Clinical trial NCT05204602: Safety and Immunogenicity of COVID-19 Vaccine Booster in Patients With Liver Diseases
Official title: Safety and Immunogenicity of Third Dose SARS-CoV-2 Vaccine Booster in Patients With Liver Diseases Following Two Doses of Inactivated Vaccines (NMCID-CHESS 2201): a Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Vaccine Reaction
Liver Diseases
Keywords: SARS-CoV-2 vaccine booster
liver diseases
safety
immunogenicity
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: LanZhou University
name: Xingtai People's Hospital
name: The Third Central Hospital of Tianjin
name: The Third People's Hospital of Taiyuan
name: Lishui Country People's Hospital
name: Baoding People's Hospital
name: The Affiliated Hospital of Qingdao University
name: Affiliated Hospital of Nanjing University of Chinese Medicine
name: The Fifth People's Hospital of Wuxi
name: Jincheng People's Hospital
name: The Sixth Peoples Hospital of Shenyang
name: Zhenjiang Third Hospital
name: The Third People's Hospital of Linfen City
name: The First Affiliated Hospital of Dalian Medical University
name: The Fourth People's Hospital of Qinghai Province
name: The Third People's Hospital of Tibet Autonomous Region
name: The Second Affiliated Hospital of Chongqing Medical University
name: Peking University Health Science Center
name: The Affiliated Hospital Of Southwest Medical University
First posted: 2022-01-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population with liver disease who completed the whole-course COVID-19 vaccination and is going to get booster vaccination.

Brief summary: Previous studies should that patients with chronic liver diseases, cirrhosis, hepatocellular carcinoma and post-liver-trasplant status had lower immunological response to SARS-CoV-2 vaccines than healthy population. Along with the waning of antibody and emerging SARS-CoV-2 variants, a third dose SARS-CoV-2 booster vaccination is now considered as an effective strategy. Previous studies showed good safety and immunogenicity of the SARS-CoV-2 booster vaccination in healthy population. However, the relevant information in patients with liver diseases need further research. This study (NMCID-CHESS 2201) aimed to investigate the safety and immunogenicity of the SARS-CoV-2 booster vaccination in population with chronic liver diseases


Eligibility criteria: Inclusion Criteria:

* Previously vaccinated with two doses of SARS-CoV-2 vaccines and planning to get booster vaccination.
* Clinically or pathologically diagnosed with pre-existing liver disease, including: chronic liver diseases, cirrhosis, liver cancer, liver transplant subjects, etc.
* Understanding and willing to comply with the study procedures and provides written informed consent.

Exclusion Criteria:

* Pregnancy or lactation.
* Active or known history of SARS-CoV-2 infection.
* Diseases causing immunosuppressive or immunodeficient status or autoimmune diseases.
* A history of discontinuing anti-HBV agents in recent three months.

Primary outcomes:
measure: Rate of neutralizing antibody serological conversion after the booster vaccination
timeFrame: Fourteen to 90 days after the booster vaccine
measure: Number and rate of all solicited and non-solicited adverse events
timeFrame: Up to 28 days after booster vaccine injection
Secondary outcomes:
measure: Number and rate of abnormal laboratory testing results after the booster vaccination
timeFrame: Up to 28 days after after booster vaccine injection
measure: Concentration and titre of neutralizing antibody after booster vaccination
timeFrame: Baseline and 14 days, 28 days, 90 days, and 180 days after the booster vaccination
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Baoding
country: China
facility: Baoding people's Hospital
state: Hebei
city: Xingtai
country: China
facility: Xingtai People's Hospital
state: Heibei
city: Nanjing
country: China
facility: Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine
state: Jiangsu
city: Wuxi
country: China
facility: The Fifth People's Hospital of Wuxi Affiliated Hospital of Jiangnan University
state: Jiangsu
city: Zhenjiang
country: China
facility: Zhenjiang Third Hospital Affiliated to Jiangsu University
state: Jiangsu
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: The Sixth Peoples Hospital of Shenyang
state: Liaoning
city: Xining
country: China
facility: The Fourth People's Hospital of Qinghai Province
state: Qinghai
city: Qingdao
country: China
facility: the Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
city: Jincheng
country: China
facility: Jincheng People's Hospital
state: Shanxi
city: Linfen
country: China
facility: The Third People's Hospital of Linfen City
state: Shanxi
city: Taiyuan
country: China
facility: The Third People's Hospital of Taiyuan
state: Shanxi
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
state: Sichuan
city: Tianjin
country: China
facility: The Third Central Hospital of Tianjin
state: Tianjin
city: Lhasa
country: China
facility: The Third People's Hospital of Tibet Autonomous Region
state: Tibet
city: Lishui
country: China
facility: Lishui People's Hospital
state: Zhejiang
Study officials:
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