Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine (PCV13) formulated with 2-phenoxyethanol in multidose vials given with routine vaccination in healthy infants: An open-label randomized controlled trial.

BACKGROUND: This open-label randomized controlled trial in infants compared safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (PCV13) formulated with the preservative 2-phenoxyethanol (2-PE) in a multidose vial (MDV) to the current PCV13 without 2-PE in a single-dose syringe (SDS). METHODS: Gambian infants were randomized 1:1 to receive PCV13 as either MDV or SDS at ages 2, 3, and 4months. Serotype-specific antipneumococcal antibody responses and opsonophagocytic activity ([OPA]; subset) were measured at age 5months. Noninferiority was declared if the lower bound of the 97.5% CI for the difference (MDV-SDS) in proportions of subjects achieving IgG concentrations ≥0.35μg/mL (primary endpoint) was greater than -10%. IgG geometric mean concentrations (GMCs) were noninferior if the lower limit of the two-sided 97.5% CI of the geometric mean ratio (MDV vs SDS) was greater than 0.5. Reactogenicity and other adverse events were collected. RESULTS: 500 participants were randomized and vaccinated; 489 (MDV: n=245; SDS: n=244) completed the trial. Noninferiority of MDV was demonstrated for all serotypes as measured by percentage of subjects achieving antibody responses above ≥0.35μg/mL. IgG GMCs (coprimary endpoint) also demonstrated noninferiority of MDV; OPA results supported these findings. Safety and tolerability were comparable between groups. CONCLUSIONS: PCV13 in MDV was safe and immunogenic when administered according to the routine schedule to infants. MDV was noninferior to SDS for all 13 pneumococcal serotypes. Comparable immunogenicity and safety profiles of PCV13 MDV and SDS suggest PCV13 MDV can help optimize vaccination in resource-limited settings. ClinicalTrials.gov NCT01964716 https://clinicaltrials.gov/ct2/show/NCT01964716

Dynamic properties of water in porous Vycor glass studied by dielectric techniques

The structure and dynamic properties of water in porous Vycor glass of 40 Å mean pore diameter, as well as their changes with temperature, were studied by dielectric relaxation spectroscopy and dc conductivity measurements. The mobility of water moledules in the pores was reduced compared with that of bulk water by a factor which decreased with increasing water content. A significant fraction of water in the first monolayer is transformed to a glassy state at about 170 K. The formation of water clusters around primary hydration sites started at about 0.02 g(H2O)/g (dry sample) where a transition to long-range connectivity amiong ater molecules was observed. © 1994

Dielectric and conductivity relaxation in dry and humid solid PEO electrolytes

The interaction of water with uncomplexed poly(ethylene oxide) (PEO) is studied by dielectric relaxation spectroscopy techniques for water contents up to about 0.60(w/w). The techniques used include thermally stimulated depolarization currents, thermally stimulated polarization currents and dc conductivity measurements in the temperature range 77-300 K, as well as broadband ac techniques in the frequency range 10-1010 Hz. The results are discussed in terms of molecular distribution and organization of water in a separate phase, restriction of the molecular mobility of water molecules, dipolar and space charge contributions to the main (α) relaxation and plasticizing action of water. © 1994