Safety of the Malaria Vaccine Candidate, RTS,S/AS01E in 5 to 17 Month Old Kenyan and Tanzanian Children

The malaria vaccine candidate, RTS,S/AS01E, showed promising protective efficacy in a trial of Kenyan and Tanzanian children aged 5 to 17 months. Here we report on the vaccine's safety and tolerability. The experimental design was a Phase 2b, two-centre, double-blind (observer- and participant-blind), randomised (1∶1 ratio) controlled trial. Three doses of study or control (rabies) vaccines were administered intramuscularly at 1 month intervals. Solicited adverse events (AEs) were collected for 7 days after each vaccination. There was surveillance and reporting for unsolicited adverse events for 30 days after each vaccination. Serious adverse events (SAEs) were recorded throughout the study period which lasted for 14 months after dose 1 in Korogwe, Tanzania and an average of 18 months post-dose 1 in Kilifi, Kenya. Blood samples for safety monitoring of haematological, renal and hepatic functions were taken at baseline, 3, 10 and 14 months after dose 1. A total of 894 children received RTS,S/AS01E or rabies vaccine between March and August 2007. Overall, children vaccinated with RTS,S/AS01E had fewer SAEs (51/447) than children in the control group (88/447). One SAE episode in a RTS,S/AS01E recipient and nine episodes among eight rabies vaccine recipients met the criteria for severe malaria. Unsolicited AEs were reported in 78% of subjects in the RTS,S/AS01E group and 74% of subjects in the rabies vaccine group. In both vaccine groups, gastroenteritis and pneumonia were the most frequently reported unsolicited AE. Fever was the most frequently observed solicited AE and was recorded after 11% of RTS,S/AS01E doses compared to 31% of doses of rabies vaccine. The candidate vaccine RTS,S/AS01E showed an acceptable safety profile in children living in a malaria-endemic area in East Africa. More data on the safety of RTS,S/AS01E will become available from the Phase 3 programme

Approaching the community about screening children for a multicentre malaria vaccine trial.

Community sensitisation, as a component of community engagement, plays an important role in strengthening the ethics of community-based trials in developing countries and is fundamental to trial success. However, few researchers have shared their community sensitisation strategies and experiences. We report on our perspective as researchers on the sensitisation activities undertaken for a phase II malaria vaccine trial in Kilifi District (Kenya) and Korogwe District (Tanzania), with the aim of informing and guiding the operational planning of future trials. We report wide variability in recruitment rates within both sites; a variability that occurred against a backdrop of similarity in overall approaches to sensitisation across the two sites but significant differences in community exposure to biomedical research. We present a range of potential factors contributing to these differences in recruitment rates, which we believe are worth considering in future community sensitisation plans. We conclude by arguing for carefully designed social science research around the implementation and impact of community sensitisation activities

Post-Arab Spring: The Arab World Between the Dilemma of the Nation-State and the Rise of Identity Conflicts

The Arab world is one of the most volatile regions in the world suffering from identity conflicts. These conflicts, which revolve around religious, sectarian, ethnic, and tribal issues, represent the other side of the crisis of nation-state building in the Arab world in the postindependence era. Although identity conflicts are not new to the region, they have intensified after the US invasion of Iraq in 2003 and the revolutions of the so-called Arab Spring. These two events revealed the deep crisis of the nation-state, thereby highlighting the failure of the postindependence ruling elites to establish nation states that can maintain a position of legitimacy and effectiveness. Being both legitimate and effective enables a state to include religious, sectarian, ethnic, and tribal pluralism within the framework of its national identity, based on the foundations and principles of citizenship, rule of law, respect for human rights, minority rights, and social justice.Additionally, identity conflicts are linked to two other factors that escalated after the US invasion of Iraq and the events of the “Arab spring.” First, was the increased politicization of religious, sectarian, and tribal affiliations, which was used to serve political ends, either by ruling regimes, political parties, or non-state actors. Second, is the current expansion of the political polarization between the forces of political Islam which rose rapidly after the “Arab spring” on one hand and the liberal, leftist, and national civil forces on the other hand. This polarization reflects the deep gap between the advocates of the “religious state” and the advocates of the “civil state.” The purpose of this chapter is to analyze and interpret the dimensions of the relationship between the deep crisis of the nation–state and identity conflicts in the post-Arab spring era

TOI 694b and TIC 220568520b: Two Low-mass Companions near the Hydrogen-burning Mass Limit Orbiting Sun-like Stars

We report the discovery of TOI 694 b and TIC 220568520 b, two low-mass stellar companions in eccentric orbits around metal-rich Sun-like stars, first detected by the Transiting Exoplanet Survey Satellite (TESS). TOI 694 b has an orbital period of 48.05131 ± 0.00019 days and eccentricity of 0.51946 ± 0.00081, and we derive a mass of 89.0 ± 5.3 MJup (0.0849 ± 0.0051 M⊙) and radius of 1.111 ± 0.017 RJup (0.1142 ± 0.0017 R⊙). TIC 220568520 b has an orbital period of 18.55769 ± 0.00039 days and eccentricity of 0.0964 ± 0.0032, and we derive a mass of 107.2 ± 5.2 MJup (0.1023 ± 0.0050 M⊙) and radius of 1.248 ± 0.018 RJup (0.1282 ± 0.0019 R⊙). Both binary companions lie close to and above the hydrogen-burning mass threshold that separates brown dwarfs and the lowest-mass stars, with TOI 694 b being 2σ above the canonical mass threshold of 0.075 M⊙. The relatively long periods of the systems mean that the magnetic fields of the low-mass companions are not expected to inhibit convection and inflate the radius, which according to one leading theory is common in similar objects residing in short-period tidally synchronized binary systems. Indeed we do not find radius inflation for these two objects when compared to theoretical isochrones. These two new objects add to the short but growing list of low-mass stars with well-measured masses and radii, and highlight the potential of the TESS mission for detecting such rare objects orbiting bright stars