A Phase 2, Observer-Blind, Randomized, Placebo-Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted with Alum+CpG 1018 in Healthy Populations Aged 18 Years and Above in Indonesia

Tahapan Penelitian : Rekrut
Sponsor:
Mitra Pelaksana:
Fakultas Kedokteran Universitas Diponegoro, Fakultas Kedokteran Universitas Andalas, Fakultas Kedokteran Universitas Hasanuddin
No Registry
INA-P7NSA4P
Tanggal Input Registry : 24-06-2022

13-04-2022
To evaluate immunogenicity of the vaccine.
1. To evaluate safety of the vaccine. 2. To compare safety and immunogenicity between vaccine and control group, to select the best formula candidate for phase 3.
 
A Phase 2, Observer-Blind, Randomized, Placebo-Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted with Alum+CpG 1018 in Healthy Populations Aged 18 Years and Above in Indonesia
A Phase 2, Observer-Blind, Randomized, Placebo-Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted with Alum+CpG 1018 in Healthy Populations Aged 18 Years and Above in Indonesia
Eksperimental
Treatment Group: SARS-CoV-2 Protein Subunit Recombinant Vaccine, 2 doses of vaccine with 28 days interval, intramuscular injection Control group: Placebo, 2 doses of placebo with 28 days interval, intramuscular injection
360
 

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 mildmoderate 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 selfreport 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.
 
80/EC/KEPK/FK-UNDIP/IV/2022, 605/UN.16.2/KEP-FK/2022, 149/UN4.6.4.5.31/PP36/2022
N.A
RG.01.06.1.3.04.22.62
COV2-020322
Prof. Dr. dr. Soedjatmiko, SpA(K), Msi