VACCELERATE Site Network: Real-time definition of clinical study capacity in Europe

Background: The inconsistent European vaccine trial landscape rendered the continent of limited interest for vaccine developers. The VACCELERATE consortium created a network of capable clinical trial sites throughout Europe. VACCELERATE identifies and provides access to state-of-the-art vaccine trial sites to accelerate clinical development of vaccines. Methods: Login details for the VACCELERATE Site Network (vaccelerate.eu/site-network/) questionnaire can be obtained after sending an email to. Interested sites provide basic information, such as contact details, affiliation with infectious disease networks, main area of expertise, previous vaccine trial experience, site infrastructure and preferred vaccine trial settings. In addition, sites can recommend other clinical researchers for registration in the network. If directly requested by a sponsor or sponsor representative, the VACCELERATE Site Network pre-selects vaccine trial sites and shares basic study characteristics provided by the sponsor. Interested sites provide feedback with short surveys and feasibility questionnaires developed by VACCELERATE and are connected with the sponsor to initiate the site selection process. Results: As of April 2023, 481 sites from 39 European countries have registered in the VACCELERATE Site Network. Of these, 137 (28.5 %) sites have previous experience conducting phase I trials, 259 (53.8 %) with phase II, 340 (70.7 %) with phase III, and 205 (42.6 %) with phase IV trials, respectively. Infectious diseases were reported as main area of expertise by 274 sites (57.0 %), followed by any kind of immunosuppression by 141 (29.3 %) sites. Numbers are super additive as sites may report clinical trial experience in several indications. Two hundred and thirty-one (47.0 %) sites have the expertise and capacity to enrol paediatric populations and 391 (79.6 %) adult populations. Since its launch in October 2020, the VACCELERATE Site Network has been used 21 times for academic and industry trials, mostly interventional studies, focusing on different pathogens such as fungi, monkeypox virus, Orthomyxoviridae/influenza viruses, SARS-CoV-2, or Streptococcus pneumoniae/pneumococcus. Conclusions: The VACCELERATE Site Network enables a constantly updated Europe-wide mapping of experienced clinical sites interested in executing vaccine trials. The network is already in use as a rapid-turnaround single contact point for the identification of vaccine trials sites in Europe.The VACCELERATE Site Network has received funding from the European Union’s Horizon 2020 research and innovation pro gramme (grant agreement No 101037867) and the German Federal Ministry of Education and Research (Bundesministerium für Bil dung und Forschung [BMBF]) (grant agreement No BMBF01KX2040).S

Feasibility and safety of high-resolution three-dimensional electroanatomical mapping of the complete heart in dogs

BACKGROUND Three-dimensional electroanatomical mapping (3D EAM) has expanded radiofrequency catheter ablation (RFCA) applications in humans to almost all complex arrhythmias and has drastically reduced fluoroscopy use, yet its potential in dogs is poorly investigated. OBJECTIVES To assess the feasibility and safety of 3D EAM of all four heart chambers in dogs using minimal fluoroscopy. ANIMALS Eight Beagles (median weight 12.2 kg (11.2–15.7)). METHODS Prospective experimental trial. Three-dimensional EAM was attempted during sinus rhythm under general anesthesia using a 22-electrode mapping catheter and CARTO 3 system. Left heart catheterization was achieved by retrograde transaortic access (n=4) or transseptal puncture (TSP) (n=4). Primary outcomes included feasibility, safety and fluoroscopy time. RESULTS Successful 3D EAM of the right atrium and ventricle was achieved in all dogs. Left atrial and ventricular 3D EAM was achieved in six and seven dogs respectively. Median fluoroscopy time was 6.8 min (0.0–45.1) and almost exclusively associated with TSP. Complications requiring intervention occurred in one dog only and were a transient third-degree atrioventricular block after interatrial septum engagement, which reversed after intracardiac pacing (10.3 min), and development of pericardial effusion following TSP treated by pericardiocentesis. Perioperative self-limiting arrhythmias were frequently observed. Only two dogs received lidocaine to resolve intra-operative ventricular tachycardia. CONCLUSIONS AND CLINICAL IMPORTANCE Three-dimensional EAM of all cardiac chambers is feasible, requires minimal fluoroscopic assistance and is promising to guide RFCA of arrhythmias in dogs. Complications were mainly related to TSP and similar to those reported in people

Feasibility and safety of three-dimensional electroanatomical cardiac mapping, mapping-guided biopsy and transseptal puncture in dogs

Introduction Three-dimensional electroanatomical mapping (3D EAM) has expanded radiofrequency catheter ablation applications in humans to almost all complex arrhythmias and has drastically reduced fluoroscopy use, yet its potential in dogs is poorly investigated. The objectives of the current study were to assess the feasibility and safety of 3D EAM of all four heart chambers, 3D EAM-guided biopsies and transseptal puncture in dogs. Animals Eight healthy purpose-bred Beagle dogs. Materials and Methods Electroanatomical mapping was performed under general anaesthesia during sinus rhythm using a 22-electrode mapping catheter. Left heart catheterisation was achieved by either retrograde transaortic access (n = 4) or transseptal puncture (n = 4). Results Successful 3D EAM of the right atrium and ventricle was achieved in all dogs at a median time of 33 (13–40) and 17 (3–52) min, respectively. Left atrial and ventricular 3D EAM was successful in six and seven dogs, at a median time of 17 (4–27) and 8 min (4–19), respectively. Complications requiring intervention occurred in one dog only and were a transient third degree atrioventricular block and pericardial effusion following transseptal puncture, which was treated by pericardiocentesis. All dogs recovered uneventfully. Fluoroscopy time was limited to a median of 7 min (0–45) and almost exclusively associated with transseptal puncture. Conclusions Three-dimensional EAM of all cardiac chambers, including mapping-guided biopsy and transseptal puncture is feasible in small dogs. Complications are similar to those reported in human patients. This suggests a potential added value of 3D EAM to conventional electrophysiology in dogs with arrhythmias

