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Safety and immunogenicity of the Ad26/protein preF RSV vaccine in adults aged 18 to 59 years with and without at-risk comorbidities for severe respiratory syncytial virus disease: A phase 3, randomized, controlled, immunobridging trial.
Vaccine
January 2025
Janssen Vaccines & Prevention B.V., Archimedesweg 4, 2333, CN, Leiden, The Netherlands.
Background: Respiratory syncytial virus (RSV) causes a significant disease burden in adults with chronic comorbidities. Rates of severe RSV disease and death are as high, or higher in younger adults with risk factors than in healthy older adults in whom RSV vaccination is recommended. We conducted an immunobridging study using the Ad26/protein RSV preF vaccine, which previously demonstrated efficacy in adults aged ≥65 years to support extrapolation of efficacy demonstrated in an older population to younger adult populations at high risk of severe RSV disease.
View Article and Find Full Text PDFSafety, tolerability, and immunogenicity of an adult pneumococcal conjugate vaccine, V116 (STRIDE-3): a randomised, double-blind, active comparator controlled, international phase 3 trial.
Lancet Infect Dis
October 2024
Merck & Co, Inc, Rahway, NJ, USA.
Article Synopsis
- The study investigates the safety, tolerability, and effectiveness of V116, a new 21-valent pneumococcal conjugate vaccine (PCV) specifically designed for adults, contrasting it with the existing PCV20.
- Conducted as a phase 3 trial across 112 clinical sites in 11 countries, participants were divided into two cohorts: those aged 50 and older and those aged 18-49, receiving either V116 or PCV20 through random assignment.
- The research focuses on four primary immunogenicity outcomes, comparing the immune responses between V116 and PCV20 to determine if V116 is non-inferior or superior, emphasizing its potential advantages for specific pneumococcal serotypes
Immunogenicity of an adjuvanted SARS-CoV-2 trimeric S-protein subunit vaccine (SCB-2019) in SARS-CoV-2-naïve and exposed individuals in a phase 2/3, double-blind, randomized study.
Vaccine
March 2023
Clover Biopharmaceuticals, Boston, MA, USA. Electronic address:
Background: We evaluated immunogenicity of SCB-2019, a subunit vaccine candidate containing a pre-fusion trimeric form of the SARS-CoV-2 spike (S)-protein adjuvanted with CpG-1018/alum.
Methods: The phase 2/3, double-blind, randomized SPECTRA trial was conducted in five countries in participants aged ≥ 18 years, either SARS-CoV-2-naïve or previously exposed. Participants were randomly assigned to receive two doses of SCB-2019 or placebo administered intramuscularly 21 days apart.
First-in-human development of a pharmacodynamic biomarker for PAC receptor antagonists using intradermal injections of maxadilan.
Clin Transl Sci
August 2022
Center for Clinical Pharmacology, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Maxadilan, a potent vasodilator peptide, selectively activates the PAC receptor, a promising target for migraine therapy. Therefore, maxadilan has been suggested as a tool to study the pharmacodynamics (PDs) of PAC receptor antagonists. The objectives of this first-in-human study were to: (1) determine the safety, tolerability, dose response, and time course of the dermal blood flow (DBF) changes after intradermal (i.
View Article and Find Full Text PDFGenomic Analysis of Tumors from Patients with Glioblastoma with Long-Term Response to Afatinib.
Onco Targets Ther
April 2022
Radiation Oncology Unit, Royal Marsden Hospital, London, UK.
Article Synopsis
- Glioblastoma is a highly aggressive brain tumor with high recurrence rates and limited effective second-line treatment options; mutations in the epidermal growth factor receptor (EGFR) gene are common in these tumors.
- Afatinib, a targeted therapy that blocks the ErbB family of receptors, showed some effectiveness in preclinical studies and in trials when used alongside the chemotherapy drug temozolomide, particularly for patients with specific gene alterations.
- A case series observed long-term responders among three patients in the trials, revealing unique genetic factors that may influence treatment response, indicating a need for further research on tailoring therapies based on genetic profiles in glioblastoma.
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