Comparison of the Safety and Immunogenicity of FAKHRAVAC and BBIBP-CorV Vaccines when Administrated as Booster Dose: A Parallel Two Arms, Randomized, Double Blind Clinical Trial
<i>Purpose</i>: This study was completed to assess the immunogenicity and safety of the FAKHRAVAC and BBIBP-CorV vaccines as a booster dose in the population with a history of receiving two doses of BBIBP-CorV vaccine. <i>Methods</i>: In this double-blind, parallel clinical t...
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| Format: | Article |
| Language: | English |
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MDPI AG
2022-10-01
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| Series: | Vaccines |
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| Online Access: | https://www.mdpi.com/2076-393X/10/11/1800 |
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| author | Mohammadreza Ahi Ramin Hamidi Farahani Pouria Basiri Ahmad Karimi Rahjerdi Ali Sheidaei Kimiya Gohari Zahra Rahimi Fatemeh Gholami Milad Moradi Farzad Ghafoori Naeeni Kosar Naderi Saffar Soheil Ghasemi Babak Barati Sohrab Moradi Arina Monazah Fatemeh Pouranvari Mohsen Forooghizadeh |
| author_facet | Mohammadreza Ahi Ramin Hamidi Farahani Pouria Basiri Ahmad Karimi Rahjerdi Ali Sheidaei Kimiya Gohari Zahra Rahimi Fatemeh Gholami Milad Moradi Farzad Ghafoori Naeeni Kosar Naderi Saffar Soheil Ghasemi Babak Barati Sohrab Moradi Arina Monazah Fatemeh Pouranvari Mohsen Forooghizadeh |
| author_sort | Mohammadreza Ahi |
| collection | DOAJ |
| description | <i>Purpose</i>: This study was completed to assess the immunogenicity and safety of the FAKHRAVAC and BBIBP-CorV vaccines as a booster dose in the population with a history of receiving two doses of BBIBP-CorV vaccine. <i>Methods</i>: In this double-blind, parallel clinical trial, we randomly assigned healthy adults with a history of receiving two doses of the BBIBP-CorV vaccine, who then received either the FAKHRAVAC or BBIBP-CorV vaccine as a booster dose. The trial is registered in the Iranian Registry of Clinical Trial document depository (Code: IRCT20210206050259N4). <i>Results</i>: The outcomes that were monitored in this study were serum neutralizing antibody (Nab) activity, immunoglobulin G (IgG) level, local and systemic adverse reactions, serious adverse events, suspected unexpected serious adverse reactions, and medically attended adverse events. After administering vaccines to 435 participants, the most frequent local and systemic adverse reactions were tenderness and nausea in 23.7% and 1.4% of cases, respectively. All adverse events were mild, occurred at a similar incidence in the two groups, and were resolved within a few days. <i>Conclusions</i>: On the 14th day after the booster dose injection, the seroconversion rate (i.e., four-fold increase) of Nabs for seronegative participants were 87% and 84.6% in the FAKHRAVAC<sup>®</sup> and BBIBP-CorV groups, respectively. This study shows that the FAKHRAVAC<sup>®</sup> vaccine, as a booster dose, has a similar function to the BBIBP-CorV vaccine in terms of increasing the titer of virus-neutralizing antibodies, the amount of specific antibodies, and safety. |
| first_indexed | 2024-03-09T18:35:18Z |
| format | Article |
| id | doaj.art-7b22729b86374dafb54293d609b7cd6a |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-09T18:35:18Z |
| publishDate | 2022-10-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-7b22729b86374dafb54293d609b7cd6a2023-11-24T07:12:53ZengMDPI AGVaccines2076-393X2022-10-011011180010.3390/vaccines10111800Comparison of the Safety and Immunogenicity of FAKHRAVAC and BBIBP-CorV Vaccines when Administrated as Booster Dose: A Parallel Two Arms, Randomized, Double Blind Clinical TrialMohammadreza Ahi0Ramin Hamidi Farahani1Pouria Basiri2Ahmad Karimi Rahjerdi3Ali Sheidaei4Kimiya Gohari5Zahra Rahimi6Fatemeh Gholami7Milad Moradi8Farzad Ghafoori Naeeni9Kosar Naderi Saffar10Soheil Ghasemi11Babak Barati12Sohrab Moradi13Arina Monazah14Fatemeh Pouranvari15Mohsen Forooghizadeh16Clinical Trial Center of Iran University of Medical Sciences (IUMS), Tehran P.O. Box 14535, IranAJA University of Medical Sciences, Tehran P.O. Box 1411718541, IranStem Cell Technology Research Center (STRC), Tehran P.O. Box 1997775555, IranStem Cell Technology Research Center (STRC), Tehran P.O. Box 1997775555, IranClinical Trial Center of Iran University of Medical Sciences (IUMS), Tehran P.O. Box 14535, IranClinical Trial Center of Iran University of Medical Sciences (IUMS), Tehran P.O. Box 14535, IranClinical Trial Center of Iran University of Medical Sciences (IUMS), Tehran P.O. Box 