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PfSPZ Vaccine, composed of radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites, is administered by direct venous inoculation (DVI) for maximal efficacy against malaria. A critical issue for advancing vaccines that are administered intravenously is the ability to efficiently administer them across multiple age groups. As part of a pediatric safety, immunogenicity, and efficacy trial in western Kenya, we evaluated the feasibility and tolerability of DVI, including ease of venous access, injection time, and crying during the procedure across age groups. Part 1 was an age de-escalation, dose escalation trial in children aged 13 months-5 years and infants aged 5–12 months; part 2 was a vaccine efficacy trial including only infants, using the most skilled injectors from part 1. Injectors could use a vein viewer, if needed. A total of 1222 injections (target 0.5 mL) were initiated by DVI in 511 participants (36 were 5–9-year-olds, 65 were 13–59-month-olds, and 410 infants). The complete volume was injected in 1185/1222 (97.0%) vaccinations, 1083/1185 (91.4%) achieved with the first DVI. 474/511 (92.8%) participants received only complete injections, 27/511 (5.3%) received at least one partial injection (<0.5 mL), and in 10/511 (2.0%) venous access was not obtained. The rate of complete injections by single DVI for infants improved from 77.1% in part 1 to 92.8% in part 2. No crying occurred in 51/59 (86.4%) vaccinations in 5–9-year-olds, 25/86 (29.1%) vaccinations in 13–59-month-olds and 172/1067 (16.1%) vaccinations in infants. Mean administration time ranged from 2.6 to 4.6 minutes and was longer for younger age groups. These data show that vaccination by DVI was feasible and well tolerated in infants and children in this rural hospital in western Kenya, when performed by skilled injectors. We also report that shipping and storage in liquid nitrogen vapor phase was simple and efficient. (Clinicaltrials.gov NCT02687373).

Fetal cardiac rhabdomyoma is one of the rare benign cardiac masses which is commonly associated with the tuberous sclerosis complex (TSC). Though mostly fetal cardiac rhabdomyoma is asymptomatic it may lead to life-threatening conditions like outflow obstruction, arrhythmias, hydrops fetalis, or sudden fetal death. We are reporting an isolated, asymptomatic fetal intra-cardiac mass (rhabdomyoma) that was discovered at 32 weeks of gestation and was followed as an outpatient until 39 weeks plus one day, at which point a cesarean section was performed. After delivery, the child underwent evaluations at the 1  day, 7  day, 30  day, 7  month, and 12  month of age. Following a checkup, the child's anthropometric and neurobehavioral growth were both healthy. Except for the tumor, which was neither growing nor shrinking in size, none of the clinical diagnostic criteria for tuberous sclerosis complex were met for this child up to the age of one year. The most common primary benign fetal cardiac tumor is cardiac rhabdomyoma, which is usually associated with tuberous sclerosis. In developing nations where it is challenging to obtain MRIs and genetic studies, and in a similar patient like ours with no other features of tuberous sclerosis, the child needs to be followed in the future, bearing in mind that tuberous sclerosis manifestations will continue to develop over a patient's lifetime.

There has been a rapid growth in the field of remote sensing and its various applications in the area of water management. Nowadays, there are several remote sensing techniques that can be used as a source to derive bathymetry data along coastal areas. The key techniques are: sonar (sound navigating and ranging), LiDAR (light detection and ranging) and high-resolution satellite images. The present paper describes a method which was developed and used to create a shallow water bathymetry data along the Dutch side of Sint Maarten Island by combining sonar measurements and satellite images in a nonlinear machine learning technique. The purpose of this work is to develop a bathymetry dataset that can be used to set up physically-based models for coastal flood modelling work. The nonlinear machine learning technique used in the work is a support vector machine (SVM) model. The sonar data were used as an output whereas image data were used as an input into the SVM model. The results were analysed for three depth ranges and the findings are promising. It remains to further verify the capacity of the new method on a dataset with higher resolution satellite imagery.

Pregnant women with opioid use disorder (OUD) face barriers to receiving substance use treatment and prenatal care, which can lead to adverse health outcomes. The purpose of the current article is to inform practice through the design of an innovative, nurse-led approach derived from King's Theory of Goal Attainment to care for pregnant women with OUD using telehealth technologies. The practice model encompasses King's theory using telehealth by addressing perceptions in the nurse–client interaction, establishing effective communication in nurse–client interactions, building mutual goal setting and decision making, and promoting clients' goal attainment using nurses' knowledge and skills. This theory-based approach using telehealth technologies can provide nurses the opportunity to increase effectiveness in nurse–client interactions, use evidence-based communication strategies for expanded access, and deliver safe care for pregnant women with OUD. [J ournal of Psychosocial Nursing and Mental Health Services, 58 (12), 13–20.]

