Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Adult - Vaccine candidate 50 µg dose, adult group (18-59 years) |
Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine
intramuscular injection
|
| Active Comparator: Adult - Control SARS-CoV-2 inactivated vaccine, adult group (18-59 years) |
Biological: SARS-CoV-2 Inactivated Vaccine
intramuscular injection
|
| Experimental: Elderly - Vaccine candidate 50 µg dose, elderly group (> 60 years) |
Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine
intramuscular injection
|
| Active Comparator: Elderly - Control SARS-CoV-2 inactivated vaccine, elderly group (> 60 years) |
Biological: SARS-CoV-2 Inactivated Vaccine
intramuscular injection
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- Deviation of laboratory evaluation [7 days after whole schedule 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Clinically healthy subjects within the following age groups: adults (18-59 years) and elderly (60 years and above.
-
Subjects have been informed properly regarding the study and signed the informed consent form.
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Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.
Exclusion Criteria:
-
Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
-
History of vaccination with any investigational product against Covid-19 during or 6 months prior to enrollment.
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Subjects who have history of Covid-19 in the last 3 months (based on anamnesis or other examinations).
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Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
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The result of rapid antigen test is positive.
-
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).
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Abnormality hematology and biochemical test results.
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History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
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History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
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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.
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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)).
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Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.
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Subjects receive any vaccination (other than Covid-19 vaccine) within 1 month before and after Investigational Product (IP) immunization.
-
Subjects plan to move from the study area before the end of study period.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fakultas Kedokteran Universitas Indonesia | Jakarta | Greater Jakarta | Indonesia |
Sponsors and Collaborators
- PT Bio Farma
- Fakultas Kedokteran Universitas Indonesia
- National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
Investigators
- Principal Investigator: Prof. Rini Sekartini, MD, Fakultas Kedokteran Universitas Indonesia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CoV2-010221