Background. This randomized, open trial compared regimens including 2 doses (2D) of human papillomavirus (HPV) 16/18 AS04-adjuvanted vaccine in girls aged 9–14 years with one including 3 doses (3D) in women aged 15–25 years.Methods. Girls aged 9–14 years were randomized to receive 2D at months 0 and 6 (M0,6; (n = 550) or months 0 and 12 (M0,12; n = 415), and women aged 15–25 years received 3D at months 0, 1, and 6 (n = 482). End points included noninferiority of HPV-16/18 antibodies by enzyme-linked immunosorbent assay for 2D (M0,6) versus 3D (primary), 2D (M0,12) versus 3D, and 2D (M0,6) versus 2D (M0,12); neutralizing antibodies; cell-mediated immunity; reactogenicity; and safety. Limits of noninferiority were predefined as <5% difference in seroconversion rate and <2-fold difference in geometric mean antibody titer ratio.Results. One month after the last dose, both 2D regimens in girls aged 9–14 years were noninferior to 3D in women aged 15–25 years and 2D (M0,12) was noninferior to 2D (M0,6). Geometric mean antibody titer ratios (3D/2D) for HPV-16 and HPV-18 were 1.09 (95% confidence interval, .97–1.22) and 0.85 (.76–.95) for 2D (M0,6) versus 3D and 0.89 (.79–1.01) and 0.75 (.67–.85) for 2D (M0,12) versus 3D. The safety profile was clinically acceptable in all groups.Conclusions. The 2D regimens for the HPV-16/18 AS04-adjuvanted vaccine in girls aged 9–14 years (M0,6 or M0,12) elicited HPV-16/18 immune responses that were noninferior to 3D in women aged 15–25 years.Clinical Trials Registration. NCT01381575.
This study supports the coadministration of MenACWY-TT with routine childhood vaccines as 2 or 3 primary doses during infancy followed by a booster dose in the second year of life.
Based on evidence of an increased rate of respiratory infections in sudden infant death (SID) infants as well as the observation of familial occurrence, we analysed in a retrospective study class II and class II genes of the major histocompatibility complex in 40 cases of SID by Southern blot analysis of DNA obtained post mortem from tissue samples. In 24 cases, the parents were interviewed and confirmatory human lymphocyte antigen (HLA) and DNA typing was carried out. Using HLA-DR beta and -DQ beta probes, no evidence of an abnormal HLA-DR frequency distribution in SID infants was detected (P = 0.97). Using DNA probes for the tandemly arranged complement C4 and steroid 21-hydroxylase genes, an increased number of C4B gene deletions in SID cases was found. The increase in C4 gene deletions was significant (P = 0.0125) in infants with recurrent infections. These data indicate a possible role of partial C4 deficiency as a genetically predisposing risk factor in SID.
SummaryHuman papillomavirus vaccination began using a 3-dose schedule. Compared with the 3-dose schedule in women, the 2-dose schedules are effective options in young girls as of 36 months after first dose. Two-dose schedules could improve compliance and vaccination coverage.
Addition of 19A and 6A CRM-conjugates did not alter immunogenicity of the PHiD-CV conjugates; for both investigational vaccines post-booster immune responses to 10 common serotypes appeared similar to those elicited by PHiD-CV. Safety and reactogenicity profiles of the investigational vaccines were comparable to PHiD-CV. Clinical trial registry: NCT01204658.
Background
Serum neurofilament light chain (sNfL) is an established biomarker of neuro-axonal damage in multiple neurological disorders. Raised sNfL levels have been reported in adults infected with pandemic coronavirus disease 2019 (COVID-19). Levels in children infected with COVID-19 have not as yet been reported.
Objective
To evaluate whether sNfL is elevated in children contracting COVID-19.
Methods
Between May 22 and July 22, 2020, a network of outpatient pediatricians in Bavaria, Germany, the Coronavirus antibody screening in children from Bavaria study network (CoKiBa), recruited healthy children into a cross-sectional study from two sources: an ongoing prevention program for 1–14 years, and referrals of 1–17 years consulting a pediatrician for possible infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We determined sNfL levels by single molecule array immunoassay and SARS-CoV-2 antibody status by two independent quantitative methods.
Results
Of the 2652 included children, 148 (5.6%) were SARS-CoV-2 antibody positive with asymptomatic to moderate COVID-19 infection. Neurological symptoms—headache, dizziness, muscle aches, or loss of smell and taste—were present in 47/148 cases (31.8%). Mean sNfL levels were 5.5 pg/ml (SD 2.9) in the total cohort, 5.1 (SD 2.1) pg/ml in the children with SARS-CoV-2 antibodies, and 5.5 (SD 3.0) pg/ml in those without. Multivariate regression analysis revealed age—but neither antibody status, antibody levels, nor clinical severity—as an independent predictor of sNfL. Follow-up of children with pediatric multisystem inflammatory syndrome (n = 14) showed no association with sNfL.
Conclusions
In this population study, children with asymptomatic to moderate COVID-19 showed no neurochemical evidence of neuronal damage.
Abnormal loading of the hip in obese children may lead to anatomic alterations and an increased prevalence of slipped capital femoral epiphysis (SCFE). The aims of this study were to examine the hip motion in obese children and adolescents and to estimate the prevalence of SCFE in a subgroup of patients characterized by pathological clinical examination and/or pain in the knee or hip joint. A total of 411 individuals (196 males), mean age 14.5 ± 2.5 years (7.8-20.4), mean BMI of 32.9 ± 5.6 kg/m(2) (20.3-51.5, z score +2.65) who were consecutively admitted for an inpatient weight loss program were included in the study. Twenty-six percent of the patients had load-dependent and 11.7 % had load-independent pain in the knee joint. A total of 9.3 % had load-dependent and 4.7 % had load-independent pain in the hip joint. Two patients (0.5 %) underwent surgical treatment of SCFE prior to entry. A total of 18.2 % of the patients showed a reduced range of motion for hip flexion (<90°) and 18.5 % a pathological decreased internal rotation (<10°). Radiological evaluation of the hips in the clinically conspicuous subgroup (n = 54) revealed an abnormal head-neck ratio as a sign of prior silent slipped capital femoral epiphysis in 11 patients (20.4 % of the 54 patients, 2.7 % of total cohort). In conclusion, these data show a high prevalence of SCFE-like tilt deformities in a selected group of severely obese children. Mild deformation of the epiphysis at young age might be a major predisposing factor for the development of hip osteoarthritis in obese adults.
Primary and booster vaccinations of infants/toddlers with DTPa-HBV-IPV/Hib and PHiD-CV coadministered with MenACWY-TT were immunogenic with clinically acceptable reactogenicity profiles. These results support the coadministration of MenACWY-TT with routine childhood vaccines.
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