Plasmodium falciparum sporozite (PfSPZ) Vaccine is a metabolically active, non-replicating, whole malaria sporozoite vaccine that has been reported to be safe and protective against P falciparum controlled human malaria infection in malaria-naive individuals. We aimed to assess the safety and protective efficacy of PfSPZ Vaccine against naturally acquired P falciparum in malaria-experienced adults in Mali. After an open-label dose-escalation study in a pilot safety cohort, we did a double-blind, randomised, placebo-controlled trial based in Donéguébougou and surrounding villages in Mali. We recruited 18–35-year-old healthy adults who were randomly assigned (1:1) in a double-blind manner, with stratification by village and block randomisation, to receive either five doses of 2·7 × 105 PfSPZ or normal saline at days 0, 28, 56, 84, and 140 during the dry season (January to July inclusive). Participants and investigators were masked to group assignments, which were unmasked at the final study visit, 6 months after receipt of the last vaccination. Participants received combined artemether and lumefantrine (four tablets, each containing 20 mg artemether and 120 mg lumefantrine, given twice per day over 3 days for a total of six doses) to eliminate P falciparum before the first and last vaccinations. We collected blood smears every 2 weeks and during any illness for 24 weeks after the fifth vaccination. The primary outcome was the safety and tolerability of the vaccine, assessed as local and systemic reactogenicity and adverse events. The sample size was calculated for the exploratory efficacy endpoint of time to first P falciparum infection beginning 28 days after the fifth vaccination. The safety analysis included all participants who received at least one dose of investigational product, whereas the efficacy analyses included only participants who received all five vaccinations. This trial is registered at ClinicalTrials.gov, number NCT01988636. Between Jan 18 and Feb 24, 2014, we enrolled 93 participants into the main study cohort with 46 participants assigned PfSPZ Vaccine and 47 assigned placebo, all of whom were evaluable for safety. We detected no significant differences in local or systemic adverse events or laboratory abnormalities between the PfSPZ Vaccine and placebo groups, and only grade 1 (mild) local or systemic adverse events occurred in both groups. The most common solicited systemic adverse event in the vaccine and placebo groups was headache (three [7%] people in the vaccine group vs four [9%] in the placebo group) followed by fatigue (one [2%] person in the placebo group), fever (one [2%] person in the placebo group), and myalgia (one [2%] person in each group). The exploratory efficacy analysis included 41 participants from the vaccine group and 40 from the placebo group. Of these participants, 37 (93%) from the placebo group and 27 (66%) from the vaccine group developed P falciparum infection. The hazard ratio for vaccine efficacy was 0·517 (95% CI 0·313–0·856) by time-to-infection analysis (log-rank p=0·01), and 0·712 (0·528–0·918) by proportional analysis (p=0·006). PfSPZ Vaccine was well tolerated and safe. PfSPZ Vaccine showed significant protection in African adults against P falciparum infection throughout an entire malaria season. US National Institutes of Health Intramural Research Program, Sanaria.

PfSPZ-CVac combines ‘PfSPZ Challenge’, which consists of infectious Plasmodium falciparum sporozoites (PfSPZ), with concurrent antimalarial chemoprophylaxis. In a previously-published PfSPZ-CVac study, three doses of 5.12x10 4 PfSPZ-CVac given 28 days apart had 100% vaccine efficacy (VE) against controlled human malaria infection (CHMI) 10 weeks after the last immunization, while the same dose given as three injections five days apart had 63% VE. Here, we conducted a dose escalation trial of similarly condensed schedules. Of the groups proceeding to CHMI, the first study group received three direct venous inoculations (DVIs) of a dose of 5.12x10 4 PfSPZ-CVac seven days apart and the next full dose group received three DVIs of a higher dose of 1.024x10 5 PfSPZ-CVac five days apart. CHMI (3.2x10 3 PfSPZ Challenge) was performed by DVI 10 weeks after the last vaccination. In both CHMI groups, transient parasitemia occurred starting seven days after each vaccination. For the seven-day interval group, the second and third vaccinations were therefore administered coincident with parasitemia from the prior vaccination. Parasitemia was associated with systemic symptoms which were severe in 25% of subjects. VE in the seven-day group was 0% (7/7 infected) and in the higher-dose, five-day group was 75% (2/8 infected). Thus, the same dose of PfSPZ-CVac previously associated with 63% VE when given on a five-day schedule in the prior study had zero VE here when given on a seven-day schedule, while a double dose given on a five-day schedule here achieved 75% VE. The relative contributions of the five-day schedule and/or the higher dose to improved VE warrant further investigation. It is notable that administration of PfSPZ-CVac on a schedule where vaccine administration coincided with blood-stage parasitemia was associated with an absence of sterile protective immunity. Clinical trials registration : NCT02773979 .

