A Phase I/II, Double-blind, Randomized, Active-controlled, Age De-escalation Trial to Assess Safety and Immunogenicity of a Measles Rubella Vaccine (MRV) Microneedle Patch (MRV-MNP) in Adults, MRV-primed Toddlers, and MRV-naïve Infants

This is a phase 1/2, single-centre, double-blind, double-dummy, randomized, active-controlled, age de-escalation trial. Age de-escalation will be based on a review of the safety data from the preceding cohort (adults for toddlers and toddlers for infants) up to day 14 post study product administration by a data monitoring committee (DMC). All participants will receive either the MRV-MNP and a placebo (0.9% sodium chloride) SC injection (PLA-SC) or a placebo-MNP (PLA-MNP) and MRV by the SC route (MRV-SC). Only those study staff randomizing participants and preparing the study products for administration will be aware of the products administered. Those administering the study products, all other trial staff and the participants and parents will be blinded to treatment group. 45 adults (18 to 40-years-of-age) will be randomized in a 2:1 ratio. Thus, 30 adults will receive MRV-MNP and PLA-SC while 15 adults will receive MRV-SC and PLA-MNP. 120 toddlers (15 to 18 months-of-age) will be randomized in a 1:1 ratio. Thus, 60 toddlers will receive MRV-MNP and PLA-SC while the same number of toddlers will receive MRV-SC and PLA-MNP. 120 infants (9 to 10 months) will also be randomized in a 1:1 ratio. Thus, 60 infants will receive MRV-MNP and PLA-SC while the same number of infants will receive MRV-SC and PLA-MNP. Solicited local and systemic AE will be collected daily from all participants from the day of study product administration to day 13 post study product administration. Unsolicited AE and SAE will be collected from the day of study product administration to day 180 post study product administration. All participants will have laboratory investigations (hepatitis B, hepatitis C, hematology and biochemistry) conducted as part of screening. Adults will have safety laboratory investigations repeated on day seven and day 14 post study product administration. Toddlers and infants will have safety laboratory investigations repeated on day seven post study product administration. All participants will have measles- and rubella-specific SNA titers and measles- and rubella-specific IgG concentrations measured at baseline and day 42 and 180 post study product administration. Other Expanded Program on Immunization (EPI) vaccines due in toddler (oral poliovirus vaccine, diphtheria-tetanus-pertussis) and in infants (oral poliovirus vaccine, yellow fever vaccine and MenAfriVac® [due at 12 months]) will be given by the investigator team at the day 42 study visit (V4).

开始日期2021-05-19

申办/合作机构

Micron Biomedical, Inc.

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100 项与 MRV-MNP 相关的临床结果

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100 项与 MRV-MNP 相关的转化医学

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100 项与 MRV-MNP 相关的专利（医药）

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353

项与 MRV-MNP 相关的文献（医药）

2025-01-27·Nanotechnology

Roadmap on magnetic nanoparticles in nanomedicine

Review

作者: Iyer, Poornima Ramesh ; Nguyen T Tran, Linh ; Kuo, Renesmee ; Natekar, Niranjan A. ; García-Prieto, Ana ; Rotherham, Michael ; Liang, Shuang ; Choe, Hyeon ; Yu, Elaine ; El-Gendy, Ahmed A ; Natekar, Niranjan A ; Gubieda, Alicia G. ; Fdez-Gubieda, Mª Luisa ; Gubieda, Alicia G ; Bryan, Jacob ; Mostufa, Shahriar ; El-Gendy, Ahmed ; Yu, Elaine Y ; Wang, Jian-Ping ; Saha, Renata ; Wu, Kai ; Chalmers, Jeffrey ; Mercedes Paz González, Karla ; Hadimani, Ravi L ; Chugh, Vinit ; Nguyen T. Tran, Linh ; Abad-Díaz-de-Cerio, Ana ; Gomez-Pastora, Jenifer ; Tay, Zhi Wei ; Wright, Abigail L. ; Broomhall, Thomas J ; El Haj, Alicia J ; Wright, Abigail L ; Strayer, Jacob ; Conolly, Steven M ; Liu, Jinming ; El Haj, Alicia ; Gandarias, Lucia ; Chugh, Vinit Kumar ; Bao, Yuping ; Saayujya, Chinmoy ; Wang, Zhiyi ; Rezaei, Bahareh ; Huynh, Quincy ; Ciannella, Stefano ; Gandarias, Lucía ; Conolly, Steven ; Fellows, Benjamin ; González-Fernández, Cristina ; Wu, Xian ; Chandrasekharan, Prashant ; Liang, Jiarong ; Hadimani, Ravi L. ; Broomhall, Thomas

