Platform Technology in Global Vaccine Regulation: Development, Applications, and Regulatory Strategies with Insights from China DOI Creative Commons
Xiaojing Li, Jin Su,

Shuyang Guo

et al.

Vaccines, Journal Year: 2024, Volume and Issue: 12(12), P. 1436 - 1436

Published: Dec. 20, 2024

The concept of "platform technology" gained prominence after the Ebola outbreak and since then has become essential to international vaccine (prophylactic vaccines against infectious disease) regulatory frameworks. Its significance was further amplified during COVID-19 pandemic, where platform technology enabled rapid development approval vaccines, optimizing processes, enhancing global public health responses. As a transformative tool, streamlines product development, allowing for reduction in number clinical trials or exemption from certain facilitating cross-referencing submissions. Despite significant efforts establish standardized procedures, challenges remain, particularly achieving unified definition application across regions. This paper explores evolution, applications, strategies technology, with focus on China's experience this field. approach, encompassing risk assessment, expedited emergency offers valuable insights into coordination. By analyzing contributions practices, highlights potential address future pandemics, including "Pathogen X", underscores importance harmonizing strengthen preparedness response.

Language: Английский

System vaccinology analysis of predictors and mechanisms of antibody response durability to multiple vaccines in humans DOI

Mario Cortese,

Thomas Hagan, Nadine Rouphael

et al.

Nature Immunology, Journal Year: 2025, Volume and Issue: 26(1), P. 116 - 130

Published: Jan. 1, 2025

Language: Английский

Citations

2
Emerging Delivery Systems for Enabling Precision Nucleic Acid Therapeutics DOI

Xiaochun Bian,

Liping Zhou,

Zhiwei Luo

et al.

ACS Nano, Journal Year: 2025, Volume and Issue: unknown

Published: Jan. 21, 2025

Nucleic acid therapeutics represent a highly promising treatment approach in modern medicine, treating diseases at the genetic level. However, these face numerous challenges practical applications, particularly regarding their stability, effectiveness, cellular uptake efficiency, and limitations delivering them specifically to target tissues. To overcome obstacles, researchers have developed various innovative delivery systems, including viral vectors, lipid nanoparticles, polymer inorganic protein carriers, exosomes, antibody oligonucleotide conjugates, DNA nanostructure-based systems. These systems enhance therapeutic efficacy of nucleic drugs by improving targeting specificity, half-life vivo. In this review, we systematically discuss different types drugs, analyze major barriers encountered delivery, summarize current research progress emerging We also highlight latest advancements application for diseases, infectious cancer, brain wound healing. This review aims provide comprehensive overview drug systems' status future directions integrating nanotechnology, biomaterials science, gene editing technologies, emphasizing transformative potential precision medicine.

Language: Английский

Citations

2
Reverse vaccinology: A strategy also used for identifying potential vaccine antigens in poultry DOI Creative Commons

Noémie Gloanec,

Muriel Guyard‐Nicodème, Marianne Chemaly

et al.

Vaccine, Journal Year: 2025, Volume and Issue: 48, P. 126756 - 126756

Published: Jan. 23, 2025

Language: Английский

Citations

0
T cell-mediated protection in absence of virus neutralizing antibodies DOI
Yeranddy A. Alpízar, Kai Dallmeier

Nature Microbiology, Journal Year: 2025, Volume and Issue: unknown

Published: Jan. 23, 2025

Language: Английский

Citations

0
Application of in-silico approaches in subunit vaccines: Overcoming the challenges of antigen and adjuvant development DOI
Xue Tang,

Jiayin Deng,

Chun‐Ting He

et al.

Journal of Controlled Release, Journal Year: 2025, Volume and Issue: unknown, P. 113629 - 113629

Published: March 1, 2025

Language: Английский

Citations

0
Prophylactic vaccination strategies for adult patients with diabetes: a narrative review of safety profiles and clinical effectiveness DOI Creative Commons
Olivia Cicilia Walewangko,

Jonathan Suciono Purnomo,

Pranasha Amabella Jo

et al.

Clinical and Experimental Vaccine Research, Journal Year: 2025, Volume and Issue: 14

Published: Jan. 1, 2025

Language: Английский

Citations

0
Mechanistic insights into the structure-based design of a CspZ-targeting Lyme disease vaccine DOI Creative Commons
Kalvis Brangulis,

Jill Malfetano,

Ashley L. Marcinkiewicz

et al.

