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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
240
This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research \& Development Co., Ltd. 0.5 ml / bottle.
This vaccine contains 1200 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research \& Development Co., Ltd. 0.5 ml / bottle.
Huai'an No.4 People's Hospital
Huai'an, Jiangsu, China
RECRUITINGTaizhou People's Hospital
Taizhou, Jiangsu, China
RECRUITINGWuxi No.5 People's Hospital
Wuxi, Jiangsu, China
RECRUITINGXuzhou Infectious Disease Hospital
Xuzhou, Jiangsu, China
RECRUITINGBinhai County Hospital of Chinese medicine
Yancheng, Jiangsu, China
RECRUITINGDanyang Center for Disease Control and Prevention
Zhenjiang, Jiangsu, China
RECRUITINGIncidence of adverse reaction within 28 days after each dose
Incidence of adverse reaction within 28 days after each dose.
Time frame: 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.
Time frame: On day 28 after the second dose
Incidence of solicited adverse events within 7 days after each dose.
Incidence of solicited adverse events within 7 days after each dose.
Time frame: within 7 days after each dose
Incidence of adverse events within 28 days after each dose.
Incidence of adverse events within 28 days after each dose.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients
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