14535, IranClinical Trial Center of Iran University of Medical Sciences (IUMS), Tehran P.O. Box 14535, IranStem Cell Technology Research Center (STRC), Tehran P.O. Box 1997775555, IranStem Cell Technology Research Center (STRC), Tehran P.O. Box 1997775555, IranStem Cell Technology Research Center (STRC), Tehran P.O. Box 1997775555, IranMilad Daro Noor Pharmaceutical (MDNP) Company, Tehran P.O. Box 1986936914, IranMilad Daro Noor Pharmaceutical (MDNP) Company, Tehran P.O. Box 1986936914, IranMilad Daro Noor Pharmaceutical (MDNP) Company, Tehran P.O. Box 1986936914, IranMilad Daro Noor Pharmaceutical (MDNP) Company, Tehran P.O. Box 1986936914, IranMilad Daro Noor Pharmaceutical (MDNP) Company, Tehran P.O. Box 1986936914, IranMilad Daro Noor Pharmaceutical (MDNP) Company, Tehran P.O. Box 1986936914, Iran<i>Purpose</i>: This study was completed to assess the immunogenicity and safety of the FAKHRAVAC and BBIBP-CorV vaccines as a booster dose in the population with a history of receiving two doses of BBIBP-CorV vaccine. <i>Methods</i>: In this double-blind, parallel clinical trial, we randomly assigned healthy adults with a history of receiving two doses of the BBIBP-CorV vaccine, who then received either the FAKHRAVAC or BBIBP-CorV vaccine as a booster dose. The trial is registered in the Iranian Registry of Clinical Trial document depository (Code: IRCT20210206050259N4). <i>Results</i>: The outcomes that were monitored in this study were serum neutralizing antibody (Nab) activity, immunoglobulin G (IgG) level, local and systemic adverse reactions, serious adverse events, suspected unexpected serious adverse reactions, and medically attended adverse events. After administering vaccines to 435 participants, the most frequent local and systemic adverse reactions were tenderness and nausea in 23.7% and 1.4% of cases, respectively. All adverse events were mild, occurred at a similar incidence in the two groups, and were resolved within a few days. <i>Conclusions</i>: On the 14th day after the booster dose injection, the seroconversion rate (i.e., four-fold increase) of Nabs for seronegative participants were 87% and 84.6% in the FAKHRAVAC<sup>®</sup> and BBIBP-CorV groups, respectively. This study shows that the FAKHRAVAC<sup>®</sup> vaccine, as a booster dose, has a similar function to the BBIBP-CorV vaccine in terms of increasing the titer of virus-neutralizing antibodies, the amount of specific antibodies, and safety.https://www.mdpi.com/2076-393X/10/11/1800immunogenicitysafetyFAKHRAVAC<sup>®</sup>BBIBP-CorVclinical trialneutralizing antibody (Nab) and booster-dose injection |
| spellingShingle | Mohammadreza Ahi Ramin Hamidi Farahani Pouria Basiri Ahmad Karimi Rahjerdi Ali Sheidaei Kimiya Gohari Zahra Rahimi Fatemeh Gholami Milad Moradi Farzad Ghafoori Naeeni Kosar Naderi Saffar Soheil Ghasemi Babak Barati Sohrab Moradi Arina Monazah Fatemeh Pouranvari Mohsen Forooghizadeh Comparison of the Safety and Immunogenicity of FAKHRAVAC and BBIBP-CorV Vaccines when Administrated as Booster Dose: A Parallel Two Arms, Randomized, Double Blind Clinical Trial Vaccines immunogenicity safety FAKHRAVAC<sup>®</sup> BBIBP-CorV clinical trial neutralizing antibody (Nab) and booster-dose injection |
| title | Comparison of the Safety and Immunogenicity of FAKHRAVAC and BBIBP-CorV Vaccines when Administrated as Booster Dose: A Parallel Two Arms, Randomized, Double Blind Clinical Trial |
| title_full | Comparison of the Safety and Immunogenicity of FAKHRAVAC and BBIBP-CorV Vaccines when Administrated as Booster Dose: A Parallel Two Arms, Randomized, Double Blind Clinical Trial |
| title_fullStr | Comparison of the Safety and Immunogenicity of FAKHRAVAC and BBIBP-CorV Vaccines when Administrated as Booster Dose: A Parallel Two Arms, Randomized, Double Blind Clinical Trial |
| title_full_unstemmed | Comparison of the Safety and Immunogenicity of FAKHRAVAC and BBIBP-CorV Vaccines when Administrated as Booster Dose: A Parallel Two Arms, Randomized, Double Blind Clinical Trial |
| title_short | Comparison of the Safety and Immunogenicity of FAKHRAVAC and BBIBP-CorV Vaccines when Administrated as Booster Dose: A Parallel Two Arms, Randomized, Double Blind Clinical Trial |
| title_sort | comparison of the safety and immunogenicity of fakhravac and bbibp corv vaccines when administrated as booster dose a parallel two arms randomized double blind clinical trial |
| topic | immunogenicity safety FAKHRAVAC<sup>®</sup> BBIBP-CorV clinical trial neutralizing antibody (Nab) and booster-dose injection |
| url | https://www.mdpi.com/2076-393X/10/11/1800 |
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