在奥密克戎大流行期间，接种BBiBP-CorV疫苗后接种低剂量皮内mRNA-1273加强疫苗。
Low-dose intradermal mRNA-1273 boosting vaccine following BBiBP-CorV vaccination during the omicron pandemics.
作者信息
Chaiwong Warawut, Takheaw Nuchjira, Laopajon Witida, Nisoong Chote, Pata Supansa, Duangjit Pilaiporn, Inchai Juthamas, Pothirat Chaicharn, Bumroongkit Chaiwat, Deesomchok Athavudh, Theerakittikul Theerakorn, Limsukon Atikun, Tajarernmuang Pattraporn, Niyatiwatchanchai Nutchanok, Trongtrakul Konlawij, Kasinrerk Watchara, Liwsrisakun Chalerm
机构信息
Division of Pulmonary, Critical Care, and Allergy, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.
Division of Clinical Immunology, Department of Medical Technology, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai 50200, Thailand; Biomedical Technology Research Center, National Center for Genetic Engineering and Biotechnology, National Science and Technology Development Agency at the Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai 50200, Thailand.
出版信息
Vaccine. 2025 Aug 13;61:127330. doi: 10.1016/j.vaccine.2025.127330. Epub 2025 Jun 4.
BACKGROUND
Long-term kinetics of the neutralizing antibody (NAb) response against Omicron using 1/10 intradermal (ID) mRNA vaccination as a booster following a complete series of inactivated vaccines, as well as its safety are still limited. Therefore, the objective of this study was to compare local and systemic reactions, NAb levels against Omicron BA.2 and BA.4/5 after four weeks of boosting, and durability of NAb against BA.2 and BA.4/5 after 12 and 24 weeks of mRNA-1273 vaccine boosting among the 1/10 ID, 1/5 ID, and full-dose IM groups in subjects who received a standard primary series of the BBIBP-CorV vaccine.
METHODS
Two-week side effects and baseline, 4-week, 12-week and 24-week NAb levels against wild type, BA.2 and BA.4/5 Omicron among 3 groups were compared.
RESULTS
There were 140 participants with 46, 47, and 47 subjects in 1/10 ID, 1/5 ID, and IM groups, respectively. The 1/10 ID-induced localized pain is less common than IM and 1/5 ID. Systemic reactions were lower than IM and comparable to 1/5 ID. BA.2 NAb was indifferent from the other 2 groups, except 2.5-fold lower than IM at 12 weeks. BA.2 NAb in 1/10 ID was higher than the cut-off level throughout the 24-week study period whereas BA.4/5 NAb at 24 weeks was below the NAb detection threshold and significantly lower than IM group.
CONCLUSION
The 1/10 ID mRNA-1273 boosting after BBIBP-CorV priming was safe and induced above-threshold NAb against BA.2 and BA.4/5 for at least 12 weeks.
CLINICAL TRIALS REGISTRY
This study was registered to the Thai Clinical Trials Registry with study ID: TCTR20210822002.
背景
在完成一系列灭活疫苗接种后，使用1/10剂量皮内（ID）mRNA疫苗作为加强针，针对奥密克戎的中和抗体（NAb）反应的长期动力学及其安全性仍然有限。因此，本研究的目的是比较在接受标准初免系列BBIBP-CorV疫苗的受试者中，1/10 ID、1/5 ID和全剂量肌肉注射（IM）组在加强免疫四周后针对奥密克戎BA.2和BA.4/5的局部和全身反应、NAb水平，以及在mRNA-1273疫苗加强免疫12周和24周后针对BA.2和BA.4/5的NAb持久性。
方法
比较三组在两周时的副作用及基线、4周、12周和24周时针对野生型、BA.2和BA.4/5奥密克戎的NAb水平。
结果
共有140名参与者，1/10 ID组、1/5 ID组和IM组分别有46、47和47名受试者。1/10 ID诱导的局部疼痛比IM组和1/5 ID组少见。全身反应低于IM组，与1/5 ID组相当。除了在12周时比IM组低2.5倍外，BA.2 NAb与其他两组无差异。在整个24周的研究期内，1/10 ID组中的BA.2 NAb高于临界水平，而24周时的BA.4/5 NAb低于NAb检测阈值，且显著低于IM组。
结论
在BBIBP-CorV初免后进行1/10 ID的mRNA-1273加强免疫是安全的，并至少在12周内诱导出高于阈值的针对BA.2和BA.4/5的NAb。
临床试验注册
本研究已在泰国临床试验注册中心注册，研究编号：TCTR20210822002。
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