Study on Three Doses of an Inactivated COVID-19 Vaccine in Chinese Pulmonary Tuberculosis Patients

Phase 4

• Conditions: COVID-19; Pulmonary Tuberculosis
• Interventions: Biological: Standard dosage inactivated vaccine; Biological: Double dosage inactivated vaccine

• Registration Number: NCT05148949
• Lead Sponsor: Jiangsu Province Centers for Disease Control and Prevention

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-03
• Study First Submitted QC: 2021-12-03
• Study First Posted: 2021-12-08
• Study Start: 2021-12-22
• Last Update Submitted: 2022-08-12
• Last Update Posted: 2022-08-16
• Primary Completion: 2022-12-10
• Study Completion: 2023-03-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational vaccine group 2	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.
Investigational vaccine group 2	Standard 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.
Standard regimen group	Standard dosage inactivated vaccine	40 healthy subjects will receive two doses of standard dosage CoronaVac at a schedule of 0, 28 days.
Investigational vaccine group 1	Standard dosage inactivated vaccine	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.
Investigational vaccine group 1	Double dosage inactivated vaccine	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.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse reaction within 28 days after each dose	within 28 days after each dose	Incidence of adverse reaction within 28 days after each 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	GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the second dose.

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events within 28 days after each dose.	within 28 days after each dose	Incidence of adverse events within 28 days after each dose.
Incidence of serious adverse events (SAE) till the 3 months after the last vaccination.	within 3 months after the last vaccination	Incidence of serious adverse events (SAE) till the 3 months after the last vaccination.
Incidence of solicited adverse events within 7 days after each dose.	within 7 days after each dose	Incidence of solicited adverse events within 7 days after each dose.
Incidence of unsolicited 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.
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	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 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 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.
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	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.
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.	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.

Trial Locations

Locations (6)

Taizhou People's Hospital; 🇨🇳 Taizhou, Jiangsu, China

Danyang Center for Disease Control and Prevention; 🇨🇳 Zhenjiang, Jiangsu, China

Huai'an No.4 People's Hospital; 🇨🇳 Huai'an, Jiangsu, China

Binhai County Hospital of Chinese medicine; 🇨🇳 Yancheng, Jiangsu, China

Wuxi No.5 People's Hospital; 🇨🇳 Wuxi, Jiangsu, China

Xuzhou Infectious Disease Hospital; 🇨🇳 Xuzhou, Jiangsu, China