Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous and Intravenous Garadacimab Following Single-Dose Administration in Healthy Japanese and White Adults.

Garadacimab, an activated factor XII (FXIIa) inhibitor monoclonal antibody, is being evaluated for the long-term prophylaxis of hereditary angioedema. Here, we report the results from a two-part, phase 1, open-label, single ascending dose study assessing the pharmacokinetics (PK), pharmacodynamics, safety, and tolerability after subcutaneous (SC) and intravenous (IV) administration of garadacimab in healthy Japanese and White participants. Part 1 assessed garadacimab PK after SC administration of a 200 mg dose in weight-matched White and Japanese participants, and 600 mg dose in Japanese participants.

Continuous Laser Versus Micropulse Laser in the Treatment of Central Serous Chorioretinopathy: A Retrospective Study.

Background: Central serous chorioretinopathy (CSCR) is a retinal disorder characterized by complex mechanisms leading to abnormal fluid accumulation under the retina. While management remains controversial, laser therapy has been successfully used. This study compares the efficacy of continuous laser (CL) and micropulse laser (ML) therapy in treating CSCR, focusing on reduction in macular thickness and improvement in visual acuity.

Efficacy and Safety of Garadacimab in Combination with Standard of Care Treatment in Patients with Severe COVID-19.

Background: Garadacimab, a fully human IgG4 monoclonal antibody, inhibits the kallikrein-kinin pathway at a key initiator, activated coagulation factor XII (FXIIa), and may play a protective role in preventing the progression of COVID-19. This phase 2 study evaluated the efficacy and safety of garadacimab plus standard of care (SOC) versus placebo plus SOC in patients with severe COVID-19.

Methods: Patients hospitalised with COVID-19 were randomised (1:1) to a single intravenous dose of garadacimab (700 mg) plus SOC or placebo plus SOC.

Proof-of-concept of a low-dose unmodified mRNA-based rabies vaccine formulated with lipid nanoparticles in human volunteers: A phase 1 trial.

Introduction: In a first-in-human study immune responses to rabies virus glycoprotein (RABV-G)-mRNA vaccine were dependent on the route of administration, necessitating specialized devices. Following successful preclinical studies with mRNA encapsulated in lipid nanoparticles (LNP), we tested an mRNA-LNP formulation (CV7202).

Methods: In this phase 1, multi-center, controlled study in Belgium and Germany we enrolled 55 healthy 18-40-year-olds to receive intramuscular injections of 5 μg (n = 10), 1 μg (n = 16), or 2 μg (n = 16) CV7202 on Day 1; subsets (n = 8) of 1 μg and 2 μg groups received second doses on Day 29.

Vaccination policies of immigrants in the EU/EEA Member States-the measles immunization example.

Background: In 2015-16, the European Union/European Economic Area Member States (EU/EEA MSs) experienced an unprecedented volume and rate of migration, posing serious challenges to existing national immunization systems and strategies and raising the questions of where, when and who to vaccinate. We assessed existing strategies for vaccinating immigrant populations in the EU/EEA using measles as an example of the most important vaccine-preventable diseases.

Methods: In this cross-sectional study, conducted from March to May 2016, an electronic questionnaire was sent to the Heads of National Immunization Technical Advisory Groups (NITAGs) or equivalent policy-making bodies in each of the 31 EU/EEA Member States.

Safety and immunogenicity of a mRNA rabies vaccine in healthy adults: an open-label, non-randomised, prospective, first-in-human phase 1 clinical trial.

Background: Vaccines based on mRNA coding for antigens have been shown to be safe and immunogenic in preclinical models. We aimed to report results of the first-in-human proof-of-concept clinical trial in healthy adults of a prophylactic mRNA-based vaccine encoding rabies virus glycoprotein (CV7201).

Methods: We did an open-label, uncontrolled, prospective, phase 1 clinical trial at one centre in Munich, Germany.