Development of Inactivated FAKHRAVAC<sup>®</sup> Vaccine against SARS-CoV-2 Virus: Preclinical Study in Animal Models
The recent viral infection disease pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has resulted in a global public health crisis. Iran, as one of the countries that reported over five million infected cases by September 2021, has been concerned with the urgent devel...
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| Format: | Article |
| Language: | English |
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MDPI AG
2021-11-01
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| Series: | Vaccines |
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| Online Access: | https://www.mdpi.com/2076-393X/9/11/1271 |
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| author | Soheil Ghasemi Kosar Naderi Saffar Firooz Ebrahimi Pezhman Khatami Arina Monazah Ghorban-Ali Alizadeh Hossein-Ali Ettehadi Iman Rad Shahrzad Nojehdehi Mousa Kehtari Fatemeh Kouhkan Hesam Barjasteh Sohrab Moradi Mohammad-Hosein Ghorbani Ali Khodaeipour Moslem Papizadeh Roghayeh Najafi Ehsan Naghneh Davood Sadeghi Ahmad Karimi Rahjerdi |
| author_facet | Soheil Ghasemi Kosar Naderi Saffar Firooz Ebrahimi Pezhman Khatami Arina Monazah Ghorban-Ali Alizadeh Hossein-Ali Ettehadi Iman Rad Shahrzad Nojehdehi Mousa Kehtari Fatemeh Kouhkan Hesam Barjasteh Sohrab Moradi Mohammad-Hosein Ghorbani Ali Khodaeipour Moslem Papizadeh Roghayeh Najafi Ehsan Naghneh Davood Sadeghi Ahmad Karimi Rahjerdi |
| author_sort | Soheil Ghasemi |
| collection | DOAJ |
| description | The recent viral infection disease pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has resulted in a global public health crisis. Iran, as one of the countries that reported over five million infected cases by September 2021, has been concerned with the urgent development of effective vaccines against SARS-CoV-2. In this paper, we report the results of a study on potency and safety of an inactivated SARS-CoV-2 vaccine candidate (FAKHRAVAC) in a preclinical study so as to confirm its potential for further clinical evaluation. Here, we developed a pilot-scale production of FAKHRAVAC, a purified inactivated SARS-CoV-2 virus vaccine candidate that induces neutralizing antibodies in Balb/c mice, guinea pigs, rabbits, and non-human primates (Rhesus macaques—RM). After obtaining ethical code of IR.IUMS.REC.1399.566, immunizations of animals were conducted by using either of three different vaccine dilutions; High (H): 10 μg/dose, Medium (M): 5 μg/dose, and Low (L): 1 μg/dose, respectively. In the process of screening for viral seeds, viral strains that resulted in the most severe clinical manifestation in patients have been isolated for vaccine development. The viral seed produced the optimal immunity against SARS-CoV-2 virus, which suggests a possible broader neutralizing ability against SARS-CoV-2 strains. The seroconversion rate at the H-, M-, and L-dose groups of all tested animals reached 100% by 28 days after immunization. These data support the eligibility of FAKHRAVAC vaccine candidate for further evaluation in a clinical trial. |
| first_indexed | 2024-03-10T05:00:02Z |
| format | Article |
| id | doaj.art-4029ad1958be4e4ea152650fa4f5f074 |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-10T05:00:02Z |
| publishDate | 2021-11-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-4029ad1958be4e4ea152650fa4f5f0742023-11-23T01:52:07ZengMDPI AGVaccines2076-393X2021-11-01911127110.3390/vaccines9111271Development of Inactivated FAKHRAVAC<sup>®</sup> Vaccine against SARS-CoV-2 Virus: Preclinical Study in Animal ModelsSoheil Ghasemi0Kosar Naderi Saffar1Firooz Ebrahimi2Pezhman Khatami3Arina Monazah4Ghorban-Ali Alizadeh5Hossein-Ali Ettehadi6Iman Rad7Shahrzad Nojehdehi8Mousa Kehtari9Fatemeh Kouhkan10Hesam Barjasteh11Sohrab Moradi12Mohammad-Hosein Ghorbani13Ali Khodaeipour14Moslem Papizadeh15Roghayeh Najafi16Ehsan Naghneh17Davood Sadeghi18Ahmad Karimi Rahjerdi19Milad Daro Noor Pharmaceutical (MDNP) Company, Unit 3, Mirsharifi Alley, Valiasr Street, Tehran 1986936914, IranMilad Daro Noor Pharmaceutical (MDNP) Company, Unit 3, Mirsharifi Alley, Valiasr Street, Tehran 1986936914, IranDepartment of Biology, Faculty of Basic Sciences, Imam Hussein University, Tehran 1698715461, IranMilad Daro Noor Pharmaceutical (MDNP) Company, Unit 3, Mirsharifi Alley, Valiasr Street, Tehran 1986936914, IranMilad Daro Noor Pharmaceutical (MDNP) Company, Unit 3, Mirsharifi Alley, Valiasr Street, Tehran 1986936914, IranMilad Daro Noor Pharmaceutical (MDNP) Company, Unit 3, Mirsharifi Alley, Valiasr Street, Tehran 1986936914, IranMilad Daro Noor Pharmaceutical (MDNP) Company, Unit 3, Mirsharifi Alley, Valiasr Street, Tehran 