COVID-19
Conditions
Interventions
Placebo
SARS CoV 2 Vaccine Inactivated Vero Cell
Sponsors
Institute of Medical Biology Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years and above (including boundary values), both female and male; 2. Legal identification of the participants shall be provided; 3. Participants shall understand the content in the Informed Consent Form (ICF) and the vaccine for administration, sign the ICF voluntarily and are capable of using thermometers and rulers, and filling in diary cards and contact cards as per the requirements; 4. Participants shall be able to communicate well with investigators, understand and comply with the requirements of this study; 5. Participants with oral temperature =37.9?. 6. Female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile [i.e., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive OR consistently use any of the following methods of contraception: a) Condoms (male or female) b) Diaphragm with spermicide c) Cervical cap with spermicide d) Intrauterine device e) Oral or patch contraceptives f) Any country regulatory-approved contraceptive method that is designed to protect against pregnancy g) Abstinence, as a form of contraception, is acceptable if in line with the participant’s lifestyle (other approaches to abstinence are not acceptable)
Exclusion criteria
Exclusion criteria: 1. Contraindications to commonly used vaccines 2. Known or suspected allergy history of vaccine or any of its components; 3. Received any vaccine within 1 month before enrollment, or received any SARS CoV-2 vaccine, SARS vaccine or Middle East respiratory syndrome (MERS) vaccine at any time before enrollment; 4. Serious diseases required to be excluded, including but not limited to pre-existing diseases in uncontrolled nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other systems, and a history of malignant tumors (uncontrolled disease refers to the change of treatment or hospitalization due to the deterioration of the disease in the past 3 months before enrollment); 5. Before enrollment, those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days; 6. Those who have a hereditary bleeding tendency or blood coagulation dysfunction, or a history of thrombosis or hemorrhagic disease; 7. Surgical removal of whole or part of spleen for any reason; 8. Those who have undergone surgery within 3 months before enrollment or those who are planning to undergo surgery throughout the study (including plastic surgery, dental and oral surgery); 9. Those who donated or lost blood (=400 mL) or received blood transfusion or used of blood products, in the past 3 months before enrollment or who are planning to donate blood throughout the study; 10. Those who received other investigational or unregistered products (drugs, vaccines, biological product or devices) in the past 3 months before enrollment, or who are planning to participate in any other clinical trials throughout the study. 11. Those who received immunosuppressant therapy within 6 months before enrollment, such as long-term systemic glucocorticoid treatment (with systemic glucocorticoid therapy for more than 2 consecutive weeks within 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - To evaluate the efficacy of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) against symptomatic and laboratory-confirmed (RT-PCR method) COVID-19 cases. - To evaluate the solicited adverse events (AE) within 7 days after each dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the efficacy of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) after at least one dose of immunization. 2.To evaluate the efficacy of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) against symptomatic and laboratory-confirmed (RT PCR method) severe COVID-19 cases. 3. To evaluate the efficacy of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) for symptomatic and laboratory-confirmed (RT-PCR method) COVID-19 cases caused by different SARS-CoV-2 variants. 4. To evaluate the levels of neutralizing antibody and IgG antibody against SARS-CoV-2 14 days after the whole-course immunization. 5.To demonstrate the consistency of 3 lots of investigational vaccine in terms of GMT on 14 days after the whole-course immunization. 6. To evaluate the immune persistence of the investigational vaccine.7. To evaluate AEs from the first dose to Day 28 after the whole-course immunization and SAEs from the first dose to at least 12 months after the whole-course immunization. 8. ADE/VED that may occur after vaccination. | — |
Countries
Ghana
Contacts
Public ContactAlberta Amu
Principal Investigator at Dodowa Health Research Centre
Outcome results
None listed