WHO recently approved a partially effective vaccine that reduces clinical malaria in children, but increased vaccine activity is required to pursue malaria elimination. A phase 1 clinical trial was done in Mali, west Africa, to assess the safety, immunogenicity, and protective efficacy of a three-dose regimen of Plasmodium falciparum sporozoite (PfSPZ) Vaccine (a metabolically active, non-replicating, whole malaria sporozoite vaccine) against homologous controlled human malaria infection (CHMI) and natural P falciparum infection. We recruited healthy non-pregnant adults aged 18–50 years in Donéguébougou, Mali, and surrounding villages (Banambani, Toubana, Torodo, Sirababougou, Zorokoro) for an open-label, dose-escalation pilot study and, thereafter, a randomised, double-blind, placebo-controlled main trial. Pilot study participants were enrolled on an as-available basis to one group of CHMI infectivity controls and three staggered vaccine groups receiving: one dose of 4·5 × 105, one dose of 9 × 105, or three doses of 1·8 × 106 PfSPZ via direct venous inoculation at approximately 8 week intervals, followed by homologous CHMI 5 weeks later with infectious PfSPZ by direct venous inoculation (PfSPZ Challenge). Main cohort participants were stratified by village and randomly assigned (1:1) to receive three doses of 1·8 × 106 PfSPZ or normal saline at 1, 13, and 19 week intervals using permuted block design by the study statistician. The primary outcome was safety and tolerability of at least one vaccine dose; the secondary outcome was vaccine efficacy against homologous PfSPZ CHMI (pilot study) or against naturally transmitted P falciparum infection (main study) measured by thick blood smear. Combined artesunate and amodiaquine was administered to eliminate pre-existing parasitaemia. Outcomes were analysed by modified intention to treat (mITT; including all participants who received at least one dose of investigational product; safety and vaccine efficacy) and per protocol (vaccine efficacy). This trial is registered with ClinicalTrials.gov, number NCT02627456. Between Dec 20, 2015, and April 30, 2016, we enrolled 56 participants into the pilot study (five received the 4·5 × 105 dose, five received 9 × 105, 30 received 1·8 × 106, 15 were CHMI controls, and one withdrew before vaccination) and 120 participants into the main study cohort with 60 participants assigned PfSPZ Vaccine and 60 placebo in the main study. Adverse events and laboratory abnormalities post-vaccination in all dosing groups were few, mainly mild, and did not differ significantly between vaccine groups (all p>0·05). Unexpected severe transaminitis occured in four participants: one participant in pilot phase that received 1·8 × 106 PfSPZ Vaccine, one participant in main phase that received 1·8 × 106 PfSPZ Vaccine, and two participants in the main phase placebo group. During PfSPZ CHMI, approximately 5 weeks after the third dose of 1·8 × 106 PfSPZ, none of 29 vaccinees and one of 15 controls became positive on thick blood smear; subsequent post-hoc PCR analysis for submicroscopic blood stage infections detected P falciparum parasites in none of the 29 vaccine recipients and eight of 15 controls during CHMI. In the main trial, 32 (58%) of 55 vaccine recipients and 42 (78%) of 54 controls became positive on thick blood smear during 24-week surveillance after vaccination. Vaccine efficacy (1–hazard ratio) was 0·51 per protocol (95% CI 0·20–0·70; log-rank p=0·0042) and 0·39 by mITT (0·04–0·62; p=0·033); vaccine efficacy (1–risk ratio) was 0·24 per-protocol (0·02–0·41; p=0·031) and 0·22 mITT (0·01–0·39; p=0·041). A three-dose regimen of PfSPZ Vaccine was safe, well tolerated, and conferred 51% vaccine efficacy against intense natural P falciparum transmission, similar to 52% vaccine efficacy reported for a five-dose regimen in a previous trial. US National Institute of Allergy and Infectious Diseases, National Institutes of Health, Sanaria. For the French translation of the abstract see Supplementary Materials section.

