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

Study Overview
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Brief Summary
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A Phase III, Observer-blind, randomized, active-controlled prospective intervention study

Detailed Description
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This trial is randomized, prospective intervention study. A total of 1,050 subjects aged 12-17 years (COVID-19 vaccine naive) who are willing to participate in the study by signing the consent form, will be involved in this trial. The subjects will be divided into twostudy subsets, namely Main Study and Exploratory Study. Main Study for immunogenicity and safety evaluation. Exploratory Study for cellular immunity evaluation,

Official Title
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A Phase III, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children Aged 12-17 Years in Indonesia

Conditions
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Vaccine Reaction, Vaccine Adverse Reaction

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically healthy children aged 12-17 years. Parent and/or legal guardian has been informed properly regarding the study and signed the informed consent form (and assent for subjects aged 12-17 years). Parent and/or legal guardian 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 COVID-19 vaccine (based on anamnesis). Subjects who have history of COVID-19 in the last 3 months (based on anamnesis). Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun). 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 IP immunization. Female who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results). 11. Subjects plan to move from the study area before the end of study period.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Vaccine candidate and active comparator are masking
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVID-19 Protein Subunit Recombinant Vaccine<br>2 doses of COVID-19 Protein Subunit Recombinant Vaccine administered with 28 days interval (0.5 mL per dose) | Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine<br>* SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma<br>|
| Active Comparator: Active Comparator<br>2 doses of Covovax® - administered with 28 days interval (0.5 mL per dose) | Biological: Active Comparator<br>* Covovax<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate immunogenic non-inferiority immune response of SARS-CoV-2 neutralizing antibody of Bio Farma vaccine compared to vaccine control at 14 days after primary series | Geometric Mean Titer (GMT) and GMT ratio of neutralizing antibody to the SARS-CoV-2, measured by neutralization assay (against omicron variant) at 14 days after primary series | 14 days after primary series | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate SARS-CoV-2 (RBD)-binding IgG antibody titer before and 14 days after primary series of Bio Farma vaccine. | Seroconversion rate and Seropositive rate of neutralizing antibody at baseline and 14 days after primary series vaccination. | 14 days after primary series | 
| To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma). | Local reactions and systemic events | 28 days after each dose | 
| To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma). | Serious Adverse Event | 12 months after primary series | 
| To compare safety between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group. | local reactions, systemic events | 28 days after each dose | 
| To compare immunogenicity between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group. | SARS-CoV-2 (RBD)-binding IgG antibody titer, neutralizing antibody | 28 days after each dose | 
| To evaluate antibody persistence 3, 6 and 12 months after primary series | SARS-CoV-2 (RBD)-binding IgG antibody titer, neutralizing antibody | 3, 6 and 12 months after primary series |