Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women.

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.

Comparación de los grados de lesión en las estructuras cocleares según los tipos de electrodos perimodiolares insertados y el tamaño de la cocleostomía realizada / Comparison of intracochlear damage according to the type of perimodiolar electrodes inserted and the size of the cochleostomy performed

Comparar los diferentes grados del trauma en las estructuras anatómicas intracocleares luego de la inserción de tres diferentes electrodos erimodeolares insertados con dos tamaños diferentes de cocleostomías. Trauma valorado fluoroscópicamente y anatómico microscópico. Diseño del estudio. Estudio experimental con dos variables. Métodos. Se realizaron cocleostomías de 1.3 y 2 mm en 15 huesos temporales de cadáver, estos fueron implantados bajo visión fluoroscopia con uno de los siguientes electrodos perimodeolares: electrodo Nucleus 24 contur (Cochlear Implant System), electrodo Hi Focus Helix (Advanced Bionics), electrodo Combi 40 + (Medel). Se efectúan microcortes en 15 cócleas con el electrodo inserto, teniendo 3 cócleas como grupo control sin implantar. Cada cóclea fue analizada con otomicroscopio a un aumento 16x, valorando cualquier posible trauma durante la inserción. Resultados: Se encontraron tres diferentes grados de alteraciones observadas durante la inserción, en algunas fue solamente observada en la visión fluoroscópica; así mismo no se encontraron diferencias estadísticamente significativas entre el tipo de electrodo y el tamaño de la colostomía. Conclusiones: La inserción de los electrodos perimodeolares crean diferentes grados de trauma histomorfológicos en la cóclea; sin embargo, este modelo aunque es efectivo no es el óptimo para documentar los grados de lesión coclear. La visión fluoroscópica de la inserción puede proveer una ubicación inicial adecuada del lugar de la lesión. Al parecer no hay una relación directa entre lo observado fluoroscópicamente y los hallazgos anatómicos cocleares luego de analizar los microcortes. Significancia clínica del estudio: El implante in vitro de huesos temporales bajo visión fluoroscópica es una poderosa herramienta académica para el entrenamiento de cirujanos en el campo de la otología.

Problem addressed. To compare the different degrees of injury in the intracochlear structures using three different perimodiolar electrode arrays inserted and two sizes of cochleostomies. Study design. Experimental study with two variables. Methods. Cochleostomies of 1.3 and 2 millimeters were used in 15 temporal bones and then were implanted under fluoroscopic vision with one of the following perimodiolar electrode arrays: electrode nucleus 24 contour (Cochlear Implant System), electrode hi focus helix (Advanced Bionics), electrode combi 40 + (MED-EL). Micro slices of the 15 study cochleae with the electrode array in place and 3 more control cochleae were studied under 16x looking for any possible trauma during insertion. Results. There were different degrees of injuries observed during insertion, as well as some resistance documented under fluoroscopic vision in some of the temporal bones. However, there were no statistical differences either with the different type of electrodes or the different sizes of cochleostomy. Conclusions. Insertion of perimodiolar electrodes assumes some degree of histological cochlear injury. Nevertheless, the study model used was not the most favorable method to document the different degrees of intracochlear lesion. The video fluoroscopy during the insertion of the electrode array showed the possible location of the commencement of a supposed lesion. There was no concurrence between the video fluoroscopic findings and the location and degrees of intracochlear damage observed in the anatomical microcuts. Clinical significance of study. The in vitro insertion of a cochlear implant assisted by a videofluoroscopy could be considered a useful tool for surgeons in training.