Study on Three Doses of an Inactivated COVID-19 Vaccine in Chinese Pulmonary Tuberculosis Patients
NCT ID: NCT05148949
Last Updated: 2022-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
240 participants
INTERVENTIONAL
2021-12-22
2023-03-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Investigational vaccine group 1
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.
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.
Double dosage inactivated vaccine
This vaccine contains 1200 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research \& Development Co., Ltd. 0.5 ml / bottle.
Investigational vaccine group 2
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.
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.
Double dosage inactivated vaccine
This vaccine contains 1200 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research \& Development Co., Ltd. 0.5 ml / bottle.
Standard regimen group
40 healthy subjects will receive two doses of standard dosage CoronaVac at a schedule of 0, 28 days.
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.
Interventions
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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.
Double dosage inactivated vaccine
This vaccine contains 1200 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research \& Development Co., Ltd. 0.5 ml / bottle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The condition is determined to be stable by the clinician.
3. The subjects can provide with informed consent and sign informed consent form (ICF).
4. 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.
5. Axillary temperature ≤ 37.0℃.
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.Other reasons the investigator consider for exclusion.
Exclusion Criteria
2. HIV positive.
3. Cancer patients under treatment.
4. Allergic to any component of the research vaccines, or a history of hypersensitivity or serious reactions to vaccination.
5. Women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan in this study.
6. Severe chronic diseases or condition in progress cannot be controlled.( Grade 3 or higher as defined in the guidelines for the classification of adverse events in clinical trials for prophylactic vaccines).
7. Transaminase ≥ 3 times ULN or total bilirubin ≥2 times ULN, or other serious adverse reactions as determined by the clinician for antituberculosis treatment.
8. Congenital or acquired angioedema / neuroedema.
9. Asplenia or functional asplenia.
10. Thrombocytopenia or other clotting disorder (this may contraindicate intramuscular injection).
11. Immunosuppressant therapy, antiallergic therapy, cytotoxic therapy, high dose inhaled corticosteroid over the past 6 months (excluding corticosteroid spray for allergic rhinitis, surface corticosteroid for acute non-complicated dermatitis, and corticosteroid with dose less than 20mg/ day)
12. Received blood products within 4 months before vaccination.
13. Received other investigational drugs within 1 month prior to receiving the investigational vaccines.
14. Received other live attenuated vaccines within 1 month prior to receiving the investigational vaccines.
15. Received subunit or inactivated vaccine within 14 days prior to receiving investigational vaccine.
1.Those who have had a severe allergic reaction after a previous dose of vaccine.
18 Years
75 Years
ALL
Yes
Sponsors
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Jiangsu Province Centers for Disease Control and Prevention
NETWORK
Responsible Party
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Principal Investigators
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Jing-Xin Li, PhD
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Provincial Center for Diseases Control and Prevention
Li-mei Zhu
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Provincial Center for Diseases Control and Prevention
Locations
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Huai'an No.4 People's Hospital
Huai'an, Jiangsu, China
Taizhou People's Hospital
Taizhou, Jiangsu, China
Wuxi No.5 People's Hospital
Wuxi, Jiangsu, China
Xuzhou Infectious Disease Hospital
Xuzhou, Jiangsu, China
Binhai County Hospital of Chinese medicine
Yancheng, Jiangsu, China
Danyang Center for Disease Control and Prevention
Zhenjiang, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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JSVCT134
Identifier Type: -
Identifier Source: org_study_id
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