1986936914, IranStem Cell Technology Research Center (STRC), Building No. 9, 2nd East Alley, Mohammad-Ali Keshavarz Blvd., Saadat Abad, Tehran 1997775555, IranStem Cell Technology Research Center (STRC), Building No. 9, 2nd East Alley, Mohammad-Ali Keshavarz Blvd., Saadat Abad, Tehran 1997775555, IranStem Cell Technology Research Center (STRC), Building No. 9, 2nd East Alley, Mohammad-Ali Keshavarz Blvd., Saadat Abad, Tehran 1997775555, IranStem Cell Technology Research Center (STRC), Building No. 9, 2nd East Alley, Mohammad-Ali Keshavarz Blvd., Saadat Abad, Tehran 1997775555, IranMilad Daro Noor Pharmaceutical (MDNP) Company, Unit 3, Mirsharifi Alley, Valiasr Street, Tehran 1986936914, IranMilad Daro Noor Pharmaceutical (MDNP) Company, Unit 3, Mirsharifi Alley, Valiasr Street, Tehran 1986936914, IranMilad Daro Noor Pharmaceutical (MDNP) Company, Unit 3, Mirsharifi Alley, Valiasr Street, Tehran 1986936914, IranMilad Daro Noor Pharmaceutical (MDNP) Company, Unit 3, Mirsharifi Alley, Valiasr Street, Tehran 1986936914, IranMilad Daro Noor Pharmaceutical (MDNP) Company, Unit 3, Mirsharifi Alley, Valiasr Street, Tehran 1986936914, IranMilad Daro Noor Pharmaceutical (MDNP) Company, Unit 3, Mirsharifi Alley, Valiasr Street, Tehran 1986936914, IranMilad Daro Noor Pharmaceutical (MDNP) Company, Unit 3, Mirsharifi Alley, Valiasr Street, Tehran 1986936914, IranDepartment of Biology, Faculty of Basic Sciences, Imam Hussein University, Tehran 1698715461, IranMilad Daro Noor Pharmaceutical (MDNP) Company, Unit 3, Mirsharifi Alley, Valiasr Street, Tehran 1986936914, IranThe recent viral infection disease pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has resulted in a global public health crisis. Iran, as one of the countries that reported over five million infected cases by September 2021, has been concerned with the urgent development of effective vaccines against SARS-CoV-2. In this paper, we report the results of a study on potency and safety of an inactivated SARS-CoV-2 vaccine candidate (FAKHRAVAC) in a preclinical study so as to confirm its potential for further clinical evaluation. Here, we developed a pilot-scale production of FAKHRAVAC, a purified inactivated SARS-CoV-2 virus vaccine candidate that induces neutralizing antibodies in Balb/c mice, guinea pigs, rabbits, and non-human primates (Rhesus macaques—RM). After obtaining ethical code of IR.IUMS.REC.1399.566, immunizations of animals were conducted by using either of three different vaccine dilutions; High (H): 10 μg/dose, Medium (M): 5 μg/dose, and Low (L): 1 μg/dose, respectively. In the process of screening for viral seeds, viral strains that resulted in the most severe clinical manifestation in patients have been isolated for vaccine development. The viral seed produced the optimal immunity against SARS-CoV-2 virus, which suggests a possible broader neutralizing ability against SARS-CoV-2 strains. The seroconversion rate at the H-, M-, and L-dose groups of all tested animals reached 100% by 28 days after immunization. These data support the eligibility of FAKHRAVAC vaccine candidate for further evaluation in a clinical trial.https://www.mdpi.com/2076-393X/9/11/1271SARS-CoV-2vaccine candidateFAKHRAVACCOVID-19 |
| spellingShingle | Soheil Ghasemi Kosar Naderi Saffar Firooz Ebrahimi Pezhman Khatami Arina Monazah Ghorban-Ali Alizadeh Hossein-Ali Ettehadi Iman Rad Shahrzad Nojehdehi Mousa Kehtari Fatemeh Kouhkan Hesam Barjasteh Sohrab Moradi Mohammad-Hosein Ghorbani Ali Khodaeipour Moslem Papizadeh Roghayeh Najafi Ehsan Naghneh Davood Sadeghi Ahmad Karimi Rahjerdi Development of Inactivated FAKHRAVAC<sup>®</sup> Vaccine against SARS-CoV-2 Virus: Preclinical Study in Animal Models Vaccines SARS-CoV-2 vaccine candidate FAKHRAVAC COVID-19 |
| title | Development of Inactivated FAKHRAVAC<sup>®</sup> Vaccine against SARS-CoV-2 Virus: Preclinical Study in Animal Models |
| title_full | Development of Inactivated FAKHRAVAC<sup>®</sup> Vaccine against SARS-CoV-2 Virus: Preclinical Study in Animal Models |
| title_fullStr | Development of Inactivated FAKHRAVAC<sup>®</sup> Vaccine against SARS-CoV-2 Virus: Preclinical Study in Animal Models |
| title_full_unstemmed | Development of Inactivated FAKHRAVAC<sup>®</sup> Vaccine against SARS-CoV-2 Virus: Preclinical Study in Animal Models |
| title_short | Development of Inactivated FAKHRAVAC<sup>®</sup> Vaccine against SARS-CoV-2 Virus: Preclinical Study in Animal Models |
| title_sort | development of inactivated fakhravac sup r sup vaccine against sars cov 2 virus preclinical study in animal models |
| topic | SARS-CoV-2 vaccine candidate FAKHRAVAC COVID-19 |
| url | https://www.mdpi.com/2076-393X/9/11/1271 |
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