Department of Epidemiology, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.
Clinical Trial Center of Iran University of Medical Sciences, Tehran, Iran.
BMC Infect Dis. 2023 Feb 24;23(1):118. doi: 10.1186/s12879-023-08079-1.
The FAKHRAVAC®, an inactivated SARS-CoV-2 vaccine, was assessed for safety and immunogenicity in a phase II trial.
We did a phase II, single-centered, randomized, double-blind, placebo-controlled clinical trial of the FAKHRAVAC inactivated SARS-CoV-2 vaccine on adults aged 18 to 70. The two parallel groups received two intramuscular injections of either a 10-µg vaccine or a placebo at 2-week intervals. The participants' immunogenicity responses and the occurrence of solicited and unsolicited adverse events were compared over the study period of up to 6 months. Immunogenicity outcomes include serum neutralizing antibody activity and specific IgG antibody levels.
Five hundred eligible participants were randomly (1:1) assigned to vaccine or placebo groups. The median age of the participants was 36 years, and 75% were male. The most frequent local adverse reaction was tenderness (21.29% after the first dose and 8.52% after the second dose), and the most frequent systemic adverse reaction was headache (11.24% after the first dose and 8.94% after the second dose). Neutralizing antibody titers two and four weeks after the second injection in the vaccine group showed about 3 and 6 times increase compared to the placebo group (GMR = 2.69, 95% CI 2.32-3.12, N:309) and (GMR = 5.51, 95% CI 3.94-8.35, N:285). A four-fold increase in the neutralizing antibody titer was seen in 69.6% and 73.4% of the participants in the vaccine group two and four weeks after the second dose, respectively. Specific ELIZA antibody response against a combination of S1 and RBD antigens 4 weeks after the second injection increased more than three times in the vaccine compared to the placebo group (GMR = 3.34, 95% CI 2.5-4.47, N:142).
FAKHRAVAC® is safe and induces a significant humoral immune response to the SARS-CoV-2 virus at 10-µg antigen dose in adults aged 18-70. A phase III trial is needed to assess the clinical efficacy.
Trial Registry Number: Ref., IRCT20210206050259N2 ( http://irct.ir ; registered on 08/06/2021).
FAKHRAVAC®是一种已灭活的 SARS-CoV-2 疫苗，在一项 2 期临床试验中评估了其安全性和免疫原性。
我们进行了一项 2 期、单中心、随机、双盲、安慰剂对照的 FAKHRAVAC 灭活 SARS-CoV-2 疫苗的临床试验，纳入 18 至 70 岁的成年人。两组参与者均在 2 周间隔内接受两次 10μg 疫苗或安慰剂的肌内注射。在长达 6 个月的研究期间，比较参与者的免疫原性反应和不良事件的发生情况，包括有症状和无症状。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。
共有 500 名合格的参与者被随机（1:1）分配到疫苗或安慰剂组。参与者的中位年龄为 36 岁，75%为男性。最常见的局部不良反应是压痛（第 1 次剂量后为 21.29%，第 2 次剂量后为 8.52%），最常见的全身不良反应是头痛（第 1 次剂量后为 11.24%，第 2 次剂量后为 8.94%）。第 2 次注射后 2 周和 4 周，疫苗组的中和抗体滴度分别比安慰剂组增加约 3 倍和 6 倍（GMR=2.69，95%CI 2.32-3.12，N=309）和（GMR=5.51，95%CI 3.94-8.35，N=285）。第 2 次注射后 2 周和 4 周，疫苗组分别有 69.6%和 73.4%的参与者的中和抗体滴度增加了 4 倍。第 2 次注射后 4 周，与安慰剂组相比，疫苗组针对 S1 和 RBD 抗原组合的特异性 ELISA 抗体反应增加了 3 倍以上（GMR=3.34，95%CI 2.5-4.47，N=142）。
FAKHRAVAC®在 18-70 岁成年人中以 10μg 抗原剂量使用是安全的，并可诱导针对 SARS-CoV-2 病毒的显著体液免疫反应。需要进行 3 期临床试验来评估临床疗效。
注册号：Ref.，IRCT20210206050259N2（http://irct.ir；注册于 2021 年 8 月 6 日）。
