A Phase 4 interventional study of Standard dosage inactivated vaccine and Double dosage inactivated vaccine in COVID-19 and Pulmonary Tuberculosis, sponsored by Jiangsu Province Centers for Disease Control and Prevention. Status unknown at 6 sites in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-16.
Sponsored by Jiangsu Province Centers for Disease Control and Prevention · Phase 4, Interventional, and Prevention
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).
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 240 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Jiangsu Province Centers for Disease Control and Prevention is the lead sponsor of 75 studies on the registry; 5 are open to participants now.
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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.
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.
Biological: Standard dosage inactivated vaccine · Biological: Double dosage inactivated vaccine
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.
Biological: Standard dosage inactivated vaccine · Biological: Double dosage inactivated vaccine
40 healthy subjects will receive two doses of standard dosage CoronaVac at a schedule of 0, 28 days.
Biological: Standard dosage inactivated vaccine
This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research \& Development Co., Ltd. 0.5 ml / bottle.
Also known as: Standard dosage CoronaVac
This vaccine contains 1200 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research \& Development Co., Ltd. 0.5 ml / bottle.
Also known as: Double dosage CoronaVac
Incidence 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
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.
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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Jiangsu Province Centers for Disease Control and Prevention