COVID-19
Conditions
Interventions
A(Mild):Inoculation of recombinant novel coronavirus vaccine for inhalation (adenovirus type 5 vector)
B(Mild):Inoculate 0.9% sodium chloride injection
C(Mild):Inoculation of inactivated novel coronavirus vaccine (Vero cells)
D(Moderate):Inoculation of recombinant novel coronavirus vaccine for inhalation (adenovirus type 5 vector)
E(Moderate):Inoculate 0.9% sodium chloride injection
F(Moderate):Inoculation of inactivated novel coronavirus vaccine (Vero cells)
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1: Mild to moderate chronic obstructive pulmonary disease diagnosed by medical institutions. 2: Volunteers are able and willing to comply with the requirements of the clinical trial protocol, sign an informed consent form, and complete a 6-month follow-up study. 3: Three doses of inactivated novel coronavirus vaccine have been inoculated, and the interval between the last vaccination and enrollment is = 3 months
Exclusion criteria
Exclusion criteria: 1: During the period of acute exacerbation of chronic obstructive pulmonary disease, there was a history of acute exacerbation within the previous month. 2: Those who currently require oral or intravenous drip or intravenous glucocorticoid maintenance therapy, and those who currently require inhaled high-dose glucocorticoid maintenance therapy. 3: Those who have previously undergone lung transplantation surgery or plan to undergo any surgery within 6 months. 4. Have a medical history of convulsions, epilepsy, encephalopathy, and severe neurological diseases (such as transverse myelitis, Guillain Barre syndrome, demyelinating diseases, etc.) in the past five years. 5: A history of serious adverse reactions related to the vaccine and/or severe allergic reactions to any component of the studied vaccine (mannitol, sucrose sodium chloride, magnesium chloride, polysorbate 80, glycerol, hydroxyethyl piperazine ethanesulfonic acid); Those who have experienced severe allergic reactions to vaccines in the past (such as acute allergic reactions, angioneurotic edema, dyspnea, etc.) have a previous history of severe allergy to any vaccine, food, or drug, such as urticaria, anaphylactic shock, skin eczema, allergic dyspnea, and angioneurotic edema. 6: Emergency treatment or hospitalization after previous vaccination (confirmed to be possibly related to the vaccine). 7: Women of childbearing age who have a positive urine pregnancy test or breast-feeding volunteers have a pregnancy plan within 6 months. 8: Infectious disease or infected person undergoing treatment. 9: Fever, axillary temperature>37.0 ?. 10: Suffering from serious chronic diseases that cannot be controlled smoothly in the advanced stage, including: diabetes, thyroid disease, respiratory disease, tuberculosis, acute infection or chronic disease activity, liver and kidney disease, cardiovascular disease (cardiopulmonary failure), drug uncontrollable hypertension (systolic pressure = 160mmHg, diastolic pressure = 100 mmHg), malignant tumors, infectious or allergic skin diseases HIV infection (test report available). 11: Absplenia or functional absence of spleen. 12: The bleeding constitution or condition associated with prolonged bleeding. 13: Have received blood products within 4 months before receiving the trial vaccine. 14: Non specific immunoglobulin was injected within 1 month before enrollment. 15: Have received other vaccines or research drugs within 1 month before receiving the trial vaccine 16: I am receiving anti-tuberculosis treatment. 17: Asthma patients. 18: Those who have a history of COVID-19 infection and SARS in the past three months. 19: According to the judgment of the researcher, due to various medical, psychological, social, or other conditions, it is contrary to the test protocol, or it affects the signing of informed consent by volunteers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of acute exacerbation attacks (acute exacerbation of respiratory symptoms leading to additional treatment);Geometric level of anti SARS CoV-2 specific Neutralizing antibody (true virus) on the 28th day after immunization Mean titer (GMT), positive conversion rate, GMI;Incidence of adverse reactions (AR) within 0-28 days after immunization;Changes in subject self-evaluation based on CAT scoring table within 6 months after exemption;FEV1 and FVC AUC: Baseline changes of subjects within the FEV1 and FVC regions of the curve at each measurement point (AUC); | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titer (GMT), positive conversion rate and GMI of anti SARS CoV-2 specific neutralizing antibody (real virus) at the 3rd and 6th month after immunization;SIgA levels of nasal lavage fluid for the first 20 people in each layer before immunization, 14 days, 28 days, and 6 months after immunization;Incidence rate of adverse events/reactions within 1 hour after exemption;Adverse event occurrence rate within 28 days after exemption;SAE incidence within 6 months after exemption;Stratified analysis of post immunization anti SARS-CoV-2 specific neutralizing antibodies (true viruses) based on previous history of glucocorticoid therapy;IL-2 and IFN for the first 20 people on each floor before and 14 days after exemption- ? Positive rate and reaction level of;Stratified analysis of post immunization anti SARS-CoV-2 specific neutralizing antibodies (true viruses) based on the severity of the disease; | — |
Countries
China
Contacts
Public ContactNanshan Zhong/Pixin Ran
The First Affiliated Hospital of Guangzhou Medical University, Datansha Hospital Area
Outcome results
None listed