PRECLINICAL RESEARCH IN HUMAN DRUG DEVELOPMENT

The paper presents the preclinical research requirements according to the legislation in force and it’s implementing guidelines in European Union (EU), tracking down it’s origins to ICH when appropriate. The development of any medicinal product requires its research in terms of quality, safety and efficacy. The new codification system for ICH guidelines adopted by ICH Steering Committee is presented in detail. The five categories of CHMP guidelines are explained. The non-clinical research represents a critical stage for the transition to studies in humans. The paper supports the researchers in their efforts to assess the needs and the timelines in the preclinical research fiel

Detection of Amblyomma mixtum (Acari: Ixodidae) in Germany on a Human Traveler Returning from Cuba

The importation of exotic ticks to Germany on infested humans is rarely reported. Here we describe the detection of an Amblyomma mixtum nymph harboring Rickettsia amblyommatis by a tourist returning from a holiday trip to Cuba. Tick infestation may be neglected by tourists. Therefore, careful anamnesis and diagnosis should be carried out when tourists return from tropical and subtropical countries suffering from nonspecific symptoms, such as fever and malaise.Fil: Chitimia Dobler, Lidia. Bundeswehr Institute Of Microbiology; Alemania. Universidad de Hohenheim; AlemaniaFil: Schaper, Sabine. Bundeswehr Institute Of Microbiology; AlemaniaFil: Mansfeld, Peter. Museum of Natural History, Kassel; AlemaniaFil: Gonschorrek, Joachim. No especifíca;Fil: Bröker, Michael. No especifíca;Fil: Nava, Santiago. Instituto Nacional de Tecnología Agropecuaria. Centro Regional Santa Fe. Estación Experimental Agropecuaria Rafaela; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Santa Fe; Argentin

An exotic souvenir on a German traveler returning from South Africa

The study reports the finding of a nymph attached to a German tourist during a holiday in South Africa. The nymph specimen was morphologically identified and confirmed by sequence analysis of the 16S rRNA and 12S rRNA genes. The nymph was identified as Rhipicephalus maculatus, a rare tick reported in humans. Screening using the pan-Rickettsia-PCR for infection gave a negative result.https://link.springer.com/journal/436hj2023Veterinary Tropical Disease

Molting incidents of Hyalomma spp. carrying human pathogens in Germany under different weather conditions

Background Hyalomma marginatum and H. rufipes are two-host tick species, which are mainly distributed in southern Europe, Africa to central Asia but may also be found in Central and Northern Europe through introduction by migratory birds. Methods Ticks were collected while feeding or crawling on animals and humans, or from the environment, in different regions in Germany, between 2019 and 2021 in a citizen science study and from 2022 to 2023 in the wake of this study. Results From 2019 to 2023, a total of 212 Hyalomma adult ticks were detected in Germany. This included 132 H. marginatum and 43 H. rufipes ticks sent to research institutions and 37 photographic records that were only identified to genus level. The number of detected ticks varied over the years, with the highest number of 119 specimens recorded in 2019, followed by 57 in 2020. Most of the specimens were collected from horses, while some were collected from other animals, humans or found crawling on human clothes or other objects inside or outside houses. The screening of 175 specimens for Crimean-Congo hemorrhagic fever virus and of 132 specimens for Babesia/Theileria spp. by PCR gave negative results, while human-pathogenic Rickettsia were detected in 44% (77/175) of the total samples. Subsequent amplicon sequencing and phylogenetic analysis of representative samples determined the species of 41 Rickettsia aeschlimannii and one R. slovaca sequences. Conclusions Analysis of climatic factors indicated a significantly higher probability of Hyalomma occurrence at locations with higher average spring temperature during the years 2019 and 2020 compared to randomly generated pseudo-absence locations. Dry and hot conditions probably facilitated Hyalomma nymphs’ survival and molting into adults during these years

A remarkable assemblage of ticks from mid-Cretaceous Burmese amber

DATA: The data reported in this paper are detailed in the main text.Four fossil ticks (Arachnida: Parasitiformes: Ixodida) are described from mid-Cretaceous (ca. 100 Ma) Burmese amber of Myanmar. Ixodes antiquorum sp. nov. (Ixodidae) is the first Mesozoic record of Ixodes and the oldest representative of the most species-rich extant tick genus. Its affinities appear to lie with modern Australian forms, consistent with the hypothesis that Burmese amber hosted Gondwanan faunal elements. Even more remarkable is Khimaira fossus gen. et sp. nov. which combines a body resembling that of a soft tick (Argasidae) with a basis capitulum more like that of a hard tick (Ixodidae). We refer it to Khimairidae fam. nov. as a possible transitional form between the two main families of ticks alive today. Another member of the extinct Deinocrotonidae is described as Deinocroton copia sp. nov., while the first described adult female for Cornupalpatum burmanicum is associated with a dinosaur feather barb.https://www.cambridge.org/core/journals/parasitologyhj2023Veterinary Tropical Disease

Haemaphysalis hoodi (Acari: Ixodidae) on a human from Yaoundé, Cameroon, and its molecular characterization

