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

NCT05148949 | Unknown Phase 4 DMC

• 1 other identifier: JSVCT134
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 6

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).

Conditions

COVID-19; Pulmonary Tuberculosis

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse reaction within 28 days after each dose

  Incidence of adverse reaction within 28 days after each dose.

  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.

  On day 28 after the second dose

Secondary Outcomes (8)

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

  within 7 days after each dose

• Incidence of 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.

  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

• 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

Other Outcomes (1)

• 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.

  on day 28 and month 3 after the last dose in all groups and day 28 after second dose in pulmonary tuberculosis patients

Study Arms (3)

Investigational vaccine group 1

EXPERIMENTAL

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

Investigational vaccine group 2

EXPERIMENTAL

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

Standard regimen group

ACTIVE COMPARATOR

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

Biological: Standard dosage inactivated vaccine

Interventions

Standard dosage inactivated vaccine BIOLOGICAL

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

Investigational vaccine group 1; Investigational vaccine group 2; Standard regimen group

Double dosage inactivated vaccine BIOLOGICAL

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

Investigational vaccine group 1; Investigational vaccine group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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℃.
• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead

Study Sites (6)

Huai'an No.4 People's Hospital

Huai'an, Jiangsu, 223001, China

RECRUITING

Taizhou People's Hospital

Taizhou, Jiangsu, 225300, China

RECRUITING

Wuxi No.5 People's Hospital

Wuxi, Jiangsu, 214000, China

RECRUITING

Xuzhou Infectious Disease Hospital

Xuzhou, Jiangsu, 221000, China

RECRUITING

Binhai County Hospital of Chinese medicine

Yancheng, Jiangsu, 224000, China

RECRUITING

Danyang Center for Disease Control and Prevention

Zhenjiang, Jiangsu, 212300, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 39523878 DERIVED

MeSH Terms

Conditions

COVID-19; Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Jing-Xin Li, PhD

  Jiangsu Provincial Center for Diseases Control and Prevention

  PRINCIPAL INVESTIGATOR

• Li-mei Zhu

  Jiangsu Provincial Center for Diseases Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing-Xin Li, PhD

CONTACT

#86-25-83759913; jingxin42102209@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and investigators will be kept blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 8, 2021
• Study Start: December 22, 2021
• Primary Completion: December 10, 2022
• Study Completion: March 10, 2023
• Last Updated: August 16, 2022

Record last verified: 2021-12

Locations

CN (6)