Booster Study of COVID-19 Protein Subunit Recombinant Vaccine
NCT ID: NCT05525208
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
696 participants
INTERVENTIONAL
2022-09-01
2023-08-04
Brief Summary
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Detailed Description
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Subject will be divided into six groups, each 150 subjects per arm who had received a complete primary dose of inactivated (Sinovac®) vaccine, mRNA (Pfizer®) vaccine, or viral vector (AstraZeneca®) vaccine will receive one booster dose of SARS-CoV-2 subunit protein recombinant vaccine or active control.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Primary dose of inactivated (Sinovac®) vaccine (1)
Subject who had received a complete primary dose of inactivated (Sinovac®) vaccine
SARS-CoV-2 subunit protein recombinant vaccine
SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
Primary dose of mRNA (Pfizer®) vaccine (1)
Subject who had received a complete primary dose of mRNA (Pfizer®) vaccine
SARS-CoV-2 subunit protein recombinant vaccine
SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
Primary dose of Viral Vector (AstraZeneca®) vaccine (1)
Subject who had received a complete primary dose of viral vector (AstraZeneca®) vaccine
SARS-CoV-2 subunit protein recombinant vaccine
SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
Primary dose of inactivated (Sinovac®) vaccine (2)
Subject who had received a complete primary dose of inactivated (Sinovac®) vaccine
Active Comparator
The Pfizer-BioNTech® COVID-19 vaccine or BNT162b2, is an mRNA vaccine encoding a P2 mutant spike protein (PS 2) and formulated as an RNA-lipid nanoparticle of nucleoside-modified mRNA (modRNA).
Primary dose of mRNA (Pfizer®) vaccine (2)
Subject who had received a complete primary dose of mRNA (Pfizer®) vaccine
Active Comparator
The Pfizer-BioNTech® COVID-19 vaccine or BNT162b2, is an mRNA vaccine encoding a P2 mutant spike protein (PS 2) and formulated as an RNA-lipid nanoparticle of nucleoside-modified mRNA (modRNA).
Primary dose of Viral Vector (AstraZeneca®) vaccine (2)
Subject who had received a complete primary dose of viral vector (AstraZeneca®) vaccine
Active Comparator
The Pfizer-BioNTech® COVID-19 vaccine or BNT162b2, is an mRNA vaccine encoding a P2 mutant spike protein (PS 2) and formulated as an RNA-lipid nanoparticle of nucleoside-modified mRNA (modRNA).
Interventions
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SARS-CoV-2 subunit protein recombinant vaccine
SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
Active Comparator
The Pfizer-BioNTech® COVID-19 vaccine or BNT162b2, is an mRNA vaccine encoding a P2 mutant spike protein (PS 2) and formulated as an RNA-lipid nanoparticle of nucleoside-modified mRNA (modRNA).
Eligibility Criteria
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Inclusion Criteria
2. Subjects who have previously received complete primary series of authorized/approved inactivated (Sinovac®), mRNA (Pfizer®), or viral vector COVID-19 vaccine (AstraZeneca®) with the last dose administered a minimum of 6 months prior to inclusion but not longer than 12 months prior to inclusion.
3. Subjects have been informed properly regarding the study and signed the informed consent form.
4. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.
Exclusion Criteria
2. Subject who has received booster dose of COVID-19 vaccine.
3. Subject who has history of COVID-19 in the last 3 months (based on anamnesis or other examinations).
4. Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
5. Women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
6. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
7. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
8. 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.
9. 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)).
10. Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.
11. Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.
12. Subjects plan to move from the study area before the end of study period.
18 Years
ALL
Yes
Sponsors
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Universitas Padjadjaran
OTHER
Udayana University
OTHER
PT Bio Farma
INDUSTRY
Responsible Party
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Principal Investigators
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Kusnandi Rusmil, Prof, MD
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medicine Universitas Padjadjaran
Locations
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Faculty of Medicine Universitas Udayana
Denpasar, Bali, Indonesia
Faculty of Medicine Universitas Padjadjaran
Bandung, West Java, Indonesia
Countries
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Other Identifiers
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CoV2-Booster-0222
Identifier Type: -
Identifier Source: org_study_id
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