Search

Background: The Zika virus epidemic and associated congenital infections have prompted rapid vaccine development. We assessed two new DNA vaccines expressing premembrane and envelope Zika virus structural proteins., Methods: We did two phase 1, randomised, open-label trials involving healthy adult volunteers. The VRC 319 trial, done in three centres, assessed plasmid VRC5288 (Zika virus and Japanese encephalitis virus chimera), and the VRC 320, done in one centre, assessed plasmid VRC5283 (wild-type Zika virus). Eligible participants were aged 18-35 years in VRC19 and 18-50 years in VRC 320. Participants were randomly assigned 1:1 by a computer-generated randomisation schedule prepared by the study statistician. All participants received intramuscular injection of 4 mg vaccine. In VRC 319 participants were assigned to receive vaccinations via needle and syringe at 0 and 8 weeks, 0 and 12 weeks, 0, 4, and 8 weeks, or 0, 4, and 20 weeks. In VRC 320 participants were assigned to receive vaccinations at 0, 4, and 8 weeks via single-dose needle and syringe injection in one deltoid or split-dose needle and syringe or needle-free injection with the Stratis device (Pharmajet, Golden, CO, USA) in each deltoid. Both trials followed up volunteers for 24 months for the primary endpoint of safety, assessed as local and systemic reactogenicity in the 7 days after each vaccination and all adverse events in the 28 days after each vaccination. The secondary endpoint in both trials was immunogenicity 4 weeks after last vaccination. These trials are registered with ClinicalTrials.gov, numbers NCT02840487 and NCT02996461., Findings: VRC 319 enrolled 80 participants (20 in each group), and VRC 320 enrolled 45 participants (15 in each group). One participant in VRC 319 and two in VRC 320 withdrew after one dose of vaccine, but were included in the safety analyses. Both vaccines were safe and well tolerated. All local and systemic symptoms were mild to moderate. In both studies, pain and tenderness at the injection site was the most frequent local symptoms (37 [46%] of 80 participants in VRC 319 and 36 [80%] of 45 in VRC 320) and malaise and headache were the most frequent systemic symptoms (22 [27%] and 18 [22%], respectively, in VRC 319 and 17 [38%] and 15 [33%], respectively, in VRC 320). For VRC5283, 14 of 14 (100%) participants who received split-dose vaccinations by needle-free injection had detectable positive antibody responses, and the geometric mean titre of 304 was the highest across all groups in both trials., Interpretation: VRC5283 was well tolerated and has advanced to phase 2 efficacy testing., Funding: Intramural Research Program of the Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

A pilot study to survey the attitudes of emergency department (ED) personnel regarding their role in injury prevention education in children and parents was conducted at a tertiary care trauma center. The survey consisted of 14 statements, asking staff members their level of agreement (from strongly agree to strongly disagree) on a forced-choice four-point scale. These were followed by two questions asking staff members to rank schools, physician's offices, emergency departments, and public health units on their value in providing injury prevention information to children and parents. Before the intervention (an in-service training program on the importance of documenting the circumstances of injury on a patient's chart), a 50% randomly selected sample of ED staff members was asked in May 1997 to complete the survey. After the data collection prepilot (4 months later), the remaining 50% was asked in September 1997 to complete the same questionnaire. Administration of the preintervention survey resulted in 53 of 62 surveys being returned (85%). The postintervention survey was completed by 35 of the 41 staff members still eligible (85%), those who were employed in the ED during the entire pilot project. There was no statistically significant difference between the pre- and post-pilot groups on any demographic characteristics. Staff members agreed least with the statement that ED physicians and staff members could impact the severity of injuries to children by providing counseling to parents (68.1% preintervention and 64.5% postintervention agreement). Of most significance was the fact that a lower percentage of staff members agreed postintervention that almost all injuries to children were avoidable. The emergency department was the lowest ranked information dissemination venue for both parents and children.

An unusual case of an anorectal fistula presenting with hip pain and extensive lower limb muscle wasting in a patient with Crohn's disease is reported. This report emphasizes the important role of a thorough history, a complete physical examination, and a thorough search for evaluating such cases. Any progressive local irritation and pain in a Crohn's disease patient may indicate possible fistulous involvement. Nonspecific laboratory findings such as leukocytosis, anemia, decreased albumin level, and thrombocytosis may be considered as supportive indicators. Barium contrast studies and enhanced computed tomography scan may be helpful but can be falsely negative in the presence of a fistula, as in this case. These findings illustrate that the clinician must not be dissuaded from the diagnosis simply based on negative radiological findings because the presence of a fistula may be impossible to determine preoperatively.

A prospective study of routine school vision tests in 1809 children aged 8 and 10 y was undertaken in schools in the Cambridge Health District over two years (1988-1990) to establish whether a significant number of defects of vision were detected. Although the visual acuity of 31% of children who had an abnormal test was recorded as abnormal, most abnormalities were minimal. Only 15 (0.83%) had newly diagnosed problems requiring treatment. Almost all children with marked visual abnormalities had already been detected before school entry, at the 5 y school vision test or on another occasion. Near vision testing did not identify any previously undiagnosed child with significant defects who did not also have distant vision abnormalities. Satisfactory colour vision test results had been recorded for most children at the 5 y school entry vision test. These data do not justify the continued use of routine screening in junior schools.