The relation between zinc status and cognitive function was examined in a cross-sectional study in the Sidama area of Southern Ethiopia. Pregnant women >24 weeks of gestation from three adjacent rural villages volunteered to participate. Mean (s.d.) plasma zinc of 99 women was 6.97 (1.07) micromol/l (below the cutoff of 7.6 micromol/l indicative of zinc deficiency at this stage of gestation). The Raven's Coloured Progressive Matrices (CPM) test was administered individually. Scores for the Raven's scale A, which is the simplest scale, ranged from 4 to 10 of a possible 12. Women with plasma zinc <7.6 micromol/l had significantly lower Raven's CPM scale A scores than women with plasma zinc concentrations >7.6 micromol/l. Plasma zinc and maternal age and education predicted 17% of the variation in Raven's CPM scale A scores. We conclude that zinc deficiency is a major factor affecting cognition in these pregnant women.

Background Although there are limited studies, recent data are lacking to accurately determine the magnitude of color blindness in Ethiopia and there is no evidence of such a study in Gish Abay town district. The purpose of thie study was to assess the prevalence of color blindness among school children in Gish Abaya town district, Ethiopia. Methods The study used a community-based analytical cross-sectional study design with multistage cluster random sampling technique from September to October 2016. Three primary schools were selected randomly in the district of Gish Abay town district. Ishihara color plates (24 –edition) was used for color vision test and Snellen’ tumbling ‘E’ chart was used for visual acuity test. The data was analyzed using Statistical Package for Social Sciences (SPSS) version 20 statistical software and binary logistic regression was used to identify factors associated with color blindness. Results Among a total of 854 subjects, 850 participants with age range of 8–18 years were screened for color vision test giving a response rate of 99.53%. Among the participants, 452 (53.2%) were males and 398 (46.8%) were females. There were 36 (4.24%) cases of impaired color vision. Among these, 27 (3.18%) were males and 9 (1.06%) were females. Out of 36 cases of color blindness, 15 (1.77%) were deutan, 7 (0.82%) were protan and 14(1.65%) were unclassified (both deutan and protan forms). The variables; sex adjusted odds ratio (AOR [95% Confidence Interval] =3.19 [1.45; 6.98], p -value = 0.004); and visual impairment (AOR [95% CI] =4.15 [1.77; 9.75], p -value = 0.001) were significantly associated with color impairment. Conclusion The prevalence of childhood color blindness in Gish Abay town district was relatively similar with other studies in Ethiopia. Sex and visual impairment are factors found to be related with the children’s color blindness. Periodical eye examination at the time of school admission is recommended to adjust the children’s occupation early in life.

Background The World Health Organization (WHO) has called for new malaria vaccines with > 90% efficacy against Plasmodium falciparum infection to expand the anti-disease benefit provided by the RTS,S/AS01 and R21/Matrix M subunit vaccines currently administered to infants and young children in sub-Saharan Africa. Attenuated P. falciparum sporozoites (PfSPZ) are being developed as a traveller’s vaccine and to fulfill WHO’s call for high-level efficacy in endemic countries to support malaria elimination. Methods PfSPZ Vaccine, comprised of radiation-attenuated PfSPZ, was compared with normal saline placebo in a randomized, double-blind trial targeting 60 malaria-naive US adults to assess safety, tolerability, immunogenicity, and efficacy against heterologous controlled human malaria infection three and twelve weeks after immunization. Pharmacists provided syringes to blinded clinicians using 3:1 (vaccine:placebo) blocked randomization, for administration by direct venous inoculation on days 1 and 8 (multidose prime) and day 29 (boost), a condensed regimen with superior efficacy. Primary outcomes included adverse events and antibody responses to the P. falciparum circumsporozoite protein (PfCSP). Results 31 participants were screened, randomized and immunized twice (V1, V2) 5–7 days apart, with one withdrawal after an intercurrent adverse event. A vial issue, later traced to the vial manufacturer, halted further immunizations. Solicited local and systemic adverse events recorded for 2 and 7 days after immunizations, respectively, occurred with equal frequency and severity in the 23 vaccinees and 7 controls receiving two immunizations, as did unsolicited adverse events recorded for 28 days and laboratory abnormalities 1 and 5 weeks after V2. Four of 23 vaccinees and one of 7 controls (p = 1.00) developed grade 2 adverse events including subjective fever, headache, malaise, fatigue, rigors, arthralgia and myalgia after V2 but not V1, these symptoms generally resolving within 24 h. Twenty-two of 23 (96%) vaccinees developed IgG (median 99-fold increase over baseline) and IgM (median 1,110-fold increase) antibodies to PfCSP one week after V2. Antibody responses were not associated with reactogenicity. Conclusions The two-dose priming immunization regimen was safe, well tolerated and highly immunogenic. Larger studies may better define the adverse event profile of condensed regimens of PfSPZ Vaccine in malaria-naive adults. Trial registration number: clinicaltrial.gov NCT05604521.