Tuberculosis (TB) is the leading infectious killer globally and new TB vaccines will be crucial to ending the epidemic. Since the introduction in 1921 of the only currently licensed TB vaccine, BCG, very few novel vaccine candidates or strategies have advanced into clinical efficacy trials. Areas covered: Recently, however, two TB vaccine efficacy trials with novel designs have reported positive results and are now driving new momentum in the field. They are the first Prevention of Infection trial, evaluating the H4:IC31 candidate or BCG revaccination in high-risk adolescents and a Prevention of Disease trial evaluating the M72/AS01 candidate in M.tuberculosis-infected, healthy adults. These trials are briefly reviewed, and lessons learned are proposed to help inform the design of future efficacy trials. The references cited were chosen by the author based on PubMed searches to provide context for the opinions expressed in this Perspective article. Expert opinion: The opportunities created by these two trials for gaining critically important knowledge are game-changing for TB vaccine development. Their results clearly establish feasibility in the relatively near term of developing novel, effective vaccines that could be crucial to ending the TB epidemic.
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http://dx.doi.org/10.1080/14760584.2019.1593143 | DOI Listing |
Cytotherapy
November 2024
Department of Translational and Precision Medicine, University of Rome, Rome, Italy. Electronic address:
Cellular and gene therapy (CGT) products have emerged as a popular approach in regenerative medicine, showing promise in treating various pancreatic and liver diseases in numerous clinical trials. Before these therapies can be tested in human clinical trials, it is essential to evaluate their safety and efficacy in relevant animal models. Such preclinical testing is often required to obtain regulatory approval for investigational new drugs.
View Article and Find Full Text PDFMed Sci Monit
January 2025
Department of Oral Implantology, The Affiliated Stomatology Hospital, Jiangxi Medical College, Nanchang University, Jiangxi Province Key Laboratory of Oral Biomedicine, Jiangxi Province Clinical Research Center for Oral Disease, Nanchang, Jiangxi, China.
BACKGROUND This study included 32 patients with single missing teeth and alveolar bone defects and aimed to compare outcomes from guided bone regeneration with a gelatin/polylactic acid (GT/PLA) barrier membrane and a Guidor® bioresorbable matrix barrier dental membrane. MATERIAL AND METHODS A total of 32 participants were recruited in the clinical study, with single missing teeth and alveolar bone defects, requiring guided bone regeneration (32 missing teeth in total). They were randomly divided into the GT/PLA membrane group (experimental) and Guidor® membrane group (control) by the envelope method (n=16).
View Article and Find Full Text PDFRheumatol Ther
January 2025
Biosplice Therapeutics, Inc., 9360 Towne Centre Dr, San Diego, CA, 92121, USA.
Introduction: Lorecivivint (LOR), a CDC-like kinase/dual-specificity tyrosine kinase (CLK/DYRK) inhibitor thought to modulate inflammatory and Wnt pathways, is being developed as a potential intra-articular knee osteoarthritis (OA) treatment. The objective of this trial was to evaluate long-term safety of LOR within an observational extension of two phase 2 trials.
Methods: This 60-month, observational extension study (NCT02951026) of a 12-month phase 2a trial (NCT02536833) and 6-month phase 2b trial (NCT03122860) was administratively closed after 36 months as data inferences became limited.
Mol Cell Biochem
January 2025
Department of Urology, Guizhou Provincial People's Hospital, Guiyang, 550002, China.
Selenium, an essential trace mineral for health, has seen a rise in clinical trials over the past nearly 5 decades. Our aim here is to provide a comprehensive and concise overview of selenium clinical trials from 1976 to 2023. Overall, the evolution of selenium clinical trials over 48 years has advanced through phases of emergence, prosperity, and either stability or transition.
View Article and Find Full Text PDFRadiat Oncol
January 2025
Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Yokohama, Kanagawa, Japan.
Introduction: Stage IV non-small cell lung carcinoma (NSCLC) with oligometastases is potentially curable by radical treatment. This study aimed to evaluate the efficacy and safety of chemoradiotherapy (CRT) for thoracic disease, including the primary lesion and lymph node metastases, combined with local consolidative therapy (LCT) for oligometastases.
Methods: This was a multicenter Phase II trial for patients with Stage IV NSCLC with oligometastases for whom CRT for thoracic disease was feasible.
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