Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine

Study Overview
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Brief Summary
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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
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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)

Official Title
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A Phase I, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Populations Aged 18 Years and Above in Indonesia

Conditions
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Covid19

Intervention / Treatment
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* Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine
* Biological: SARS-CoV-2 Inactivated Vaccine


Participation Criteria
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Eligibility Criteria
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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. 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. Subjects who have history of Covid-19 in the last 3 months (based on anamnesis or other examinations). Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun). 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). Abnormality hematology and biochemical test results. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema. History of uncontrolled coagulopathy or 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. 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)). Subjects who have 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 Investigational Product (IP) immunization. Subjects plan to move from the study area before the end of study period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adult - Vaccine candidate<br>50 µg dose, adult group (18-59 years) | Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine<br>* intramuscular injection<br>|
| Active Comparator: Adult - Control<br>SARS-CoV-2 inactivated vaccine, adult group (18-59 years) | Biological: SARS-CoV-2 Inactivated Vaccine<br>* intramuscular injection<br>|
| Experimental: Elderly - Vaccine candidate<br>50 µg dose, elderly group (> 60 years) | Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine<br>* intramuscular injection<br>|
| Active Comparator: Elderly - Control<br>SARS-CoV-2 inactivated vaccine, elderly group (> 60 years) | Biological: SARS-CoV-2 Inactivated Vaccine<br>* intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose | percentage of subjects with solicited and unsolicited Adverse Events (AE) | 7 days after each dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of the SARS-CoV-2 protein subunit recombinant vaccine within 28 days after each dose | percentage of subjects with solicited and unsolicited AE | 28 days after each dose | 
| Comparison of AE/ Serious Adverse Events (SAE) between intervention vaccine and active control | percentage of subjects with AE and SAE between vaccine and active control group | 28 days after each dose | 
| Deviation of laboratory evaluation | Any deviation from routine laboratory evaluation that probably related to the dosing | 28 days after the first dose | 
| Deviation of laboratory evaluation | Any deviation from routine laboratory evaluation that probably related to the dosing | 7 days after whole schedule dose | 
| Immunogenicity profile of the SARS-CoV-2 protein subunit recombinant vaccine after second dose | seropositive rate, seroconversion rate and GMT of IgG antibody and neutralization antibody | 28 days after each dose | 
| Comparison of immunogenicity between 2 and 3 doses | seropositive rate, seroconversion rate and GMT of IgG antibody and neutralization antibody | 28 days after second and third dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covid19 vaccine