Post-Marketing clinical study of inactivated new coronavirus vaccine (Vero cells): Evaluation of immunogenicity and safety in people with hypertension and diabetes

开始日期2021-07-16

申办/合作机构-

ChiCTR2100047917 / Recruiting临床1期IIT

Comprehensive evaluations of dynamic changes in the immune system of healthy volunteers with sequential vaccination of inactivated Novel Coronavirus Pneumonia vaccine (Vero cells) followed by Novel Coronavirus Pneumonia mRNA vaccine (DF104B1)

开始日期2021-06-21

申办/合作机构

上海市东方医院

ChiCTR2100046227 / Recruiting临床4期IIT

A Randomized, Controlled, Multi-Center Clinical Study to Evaluate the Immunogenicity and Safety of Combined Immunization of Inactivated SARS-CoV-2 Vaccines (Vero Cell) (COVIV) and 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) or Quadrivalent Inactivated Influenza Vaccine (IIV4)

开始日期2021-05-14

申办/合作机构-

100 项与 COVID-19病毒灭活疫苗(中国医学科学院医学生物学研究所) 相关的临床结果

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100 项与 COVID-19病毒灭活疫苗(中国医学科学院医学生物学研究所) 相关的转化医学

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100 项与 COVID-19病毒灭活疫苗(中国医学科学院医学生物学研究所) 相关的专利（医药）

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项与 COVID-19病毒灭活疫苗(中国医学科学院医学生物学研究所) 相关的文献（医药）

2023-12-31·Emerging microbes & infections

Antibody persistence and safety after heterologous boosting with orally aerosolised Ad5-nCoV in individuals primed with two-dose CoronaVac previously: 12-month analyses of a randomized controlled trial

Article

作者: Chen, Wei ; Feng, Jialu ; Xia, Xin ; Zhu, Fengcai ; Li, Zhuopei ; Tang, Rong ; Zhong, Jin ; Pan, Hongxing ; Zhang, Xiaoyin ; Guo, Xiling ; Chen, Yin ; Jin, Lairun ; Zhao, Qi ; Cui, Lunbiao ; Huang, Haitao ; Zhu, Tao ; Li, Jingxin ; Hou, Lihua ; Xu, XiaoYu ; Wu, Shipo ; Gou, Jinbo ; Chen, Xiaoqin ; Wang, Xue

Antibody persistence and safety up to 12 months of heterologous orally administered adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in individuals who were primed with two-dose inactivated SARS-CoV-2 vaccine (CoronaVac) previously, has not been reported yet. This randomized, open-label, single-centre trial included Chinese adults who have received two-dose CoronaVac randomized to low-dose or high-dose aerosolised Ad5-nCoV group, or CoronaVac group. In this report, we mainly evaluated the geometric mean titres (GMTs) of neutralizing antibodies (NAbs) against live wild-type SARS-CoV-2 virus and omicron BA.4/5 pseudovirus at 12 months after the booster dose and the incidence of serious adverse events (SAEs) till month 12. Of 419 participants, all were included in the safety analysis and 120 (28.64%) were included in the immunogenicity analysis. Serum NAb GMT against live wild-type SARS-CoV-2 was 204.36 (95% CI 152.91, 273.14) in the low-dose group and 171.38 (95% CI 121.27, 242.19) in the high-dose group at month 12, significantly higher than the GMT in the CoronaVac group (8.00 [95% CI 4.22, 15.17], p < 0.0001). Serum NAb GMT against omicron BA.4/5 pseudovirus was 40.97 (95% CI 30.15, 55.67) in the low-dose group and 35.08 (95% CI 26.31, 46.77) in the high-dose group at month 12, whereas the GMT in the CoronaVac group was below the lower limit of detection. No vaccine-related SAEs were observed. Orally administered aerosolised Ad5-nCoV following two-dose CoronaVac priming has a good safety profile and is persistently more immunogenic than three-dose CoronaVac within 12 months after the booster dose.Trial registration: ClinicalTrials.gov identifier: NCT05043259..

2023-12-12·Annals of medicine

Analysis of participant-reported adverse events following the first dose of inactivated SARS-Cov-2 vaccine (TURKOVAC™) through telephone survey in Türkiye

Article

作者: Ateş, Ihsan ; Özelci, Pervin ; Temel, Fehminaz ; Coskun, Aslihan ; Kara, Ateş ; Topal, Selmur

BACKGROUND/OBJECTIVE(S)/INTRODUCTION:

TURKOVAC™ is a whole-virion inactivated COVID-19 vaccine, which was developed and recently granted emergency use authorization (conditional marketing authorization) in Türkiye. The objective of this study is to assess the spectrum and the distribution of adverse events reported following the administration of the first 150,000 doses as primary and booster vaccine doses in 22 state hospitals of 17 provinces in Türkiye.

