COVID-19
Conditions
Interventions
Sponsors
Chengdu Xinhua Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1)Healthy adults aged 18 to 59 years who completed two-dose homologous vaccination with inactivated vaccine in the past 12-18 months; BMI as 18~30 kg/m2(including the cut-off value) and can provide valid identification; 2)Negative result of SARS-CoV-2 nucleic acid test (RT-PCR) performed with nasal/throat swab sample; 3)Subjects who agree to participate in this clinical trial voluntarily and sign the informed consent form, 4)Subjects have the ability to understand (non-literate) study procedures and to participate in all scheduled follow-up visits; 5)Female subjects of childbearing potential and male subjects agree to use effective contraception from study entry until 6 months of study vaccination.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria are not eligible: 1) Subjects who have a history of human coronavirus infection/disease, e.g., severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), or SARS-CoV-2 infection; OR those received heterologous SARS-CoV-2 vaccination; 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: systolic blood pressure =140mmHg and/or diastolic blood pressure =90mmHg after lifestyle adjustment and/or pharmaceutical intervention; 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. (Subject with a history of stably-controlled chron
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immediate AEs;solicited local and systemic AEs;unsolicited AEs;SAEs;Changes of safety laboratory measures;Level of humoral immunity;Level of cellular immunity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Level of humoral immunity;Level of cellular immunity; | — |
Countries
China
Contacts
Public ContactXiaolan Yong ?Guangxing Bai
Chengdu Xinhua Hospital, No. 180, Chengdu District, Chengdu, Sichuan Province, China
Outcome results
None listed