Status:
COMPLETED
Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine
Lead Sponsor:
PT Bio Farma
Collaborating Sponsors:
Indonesia University
Faculty of Medicine, Diponegoro University, Semarang
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This trial is observer-blind, comparative, randomized, placebo-controlled phase 2 study. The population is healthy subjects aged 18 and above
Detailed Description
The phase 2 is dose-ranging study which will recruit 360 subjects to compare two vaccine formulas to placebo (1:1:1), to evaluate the safety and immunogenicity of the vaccine. The subjects will be giv...
Eligibility Criteria
Inclusion
- Clinically healthy subjects aged 18 years and above.
- Subjects have been informed properly regarding the study and signed the informed consent form.
- Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.
Exclusion
- Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
- History of vaccination with any COVID-19 vaccine.
- History of COVID-19 within 1 month (for mild-moderate disease) or 3 months (for severe disease) prior to enrollment.
- Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
- Women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
- History of uncontrolled asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
- History of blood disorders contraindicating intramuscular injection.
- 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.
- History of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immuneresponse (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (\> 2 weeks)).
- History of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre syndrome.
- Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.
- Subjects plan to move from the study area before the end of study period.
Key Trial Info
Start Date :
April 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2023
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT05313035
Start Date
April 13 2022
End Date
February 28 2023
Last Update
April 13 2023
Active Locations (3)
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1
Faculty of Medicine, Diponegoro University, Semarang
Semarang, Central Java, Indonesia
2
Faculty of Medicine Universitas Hassanudin
Makassar, South Sulawesi, Indonesia
3
Faculty of Medicine, Universitas Andalas, Padang
Padang, West Sumatera, Indonesia