School of Public Health, Iran University of Medical Sciences, Tehran, Iran; Reproductive Biotechnology Research Center, Avicenna Research Institute Tehran, ACECR, Tehran, Iran.
Department of epidemiology, Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organization (AREEO), Karaj, Iran.
J Pharm Sci. 2023 Dec;112(12):3012-3021. doi: 10.1016/j.xphs.2023.09.027. Epub 2023 Oct 11.
This study explores the safety and immunogenicity of the Razi-Cov-Pars (RCP) SARS Cov-2 recombinant spike protein vaccine.
In a randomized, double-blind, placebo-controlled trial, adults aged 18-70 were randomly allocated to receive selected 10 µg/200 µl vaccine strengths or placebo (adjuvant). It included two intramuscular injections at days 0 and 21, followed by an intranasal dose at day 51. Immediate and delayed solicited local and systemic adverse reactions after each dose up to a week, and specific IgG antibodies against SARS Cov-2 spike antigens two weeks after the 2nd dose were assessed as primary outcomes. Secondary safety outcomes were abnormal laboratory findings and medically attended adverse events (MAAE) over six months follow up. Secondary immunogenicity outcomes were neutralizing antibody activity and cell-mediated immune response.
Between May 27th and July 15th, 2021, 500 participants were enrolled. Participants' mean (SD) age was 37.8 (9.0), and 67.0 % were male. No immediate adverse reaction was observed following the intervention. All solicited local and systemic adverse events were moderate (Grade I-II). Specific IgG antibody response against S antigen in the vaccine group was 5.28 times (95 %CI: 4.02-6.94) the placebo group with a 75 % seroconversion rate. During six months of follow-up, 8 SAEs were reported, unrelated to the study intervention. The participants sustained their acquired humoral responses at the end of the sixth month. The vaccine predominantly resulted in T-helper 1 cell-mediated immunity, CD8 cytotoxic T-cell increase, and no increase in inflammatory IL-6 cytokine.
RCP vaccine is safe and creates strong and durable humoral and cellular immunity.
(IRCT20201214049709N2).
本研究旨在探索 Razi-Cov-Pars（RCP）SARS-CoV-2 重组刺突蛋白疫苗的安全性和免疫原性。
在一项随机、双盲、安慰剂对照试验中，18-70 岁的成年人被随机分配接受选定的 10μg/200μl 疫苗剂量或安慰剂（佐剂）。它包括在第 0 天和第 21 天进行两次肌肉注射，然后在第 51 天进行一次鼻腔内剂量。每次剂量后一周内评估即刻和延迟的局部和全身不良事件（包括局部疼痛、红肿、发热、乏力、头痛等），以及第 2 次剂量后两周内针对 SARS-CoV-2 刺突抗原的特异性 IgG 抗体。主要安全性结局为 6 个月随访期间的异常实验室发现和需要医疗处理的不良事件（MAAE）。次要免疫原性结局为中和抗体活性和细胞介导免疫反应。
2021 年 5 月 27 日至 7 月 15 日，共纳入 500 名参与者。参与者的平均（SD）年龄为 37.8（9.0）岁，67.0%为男性。干预后无即刻不良反应。所有局部和全身不良事件均为中度（I-II 级）。疫苗组针对 S 抗原的特异性 IgG 抗体反应是安慰剂组的 5.28 倍（95%CI：4.02-6.94），血清转化率为 75%。在 6 个月的随访期间，报告了 8 例 SAE，与研究干预无关。参与者在第六个月末维持了获得的体液反应。该疫苗主要导致辅助性 T 细胞介导的免疫、CD8 细胞毒性 T 细胞增加，而不会增加炎症性白细胞介素-6 细胞因子。
RCP 疫苗是安全的，能产生强烈而持久的体液和细胞免疫。
（IRCT20201214049709N2）。
