Background
Ebola vaccine development was accelerated in response to the 2014 Ebola virus infection outbreak. This phase 1 study (VAC52150EBL1004) assessed safety, tolerability, and immunogenicity of heterologous 2-dose Ad26.ZEBOV, MVA-BN-Filo vaccination regimens in the Lake Victoria Basin of Tanzania and Uganda in mid-level altitude, malaria-endemic settings.
Methods
Healthy volunteers aged 18–50 years from Tanzania (n = 25) and Uganda (n = 47) were randomized to receive placebo or active vaccination with Ad26.ZEBOV or MVA-BN-Filo (first vaccination), followed by MVA-BN-Filo or Ad26.ZEBOV (second vaccination) dose 2, respectively, with intervals of 28 or 56 days.
Results
Seventy-two adults were randomized to receive vaccine (n = 60) or placebo (n = 12). No vaccine-related serious adverse events were reported. The most frequent solicited local and systemic adverse events were injection site pain (frequency, 70%, 66%, and 42% per dose for MVA-BN-Filo, Ad26.ZEBOV, and placebo, respectively) and headache (57%, 56%, and 46%, respectively). Adverse event patterns were similar among regimens. Twenty-one days after dose 2, 100% of volunteers demonstrated binding antibody responses against Ebola virus glycoprotein, and 87%–100% demonstrated neutralizing antibody responses. Ad26.ZEBOV dose 1 vaccination induced more-robust initial binding antibody and cellular responses than MVA-BN-Filo dose 1 vaccination.
Conclusions
Heterologous 2-dose vaccination with Ad26.ZEBOV and MVA-BN-Filo against Ebola virus is well tolerated and immunogenic in healthy volunteers.
Clinical trials registration
NCT02376400.
Background
During the 2014 West African Ebola outbreak, Ebola vaccine development was accelerated. The phase 1 VAC52150EBL1003 study was performed to investigate 2-dose heterologous vaccination with Ad26.ZEBOV and MVA-BN-Filo in an African population located in a high-altitude setting in Nairobi, Kenya.
Methods
Healthy adult volunteers were randomized to receive one of four 2-dose vaccination schedules. The first vaccination was administered at baseline (Ad26.ZEBOV or MVA-BN-Filo), followed by the second vaccination with the alternate vaccine after either 28 or 56 days. Each schedule had a placebo comparator group. The primary objective was to assess the safety and tolerability of these regimens.
Results
Seventy-two volunteers were randomized into 4 groups of 18 (15 received vaccine, and 3 received placebo). The most frequent solicited systemic adverse event was headache (frequency, 50%, 61%, and 42% per dose for MVA-BN-Filo, Ad26.ZEBOV, and placebo, respectively). The most frequent solicited local AE was injection site pain (frequency, 78%, 63%, and 33% per dose for MVA-BN-Filo, Ad26.ZEBOV, and placebo, respectively). No differences in adverse events were observed among the different vaccine regimens. High levels of binding and neutralizing anti–Ebola virus glycoprotein antibodies were induced by all regimens and sustained to day 360 after the first dose.
Conclusions
Two-dose heterologous vaccination with Ad26.ZEBOV and MVA-BN-Filo was well tolerated and highly immunogenic against Ebola virus glycoprotein.
Clinical trials registration
NCT02376426
Dental occlusion varies among individuals, and achieving correct physiological occlusion after osteotomy is essential for the complex functioning of the stomatognathic system. The T-Scan system records the centre of force, first contact, maximum bite force, and maximum intercuspation. The aim of the present study was to investigate the usefulness and consistency of T-Scan in assessing occlusion before and after orthognathic surgery. Occlusal information was evaluated for 30 healthy adults with normal occlusion and 40 patients undergoing orthognathic surgery. T-Scan had a high degree of reliability for consecutive measurements (Pearson correlation, r = 0.98). For most parameters, occlusal distribution was better after surgery than before surgery. More teeth contributed to occlusion at maximum intercuspation after surgery than before surgery (14 vs. 10). In addition, the difference in the posterior force distribution was reduced after surgery (17.6 ± 13.8 vs. 22.7 ± 21.4 before surgery), indicating better occlusal force distribution after surgery. The maximum percentage force on teeth (p = 0.004) and the number of teeth contributing to occlusion (p < 0.001) also differed significantly. Thus, T-Scan is good for assessing occlusal discrepancies and can be used to portray the pre- and post-operative occlusal contact distribution during treatment planning and follow-up.
This study investigated the effects of student and classroom characteristics on math self-confidence, perceived usefulness, and enjoyment of mathematics as multiple outcomes. A sample of 7th-grade students from 78 classes of 49 schools was studied. The data were collected using, among other instruments, an attitude questionnaire. The results of the multivariate multilevel analysis showed that the variance of the 3 indicators was situated mostly at the student level, and that the indicators correlated strongly at the class level. Higher prior mathematics achievement and positive parental beliefs and attitudes were significant predictors of higher scores across the 3 indicators. Each of the baseline indicators was significantly associated with its corresponding final indicator. At the classroom level, classroom assessment was significantly associated with less endorsement of all 3 indicators, higher levels of classroom modeling with greater endorsement of perceived usefulness of mathematics, and classroom questioning with greater enjoyment of mathematics.
ARTICLE HISTORY
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.