Clinical trial NCT05043246: Safety and Immune Response of COVID-19 Vaccination in Patients With Basic Disease
Official title: Safety and Immune Response of COVID-19 Vaccination in Patients With Basic Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diseases, Chronic
Covid19
Adverse Reaction to Vaccine
Keywords: COVID-19
vaccine
basic diseases
cancer diseases
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 2300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with basic diseases vaccinated with SARS-Cov-2 vaccine.

Brief summary: On 11 February 2020, the International Committee for the Classification of Viruses named the disease caused by SAＲS-CoV-2 infection in humans as the new coronavirus pneumonia (coronavirus disease 2019, COVID-19).Due to the decline of immunity and cardiopulmonary function in patients with basic diseases (hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease, cancer diseases, etc.), COVID-19 's severe illness and mortality mainly increase in these special population. Vaccination of COVID-19 vaccine can effectively prevent COVID-19 virus infection and delay or prevent patients from developing into critical illness and reduce mortality.To evaluate the safety and effectiveness of the population vaccinated with COVID-19 vaccine, and to play a scientific and theoretical supporting role in guiding COVID-19 vaccination scientifically, reasonably and effectively, so this study was carried out.

Detailed description: Due to the decline of immunity and cardiopulmonary function in patients with basic diseases (hypertension, diabetes, chronic obstructive pulmonary disease, chronic kidney disease, cancer diseases, etc.), COVID-19 's severe illness and mortality mainly increase in these special population. At present, there is no evidence that these special population have been vaccinated against COVID-19, but CDC vaccination and the guidelines and consensus of various professional societies hold that: (1) the people with underlying diseases have low immunity and are easy to develop into severe patients with high mortality; (2) although there is no direct evidence of evidence-based medicine, it is best to be vaccinated with COVID-19 vaccine in the absence of disease progression activities to reduce high risk. To evaluate the safety and effectiveness of the population vaccinated with COVID-19 vaccine, and to play a scientific and theoretical supporting role in guiding COVID-19 vaccination scientifically, reasonably and effectively, so this study was carried out.

Eligibility criteria: Inclusion Criteria:

* The selection criteria should follow the disease diagnosis guidelines developed by various colleges and the consensus of expert recommendations on vaccination.

Exclusion Criteria:

* The exclusion criteria should follow the disease diagnosis guidelines developed by various colleges and the consensus of expert recommendations on vaccination.

Primary outcomes:
measure: Number of participants with adverse events 15 days after vaccination
timeFrame: 15 days：Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc.
measure: Number of participants with adverse events 30 days after vaccination
timeFrame: 30 days:Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc.
measure: Number of participants with adverse events 60 days after vaccination
timeFrame: 60 days:Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc.
measure: Number of participants with adverse events 90 days after vaccination
timeFrame: 90 days:Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc.
measure: Number of participants with adverse events 180 days after vaccination
timeFrame: 180 days:Record the number of adverse reactions such as fever, dizziness, nausea, headache, fatigue, myalgia, etc.
measure: Titer and duration of COVID-19 antibody production 15 days after vaccination
timeFrame: 15 days:Detect the titer and duration of COVID-19 antibodies in the body.
measure: Titer and duration of COVID-19 antibody production 30 days after vaccination
timeFrame: 30 days:Detect the titer and duration of COVID-19 antibodies in the body.
measure: Titer and duration of COVID-19 antibody production 60 days after vaccination
timeFrame: 60 days:Detect the titer and duration of COVID-19 antibodies in the body.
measure: Titer and duration of COVID-19 antibody production 90 days after vaccination
timeFrame: 90 days:Detect the titer and duration of COVID-19 antibodies in the body.
measure: Titer and duration of COVID-19 antibody production180 days after vaccination
timeFrame: 180 days:Detect the titer and duration of COVID-19 antibodies in the body.
Secondary outcomes:
measure: Study on the immune mechanism related to the production of neutralizing antibodies 15 days after vaccination
timeFrame: 15 days:Detect the levels of B cells and related subgroups, Treg and CTL
measure: Study on the immune mechanism related to the production of neutralizing antibodies 30 days after vaccination
timeFrame: 30 days：Detect the levels of B cells and related subgroups, Treg and CTL
measure: Study on the immune mechanism related to the production of neutralizing antibodies 60 days after vaccination
timeFrame: 60 days：Detect the levels of B cells and related subgroups, Treg and CTL
measure: Study on the immune mechanism related to the production of neutralizing antibodies 90 days after vaccination
timeFrame: 90 days：Detect the levels of B cells and related subgroups, Treg and CTL
measure: Study on the immune mechanism related to the production of neutralizing antibodies 180 days after vaccination
timeFrame: 180 days：Detect the levels of B cells and related subgroups, Treg and CTL
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The second affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Hong Ren, PH D
role: PRINCIPAL_INVESTIGATOR
References: