A double-blind, randomized, multicenter, controlled study to evaluate the immunogenicity, safety, and tolerability of varicella vaccine (VARIVAX™) passage extension 34 (PE34) process administered concomitantly with measles, mumps, and rubella vaccine (M-M-R™ II).

The varicella vaccine passage extension (VAR-PE) process was undertaken to extend the availability of varicella zoster virus (VZV)-containing vaccines. This study (V210-A03; NCT03239873) assessed the immunogenicity, safety, and tolerability of VAR-PE process in comparison with varicella vaccine commercial product 2016 (VAR) randomized 1:1 in 600 healthy children 12 to 23 months of age administered concomitantly with measles-mumps-rubella (MMR) vaccine. The VZV seroconversion rate at 6 weeks Postdose 1 in the PP population was 100% for both groups. VZV antibody response rates and GMTs of VZV antibodies to VAR-PE induced and were non-inferior to those induced by VAR 6 weeks Postdose 1. From Day 1 through Day 42, adverse events (AEs) were reported by 81.3% of participants Postdose 1 and 67.9% Postdose 2. From Day 1 through Day 42 Postdose 1, injection-site AEs related to varicella vaccine were reported by 31.1% and 29.7% of participants in VAR-PE and VAR, respectively, and Postdose 2, by 25.7% and 25.5% of participants in the VAR-PE and VAR groups, respectively. Systemic AEs were generally comparable for the 2 vaccination groups, with the exception of pyrexia and otitis media higher in VAR-PE, and diarrhea and teething higher in VAR. The incidence of systemic AEs was generally lower Postdose 2 compared with Postdose 1.

Sparse canonical correlation analysis between an alcohol biomarker and self-reported alcohol consumption.

In investigating the correlation between an alcohol biomarker and self-report, we developed a method to estimate the canonical correlation between two high-dimensional random vectors with a small sample size. In reviewing the relevant literature, we found that our method is somewhat similar to an existing method, but that the existing method has been criticized as lacking theoretical grounding in comparison with an alternative approach. We provide theoretical and empirical grounding for our method, and we customize it for our application to produce a novel method, which selects linear combinations that are step functions with a sparse number of steps.

Neurocognitive Functioning of Children Treated for High-Risk B-Acute Lymphoblastic Leukemia Randomly Assigned to Different Methotrexate and Corticosteroid Treatment Strategies: A Report From the Children's Oncology Group.

Purpose Survivors of childhood acute lymphoblastic leukemia (ALL) are at risk for neurocognitive deficits that are associated with treatment, individual, and environmental factors. This study examined the impact of different methotrexate (MTX) and corticosteroid treatment strategies on neurocognitive functioning in children with high-risk B-lineage ALL. Methods Participants were randomly assigned to receive high-dose MTX with leucovorin rescue or escalating dose MTX with PEG asparaginase without leucovorin rescue. Patients were also randomly assigned to corticosteroid therapy that included either dexamethasone or prednisone. A neurocognitive evaluation of intellectual functioning (IQ), working memory, and processing speed (PS) was conducted 8 to 24 months after treatment completion (n = 192). Results The method of MTX delivery and corticosteroid assignment were unrelated to differences in neurocognitive outcomes after controlling for ethnicity, race, age, gender, insurance status, and time off treatment; however, survivors who were age < 10 years at diagnosis (n = 89) had significantly lower estimated IQ ( P < .001) and PS scores ( P = .02) compared with participants age ≥ 10 years. In addition, participants who were covered by US public health insurance had estimated IQs that were significantly lower ( P < .001) than those with US private or military insurance. Conclusion Children with high-risk B-lineage ALL who were age < 10 years at diagnosis are at risk for deficits in IQ and PS in the absence of cranial radiation, regardless of MTX delivery or corticosteroid type. These data may serve as a basis for developing screening protocols to identify children who are at high risk for deficits so that early intervention can be initiated to mitigate the impact of therapy on neurocognitive outcomes.