Safety and Allele-Specific Immunogenicity of a Malaria Vaccine in Malian Adults: Results of a Phase I Randomized Trial

OBJECTIVES: The objectives were to evaluate the safety, reactogenicity, and allele-specific immunogenicity of the blood-stage malaria vaccine FMP1/AS02A in adults exposed to seasonal malaria and the impact of natural infection on vaccine-induced antibody levels. DESIGN: We conducted a randomized, double-blind, controlled phase I clinical trial. SETTING: Bandiagara, Mali, West Africa, is a rural town with intense seasonal transmission of Plasmodium falciparum malaria. PARTICIPANTS: Forty healthy, malaria-experienced Malian adults aged 18–55 y were enrolled. INTERVENTIONS: The FMP1/AS02A malaria vaccine is a 42-kDa recombinant protein based on the carboxy-terminal end of merozoite surface protein-1 (MSP-1(42)) from the 3D7 clone of P. falciparum, adjuvanted with AS02A. The control vaccine was a killed rabies virus vaccine (Imovax). Participants were randomized to receive either FMP1/AS02A or rabies vaccine at 0, 1, and 2 mo and were followed for 1 y. OUTCOME MEASURES: Solicited and unsolicited adverse events and allele-specific antibody responses to recombinant MSP-1(42) and its subunits derived from P. falciparum strains homologous and heterologous to the 3D7 vaccine strain were measured. RESULTS: Transient local pain and swelling were more common in the malaria vaccine group than in the control group (11/20 versus 3/20 and 10/20 versus 6/20, respectively). MSP-1(42) antibody levels rose during the malaria transmission season in the control group, but were significantly higher in malaria vaccine recipients after the second immunization and remained higher after the third immunization relative both to baseline and to the control group. Immunization with the malaria vaccine was followed by significant increases in antibodies recognizing three diverse MSP-1(42) alleles and their subunits. CONCLUSIONS: FMP1/AS02A was well tolerated and highly immunogenic in adults exposed to intense seasonal malaria transmission and elicited immune responses to genetically diverse parasite clones. Anti-MSP-1(42) antibody levels followed a seasonal pattern that was significantly augmented and prolonged by the malaria vaccine

Safety and Immunogenicity of an AMA-1 Malaria Vaccine in Malian Adults: Results of a Phase 1 Randomized Controlled Trial

The objective was to evaluate the safety, reactogenicity and immunogenicity of the AMA-1-based blood-stage malaria vaccine FMP2.1/AS02A in adults exposed to seasonal malaria.A phase 1 double blind randomized controlled dose escalation trial was conducted in Bandiagara, Mali, West Africa, a rural town with intense seasonal transmission of Plasmodium falciparum malaria. The malaria vaccine FMP2.1/AS02A is a recombinant protein (FMP2.1) based on apical membrane antigen-1 (AMA-1) from the 3D7 clone of P. falciparum, adjuvanted with AS02A. The comparator vaccine was a cell-culture rabies virus vaccine (RabAvert). Sixty healthy, malaria-experienced adults aged 18-55 y were recruited into 2 cohorts and randomized to receive either a half dose or full dose of the malaria vaccine (FMP2.1 25 microg/AS02A 0.25 mL or FMP2.1 50 microg/AS02A 0.5 mL) or rabies vaccine given in 3 doses at 0, 1 and 2 mo, and were followed for 1 y. Solicited symptoms were assessed for 7 d and unsolicited symptoms for 30 d after each vaccination. Serious adverse events were assessed throughout the study. Titers of anti-AMA-1 antibodies were measured by ELISA and P. falciparum growth inhibition assays were performed on sera collected at pre- and post-vaccination time points. Transient local pain and swelling were common and more frequent in both malaria vaccine dosage groups than in the comparator group. Anti-AMA-1 antibodies increased significantly in both malaria vaccine groups, peaking at nearly 5-fold and more than 6-fold higher than baseline in the half-dose and full-dose groups, respectively.The FMP2.1/AS02A vaccine had a good safety profile, was well-tolerated, and was highly immunogenic in malaria-exposed adults. This malaria vaccine is being evaluated in Phase 1 and 2 trials in children at this site

Analysis and assessment of the Podkarpackie voivodship socio-economic development

Zagadnienie rozwoju społeczno-gospodarczego to zjawisko o charakterze złożonym, wielokryteriowym. Związane jest zarówno z aspektem ekonomicznym, demograficznym jak i przyrodniczym. Rozwój wiąże się bezpośrednio ze wzrostem liczby inwestycji, z zainteresowaniem turystycznym, z rozbudową infrastruktury technicznej oraz społecznej. Nie można także zapomnieć o kapitale ludzkim. Dodatkowy odpływ ludności z terenów słabo zaludnionych powoduje bowiem regres w rozwoju społeczno- gospodarczym. Przemiany społeczno-gospodarcze po 1990 roku były bezpośrednią przyczyną reorganizacji struktury przestrzennej kraju oraz powiązań regionalnych. Województwa tzw. „ściany wschodniej” są postrzegane jako obszary rolnicze, słabiej rozwinięte. Wciąż aktualne pozostaje pytanie czy należy podejmować próby hamowania niekorzystnych procesów na obszarach słabiej rozwiniętych (rolniczych), wspierać je i dążyć do ich rozwoju, czy może wspierać te obszary, które same posiadają już zdolności rozwojowe. Artykuł przedstawia analizę i próbę oceny warunków rozwoju społeczno-gospodarczego województwa podkarpackiego, przyjmując jako pole podstawowej oceny powiat. Na potrzeby oceny zróżnicowania przestrzennego badanego województwa zastosowano metodę taksonomii wrocławskiej. Materiały źródłowe stanowiące podstawę badań dotyczyły stanu na 2011 r. Dane pochodzą ze źródeł statystyki publicznej Głównego Urzędu Statystycznego. W wyniku przeprowadzonych analiz wydzielono typy przestrzenne warunków rozwoju społeczno-gospodarczego w województwie podkarpackim oraz dokonano ich charakterystyki.The issue of socio-economic development is a phenomenon with a complex analysis. It is associated with both the economic aspect, demographic and natural. The development is directly related to the increase in investment, with interest tourism, the development of technical and social infrastructure. It cannot be forget the human capital. The outflow causes a decline in socio-economic development. Social and economic changes after 1990 were the direct cause of the reorganization of the spatial structure of the country and regional links. Province called „Eastern wall” are seen as agricultural areas, less developed. Question remains whether to attempt to inhibit the unfavorable processes in less developed areas (agricultural), to support them and strive for their development, or support these areas, which themselves already have development potential. The article presents the analysis the socio-economic development of Podkarpackie, taking as a primary field assessment district. Analysis was performed according to the state for the year 2011, the data come from sources of official statistics of the Central Statistical Office. These analyzes gave the zone set for the differentiation of areas for the socio-economic development. The testing method used to analysis was the taxonomy, created by the researcher in Wrocław