COVID-19
Conditions
Interventions
Placebo
Sponsors
Jiangsu Recbio Technology Co Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years and older. 2. Able and willing to comply with all study requirements. 3. Willing to allow investigators to discuss the medical history with his/her general practitioner/personal doctors and access all medical records which are relevant to study procedures. 4. Healthy adults, or adults with stable medical condition who have a pre-existing medical condition that does not meet any exclusion criteria. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment. 5. For females of childbearing potential only, willing to practice continuous effective contraception until 90 days after the final dose vaccination, and have negative pregnancy tests before each dose vaccination. ? Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal. A follicle-stimulating hormone (FSH) level and the amenorrhea duration (e.g. amenorrhea for = 12 consecutive months prior to screening without an alternative medical cause) may be measured at the discretion of investigator to confirm postmenopausal status. ? The effective contraceptive methods include sexual abstinence or adequate contraceptive measures such as intrauterine or implanted contraceptive device, oral contraceptives, injected or implanted contraceptives, sustained-release topical contraceptives, condoms (male), diaphragm, and cervical cap, etc. 6. Males participating in this study who are involved in heterosexual sexual activity must agree to practice adequate contraception (as described above) and refrain from donating sperm until 90 days after receiving the final dose vaccination. 7. Agreement to refrain from blood donation during the study. 8. Provide written informed consent form (ICF) prior to study enrollment.
Exclusion criteria
Exclusion criteria: 1. Laboratory confirmed SARS-CoV-2 infection, defined by RT-PCR assay or rapid COVID-19 antigen test or an equivalent. The result of RT-PCR testing shall prevail, if there are results of multiple tests at the same time. 2. Medical history of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS) and other human coronavirus (such as SARS-CoV-2) infections or diseases. 3. Fever (oral temperature = 37.5°C / axillary temperature = 37.3°C) on the day of vaccination or within recent 72 hours. 4. History of severe allergic disease or reactions likely to be exacerbated by any component of ReCOV, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopaenic purpura, local hypersensitive necrosis reaction (Arthus reaction), or prior history of serious adverse reaction to any vaccine or drug, such as allergy, urticaria eczema, dyspnea, and angioneurotic edema. 5. Have malignant tumor (except for skin basal cell carcinoma or carcinoma uterine cervix in situ) and immune disease (e.g., human immunodeficiency virus [HIV] infection, systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy, and other immune disease that may influence immune response at investigator’s discretion). 6. Have other severe and/or uncontrolled conditions, including but not limited to, acute infectious disease, cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, hematology disease, endocrine disorder, psychiatric condition and neurological illness. Mild/moderate well-controlled comorbidities are allowed to participate. 7. Have bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture. 8. Received immunosuppressant or other immunomodulators, antiallergic therapy, or cytotoxicity therapy for 14 or more consecutive days within 6 months before using the investigational.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. RT-PCR confirmed symptomatic COVID-19 cases (regardless of severity) that occurred > 14 days after 2 doses vaccination in the Period. 2.The occurrence of AEs from the 1st dose to 28 days after the 2nd dose vaccination in Period 2. 3.The occurrence of SAEs and AESIs from the 1st dose to the end of Period 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| ? The occurrence of solicited local and systemic AEs within 7 days after each vaccination. ? The occurrence of unsolicited AEs from the 1st dose to 28 days after the 2nd vaccination. ? The occurrence of SAEs and AESIs from the 1st dose to the end of Period 1 (prior to crossover vaccination in Period 2). ? RT-PCR confirmed moderate, severe, critical COVID-19, or death that occurred > 14 days after 2 doses vaccination in Period 1. ? RT-PCR confirmed severe, critical COVID-19, or death that occurred > 14 days after 2 doses vaccination in Period 1. ? RT-PCR confirmed symptomatic COVID-19 cases (regardless of severity) that occurred > 14 days after 2 doses vaccination in Period 1 in different age groups (18-59 years and = 60 years). ? The SCR, GMT and GMI of live-virus neutralizing antibody at 14 days after 2 doses vaccination in Period 1. ? The SCR, GMT and GMI of anti-NTD and anti-RBD specific IgG at 14 days after 2 doses vaccination in Period 1. ? RT-PCR confirmed symptomatic COVID-19 cases (regardless of severity) that occurred > 14 days after 2 doses vaccination in the Period 2. ? RT-PCR confirmed moderate, severe, critical COVID-19, or death that occurred > 14 days after 2 doses vaccination in Period 2. ? RT-PCR confirmed severe, critical COVID-19, or death that occurred > 14 days after 2 doses vaccination in Period 2. | — |
Countries
Ghana
Contacts
Public ContactAlberta Amu
Principal Investigator at Dodowa Health Research Centre
Outcome results
None listed