COVID-19
Conditions
Interventions
Sponsors
Chengdu Xinhua Hospital
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Healthy subjects who are =60 years old and have completed 2 or 3 doses of homologous inactivated vaccine =6 months ago; body mass index (BMI) is in the range of 18 to 30 (inclusive of the cut-off value), and are able to provide valid identification; 2)SARS-CoV-2 nucleic acid test (RT-PCR) from a nose/throat swab was negative; 3)Antibody test negative (Colloidal gold method); 4)The time interval from the last COVID-19 infection is at least 3 months; 5)Voluntarily participated in this study and signed the informed consent form; 6)Subjects have the ability to understand study procedures and attending all scheduled follow-up visits; 7)(Screening query) Subjects agree to take effective contraceptive measures from the beginning of the study to 6 months after the exemption, and not to donate eggs (egg cells, oocytes) for assisted reproduction (referring to female subjects of childbearing age) or avoid sperm donation (referring to male subjects) ;
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria are not eligible: 1.(Screening query) Have a history of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS) infection or disease. or have received other types of inactivated vaccines; 2. *Subjects who have abnormalities found via physical examination, vaccination site (for any abnormalities or permanent body art, such as tattoos or other conditions that, in the opinion of the investigator, would interfere the evaluation of local reactions at the vaccination site), orthopantomogram, electrocardiogram, or laboratory test, and judged by the clinician to be clinically significant that would affect the assessment of vaccine safety; OR those suspected or confirmed to have fever (axillary temperature >= 37.3 ?). 3. Subjects who have unstably-controlled hypertension: after lifestyle adjustment and/or pharmaceutical intervention, systolic blood pressure =140mmHg and/or diastolic blood pressure =90mmHg; OR Systolic blood pressure < 90mmHg and/or diastolic blood pressure < 60mmHg; 4. *Subjects who has a history of acute disease or acute onset of chronic disease in the prior 3 days of study vaccination; A history of taking antipyretic, analgesic or anti-allergic medicine in the prior 24 hours of study vaccination; 5. Subjects who have received an inactivated vaccine, subunit vaccine, or recombinant vaccine in the prior 14 days of study enrollment, or received any live attenuated vaccine, nucleic acid vaccine, or adenovirus vector vaccine in the prior 28 days of study enrollment; Or plan to receive other vaccines (including the novel coronavirus vaccine) within 1 month after the study vaccination; 6. Subjects who have received any other investigational drug in the pior 3 months of study enrollment or plan to receive any other investigational drug during study participation; Those who have received whole blood, plasma and immunoglobulin treatment in the prior 3 months; 7. Subjects who have a history of severe allergy to any component of the experimental vaccine or a prior history of severe allergy to any vaccine or drug (including but not limited to: anaphylactic shock, allergic laryngeal edema, purpura, thrombocytopenic purpura, local allergic necrosis reaction, dyspnea, angioneurotic edema, etc.); Or have a history of the above serious adverse reactions after use of any vaccine or drug; 8. Subjects who have contraindications to intramuscular injections, such as a diagnosis of thrombocytopenia, any clotting disorder, or treatment with anticoagulants; 9. Subjects who have been diagnosed with concurrent contagious diseases, such as active tuberculosis, hepatitis B, syphilis, hepatitis C and/or human immunodeficiency virus (HIV) infection; 10. Subjects who have known or suspected concurrent serious diseases including: liver or kidney disease, malignancy, infectious or allergic skin disease; those has presence of severe or uncontrollable or hospitalizable cardiovascular disease, diabetes, neurological disease (e.g., Gullian-Barre's syndrome), hematologic and lymphatic disorders (e.g., lymphadenitis, lymph node adhesions, lymphatic tuberculosis, tumor metastases, etc. or scars/fistulas at lymph node sites, and swollen lymph nodes, tenderness, and skin redness at the lymph node sites in the prior 7 days of study vaccination), immune system diseases, liver and kidney diseases, respiratory system diseases, metabolic and skeletal system diseases, or malignant tumors. (Subjects wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immediate AEs;solicited local and systemic AEs;unsolicited AEs;SAEs;Changes of safety laboratory measures;Level of cellular immunity;Level of humoral immunity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Level of humoral immunity;Level of cellular immunity; | — |
Countries
China
Contacts
Public ContactXiaolan Yong; Guangxing Bai
Chengdu Xinhua Hospital
Outcome results
None listed