Comprehensive review of preclinical evaluation strategies for COVID-19 vaccine candidates: assessing immunogenicity, toxicology, and safety profiles
Following the worldwide spread of Severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), there is a vital requirement for safe and effective vaccines against Coronavirus disease 2019 (COVID-19). Therefore, several vaccine-candidate platforms have been designed, tested, and developed. Based o...
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| Format: | Article |
| Language: | English |
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Tehran University of Medical Sciences
2025-02-01
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| Series: | Iranian Journal of Microbiology |
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| Online Access: | https://ijm.tums.ac.ir/index.php/ijm/article/view/4911 |
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| author | Delaram Doroud Mojtaba Daneshi Fatemeh Kazemi-Lomedash Zohre Eftekhari |
| author_facet | Delaram Doroud Mojtaba Daneshi Fatemeh Kazemi-Lomedash Zohre Eftekhari |
| author_sort | Delaram Doroud |
| collection | DOAJ |
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Following the worldwide spread of Severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), there is a vital requirement for safe and effective vaccines against Coronavirus disease 2019 (COVID-19). Therefore, several vaccine-candidate platforms have been designed, tested, and developed. Based on guidelines, preclinical studies are recommended to assess the safety and potency of COVID-19 vaccines in appropriate in vitro and in vivo settings. These studies provide essential information to describe the potential toxic properties of a vaccine and the formulation of vaccine agents during the preclinical trial phase. In toxicology studies, several factors must be considered, such as the appropriate animal species and strains, dosing timetable, mode of administration, time of sampling for biochemistry and antibody evaluation, and necropsy. Pharmacokinetic/ biodistribution studies are not usually required for infectious disease prophylaxis vaccines unless the vaccine contains a novel substance. Evaluating their biodistribution is crucial for newly developed vaccines, such as lipid nanoparticles –messenger RNA (LNP-mRNA), DNA, and Viral vectors in non-replicated (VVnr), or recombinant virus vaccines. The review highlights the importance of preclinical studies in assessing the safety and efficacy of vaccine candidates. This guidance is essential for researchers and manufacturers to design effective vaccines that can progress to clinical trials safely.
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| format | Article |
| id | doaj-art-5976202eee064f2aa6400a86ba14bb7e |
| institution | Kabale University |
| issn | 2008-3289 2008-4447 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Tehran University of Medical Sciences |
| record_format | Article |
| series | Iranian Journal of Microbiology |
| spelling | doaj-art-5976202eee064f2aa6400a86ba14bb7e2025-02-09T09:01:35ZengTehran University of Medical SciencesIranian Journal of Microbiology2008-32892008-44472025-02-01171Comprehensive review of preclinical evaluation strategies for COVID-19 vaccine candidates: assessing immunogenicity, toxicology, and safety profilesDelaram Doroud0Mojtaba Daneshi1Fatemeh Kazemi-Lomedash2Zohre Eftekhari3Department of Immunotherapy and Leishmania Vaccine Research, Pasteur Institute of Iran, Tehran, IranDepartment of Animal Sciences, Center for Nutrition and Pregnancy, North Dakota State University, Fargo,USABiotechnology Research Center, Department of Biotechnology, Pasteur Institute of Iran, Tehran, IranBiotechnology Research Center, Department of Biotechnology, Pasteur Institute of Iran, Tehran, Iran Following the worldwide spread of Severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), there is a vital requirement for safe and effective vaccines against Coronavirus disease 2019 (COVID-19). Therefore, several vaccine-candidate platforms have been designed, tested, and developed. Based on guidelines, preclinical studies are recommended to assess the safety and potency of COVID-19 vaccines in appropriate in vitro and in vivo settings. These studies provide essential information to describe the potential toxic properties of a vaccine and the formulation of vaccine agents during the preclinical trial phase. In toxicology studies, several factors must be considered, such as the appropriate animal species and strains, dosing timetable, mode of administration, time of sampling for biochemistry and antibody evaluation, and necropsy. Pharmacokinetic/ biodistribution studies are not usually required for infectious disease prophylaxis vaccines unless the vaccine contains a novel substance. Evaluating their biodistribution is crucial for newly developed vaccines, such as lipid nanoparticles –messenger RNA (LNP-mRNA), DNA, and Viral vectors in non-replicated (VVnr), or recombinant virus vaccines. The review highlights the importance of preclinical studies in assessing the safety and efficacy of vaccine candidates. This guidance is essential for researchers and manufacturers to design effective vaccines that can progress to clinical trials safely. https://ijm.tums.ac.ir/index.php/ijm/article/view/4911Animals;COVID-19 vaccines;Immunogenicity;Toxicity tests |
| spellingShingle | Delaram Doroud Mojtaba Daneshi Fatemeh Kazemi-Lomedash Zohre Eftekhari Comprehensive review of preclinical evaluation strategies for COVID-19 vaccine candidates: assessing immunogenicity, toxicology, and safety profiles Iranian Journal of Microbiology Animals; COVID-19 vaccines; Immunogenicity; Toxicity tests |
| title | Comprehensive review of preclinical evaluation strategies for COVID-19 vaccine candidates: assessing immunogenicity, toxicology, and safety profiles |
| title_full | Comprehensive review of preclinical evaluation strategies for COVID-19 vaccine candidates: assessing immunogenicity, toxicology, and safety profiles |
| title_fullStr | Comprehensive review of preclinical evaluation strategies for COVID-19 vaccine candidates: assessing immunogenicity, toxicology, and safety profiles |
| title_full_unstemmed | Comprehensive review of preclinical evaluation strategies for COVID-19 vaccine candidates: assessing immunogenicity, toxicology, and safety profiles |
| title_short | Comprehensive review of preclinical evaluation strategies for COVID-19 vaccine candidates: assessing immunogenicity, toxicology, and safety profiles |
| title_sort | comprehensive review of preclinical evaluation strategies for covid 19 vaccine candidates assessing immunogenicity toxicology and safety profiles |
| topic | Animals; COVID-19 vaccines; Immunogenicity; Toxicity tests |
| url | https://ijm.tums.ac.ir/index.php/ijm/article/view/4911 |
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