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两剂灭活 SARS-CoV-2 疫苗初免后，用口服雾化 Ad5-nCoV 进行异源加强免疫在中国成年人中的安全性和免疫原性：一项随机、开放标签、单中心试验。

Safety and immunogenicity of heterologous boost immunisation with an orally administered aerosolised Ad5-nCoV after two-dose priming with an inactivated SARS-CoV-2 vaccine in Chinese adults: a randomised, open-label, single-centre trial.

机构信息

National Health Commission (NHC) Key laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China; School of Public Health, Nanjing Medical University, Nanjing, China; Institute of Global Public Health and Emergency Pharmacy, China Pharmaceutical University, Nanjing, China.

Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China.

出版信息

Lancet Respir Med. 2022 Aug;10(8):739-748. doi: 10.1016/S2213-2600(22)00087-X. Epub 2022 May 20.

DOI:10.1016/S2213-2600(22)00087-X
PMID:35605625
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9122540/
Abstract

BACKGROUND: Due to waning immunity and protection against infection with SARS-CoV-2, a third dose of a homologous or heterologous COVID-19 vaccine has been proposed by health agencies for individuals who were previously primed with two doses of an inactivated COVID-19 vaccine. METHODS: We did a randomised, open-label, controlled trial to evaluate the safety and immunogenicity of heterologous boost immunisation with an orally administered aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in Chinese adults (≥18 years old) who had previously received two doses of an inactivated SARS-CoV-2 vaccine-Sinovac CoronaVac. Eligible participants were randomly assigned (1:1:1) to receive a heterologous booster vaccination with a low dose (1·0 × 10 viral particles per mL; 0·1 mL; low dose group), or a high dose (1·0 × 10 viral particles per mL; 0·2 mL; high dose group) aerosolised Ad5-nCoV, or a homologous intramuscular vaccination with CoronaVac (0·5 mL). Only laboratory staff were masked to group assignment. The primary endpoint for safety was the incidence of adverse reactions within 14 days after the booster dose. The primary endpoint for immunogenicity was the geometric mean titres (GMTs) of serum neutralising antibodies (NAbs) against live SARS-CoV-2 virus 14 days after the booster dose. This study was registered with ClinicalTrials.gov, NCT05043259. FINDINGS: Between Sept 14 and 16, 2021, 420 participants were enrolled: 140 (33%) participants per group. Adverse reactions were reported by 26 (19%) participants in the low dose group and 33 (24%) in the high dose group within 14 days after the booster vaccination, significantly less than the 54 (39%) participants in the CoronaVac group (p<0·0001). The low dose group had a serum NAb GMT of 744·4 (95% CI 520·1-1065·6) and the high dose group had a GMT of 714·1 (479·4-1063·7) 14 days after booster dose, significantly higher than the GMT in the CoronaVac group (78·5 [60·5-101·7]; p<0·0001). INTERPRETATION: We found that a heterologous booster vaccine with an orally administered aerosolised Ad5-nCoV is safe and highly immunogenic in adults who have previously received two doses of CoronaVac as the primary series vaccination. FUNDING: National Natural Science Foundation of China and Jiangsu Provincial Key Research and Development Program.

摘要

背景：由于 SARS-CoV-2 感染的免疫力和保护作用逐渐减弱，卫生机构建议曾接种过两剂灭活 COVID-19 疫苗的个体接种同源或异源的 COVID-19 疫苗加强针。

方法：我们进行了一项随机、开放标签、对照试验，以评估先前接种过两剂灭活 SARS-CoV-2 疫苗-Sinovac CoronaVac 的中国成年人（≥18 岁）中，使用经口吸入的腺病毒 5 型载体 COVID-19 疫苗（Ad5-nCoV）进行异源加强免疫的安全性和免疫原性。符合条件的参与者按照 1:1:1 的比例随机分配（低剂量组：1.0×10 病毒颗粒/毫升；0.1 毫升；低剂量组）、高剂量组（1.0×10 病毒颗粒/毫升；0.2 毫升；高剂量组）或肌肉内接种 CoronaVac（0.5 毫升）。只有实验室工作人员对分组情况进行了设盲。安全性的主要终点是加强剂量后 14 天内不良反应的发生率。免疫原性的主要终点是加强剂量后 14 天血清中和抗体（NAb）对活 SARS-CoV-2 病毒的几何平均滴度（GMT）。该研究在 ClinicalTrials.gov 上注册，NCT05043259。

结果：2021 年 9 月 14 日至 16 日期间，共纳入 420 名参与者：每组 140 名（33%）参与者。低剂量组有 26 名（19%）参与者和高剂量组有 33 名（24%）参与者在加强疫苗接种后 14 天内报告了不良反应，明显少于 CoronaVac 组的 54 名（39%）参与者（p<0.0001）。低剂量组的血清 NAb GMT 为 744.4（95%CI 520.1-1065.6），高剂量组为 714.1（479.4-1063.7），均明显高于 CoronaVac 组的 GMT（78.5[60.5-101.7]；p<0.0001）。

结论：我们发现，先前接种过两剂 CoronaVac 作为基础免疫的成年人中，经口吸入的 Ad5-nCoV 异源加强疫苗安全且具有高度免疫原性。

资助：国家自然科学基金和江苏省重点研发计划。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c7de/9122540/e5fa8e1622d8/gr4_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c7de/9122540/b6c1e7e867fe/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c7de/9122540/141155b97a47/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c7de/9122540/0e9357fc31ab/gr3_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c7de/9122540/e5fa8e1622d8/gr4_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c7de/9122540/b6c1e7e867fe/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c7de/9122540/141155b97a47/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c7de/9122540/0e9357fc31ab/gr3_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c7de/9122540/e5fa8e1622d8/gr4_lrg.jpg

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[3]
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[4]
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[6]
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[7]
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[8]
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[9]
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