccine effectiveness against HPV6/11/16/18-related persistent infection or disease. RESULTS: For each of the HPV4 vaccine types, vaccination-induced anti-HPV response persisted through month 96. Among 429 subjects who received HPV4 vaccine at a mean age of 12, none developed HPV6/11/16/18-related disease or persistent infection of ≥ 12 months' duration. Acquisition of new sexual partners (among those ≥ 16 years) was ∼1 per year. Subjects receiving HPV4 vaccine at month 30 (mean age 15 years) had a similar baseline rate of seropositivity to ≥ 1 of the 4 HPV types to those vaccinated at day 1 (mean age 12 years; 1.9% [9 of 474] vs 1.7% [20 of 1157]); however, 4 of the 9 subjects vaccinated at the later age were seropositive to 3 vaccine types, indicating previous HPV exposure. No new significant serious adverse events were observed for 8 years postvaccination in both genders. CONCLUSIONS: When administered to adolescents, the HPV4 vaccine demonstrated durability in clinically effective protection and sustained antibody titers over 8 years.

Sentidos de ciudadanía en un grupo de jóvenes escolarizados de la ciudad de Manizales, Colombia / Sentidos de cidadania em um grupo de jovens escolarizados da cidade de Manizales, Colombia / Meanings of citizenship in a group of high school students from Manizales, Colombia

El presente artículo se deriva de una investigación realizada con 29 jóvenes escolarizados de la ciudad de Manizales, Colombia, en la cual se indagó por los sentidos y significados de la ciudadanía. Para la recolección de información se utilizó el taller pedagógico, en tanto permitió combinar diversas técnicas e instrumentos tales como la entrevista semiestructurada, la entrevista a profundidad y la discusión. El estudio concluye que las y los jóvenes significan y comprenden la ciudadanía desde cuatro referentes: el lugar del sujeto en la sociedad y la cultura, el sentido del derecho y la ley en la organización y la convivencia, las percepciones del actuar moral y político de los líderes y de los políticos, y las percepciones y consumos de ciudad que hacen los ciudadanos. Se concluye que las y los jóvenes sitúan la ciudadanía desde un referente de la acción, manifestado fundamentalmente en la participación, el enjuiciamiento político y la posibilidad de ser representados por otros. Igualmente, se plantea que las y los jóvenes orientan la ciudadanía desde los principios y marcos de significación cultural de ciudad, expresados en los vínculos y compromisos que adquieren los ciudadanos con su ciudad y viceversa. Finalmente, se afirma que se trata de una ciudadanía significada en el respeto, la libertad, la justicia social y el reconocimiento del potencial humano universal.

O presente artigo deriva-se de uma pesquisa realizada com 29 jovens escolarizados da cidade de Manizales, na qual se indagou pelos sentidos e significados da cidadania. Para a coleta de informação foi utilizada uma oficina pedagógica, por quanto permitiu combinar diversas técnicas e instrumentos tais como a entrevista semi-estruturada, a entrevista em profundidade e a discussão. O estudo conclui que os jovens significam e compreendem a cidadania desde quatro referentes: o lugar do sujeito na sociedade e a cultura, o sentido do direito e a lei na organização e a convivência, percepções a respeito do acionar moral e político dos líderes e dos políticos e as percepções e consumos da cidade que fazem os cidadãos. Conclui-se que os jovens situam a cidadania desde o referente da ação, o qual se manifesta, fundamentalmente, na participação, o juízo político e a possibilidade de ser representado por outros. Igualmente, se planteia que os jovens orientam a cidadania desde os princípios e marcos de significação cultural da cidade, expressados nos vínculos e compromissos que adquirem os cidadãos com a sua cidade, e vice-versa. Finalmente, se afirma que se trata de uma cidadania significada no respeito, a liberdade, a justiça social e o reconhecimento do potencial humano universal.

This paper gives an account of a research project that inquired for the meanings of citizenship in a group of 29 high-school students in Manizales (Colombia). The technique of pedagogical workshops wasused to obtain information, because it has advantages such as combining semi-structured interviews, in-depth interviews and group discussions. Conclusions indicate that this group of high school boys and girls understand citizenship as referred to four main ideas: the position occupied by the subject in society and culture, the sense of law in the organization of society, the perceptions of the moral and political behavior of leaders and politicians, and the perceptions of the meaning of the city and their relationship to it. It was concluded that this group of boys and girls refers citizenship to action expressed in participation, judgments on the political reality, and the possibility of being represented by others. It is also argued that these students see citizenship within the principles and frameworks of the cultural meaning of the city, expressed in the duties of citizens towards the city, and viceversa. Finally, it si concluded that this group’s understanding of citizenship is related to ideas of respect, freedom, social justice and recognition of human potential.