Journal of Vaccine Research 2024, Vol.14, No.3, 147-156 http://medscipublisher.com/index.php/jvr 152 In conclusion, while mRNA vaccines hold great promise for the treatment of breast cancer, addressing these technical, biological, regulatory, and ethical challenges is critical for their successful development and widespread adoption. Table 1 Clinical trials with mRNA vaccines against breast cancer (Adopted from Jiang and Liu, 2023) Trial Numbe r (Clinic al Phase) Vaccine Type Target Antigen or Agonist Dosage of mRNA Com binati on Ther apy Route of Admi nistrat ion Condition Results or Recruitment Status NCT01 526473 (I) SAM vaccine (AVX90 1) HER2 4 × 10^8 IU given every 2 weeks for 3 injections total N/A i.m. HER2+ Breast Cancer Completed, Safety and Toxicities NCT03 632941 (II) SAM vaccine (AVX90 1) HER2 4 × 10^8 IU given every 2 weeks for 3 injections total Pemb roliz umab i.m. + i.v. HER2+ Breast Cancer Recruiting NCT00 978913 (I) DC vaccine Survivin, hTERT, and p53 Primary 6 biweekly injections with a minimum of 1 × 10^6 dendritic cells per treatment Cycl opho spha mide i.d. Breast Cancer or Malignant Melanoma Completed, Safety and Toxicities NCT00 004604 (I) DC vaccine CEA N/A N/A i.v. Metastatic Cancer with CEA expression Completed, Safety and Toxicities NCT01 291420 (I/II) DC vaccine WT1 4 biweekly injections with a minimum of 10 × 10^6 dendritic cells per treatment N/A i.d. Solid Tumors Phase I study: vaccination with DC will be well-tolerated and will increase WT1-specific CD8+ T-cell responses NCT02 316457 (I) LNP mRNA vaccine Neoantigens + 4 TAAs (2-3 variant RNAs + p53 RNA) N/A N/A i.m. Triple Negative Breast Cancer Active, not recruiting NCT03 739931 (I) ISV (LNP encapsula ted) mRNA-2 752 Human OX40L, IL-23, and IL-36γ N/A Durv alum ab i.t. + i.v. Triple Negative Breast Cancer, Head, and Neck Squamous Cell Carcinoma, Non-Hodgkin Lymphoma Recruiting NCT03 788083 (I) ISV TriMix caTLR4, CD40L and CD70 N/A N/A i.t. Early Stage Breast Cancer Recruiting 6 Innovations and Technological Advancements 6.1 Nanoparticle delivery systems Nanoparticle delivery systems have revolutionized the field of mRNA vaccines by enhancing the stability, delivery, and efficacy of these vaccines. Lipid nanoparticles (LNPs) are among the most promising delivery vehicles due to their ability to protect mRNA from degradation and facilitate its uptake by cells. LNPs encapsulate mRNA, ensuring its stability and efficient delivery to antigen-presenting cells (APCs) such as dendritic cells (DCs). This targeted delivery is crucial for
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