Surgical correction of infundibular pulmonic stenosis and ventricular septal defect in a Shetland sheepdog

Introduction - Right ventricular outflow tract obstruction is a rare congenital disorder in dogs, which is categorized as primary infundibular pulmonic stenosis (IPS) or double-chambered right ventricle.(1) This case presentation discusses the echocardiographic findings, treatment and outcome of a dog with primary IPS and a ventricular septal defect (VSD). Case description - A 4-month-old male Shetland Sheepdog presented with exercise intolerance. Physical examination revealed a 4/6 left cranial systolic heart murmur. Echocardiographic examination showed a severe IPS and concomitant right-to-left shunting VSD (Figure 1, 2). The dog developed worsening signs of congestive right heart failure refractory to medical treatment. Surgical correction was advised. Results - With cardiopulmonary bypass and cardiac arrest via sternotomy, VSD closure and resection of the stenotic infundibular band was performed through right ventriculotomy, followed by a patch enlargement (Figure 3). Post-operative recovery was uneventful and echocardiography showed complete resolution of the stenosis and successful VSD closure (Figure 4). Follow-up echocardiography revealed restenosis after 6 weeks and recurrence of right heart failure symptoms. Transventricular stenting of the restenosis was successfully performed 3 months after initial surgery; however, the dog developed ventricular fibrillation during stent deployment requiring cardio-pulmonary resuscitation which was unsuccessful. Discussion - Correction of IPS has seldom been described in dogs, mostly based on catheter-based techniques.(2,3) Right ventricular patch enlargement provided temporary effective relief of the IPS; however, with early recurrence in this dog. This is the first case reporting the sequential use of both techniques for IPS and right-to-left shunting VSD in a dog

Vaccination rates in Europe are not associated with online media intensity

To map the public information about COVID-19 vaccines and vaccine trials in Europe, we have compiled an inventory of online communication materials from official sources (e.g., governments, public agencies, and NGOs) via directed online research. While information for the general public was abundant across Europe, we found a large variation in number, type and target audiences among countries. Little or no information was found for population groups that are typically underrepresented in vaccine clinical trials. Materials about clinical trials and trial participation were also limited. Interestingly, higher number of media materials was not reflected in higher national vaccination rates.publishedVersio

Vaccination rates in Europe are not associated with online media intensity

To map the public information about COVID-19 vaccines and vaccine trials in Europe, we have compiled an inventory of online communication materials from official sources (e.g., governments, public agencies, and NGOs) via directed online research. While information for the general public was abundant across Europe, we found a large variation in number, type and target audiences among countries. Little or no information was found for population groups that are typically underrepresented in vaccine clinical trials. Materials about clinical trials and trial participation were also limited. Interestingly, higher number of media materials was not reflected in higher national vaccination rates.publishedVersio

Perspectives of European Patient Advocacy Groups on Volunteer Registries and Vaccine Trials: VACCELERATE Survey Study

Background: The VACCELERATE Pan-European Scientific network aims to strengthen the foundation of vaccine trial research across Europe by following the principles of equity, inclusion, and diversity. The VACCELERATE Volunteer Registry network provides access to vaccine trial sites across the European region and supports a sustainable volunteer platform for identifying potential participants for forthcoming vaccine clinical research. Objective: The aim of this study was to approach members of patient advocacy groups (PAGs) across Europe to assess their willingness to register for the VACCELERATE Volunteer Registry and their perspectives related to participating in vaccine trials. Methods: In an effort to understand how to increase recruitment for the VACCELERATE Volunteer Registry, a standardized survey was developed in English and translated into 8 different languages (Dutch, English, French, German, Greek, Italian, Spanish, and Swedish) by the respective National Coordinator team. The online, anonymous survey was circulated, from March 2022 to May 2022, to PAGs across 10 European countries (Belgium, Cyprus, Denmark, France, Germany, Greece, Ireland, Italy, Spain, and Sweden) to share with their members. The questionnaire constituted of multiple choice and open-ended questions evaluating information regarding participants' perceptions on participating in vaccine trials and their willingness to become involved in the VACCELERATE Volunteer Registry. Results: In total, 520 responses were collected and analyzed. The PAG members reported that the principal criteria influencing their decision to participate in clinical trials overall are (1) the risks involved, (2) the benefits that will be gained from their potential participation, and (3) the quality and quantity of information provided regarding the trial. The survey revealed that, out of the 520 respondents, 133 individuals across all age groups were "positive" toward registering in the VACCELERATE Volunteer Registry, with an additional 47 individuals reporting being "very positive." Respondents from Northern European countries were 1.725 (95% CI 1.206-2.468) times more likely to be willing to participate in the VACCELERATE Volunteer Registry than respondents from Southern European countries. Conclusions: Factors discouraging participants from joining vaccine trial registries or clinical trials primarily include concerns of the safety of novel vaccines and a lack of trust in those involved in vaccine development. These outcomes aid in identifying issues and setbacks in present registries, providing the VACCELERATE network with feedback on how to potentially increase participation and enrollment in trials across Europe. Development of European health communication strategies among diverse public communities, especially via PAGs, is the key for increasing patients' willingness to participate in clinical studies