SK Chemicals · 细胞治疗 · 细胞治疗
tuberculosis vaccine 是一种细胞治疗，由SK Chemicals研发。该药已获批，用于治疗相关适应症，给药途径：Injectable (Others)、Intradermal Injection。
| 公司 | SK Chemicals |
| 药物类别 | 细胞治疗, 疫苗 |
| 给药途径 | Injectable (Others), Intradermal Injection |
| 状态 | Approved |
Brehm Thomas Theo TT, Yedilbayev Askar A, Perehinets Ihor I, Ashiru-Oredope Diane D et al.
Hisamoto Koji K, Yamanaka Masaki M, Nomura Masayasu M, Kanno Nobufumi N et al.
Efficacy of the nine-valent human papillomavirus (9vHPV; HPV6, 11, 16, 18, 31, 33, 45, 52, and 58) vaccine was shown in females and inferred for males through immunobridging. We evaluated the efficacy of the 9vHPV vaccine in males aged 16-26 years. This randomised, double-blind, placebo-controlled, efficacy, immunogenicity, and safety phase 3 trial was conducted at 22 clinical research, hospital, medical, or treatment sites in Japan, with masking of investigators, sponsor personnel, and participants. Healthy males aged 16-26 years with no history of human papillomavirus (HPV)-related lesions and no previous HPV vaccination were randomly assigned (1:1) centrally, using permutated blocks (block sizes of four), to receive three intramuscular injections of the 9vHPV vaccine or placebo (saline) at day 1, month 2, and month 6. The primary and secondary efficacy endpoints were the combined incidences of 6-month anogenital persistent infection related to HPV6, 11, 16, and 18 and HPV31, 33, 45, 52, and 58. Anogenital swabs and external genital tissue samples were tested for the presence of HPV DNA. Tissue samples were adjudicated for histopathology diagnosis. The primary and secondary efficacy evaluations were tested for superiority with a margin of 0% in the per-protocol population. Another secondary endpoint was antibody responses to each vaccine-targeted HPV type at month 7; immunogenicity analyses were conducted in the per-protocol immunogenicity population. Safety was assessed in participants who received at least one dose of vaccine or placebo. This study is registered with ClinicalTrials.gov (NCT04635423) and is completed. Between Nov 30, 2020, and Dec 25, 2021, 1059 participants were enrolled and randomly assigned to receive the 9vHPV vaccine (n=529) or placebo (n=530). Vaccine efficacy for the primary and secondary endpoints was 89·3% (95% CI 55·4-98·2; p=0·0002) and 63·5% (2·7-86·0; p=0·023), respectively, in the initial efficacy analysis based on a visit cutoff date of Dec 29, 2023, and 91·6% (67·7-98·6) and 72·9% (38·7-89·3) in the end-of-study efficacy analysis based on a visit cutoff date of July 16, 2024. Seroconversion rates were greater than 98% for each vaccine-targeted HPV type. Injection-site adverse events were reported in 370 (70%) of 529 9vHPV vaccine recipients and 162 (31%) of 530 placebo recipients, and vaccine-related systemic adverse events in 58 (11%) vaccine recipients and 52 (10%) placebo recipients; most cases were mild or moderate. No deaths, vaccine-related serious adverse events, or discontinuations due to adverse events were reported. The 9vHPV vaccine prevents anogenital persistent infection related to vaccine-targeted HPV types in males and has an acceptable safety profile. These findings support the use of the 9vHPV vaccine in males to prevent HPV-related anogenital diseases. Merck Sharp & Dohme. For the Japanese translation of the abstract see Supplementary Material section.
Akkoul Nour N, Kumar Tarun T, Sharma Swaati S, Sharma Vipasha V et al.
