Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children
Study Details
Study Description
Brief Summary
A Phase II/III, Observer-blind, randomized, active-controlled prospective intervention study
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
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 I and Exploratory Study.
Main Study I for immunogenicity and safety evaluation.
Exploratory Study for cellular immunity evaluation,
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: COVID-19 Protein Subunit Recombinant Vaccine 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
SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
|
| Active Comparator: Active Comparator 2 doses of Covovax® - administered with 28 days interval (0.5 mL per dose) |
Biological: Active Comparator
Covovax
|
Outcome Measures
Primary Outcome Measures
- 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 [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
Secondary Outcome Measures
- To evaluate SARS-CoV-2 (RBD)-binding IgG antibody titer before and 14 days after primary series of Bio Farma vaccine. [14 days after primary series]
Seroconversion rate and Seropositive rate of neutralizing antibody at baseline and 14 days after primary series vaccination.
- To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma). [28 days after each dose]
Local reactions and systemic events
- To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma). [12 months after primary series]
Serious Adverse Event
- To compare safety between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group. [28 days after each dose]
local reactions, systemic events
- To compare immunogenicity between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group. [28 days after each dose]
SARS-CoV-2 (RBD)-binding IgG antibody titer, neutralizing antibody
- To evaluate antibody persistence 3, 6 and 12 months after primary series [3, 6 and 12 months after primary series]
SARS-CoV-2 (RBD)-binding IgG antibody titer, neutralizing antibody
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Clinically healthy children aged 12-17 years.
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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).
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Parent and/or legal guardian will commit to comply with the instructions of the investigator and the schedule of the trial.
Exclusion Criteria:
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Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
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History of vaccination with any COVID-19 vaccine (based on anamnesis).
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Subjects who have history of COVID-19 in the last 3 months (based on anamnesis).
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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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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 IP immunization.
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Subjects plan to move from the study area before the end of study period.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- PT Bio Farma
- Center for Child Health Universitas Gadjah Mada (CCH-PRO UGM
- Cipto Mangunkusumo Hospital/Department of Child Health, Faculty of Medicine, University of Indonesia, Jakarta
- Faculty of Medicine, Andalas University
Investigators
- Principal Investigator: Cahya Satria, MD, CC PRO UGM
- Principal Investigator: Bernie Medise, MD, Fakultas Kedokteran Universitas Indonesia
- Principal Investigator: Asrawati Asrawati, MD, Faculty of Medicine Universitas Andalas
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CoV2-Children-020322