Ahi Mohammadreza, Hamidi Farahani Ramin, Basiri Pouria, Karimi Rahjerdi Ahmad, Sheidaei Ali, Gohari Kimiya, Rahimi Zahra, Gholami Fateme, Moradi Milad, Ghafoori Naeeni Farzad, Saffar Kosar Naderi, Ghasemi Soheil, Barati Babak, Moradi Sohrab, Monazah Arina, Pouranvari Fatemeh, Forooghizadeh Mohsen
Clinical Trial Center of Iran University of Medical Sciences (IUMS), Tehran P.O. Box 14535, Iran.
AJA University of Medical Sciences, Tehran P.O. Box 1411718541, Iran.
Vaccines (Basel). 2022 Oct 26;10(11):1800. doi: 10.3390/vaccines10111800.
: 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. : 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). : 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. : 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 and BBIBP-CorV groups, respectively. This study shows that the FAKHRAVAC 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.
本研究旨在评估FAKHRAVAC疫苗和BBIBP-CorV疫苗作为加强剂量在已接种两剂BBIBP-CorV疫苗人群中的免疫原性和安全性。
在这项双盲、平行临床试验中，我们将有两剂BBIBP-CorV疫苗接种史的健康成年人随机分组，然后分别给予FAKHRAVAC疫苗或BBIBP-CorV疫苗作为加强剂量。该试验已在伊朗临床试验注册文档库注册（编号：IRCT20210206050259N4）。
本研究监测的结果包括血清中和抗体（Nab）活性、免疫球蛋白G（IgG）水平、局部和全身不良反应、严重不良事件、疑似意外严重不良反应以及需就医的不良事件。在对435名参与者接种疫苗后，最常见的局部和全身不良反应分别为压痛（23.7%的病例）和恶心（1.4%的病例）。所有不良事件均为轻度，两组发生率相似，且在数天内缓解。
在加强剂量注射后第14天，FAKHRAVAC组和BBIBP-CorV组血清阴性参与者的Nab血清转化率（即四倍增长）分别为87%和84.6%。本研究表明，FAKHRAVAC疫苗作为加强剂量，在提高病毒中和抗体滴度、特异性抗体量以及安全性方面与BBIBP-CorV疫苗具有相似的作用。