The genus Haemaphysalis Koch, 1844 (Acari: Ixodidae) is the second-largest genus, with more than 170 described species that primarily parasitize mammals and birds (Guglielmone et al. 2014, Guglielmone et al. 2020). Haemaphysalis species are three-host ticks, mainly distributed in southern and southeastern Asia and tropical Africa (Guglielmone et al. 2014). The present study identified a tick, Haemaphysalis hoodi Warburton & Nuttall, 1909, collected from a human in Yaoundé, Cameroon. This tick species feed on birds in sub-Saharan Africa. To the best of our knowledge, this is the second record of H. hoodi from humans. In addition, 16S ribosomal RNA and cytochrome oxidase I sequences were generated for this species for the first time. Screening pan-Rickettsia-PCR infection gave a negative result.Open Access funding enabled and organized by Projekt DEAL.https://link.springer.com/journal/436hj2023Veterinary Tropical Disease

Tick species from cattle in the Adama Region of Ethiopia and pathogens detected

Ticks will diminish productivity among farm animals and transmit zoonotic diseases. We conducted a study to identify tick species infesting slaughter bulls from Adama City and to screen them for tick-borne pathogens. In 2016, 291 ticks were collected from 37 bulls in Adama, which were ready for slaughter. Ticks were identified morphologically. Total genomic DNA was extracted from ticks and used to test for Rickettsia spp. with real-time PCR. Species identification was done by phylogenetic analysis using sequencing that targeted the 23S-5S intergenic spacer region and ompA genes. Four tick species from two genera, Amblyomma and Rhipicephalus, were identified. Amblyomma cohaerens was the dominant species (n = 241, 82.8%), followed by Amblyomma variegatum (n = 22, 7.5%), Rhipicephalus pulchellus (n = 19, 6.5%), and Rhipicephalus decoloratus (n = 9, 3.0%). Among all ticks, 32 (11%) were positive for Rickettsia spp. and 15 (5.2%) of these were identified as R. africae comprising at least two genetic clades, occurring in A. variegatum (n = 10) and A. cohaerens (n = 5). The remainder of Rickettsia-positive samples could not be amplified due to low DNA yield. Furthermore, another 15 (5.2%) samples carried other pathogenic bacteria: Ehrlichia ruminantium (n = 9; 3.1%) in A. cohaerens, Ehrlichia sp. (n = 3; 1%) in Rh. pulchellus and A. cohaerens, Anaplasma sp. (n = 1; 0.5%) in A. cohaerens, and Neoehrlichia mikurensis (n = 2; 0.7%) in A. cohaerens. All ticks were negative for Bartonella spp., Babesia spp., Theileria spp., and Hepatozoon spp. We reported for the first time E. ruminatium, N. mikurensis, Ehrlichia sp., and Anaplasma sp. in A. cohaerens. Medically and veterinarily important pathogens were mostly detected from A. variegatum and A. cohaerens. These data are relevant for a One-health approach for monitoring and prevention of tick-borne disease transmission

Seabird ticks (<i>Ixodes uriae</i>) distribution along the Antarctic Peninsula

The distribution of the tick Ixodes uriae is studied in the South Shetlands and different locations along the Antarctic Peninsula. Ticks were found beneath stones close to penguin rookeries of chinstrap, gentoo and adelie penguin, although no individuals were found parasitized. Our results showed that ticks are not distributed evenly along the Antarctic Peninsula being more common and abundant in the northern part with relative abundances of ticks ranging from 1 to 57 individuals per stone and from 2 to 26% of the stone inspected. Ticks are probably absent in the south.Centro de Estudios Parasitológicos y de Vectore

Dermacentor reticulatus: a vector on the rise

Dermacentor reticulatus is a hard tick species with extraordinary biological features. It has a high reproduction rate, a rapid developmental cycle, and is also able to overcome years of unfavourable conditions. Dermacentor reticulatus can survive under water for several months and is cold-hardy even compared to other tick species. It has a wide host range: over 60 different wild and domesticated hosts are known for the three active developmental stages. Its high adaptiveness gives an edge to this tick species as shown by new data on the emergence and establishment of D. reticulatus populations throughout Europe. The tick has been the research focus of a growing number of scientists, physicians and veterinarians. Within the Web of Science database, more than a fifth of the over 700 items published on this species between 1897 and 2015 appeared in the last three years (2013–2015). Here we attempt to synthesize current knowledge on the systematics, ecology, geographical distribution and recent spread of the species and to highlight the great spectrum of possible veterinary and public health threats it poses. Canine babesiosis caused by Babesia canis is a severe leading canine vector-borne disease in many endemic areas. Although less frequently than Ixodes ricinus, D. reticulatus adults bite humans and transmit several Rickettsia spp., Omsk haemorrhagic fever virus or Tick-borne encephalitis virus. We have not solely collected and reviewed the latest and fundamental scientific papers available in primary databases but also widened our scope to books, theses, conference papers and specialists colleagues’ experience where needed. Besides the dominant literature available in English, we also tried to access scientific literature in German, Russian and eastern European languages as well. We hope to inspire future research projects that are necessary to understand the basic life-cycle and ecology of this vector in order to understand and prevent disease threats. We conclude that although great strides have been made in our knowledge of the eco-epidemiology of this species, several gaps still need to be filled with basic research, targeting possible reservoir and vector roles and the key factors resulting in the observed geographical spread of D. reticulatus. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13071-016-1599-x) contains supplementary material, which is available to authorized users