Background: Nepalese infants receive PCV10 with a one-month interval between priming doses for programmatic reasons. We aimed to investigate whether immune responses to PCV10 serotypes were non-inferior if the second priming dose of PCV10 was delivered at a one-month as opposed to a two-month interval. Methods: We conducted an open-label, randomised, parallel group trial in healthy Nepalese infants aged 40-60 days in Kathmandu, Nepal. Participants were randomised (1:1) using a computer-generated list with randomly varying permuted block sizes accessed through a validated web-based interface, to receive PCV10 at 6 and 10 weeks (6+10) or 6 and 14 weeks (6+14) of age, with both groups receiving a booster at 9 months of age. Laboratory staff, blinded to study intervention, analysed sera for antibodies against PCV10 serotypes by ELISA. The primary objective, using the intention-to-treat population, was to determine whether the 6+10 schedule was non-inferior to the 6+14 schedule at 9 months of age, based on the proportion of infants with serotype-specific IgG ≥ 0•35 μg/mL and a 10% margin. Secondary objectives included, determining if there were any differences between the groups when comparing the proportion of infants with serotype-specific IgG ≥ 0•35 μg/mL. This trial is registered at ClinicalTrials.gov, number NCT02385513.
Visual field biases have been identified as markers of atypical lateralization in children with developmental conditions, but this is the first investigation to consider early lateralized gaze behaviors for social stimuli in preterm infants. Eye‐tracking methods with 51 preterm (33 male, 92.1% White) and 61 term‐born (31 male, 90.1% White) infants aged 8–10 months from Edinburgh, UK, captured the development of visual field biases, comparing gaze behavior to social and non‐social stimuli on the left versus right of the screen. Preterm infants showed a significantly reduced interest to social stimuli on the left versus right compared to term children (d = .58). Preterm children exhibit early differential orienting preferences that may be an early indicator of atypical lateralized function.
In 2011, the human pneumococcal standard reference serum, 007sp, was established as a replacement for the previous standard, lot 89SF, supplies of which were dwindling. The pneumococcal reference serum is used primarily in the standardized pneumococcal enzyme-linked immunosorbent assay (World Health Organization reference enzyme-linked immunosorbent assay) but has also been used in functional assays. Serotype-specific IgG values for 24 pneumococcal capsular serotypes have previously been assigned to 007sp by bridging to the original values derived for lot 89SF. In this study, by bridging to existing values in lot 89SF, we assign weight-based serotype-specific IgA, IgG1, and IgG2 to 007sp for 11 pneumococcal capsular serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F), as well as serotype 19A-specific IgA. Concentrations for serotype-specific IgA, IgG1, and IgG2 present in 007sp were comparable to those previously assigned to lot 89SF. In addition, the concentration of serotype-specific IgG1 plus IgG2 assigned to 007sp significantly correlated to previously assigned 007sp IgG values. The accuracy of antibody assignments to 007sp from lot 89SF was assessed by comparing the concentration of serotype-specific IgA, IgG1, and IgG2 in 16 unknown samples using both 007sp and lot 89SF as the standard. Interpolated values for the unknown samples were highly correlated with average R2 values of 0.9729, 0.9951, and 0.9933 for IgA, IgG1, and IgG2, respectively, for all serotypes demonstrating the precise nature assignments to 007sp made in this study. Nonparallelism between 007sp and lot 89SF has precluded the derivation of serotype-specific IgM values. IMPORTANCE A well-characterized antibody standard is an indispensable reagent for use in assays designed to measure antibodies with precision and where assays between laboratories need to be comparable. The human pneumococcal standard reference serum, lot 89SF, greatly facilitated the standardization of enzyme-linked immunosorbent assay methodologies during a critical period when the first pneumococcal polysaccharide-conjugate vaccines were being evaluated for licensure. Due to dwindling supplies of lot 89SF, a new reference standard, 007sp, was produced in 2011. Understanding the isotype and subclass composition of either natural or vaccine induced responses to pathogens has assumed increasing importance. In this study, we have assigned IgA, IgG1, and IgG2 values to pneumococcal serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F by bridging to existing values in lot 89SF.
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