Ansarifar Akram, Farahani Ramin Hamidi, Rahjerdi Ahmad Karimi, Ahi Mohammadreza, Sheidaei Ali, Gohari Kimiya, Rahimi Zahra, Gholami Fatemeh, Basiri Pouria, Moradi Milad, Jahangiri Arash, Naderi Kosar, Ghasemi Soheil, Khatami Pezhman, Honari Mohsen, Khodaverdloo Samane, Shooshtari Mohammad, Azin Hajar Mehr, Moradi Sohrab, Shafaghi Batool, Allahyari Hossein, Monazah Arina, Poor Ali Khodaei, Bakhshande Hooman, Taghva Zahra, Nia Mohammad Karimi, Dodaran Masoud Solaymani, Foroughizadeh Mohsen
Clinical Trial Center of Iran University of Medical Sciences, Tehran, Iran.
AJA University of Medical Sciences, Tehran, Iran.
Vaccine X. 2023 Oct 27;15:100401. doi: 10.1016/j.jvacx.2023.100401. eCollection 2023 Dec.
The FAKHRAVAC®, an inactivated SARS-CoV-2 vaccine, was assessed for safety and immunogenicity.
In this double-blind, placebo-controlled, phase I trial, we randomly assigned 135 healthy adults between 18 and 55 to receive vaccine strengths of 5 or 10 μg/dose or placebo (adjuvant only) in 0-14 or 0-21 schedules. This trial was conducted in a single center in a community setting. The safety outcomes in this study were reactogenicity, local and systemic adverse reactions, abnormal laboratory findings, and Medically Attended Adverse Events (MAAE). Immunogenicity outcomes include serum neutralizing antibody activity and specific IgG antibody levels.The most frequent local adverse reaction was tenderness (28.9%), and the most frequent systemic adverse reaction was headache (9.6%). All adverse reactions were mild, occurred at a similar incidence in all six groups, and were resolved within a few days. In the 10-µg/dose vaccine group, the geometric mean ratio for neutralizing antibody titers at two weeks after the second injection compared to the placebo group was 9.03 (95% CI: 3.89-20.95) in the 0-14 schedule and 11.77 (95% CI: 2.77-49.94) in the 0-21 schedule. The corresponding figures for the 5-µg/dose group were 2.74 (1.2-6.28) and 5.2 (1.63-16.55). The highest seroconversion rate (four-fold increase) was related to the 10-µg/dose group (71% and 67% in the 0-14 and 0-21 schedules, respectively).
FAKHRAVAC® is safe and induces a strong humoral immune response to the SARS-CoV-2 virus at 10-µg/dose vaccine strength in adults aged 18-55. This vaccine strength was used for further assessment in the phase II trial.Trial registrationThis study is registered with https://www.irct.ir; IRCT20210206050259N1.
评估了灭活SARS-CoV-2疫苗FAKHRAVAC®的安全性和免疫原性。
在这项双盲、安慰剂对照的I期试验中，我们将135名18至55岁的健康成年人随机分配，使其按照0-14或0-21的接种程序接受5或10μg/剂的疫苗剂量或安慰剂（仅佐剂）。该试验在社区环境中的一个单一中心进行。本研究中的安全性结果包括反应原性、局部和全身不良反应、实验室检查异常以及需就医的不良事件（MAAE）。免疫原性结果包括血清中和抗体活性和特异性IgG抗体水平。最常见的局部不良反应是压痛（28.9%），最常见的全身不良反应是头痛（9.6%）。所有不良反应均为轻度，在所有六个组中的发生率相似，并在几天内消退。在10μg/剂疫苗组中，0-14接种程序下，第二次注射后两周中和抗体滴度的几何平均比值与安慰剂组相比为9.03（95%CI：3.89-20.95），0-21接种程序下为11.77（95%CI：2.77-49.94）。5μg/剂组的相应数字分别为2.74（1.2-6.28）和5.2（1.63-16.55）。最高血清转化率（四倍增长）与10μg/剂组相关（0-14和0-21接种程序下分别为71%和67%）。
FAKHRAVAC®是安全的，并且在18至55岁成年人中，10μg/剂的疫苗剂量可诱导对SARS-CoV-2病毒产生强烈的体液免疫反应。该疫苗剂量用于II期试验的进一步评估。试验注册本研究已在https://www.irct.ir注册；IRCT20210206050259N1。
