Immunogenicity, safety and tolerability of 3 lots of 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in the United States.

BACKGROUND: The 7-valent pneumococcal conjugate vaccine (PCV7; serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) has decreased invasive pneumococcal disease incidence. This study was performed to support licensure of a 13-valent pneumococcal conjugate vaccine (PCV13), which expands serotype coverage to include serotypes 1, 3, 5, 6A, 7F and 19A. This study assessed the immunogenicity, safety and manufacturing consistency of PCV13. METHODS: Randomized, double-blind, multicenter trial. Healthy United States infants were randomized 2:2:2:1 to receive 1 of 3 lots of PCV13 or PCV7, along with routine US pediatric vaccines at ages 2, 4 and 6 months (infant series), and 12 months (toddler dose). RESULTS: Among 1709 vaccinated infants, 1 month postinfant series and 1 month posttoddler dose, immunoglobulin G geometric mean concentrations (GMCs) were within 2-fold among the PCV13 lots, meeting equivalence criteria for all 13 serotypes. In a post hoc analysis, based on percent responders at ≥0.35 µg/mL postinfant series and immunoglobulin G GMC ratios postinfant series and posttoddler dose, noninferiority criteria were met for combined PCV13 lots compared with PCV7 for all common serotypes. Posttoddler dose immunoglobulin G GMCs were higher than postinfant series GMCs for all serotypes. Local reactions and fevers were generally mild; incidences of local reactions, systemic events and adverse events were generally similar between groups. CONCLUSIONS: PCV13 can be manufactured in a manner that elicits consistent immune responses. PCV13 provides increased serotype coverage and immunogenicity that is noninferior to PCV7 and has a safety profile similar to PCV7 when given with routine pediatric vaccines.

Only the nose knows: penile hemodynamic study of the perineum-saddle interface in men with erectile dysfunction utilizing bicycle saddles and seats with and without nose extensions.

PURPOSE: To investigate the differential impact of straddles (A(ns) and B(ns)) and noseless two-cheek seats (A(ntcs) and B(ntcs)) on penile hemodynamics and perineal compressive forces in subjects who cycle in a stationary bicycle. MATERIALS AND METHODS: Subjects underwent cavernosal artery peak systolic velocity (CAPSV) measurements after intracavernosal injection of vasoactive agents while supine, sitting upright on an examination table, straddling a saddle, sitting on a seat, and again supine. Mean perineal compression pressures recorded while straddling the saddles were compared with those while sitting upright. RESULTS: No differences were found in right and left CAPSV values while supine, sitting upright on an examination table, sitting on a seat, and supine again. Right/left CAPSV (cm/second) values straddling A(ns) and saddle B(ns) (0.7 +/- 2.9/1.5 +/- 6.2 and 0/0, respectively) were significantly lower than values obtained while sitting on A(ntcs) and B(ntcs) (25.6 +/- 13.4/23.8 +/- 12.0 and 17.3 +/- 6.4/18.3 +/- 6.5, respectively) (P < 0.001). Mean perineal compression pressures (mm Hg) on A(ns) and saddle B(ns) (315.2 +/- 39 and 387.9 +/- 64.3, respectively) were significantly higher than values obtained while sitting upright on an examination table (47.6 +/- 5.2 and 46.0 +/- 8.1, respectively) (P < 0.001). CONCLUSIONS: We have identified an objective test to assess if an individual bicycle rider, sitting on a certain shape of bicycle saddle or seat generates sufficient compressive forces at the perineal-saddle interface to obstruct cavernosal arterial inflow. This study also demonstrated that straddling bicycle saddles with nose extensions is associated with perineum-saddle interface compressive pressures that exceed systolic perfusion pressures, significantly diminishing penile hemodynamics.

Health care clinicians in sexual health medicine: focus on erectile dysfunction.

A consensus guidelines model was developed for managing erectile dysfunction (ED) by urology nurses and other health care clinicians. The model emphasizes identification of ED in all males older than 40, education and counseling as keys to intervention, and inclusion of partners whenever possible. These guidelines are intended to provide a comprehensive care model for ED patients and their partners, which would be optimally cost effective and clinically relevant. If successful, this new model will allow quality sexual health care to be provided to increasing numbers of patients and their partners.