COVID-19
Conditions
Keywords
COVID-19 vaccine, healthy population
Brief summary
The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is to evaluate the safety and immunogenicity of the SARS-CoV-2 protein subunit recombinant vaccine adjuvanted with Alum+CpG1018
Detailed description
This trial is observer blinded, comparative, randomized, phase I study. Approximately 175 subjects will be recruited (18 years and above). The investigational product is 0.5 ml in two dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine). There will be 4 formula of investigational product used with different concentration of Receptor Binding Domain (RBD) antigen and adjuvant CpG 1018.
Interventions
candidate vaccine manufactured by PT. Bio Farma
BIOLOGICALSARS-CoV-2 inactivated vaccine
active control manufactured by Sinovac Life Sciences Co.Ltd
Sponsors
Fakultas Kedokteran Universitas Indonesia
Faculty of Medicine, Diponegoro University, Semarang
PT Bio Farma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Observer blind: Investigational Product and Active Comparator are masking. Lot number is masking
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Clinically healthy subjects aged 18 years and above. 2. Subjects have been informed properly regarding the study and signed the informed consent form. 3. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.
Exclusion criteria
1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial. 2. History of vaccination with any investigational product against COVID-19 (based on anamnesis) 3. Subjects who have history of COVID-19 (based on anamnesis or other examinations). 4. Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun). 5. The result of RT-PCR test for SARS-CoV-2 is positive. 6. Women who are lactating, pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results). 7. Abnormality hematology and biochemical test results (for main study subset). 8. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema. 9. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. 10. Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives. 11. Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (\> 2 weeks)). 12. Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome. 13. Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization. 14. Subjects plan to move from the study area before the end of study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the vaccine within 7 days after each dose | 7 days after each dose | percentage of subjects with solicited and unsolicited Adverse Events (AE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety of the vaccine within 28 days after each dose | 28 days after each dose | percentage of subjects with solicited and unsolicited AE |
| Serious Adverse Event (SAE) of the vaccine | 6 months after the last dose | percentage of subjects with at least 1 SAE |
| Comparison of safety between vaccine and active control | 28 days after each dose and 6 months after the last dose | percentage of subjects with AE and SAE between vaccine and active control group |
| Inflammatory factor evaluation | 7 days after the first dose and 14 days after the last dose | The change of interleukin-6 (IL-6) in serum |
| Immunogenicity profile after the last dose | 14 days and 28 days after the last dose | GMT of IgG antibody and neutralization antibody |
| Comparison of immunogenicity profile | 14 days and 28 days after the last dose | GMT of IgG antibody and neutralization antibody |
| Deviation of laboratory evaluation | 7 days after the first dose and 14 days after the last dose | Any deviation from routine laboratory evaluation that probably related to the dosing |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cellular immunity evaluation | 14 days after the last dose | Positive rate of specific T-cell response |
Countries
Indonesia
Outcome results
None listed