在非人类灵长类动物模型上进行的灭活严重急性呼吸综合征冠状病毒2候选疫苗免疫接种：B细胞和T细胞应答的免疫评估
Inactivated SARS-CoV-2 vaccine candidate immunization on non-human primate animal model: B-cell and T-cell responses immune evaluation.
作者信息
A'la Rofiqul, Wijaya Andi Yasmin, Susilowati Helen, Kuncorojakti Suryo, Rahmahani Jola, Rantam Fedik Abdul
机构信息
Faculty of Veterinary Medicine, Universitas Airlangga, Surabaya, Indonesia.
Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia.
出版信息
Heliyon. 2023 Jul 7;9(7):e18039. doi: 10.1016/j.heliyon.2023.e18039. eCollection 2023 Jul.
BACKGROUND
SARS-CoV-2 vaccine was proven to be an effective and efficient measure for mitigating pandemic. COVID-19 infection and mortality subsided along with the increaseing COVID-19 vaccination coverage. Vaccine and health resource equity are predominant factors in COVID-19 pandemic management. Vaccine development for Indonesia, aims to ensure a sustainable pandemic control and steady national stability restoration. A decent vaccine must induce immunity against COVID-19 with minimum adverse reaction. Immunogenicity and ability to induce neutralizing antibody evaluation needs to be performed as part of the SARS-CoV-2 inactivated vaccine development from East Java, Indonesia isolate ().
OBJECTIVE
This research demonstrated INAVAC performance in inducing the production neutralizing antibody along with its effects on CD4 and CD8 cells response in (non-human primate).
METHODS
Two dosages of 3 μg and 5 μg were tested, compared to sham (NaCl 0.9%) in 10 (2 injection intramuscular with 14 days interval). All animals were monitored daily for clinical signs. Nasopharyngeal samples were analyzed using qRT-PCR while the serum were tested using ELISA and neutralization assay, whereas PBMCs were flowcytrometrically analyzed to measure CD4 and CD8 population.
RESULTS
It is observed that both vaccine doses could stimulate relatively similar immune response and neutralizing antibody (end GMT post challenge = 905,1), whereas higher CD8 cells response were reported in the 5 μg group after the 3rd day post-challenge. The dose of vaccine that produce adequate immune cell stimulation with neutralizing antibody induction can be adopted to clinical study, as favorable result of these parameters could predict minimum adverse reaction from inflammation response with balanced immune response.
CONCLUSIONS
Therefore, it is concluded that with 3 μg dose showed a favorable potential to be developed and tested as human vaccine.
背景
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）疫苗被证明是减轻疫情的有效措施。随着新冠病毒疾病（COVID-19）疫苗接种覆盖率的提高，COVID-19感染率和死亡率有所下降。疫苗和卫生资源公平性是COVID-19疫情管理的主要因素。印度尼西亚的疫苗研发旨在确保疫情得到可持续控制，并稳步恢复国家稳定。一种合适的疫苗必须能诱导针对COVID-19的免疫，且不良反应最小。作为来自印度尼西亚东爪哇分离株的SARS-CoV-2灭活疫苗研发的一部分，需要进行免疫原性和诱导中和抗体能力的评估。
目的
本研究展示了印度尼西亚东爪哇SARS-CoV-2灭活疫苗（INAVAC）在诱导中和抗体产生方面的性能及其对食蟹猴CD4和CD8细胞反应的影响。
方法
测试了3μg和5μg两种剂量，与假注射组（0.9%氯化钠）进行比较，对10只食蟹猴进行2次肌肉注射（间隔14天）。每天对所有动物进行临床症状监测。使用定量逆转录聚合酶链反应（qRT-PCR）分析鼻咽样本，使用酶联免疫吸附测定（ELISA）和中和试验检测血清，同时通过流式细胞术分析外周血单核细胞（PBMCs）以测量CD4和CD8细胞群体。
结果
观察到两种疫苗剂量均可刺激产生相对相似的免疫反应和中和抗体（攻毒后终点几何平均滴度（GMT）=905.1），而在攻毒后第3天，5μg组的CD8细胞反应较高。能够产生足够免疫细胞刺激并诱导中和抗体的疫苗剂量可用于临床研究，因为这些参数的良好结果可预测炎症反应引起的最小不良反应以及平衡的免疫反应。
结论
因此，得出结论，3μg剂量的印度尼西亚东爪哇SARS-CoV-2灭活疫苗显示出作为人类疫苗进行研发和测试的良好潜力。
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