Tuberculosis (TB), caused by Mycobacterium tuberculosis (Mtb), remains a major global health challenge due to persistent diagnostic gaps. CRISPR-Cas-based diagnostics have emerged as highly sensitive and programmable platforms for nucleic acid detection, enabling rapid identification of Mtb targets, including drug-resistance-associated mutations. These systems integrate isothermal amplification, diverse Cas effectors, and multiple signal readout strategies to achieve high analytical performance. This review provides a comparative analysis of clinically evaluated CRISPR-based TB diagnostic platforms, highlighting substantial variability in assay design, performance, and translational readiness. While many platforms demonstrate strong analytical sensitivity, their implementation remains constrained by workflow complexity and limited integration into true point-of-care formats. This highlights that successful clinical translation of CRISPR-based TB diagnostics is determined more by real-world adaptability than by analytical performance alone. The current review presents a comparative analysis of CRISPR-based diagnostic platforms for tuberculosis, evaluating the variability in assay design, analytical and clinical performance, and translational readiness across currently available systems.
Al-Jabri Maha M, Rosero Christian C, Saade Elie A EA
Older adults are at an increased risk of vaccine-preventable diseases partly because of physiologic changes in the immune and other body systems related to age and/or accumulating comorbidities that increase the vulnerability to infections and decrease the response to vaccines. Strategies to improve the response to vaccines include using a higher antigenic dose (such as in the high-dose inactivated influenza vaccines) as well as adding adjuvants (such as MF59 in the adjuvanted inactivated influenza vaccine).
Niu Jing J, Zhang Peng P, Wei Zihan Z, Zou Yuanwu Y et al.
Culturability remains the predominant method for assessing bacterial viability in tuberculosis research and clinical practice. However, growth-based detection provides only a limited and context-dependent dimension of Mycobacterium tuberculosis (MTB) survival. MTB populations may evade recovery by standard culture while retaining molecular, metabolic, or functional features inconsistent with irreversible cellular death, resulting in persistent discrepancies between culture outcomes and other biological or clinical indicators. This review explores viable but non-culturable (VBNC)-like phenotypes and differentially culturable tubercle bacilli (DCTB) as detection-defined frameworks for interpreting such growth-invisible populations. We analyze their methodological foundations and interpretative limitations, emphasizing that neither reflects a discrete or stable physiological state. Integrating evidence from resuscitation assays, molecular viability measurements, and clinical observations, we propose a continuum-based interpretation of MTB viability in which bacterial populations occupy diverse physiological states spanning survival potential and growth competence. Within this framework, apparent non-culturability is more accurately conceptualized as a conditional result of physiological limitations and methodological sensitivity, rather than as conclusive evidence of bacterial death or dormancy. This perspective provides a coherent conceptual foundation for interpreting bacterial persistence, clearance, and treatment response in tuberculosis.
Howlader Debaki R DR, Das Sayan S, Biswas Satabdi S, Dietz Zackary K ZK et al.
Pseudomonas aeruginosa (Pa) is a ubiquitous, opportunistic nosocomial pathogen that poses a significant threat due to its innate and acquired multidrug resistance. Novel vaccine strategies are urgently needed for vulnerable populations, many of which harbor pre-existing immunity from prior encounters with Pa. Here, we evaluated a multivalent subunit vaccine combining type III secretion system (T3SS) antigens and exolysin A (ExlA) in a nanoemulsion formulation using a clinically relevant murine pulmonary pre-exposure model. This approach allowed us to determine whether vaccination could overcome the limitations of the host's initial, ineffective immune response. Vaccination fundamentally transforms suboptimal baseline memory into a potent, multi-faceted Th1/Th17-polarized response. This globally transformed signature was characterized by significantly enhanced antigen-specific IFN-γ and IL-17A production, both locally and systematically in the lung, with exceptionally large biological effect sizes (Cohen's d values reaching 21.35). By utilizing log10 transformation to accurately reflect pathogen growth kinetics, we demonstrated that this vaccine-augmented immunity conferred statistically significant protection following heterologous challenge. In the twice-exposed cohort, vaccination promoted superior bacterial clearance of the T3SS-positive strain, though clearance of the ExlA-positive strain was not enhanced, potentially due to immunological interference from pre-existing T3SS memory. In the thrice-exposed cohort, a functional protective threshold was observed, where high levels of natural immunity matched the vaccine-induced clearance levels. Our findings established that our vaccine formulation can effectively boost and redirect pre-existing immunity, offering a promising approach to overcome the limitations of natural exposure and protect at-risk individuals from diverse Pa infections.
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