Covid19
Conditions
Keywords
covid19 vaccine
Brief summary
The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is To evaluate the safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose.
Detailed description
This trial is observer blinded, comparative, randomized, phase I study. Approximately 60 subjects will be recruited (18 years and above). The investigational product is 0.5 ml in three dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine)
Interventions
intramuscular injection
BIOLOGICALSARS-CoV-2 Inactivated Vaccine
intramuscular injection
Sponsors
Fakultas Kedokteran Universitas Indonesia
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
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 No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Clinically healthy subjects within the following age groups: adults (18-59 years) and elderly (60 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 during or 6 months prior to enrollment. 3. Subjects who have history of Covid-19 in the last 3 months (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 rapid antigen test 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. 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 Investigational Product (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 SARS-CoV-2 protein subunit recombinant 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 SARS-CoV-2 protein subunit recombinant vaccine within 28 days after each dose | 28 days after each dose | percentage of subjects with solicited and unsolicited AE |
| Comparison of AE/ Serious Adverse Events (SAE) between intervention vaccine and active control | 28 days after each dose | percentage of subjects with AE and SAE between vaccine and active control group |
| Deviation of laboratory evaluation | 28 days after the first dose | Any deviation from routine laboratory evaluation that probably related to the dosing |
| Immunogenicity profile of the SARS-CoV-2 protein subunit recombinant vaccine after second dose | 28 days after each dose | seropositive rate, seroconversion rate and GMT of IgG antibody and neutralization antibody |
| Comparison of immunogenicity between 2 and 3 doses | 28 days after second and third dose | seropositive rate, seroconversion rate and GMT of IgG antibody and neutralization antibody |
Countries
Indonesia
Outcome results
None listed