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This is a randomized, double-blind, parallel-controlled study, for evaluation of safety and immunogenicity of three doses of an inactivated COVID-19 vaccine (CoronaVac) in pulmonary tuberculosis patients aged 18-75 years. 200 tuberculosis patients and 40 healthy adults aged 18-75 years will be recruited in this study. Of them, 200 pulmonary tuberculosis patients will be randomized at a 1:1 ratio to receive two doses of standard dosage CoronaVac plus one dose of double dosage CoronaVac or two doses of standard dosage CoronaVac plus one dose of standard dosage CoronaVac at a schedule of 0, 28, 56 days, respectively. Other 40 healthy subjects served as an external control group will be vaccinated with two doses of standard dosage CoronaVac at a schedule of 0, 28 days. The occurrence of adverse events within 28 days after each dose vaccination and serious adverse events within 3 months after full vaccination will be observed. In addition, blood samples will be collected on day 0 before the first dose and 28 days and 3 months after the last dose vaccination in all participants and 28 days after second dose in pulmonary tuberculosis patients. Each subject will remain in this study for 5 months (healthy group) or 6 months (tuberculosis group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational vaccine group 1 | Experimental | 100 tuberculosis patients will receive two doses of standard dosage CoronaVac plus one dose of double dosage CoronaVac at a schedule of 0, 28, 56 days. |
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| Investigational vaccine group 2 | Experimental | 100 tuberculosis patients will receive two doses of standard dosage CoronaVac plus one dose of standard dosage CoronaVac at a schedule of 0, 28, 56 days. |
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| Standard regimen group | Active Comparator | 40 healthy subjects will receive two doses of standard dosage CoronaVac at a schedule of 0, 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard dosage inactivated vaccine | Biological | This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research & Development Co., Ltd. 0.5 ml / bottle. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reaction within 28 days after each dose | Incidence of adverse reaction within 28 days after each dose. | within 28 days after each dose |
| GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the second dose. | GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the second dose. | On day 28 after the second dose |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of solicited adverse events within 7 days after each dose. | Incidence of solicited adverse events within 7 days after each dose. | within 7 days after each dose |
| Incidence of adverse events within 28 days after each dose. |
| Measure | Description | Time Frame |
|---|---|---|
| GMT of neutralizing antibodies against SARS-CoV-2 variants on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients. | GMT of neutralizing antibodies against SARS-CoV-2 variants on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients. | on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients |
Inclusion criteria for pulmonary tuberculosis patients:
Inclusion criteria for healthy participants:
1.Healthy subjects aged 18-75 years who have not received COVID-19 vaccine. 2.The subjects can provide with informed consent and sign informed consent form (ICF).
3.The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the follow-up of the study.
4.Axillary temperature ≤ 37.0℃. Exclusion criteria for the first vaccination
1.Those who have had a severe allergic reaction after a previous dose of vaccine.
2.Serious adverse events causally related to the previous vaccination. 3.The newly discovered or newly emerging cases who don't meet the inclusion criteria or meet the exclusion criteria for the first dose, the investigator will decide whether they will continue to participate in the study.
4.Other reasons the investigator consider for exclusion.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing-Xin Li, PhD | Contact | #86-25-83759913 | jingxin42102209@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing-Xin Li, PhD | Jiangsu Provincial Center for Diseases Control and Prevention | Principal Investigator |
| Li-mei Zhu | Jiangsu Provincial Center for Diseases Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huai'an No.4 People's Hospital | Recruiting | Huai'an | Jiangsu | 223001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39523878 | Derived | Jin P, Liu Q, Chen W, Guo X, Jiang H, Zhang R, Ding M, Zhang K, Cao Z, He J, Jia S, Wei M, Hu Y, Cui L, Wang J, Li Z, Zhang X, Xia X, Wu Y, Zhou L, Zhu Y, Gao C, Zhang T, Zhu F, Zeng G, Zhu L, Li J. Immunogenicity and safety of two-dose or three-dose regimens of inactivated COVID-19 vaccines in patients with pulmonary tuberculosis: a randomised clinical trial. Expert Rev Vaccines. 2024 Jan-Dec;23(1):1041-1051. doi: 10.1080/14760584.2024.2425283. Epub 2024 Nov 11. |
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Pulmonary tuberculosis patients will be randomized at a 1:1 ratio to receive two doses of standard dosage CoronaVac plus one dose of double dosage CoronaVac or two doses of standard dosage CoronaVac plus one dose of standard dosage CoronaVac at a schedule of 0, 28, 56 days, respectively. Healthy subjects served as an external control group will be vaccinated with two doses of standard dosage CoronaVac at a schedule of 0, 28 days.
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Participants and investigators will be kept blinded.
|
| Double dosage inactivated vaccine | Biological | This vaccine contains 1200 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research & Development Co., Ltd. 0.5 ml / bottle. |
|
|
Incidence of adverse events within 28 days after each dose.
| within 28 days after each dose |
| Incidence of unsolicited adverse events within 28 days after each dose. | Incidence of unsolicited adverse events within 28 days after each dose. | within 28 days after each dose |
| Incidence of serious adverse events (SAE) till the 3 months after the last vaccination. | Incidence of serious adverse events (SAE) till the 3 months after the last vaccination. | within 3 months after the last vaccination |
| GMT of anti-S protein of SARS-CoV-2 binding antibodies on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients. | GMT of anti-S protein of SARS-CoV-2 binding antibodies measured by ELISA on day 28 and month 3 after the last dose in all groups and day 28 after second dose in tuberculosis patients. | on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients |
| Fold increase of anti-S protein of SARS-CoV-2 binding antibodies on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients. | Fold increase of anti-S protein of SARS-CoV-2 binding antibodies on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients. | on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients |
| GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 3 after the last dose in pulmonary tuberculosis patients. | GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 3 after the last dose in pulmonary tuberculosis patients. | on day 28 and month 3 after the last dose in pulmonary tuberculosis patients |
| 8. Fold increase of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients. | Fold increase of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients. | on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients |
| Taizhou People's Hospital | Recruiting | Taizhou | Jiangsu | 225300 | China |
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| Wuxi No.5 People's Hospital | Recruiting | Wuxi | Jiangsu | 214000 | China |
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| Xuzhou Infectious Disease Hospital | Recruiting | Xuzhou | Jiangsu | 221000 | China |
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| Binhai County Hospital of Chinese medicine | Recruiting | Yancheng | Jiangsu | 224000 | China |
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| Danyang Center for Disease Control and Prevention | Recruiting | Zhenjiang | Jiangsu | 212300 | China |
|
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D014397 | Tuberculosis, Pulmonary |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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