{"title":"肺结核患者接种两剂或三剂 COVID-19 灭活疫苗的免疫原性和安全性：随机临床试验。","authors":"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","doi":"10.1080/14760584.2024.2425283","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Research design and methods: </strong>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. 40 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.</p><p><strong>Results: </strong>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 (<i>p</i> = 0.4618) and seroconversion rates of 83.9% vs 87.5% (<i>p</i> = 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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Clinical trials registration: </strong>www.clinicaltrials.gov identifier: NCT05148949.</p>","PeriodicalId":12326,"journal":{"name":"Expert Review of Vaccines","volume":" ","pages":""},"PeriodicalIF":5.5000,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Immunogenicity and safety of two-dose or three-dose regimens of inactivated COVID-19 vaccines in patients with pulmonary tuberculosis: a randomized clinical trial.\",\"authors\":\"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\",\"doi\":\"10.1080/14760584.2024.2425283\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Research design and methods: </strong>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. 40 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.</p><p><strong>Results: </strong>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 (<i>p</i> = 0.4618) and seroconversion rates of 83.9% vs 87.5% (<i>p</i> = 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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Clinical trials registration: </strong>www.clinicaltrials.gov identifier: NCT05148949.</p>\",\"PeriodicalId\":12326,\"journal\":{\"name\":\"Expert Review of Vaccines\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":5.5000,\"publicationDate\":\"2024-11-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Expert Review of Vaccines\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/14760584.2024.2425283\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"IMMUNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert Review of Vaccines","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/14760584.2024.2425283","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"IMMUNOLOGY","Score":null,"Total":0}
Immunogenicity and safety of two-dose or three-dose regimens of inactivated COVID-19 vaccines in patients with pulmonary tuberculosis: a randomized clinical trial.
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: 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. 40 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.
期刊介绍：
Expert Review of Vaccines (ISSN 1476-0584) provides expert commentary on the development, application, and clinical effectiveness of new vaccines. Coverage includes vaccine technology, vaccine adjuvants, prophylactic vaccines, therapeutic vaccines, AIDS vaccines and vaccines for defence against bioterrorism. All articles are subject to rigorous peer-review.
The vaccine field has been transformed by recent technological advances, but there remain many challenges in the delivery of cost-effective, safe vaccines. Expert Review of Vaccines facilitates decision making to drive forward this exciting field.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
