Immunogenicity and safety of two-dose or three-dose regimens of inactivated COVID-19 vaccines in patients with pulmonary tuberculosis: a randomised clinical trial

Autor: Pengfei Jin, Qiao Liu, Wenli Chen, Xilin Guo, Hongmei Jiang, Ruimei Zhang, Mingdong Ding, Kui Zhang, Zhaolan Cao, Jiexiao He, Siyue Jia, Mingwei Wei, Yuansheng Hu, Lunbiao Cui, Jianfeng Wang, Zhuopei Li, Xiaoyin Zhang, Xin Xia, Yanfei Wu, Li Zhou, Yawen Zhu, Chunjing Gao, Tiantian Zhang, Fengcai Zhu, Gang Zeng, Limei Zhu, Jingxin Li
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Expert Review of Vaccines, Vol 23, Iss 1, Pp 1041-1051 (2024)
Druh dokumentu: article
ISSN: 14760584
1744-8395
1476-0584
DOI: 10.1080/14760584.2024.2425283
Popis: Background To assess the immunogenicity and safety of two-dose regimen of inactivated COVID-19 vaccines in patients with pulmonary tuberculosis (PTB) and explored the potential benefits of additional dose.Research design and methods In total, 182 PTB patients were randomly (1:1) assigned to the standard-dose group to receive three standard doses of inactivated COVID-19 vaccines, or the double-dose boosting group to receive two standard doses plus a double dose, with a 28-day interval. Forty healthy controls were assigned to receive two doses of inactivated COVID-19 vaccines 28 days apart. The primary endpoint was neutralizing antibodies 28 days after the second vaccination.Results Two doses of inactivated COVID-19 vaccines induced comparable neutralizing antibodies in PTB patients and the healthy controls, with GMTs against ancestral SARS-CoV-2 of 36.8 vs 31.4 (p = 0.4618) and seroconversion rates of 83.9% vs 87.5% (p = 0.6965). In the PTB patients, a third dose at day 56 led to a modest increase in neutralizing antibodies compared to the second dose, with a GMT fold increase of 1.3–1.8. Most adverse reactions were mild pain at the injection site.Conclusions Inactivated COVID-19 vaccine was safe and immunogenic in PTB patients, and two-dose immunization could induce moderate level of humoral responses similar to the healthy adults.Clinical trials registration www.clinicaltrials.gov identifier: NCT05148949.
Databáze: Directory of Open Access Journals
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