Nature Communications, Journal Year: 2025, Volume and Issue: 16(1)

Published: April 6, 2025

Abstract Borrelia burgdorferi ( Bb ) causes Lyme disease (LD), one of the most common vector-borne diseases in Northern Hemisphere. Here, we solve crystal structure a mutated vaccine antigen, CspZ-YA that lacks ability to bind host complement factor H (FH). We generate point mutants and identify I183Y C187S trigger more robust bactericidal responses. Compared CspZ-YA, these require lower immunization frequency protect mice from LD-associated inflammation bacterial colonization. Antigenicity wild-type mutant proteins are similar, as measured using sera infected people or immunized female mice. Structural comparison with shows enhanced interactions two helices adjacent FH-binding sites mutants, consistent their elevated thermostability. In line findings, protective monoclonal antibodies show increased binding at physiological temperature (37 °C). summary, this proof-of-concept study applies structural vaccinology enhance intramolecular for long-term stability antigen while maintaining its epitopes, thus promoting LD development.

Language: Английский

Citations

0
Polyoxazoline‐Based Gene Delivery System Mediated Tumor Vascular Normalization and Extracellular Matrix Degradation to Inhibit Cancer Growth, Recurrence, and Metastasis DOI
Hongqian Liu,

Qiannan Cao,

Yufei Yao

et al.

Advanced Functional Materials, Journal Year: 2025, Volume and Issue: unknown

Published: April 9, 2025

Abstract Gene therapy has brought hope for curing major diseases including cancer. However, an efficient and safe delivery system is key successful gene therapy. In this study, PPERD (i.e., OHC‐PEG‐CHO/PEtOx 0.2 ‐PEI 0.73 ‐PRGD 0.07 /DNA), polyoxazoline‐based developed to mediate tumor vascular normalization extracellular matrix (ECM) degradation cancer The aldehyde groups of OHC‐PEG‐CHO can form Schiff base bonds with the amine PER PEtOx ), thereby enabling in situ encapsulation PERD PER/DNA) rapid pH responsiveness tissues. possesses excellent vitro transfection performance good biocompatibility. efficiently accumulate, penetrate, transfect tumors once intravenous administration. effectively normalizes vasculature degradates ECM, enhances infiltration function cytotoxic T lymphocytes, inducing antitumor immune response vivo. Moreover, PPERVH ((i.e., /(pshVEGF+pHAase)) also inhibit recurrence metastasis by triggering durable anti‐tumor memory effect. Furthermore, significantly effectiveness checkpoint blockade‐mediated immunotherapy. This strategy provides a promising paradigm inhibiting growth, recurrence, metastasis.

Language: Английский

Citations

0
Vaccinology in the artificial intelligence era DOI
Gianmarco Gasperini,

Norman W. Baylor,

Steve Black

et al.

Science Translational Medicine, Journal Year: 2025, Volume and Issue: 17(794)

Published: April 16, 2025

Artificial intelligence (AI) has already transformed vaccine antigen design and could transform the entire vaccinology pipeline, including immune responses emerging infectious disease prediction, manufacturing regulatory processes, clinical trial implementation, access equity. However, realizing promise of AI for requires more high-quality data.

Language: Английский

Citations

0
AI in the development of vaccines for emerging and re-emerging diseases DOI
Rita Elizabeth Velastegui-Hernández, Verónica Gabriela Salinas Velasteguí, Diana Catalina Velasteguí Hernández

et al.

Salud Ciencia y Tecnología, Journal Year: 2025, Volume and Issue: 4

Published: Jan. 15, 2025

Introduction: The integration of artificial intelligence (AI) into vaccine development has revolutionized traditional methodologies, significantly enhancing the speed, precision, and scalability immunological research. Emerging re-emerging infectious diseases, driven by zoonotic spillovers, antimicrobial resistance, global environmental changes, pose substantial challenges. Addressing these requires innovative approaches, with AI playing a pivotal role in advancing solutions.Development: applications vaccinology include antigen detection, adjuvant optimization, immune response simulation. Deep learning algorithms streamline identification immunogenic targets conserved antigens, enabling for highly mutable pathogens such as SARS-CoV-2, HIV, influenza. Case studies demonstrate AI's transformative impact, including its rapid creation mRNA vaccines COVID-19, promising antigens malaria, enhanced efficacy influenza through predictive modeling. However, challenges unequal access to technology, biases data models, ethical concerns regarding genomic privacy persist. Recommendations address barriers increasing diversity, strengthening frameworks, investing infrastructure democratize AI-driven innovations.Conclusions: ability reduce time cost, improve enable personalized immunization strategies positions it cornerstone modern vaccinology. With continued advancements equitable implementation, holds potential reshape development, pandemic preparedness, longstanding public health disparities globally.

Language: Английский

Citations

0