AbstractMagnetic nanoparticles (MNPs) represent a class of small particles typically with diameters ranging from 1 to 100 nanometers. These nanoparticles are composed of magnetic materials such as iron, cobalt, nickel, or their alloys. The nanoscale size of MNPs gives them unique physicochemical (physical and chemical) properties not found in their bulk counterparts. Their versatile nature and unique magnetic behavior make them valuable in a wide range of scientific, medical, and technological fields. Over the past decade, there has been a significant surge in MNP-based applications spanning biomedical uses, environmental remediation, data storage, energy storage, and catalysis. Given their magnetic nature and small size, MNPs can be manipulated and guided using external magnetic fields. This characteristic is harnessed in biomedical applications, where these nanoparticles can be directed to specific targets in the body for imaging, drug delivery, or hyperthermia treatment. Herein, this roadmap offers an overview of the current status, challenges, and advancements in various facets of MNPs. It covers magnetic properties, synthesis, functionalization, characterization, and biomedical applications such as sample enrichment, bioassays, imaging, hyperthermia, neuromodulation, tissue engineering, and drug/gene delivery. However, as MNPs are increasingly explored for in vivo applications, concerns have emerged regarding their cytotoxicity, cellular uptake, and degradation, prompting attention from both researchers and clinicians. This roadmap aims to provide a comprehensive perspective on the evolving landscape of MNP research.

2024-12-01·Journal of Hazardous Materials

Multigenerational effects of combined exposure of triphenyltin and micro/nanoplastics on marine medaka (Oryzias melastigma): From molecular levels to behavioral response

Article

作者: Li, Ping ; Liu, Bin ; Feng, Jian-Xue ; Wang, Cun-Long ; Li, Zhi-Hua ; Liu, Ling ; Ma, Yu-Qing ; Xu, Ya-Nan ; Chen, Cheng-Zhuang

In natural environments, micro/nanoplastics (MNP) inevitably coexist with various pollutants, making it essential to examine their combined toxicity and intergenerational effects on marine organisms. This study investigated the combined toxicity and intergenerational effects of exposure to triphenyltin (T), microplastics (M), nanoplastics (N), a combination of microplastics and triphenyltin (MT), and a combination of nanoplastics and triphenyltin (NT) on marine medaka. The results showed that all treatments had adverse and intergenerational effects on marine medaka. Regarding oxidative stress and energy metabolism, smaller sized plastic particles caused more significant damage to the organisms. However, MT inflicted greater gonadal system damage than NT, leading to imbalanced sex hormone levels. Additionally, T induced hyperactivity in fish, whereas MNP tended to induce behavioral depression. Notably, large plastic particles in the F0 generation had a more pronounced impact on depressive behaviors compared to smaller particles. These findings suggest that both individual and combined exposures to TPT and MNP can detrimentally affect marine medaka from the molecular to behavioral levels, posing risks to population sustainability. This study provided a robust theoretical foundation and deeper insights into the ecotoxicological impacts and risk assessments of coexisting pollutants.

2024-11-01·Ecotoxicology and Environmental Safety

Reproductive and developmental implications of micro- and nanoplastic internalization: Recent advances and perspectives

Review

作者: Li, Ning ; Li, Fei ; Yun, Xiang ; Meng, Jiahua ; Tian, Jiaqi ; Chen, Zhen ; Zhang, Lin ; Song, Dandan ; Zhang, Zitong ; Duan, Shuyin

A growing body of evidence exhibits the ubiquitous presence and accumulation of micro- and nanoplastics (MNPs) in the air, drinking water, food, and even inside the body, which has raised concerns about their potential impact on reproductive and developmental health. To comprehensively examine the current state of knowledge regarding MNPs-induced reproductive and developmental toxicity, we conducted this systematic review by focusing on the prevalence of MNPs determined in reproductive tissues and their influences on parental reproduction and offspring development. Our findings demonstrate the detection of MNPs in various human reproductive tissues, including semen, placenta, and ovarian follicular fluid, as well as in reproductive tissues of diverse animal species. We show a potential relationship between MNP exposure and increased prevalence of infertility and adverse pregnancy outcomes based on the fact that MNPs exert detrimental effects on reproductive parameters, including sperm quality, ovarian function, and steroidogenesis. In male reproductive systems, MNPs disrupt testicular tissue structure, impair reproductive endocrinology, and reduce sperm quality. In females, MNPs affect ovarian tissue structure and function, interfere with hormone secretion, and impact the endometrium and embryo implantation. Additionally, MNPs cause developmental toxicity in animal models, affecting embryonic development and offspring health, and produce transgenerational effects. Notably, in-depth literature study suggests a crucial role for oxidative stress, inflammation, and epigenetic modification in MNPs-induced toxicity. In conclusion, we integrated systematic knowledge on MNPs-induced reproductive and developmental toxicity, and the systematic finding underscores future study to fully elucidate the risks posed by MNPs to reproductive and developmental health and to inform policy decisions and public health interventions aimed at mitigating their harmful effects.

100 项与 MRV-MNP 相关的药物交易

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