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

Primary Purpose

COVID-19, Pulmonary Tuberculosis

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Standard dosage inactivated vaccine
Double dosage inactivated vaccine
Sponsored by
Jiangsu Province Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria for pulmonary tuberculosis patients:

  1. Pulmonary tuberculosis patients aged 18-75 years who have not received COVID-19 vaccine.
  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℃.

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. Medical history or family history of convulsion, epilepsy, encephalopathy and psychosis.
  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.
  16. Any medical, psychological, social or other conditions that, in the investigator's judgment, are inconsistent with the study protocol or affect the subjects' informed consent Exclusion criteria for subsequent 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.

Sites / Locations

  • Huai'an No.4 People's HospitalRecruiting
  • Taizhou People's HospitalRecruiting
  • Wuxi No.5 People's HospitalRecruiting
  • Xuzhou Infectious Disease HospitalRecruiting
  • Binhai County Hospital of Chinese medicineRecruiting
  • Danyang Center for Disease Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Investigational vaccine group 1

Investigational vaccine group 2

Standard regimen group

Arm Description

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.

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.

40 healthy subjects will receive two doses of standard dosage CoronaVac at a schedule of 0, 28 days.

Outcomes

Primary Outcome Measures

Incidence of adverse reaction 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.
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the second dose.

Secondary Outcome Measures

Incidence of solicited adverse events within 7 days after each dose.
Incidence of solicited adverse events 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.
Incidence of unsolicited adverse events within 28 days after each dose.
Incidence of unsolicited adverse events 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.
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.
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.
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.
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.

Full Information

First Posted
December 3, 2021
Last Updated
August 12, 2022
Sponsor
Jiangsu Province Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT05148949
Brief Title
Study on Three Doses of an Inactivated COVID-19 Vaccine in Chinese Pulmonary Tuberculosis Patients
Official Title
Safety and Immunogenicity of Three Doses of an Inactivated SARS-CoV-2 Vaccine in Chinese Pulmonary Tuberculosis Patients Aged 18-75 Years: a Randomized, Double-blind, Parallel-controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2021 (Actual)
Primary Completion Date
December 10, 2022 (Anticipated)
Study Completion Date
March 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Province Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Pulmonary Tuberculosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participants and investigators will be kept blinded.
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational vaccine group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Investigational vaccine group 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard regimen group
Arm Type
Active Comparator
Arm Description
40 healthy subjects will receive two doses of standard dosage CoronaVac at a schedule of 0, 28 days.
Intervention Type
Biological
Intervention Name(s)
Standard dosage inactivated vaccine
Other Intervention Name(s)
Standard dosage CoronaVac
Intervention Description
This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research & Development Co., Ltd. 0.5 ml / bottle.
Intervention Type
Biological
Intervention Name(s)
Double dosage inactivated vaccine
Other Intervention Name(s)
Double dosage CoronaVac
Intervention Description
This vaccine contains 1200 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research & Development Co., Ltd. 0.5 ml / bottle.
Primary Outcome Measure Information:
Title
Incidence of adverse reaction within 28 days after each dose
Description
Incidence of adverse reaction within 28 days after each dose.
Time Frame
within 28 days after each dose
Title
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the second dose.
Description
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
Secondary Outcome Measure Information:
Title
Incidence of solicited adverse events within 7 days after each dose.
Description
Incidence of solicited adverse events within 7 days after each dose.
Time Frame
within 7 days after each dose
Title
Incidence of adverse events within 28 days after each dose.
Description
Incidence of adverse events within 28 days after each dose.
Time Frame
within 28 days after each dose
Title
Incidence of unsolicited adverse events within 28 days after each dose.
Description
Incidence of unsolicited adverse events within 28 days after each dose.
Time Frame
within 28 days after each dose
Title
Incidence of serious adverse events (SAE) till the 3 months after the last vaccination.
Description
Incidence of serious adverse events (SAE) till the 3 months after the last vaccination.
Time Frame
within 3 months after the last vaccination
Title
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.
Description
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
Title
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.
Description
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
Title
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 and month 3 after the last dose in pulmonary tuberculosis patients.
Description
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
Title
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.
Description
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
Other Pre-specified Outcome Measures:
Title
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.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria for pulmonary tuberculosis patients: Pulmonary tuberculosis patients aged 18-75 years who have not received COVID-19 vaccine. The condition is determined to be stable by the clinician. The subjects can provide with informed consent and sign informed consent form (ICF). 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. Axillary temperature ≤ 37.0℃. 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 Medical history or family history of convulsion, epilepsy, encephalopathy and psychosis. HIV positive. Cancer patients under treatment. Allergic to any component of the research vaccines, or a history of hypersensitivity or serious reactions to vaccination. Women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan in this study. 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). Transaminase ≥ 3 times ULN or total bilirubin ≥2 times ULN, or other serious adverse reactions as determined by the clinician for antituberculosis treatment. Congenital or acquired angioedema / neuroedema. Asplenia or functional asplenia. Thrombocytopenia or other clotting disorder (this may contraindicate intramuscular injection). 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) Received blood products within 4 months before vaccination. Received other investigational drugs within 1 month prior to receiving the investigational vaccines. Received other live attenuated vaccines within 1 month prior to receiving the investigational vaccines. Received subunit or inactivated vaccine within 14 days prior to receiving investigational vaccine. Any medical, psychological, social or other conditions that, in the investigator's judgment, are inconsistent with the study protocol or affect the subjects' informed consent Exclusion criteria for subsequent 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jing-Xin Li, PhD
Phone
#86-25-83759913
Email
jingxin42102209@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing-Xin Li, PhD
Organizational Affiliation
Jiangsu Provincial Center for Diseases Control and Prevention
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Li-mei Zhu
Organizational Affiliation
Jiangsu Provincial Center for Diseases Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huai'an No.4 People's Hospital
City
Huai'an
State/Province
Jiangsu
ZIP/Postal Code
223001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing-Xin Li, Ph.D
Phone
#86-25-83759913
Email
jingxin42102209@126.com
Facility Name
Taizhou People's Hospital
City
Taizhou
State/Province
Jiangsu
ZIP/Postal Code
225300
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing-Xin Li, Ph.D
Phone
#86-25-83759913
Email
jingxin42102209@126.com
Facility Name
Wuxi No.5 People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing-Xin Li, Ph.D
Phone
#86-25-83759913
Email
jingxin42102209@126.com
Facility Name
Xuzhou Infectious Disease Hospital
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing-Xin Li, PhD
Phone
#86-25-83759913
Email
jingxin42102209@126.com
First Name & Middle Initial & Last Name & Degree
Jing-Xin Li, PhD
Facility Name
Binhai County Hospital of Chinese medicine
City
Yancheng
State/Province
Jiangsu
ZIP/Postal Code
224000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing-Xin Li, Ph.D
Phone
#86-25-83759913
Email
jingxin42102209@126.com
Facility Name
Danyang Center for Disease Control and Prevention
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212300
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing-Xin Li, Ph.D
Phone
#86-25-83759913
Email
jingxin42102209@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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