Immunogenicity & Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted with Alum+CpG 1018 Compared to Registered Covid-19 Vaccine (Covovax – Protein Subunit Vaccine) in Healthy Populations Aged 18 Years and Above in Indonesia (Phase III)

Tahapan Penelitian : Rekrut
Sponsor:
Mitra Pelaksana:
Fakultas Kedokteran Universitas Indonesia, Fakultas Kedokteran Universitas Diponegoro, Fakultas Kedokteran Universitas Andalas, Fakultas Kedokteran Universitas Hasanuddin
No Registry
INA-R5752S9
Tanggal Input Registry : 24-06-2022

07-06-2022
To evaluate immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma)
1. To evaluate safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) 2. To compare safety and immunogenicity between SARS-CoV-2 protein subunit recombinant vaccine (Bio Farma) and control group 3. To evaluate safety and immunogenicity of lot-to-lot consistency using three batches of the vaccine 4. To evaluate antibody persistence at 3, 6 and 12 months after primary series 5. Exploratory: to assess cellular immunity of the vaccine at 14 days, 6 months and 12 months after primary series (for Exploratory Study subset)
 
Immunogenicity & Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted with Alum+CpG 1018 Compared to Registered Covid-19 Vaccine (Covovax – Protein Subunit Vaccine) in Healthy Populations Aged 18 Years and Above in Indonesia (Phase III)
Immunogenicity & Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted with Alum+CpG 1018 Compared to Registered Covid-19 Vaccine (Covovax – Protein Subunit Vaccine) in Healthy Populations Aged 18 Years and Above in Indonesia (Phase III)
Eksperimental
Treatment Group: SARS-CoV-2 Protein Subunit Recombinant Vaccine, 2 doses of vaccine 28 days interval, intramuscular injection Control group: Covovax – SARS-CoV-2 rS Protein (COVID-19)recombinant Vaccine, 2 doses of vaccine 28 days interval, intramuscular injection
4050
 

Inclusion Criteria:

1. Clinically healthy subjects aged 18 years and above. 2. Subjects have been informed properly regarding the study and signed the informed consent form. 3. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial. 2. History of vaccination with any COVID-19 vaccine. 3. History of COVID-19 within 1 month (for mild-moderate disease) or 3 months (for severe disease) prior to enrollment. 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 uncontrolled asthma, allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema. 7. History of 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. History of confirmed or suspected immunosuppressive or immunodeficient state or in the previous 4 weeks received a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or long-term corticosteroid therapy (> 2 weeks)). 10. 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
 
725/UN.16.2/KEP-FK/2022, 123/EC/KEPK/FK-UNDIP/V/2022, 266/U1.i4.6.4.5.31/PP36/2022, KET-549/UN2.F1/ETIK/PPM.00.02/2022
N.A
RG.01.06.1.1.06.22.147, B-RG.01.06.3.32.06.22.345
COV2-IB-0322
Prof. Dr. dr. Soedjatmiko, SpA(K), Msi