PATIENTS/MATERIALS AND METHODS:

In this cohort study, a verbal survey was conducted via telephone calls between 10 January and 17 January 2022, utilizing a structured questionnaire algorithm on a sample group of 20,000 persons on the third- and seventh-days following vaccination. The algorithm consisted of two parts focusing on both systemic and local adverse effects. Other adverse events reported by the participants were also recorded. 6023 people and 5345 people agreed to participate in the telephone survey on the 3rd- and 7th- days of having received the first dose of the vaccine, respectively.

RESULTS:

Thirty-six-point-six percent of the participants on the 3rd day and 22.5% of the participants on the 7th day reported any adverse event following the first dose of the vaccine. On both follow-up days, the most commonly reported (29.7% for Day 3 and 13.1% for Day 7) adverse events were on the injection site. Among the local adverse events, the most frequently reported one was the pain on the injection site (27.9% for Day 3 and 12.4% for Day 7), induration (4.8% for Day 3 and 2.7% for Day 7) and swelling (3.5% for Day 3 and 2.0% for Day 7). Fatigue/weakness (9.6% for Day 3 and 8.3% for Day 7) and headache (7.9% for Day 3 and 8.0% for Day 7) were the most frequent systemic adverse events. Younger age, vaccine dose, and female sex were associated with having any adverse event and pain (on the injection site). Female sex was associated with more swelling (on the injection site), induration (on the injection site), fever, and a higher impact on daily living.

CONCLUSION(S):

In this study, we conducted a rapid assessment of adverse events following the first dose of the TURKOVAC vaccine. The vaccine appears to have a good safety profile in the first 7 days following vaccination. Younger age, vaccine dose, and female sex are associated with any adverse event and pain (on the injection site). These results present valuable information for the community and may contribute to increasing vaccine confidence.KEY MESSAGESAs a whole-virion inactivated SARS-CoV-2 vaccine, the TURKOVAC™ vaccine, which has a favorable safety profile, can be an alternative to other COVID-19 vaccines including mRNA and viral vector vaccines.

2023-12-01·Emerging microbes & infections

Characterizing the cellular and molecular variabilities of peripheral immune cells in healthy recipients of BBIBP-CorV inactivated SARS-CoV-2 vaccine by single-cell RNA sequencing.

Article

作者: Zhong, Jianmei ; Li, Ronghong ; Hu, Liuhua ; Chen, Yifan ; Shuang, Tian ; Zhang, Zheng ; Zhang, Chenjie ; Hu, Li ; Qian, Kun ; Luo, Lingjie ; Shi, Jianfeng ; Zhao, Yichao ; Yuan, Ancai ; Tong, Renyang ; Sun, Lingyue ; Liu, Qi ; Chen, Alex F ; Li, Zheng ; Pu, Jun ; Chen, Lei ; Lin, Wei ; Guo, Xiao ; Sun, Mingze ; Lyu, Yuyan ; Wang, Feng

Over 3 billion doses of inactivated vaccines for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been administered globally. However, our understanding of the immune cell functional transcription and T cell receptor (TCR)/B cell receptor (BCR) repertoire dynamics following inactivated SARS-CoV-2 vaccination remains poorly understood. Here, we performed single-cell RNA and TCR/BCR sequencing on peripheral blood mononuclear cells at four time points after immunization with the inactivated SARS-CoV-2 vaccine BBIBP-CorV. Our analysis revealed an enrichment of monocytes, central memory CD4⁺ T cells, type 2 helper T cells and memory B cells following vaccination. Single-cell TCR-seq and RNA-seq comminating analysis identified a clonal expansion of CD4⁺ T cells (but not CD8⁺ T cells) following a booster vaccination that corresponded to a decrease in the TCR diversity of central memory CD4⁺ T cells and type 2 helper T cells. Importantly, these TCR repertoire changes and CD4⁺ T cell differentiation were correlated with the biased VJ gene usage of BCR and the antibody-producing function of B cells post-vaccination. Finally, we compared the functional transcription and repertoire dynamics in immune cells elicited by vaccination and SARS-CoV-2 infection to explore the immune responses under different stimuli. Our data provide novel molecular and cellular evidence for the CD4⁺ T cell-dependent antibody response induced by inactivated vaccine BBIBP-CorV. This information is urgently needed to develop new prevention and control strategies for SARS-CoV-2 infection. (ClinicalTrials.gov Identifier: NCT04871932).

100 项与 COVID-19病毒灭活疫苗(中国医学科学院医学生物学研究所) 相关的药物交易

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