Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018

Tahapan Penelitian : Rekrut
Sponsor:
Mitra Pelaksana:
Fakultas Kedokteran Universitas Indonesia, Fakultas Kedokteran Universitas Diponegoro
No Registry
INA-GYTE3LR
Tanggal Input Registry : 17-02-2022

16-02-2022
To evaluate the safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose
- To evaluate the safety of the SARS-CoV-2 protein subunit recombinant vaccine within 28 days after each dose. - To evaluate serious adverse events until 6 months after last dose. - To evaluate preliminary immunogenicity of the SARS-CoV-2 protein subunit recombinant vaccine. - To compare safety and immunogenicity between SARS-CoV-2 protein subunit recombinant vaccine and control group.
 
Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018
A Phase I, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Adjuvanted with Alum+CpG 1018) in Healthy Populations Aged 18 Years and Above in Indonesia
Eksperimental
Randomized, observer-blind, controlled, prospective intervention study. Test product: SARS-CoV-2 protein subunit recombinant vaccine, 2 doses 28 days interval, 0.5mL each dose Comparator: COVID-19 vaccine Bio Farma (inactivated vaccine), 2 doses 28 days interval, 0.5mL each dose
175
 

Inclusion Criteria:

1. Clinically healthy subjects aged 18 – 70 years. 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 (based on anamnesis) 3. Subjects who have history of COVID-19 (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. The result of RT-PCR test for SARS-CoV-2 is positive. 6. Women who are lactating, pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results). 7. Abnormality hematology and biochemical test results (for main study subset). 8. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema. 9. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. 10. 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. 11. 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 immuneresponse (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (> 2 weeks)). 12. Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome. 13. Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization. 14. Subjects plan to move from the study area before the end of study period.
 
121/UN2.F1/ETIK/PPM.00.02/2022; 24/EC/KEPK/FK-UNDIP/I/2022
NA
B-RG.01.06.1.1.02.22.22
CoV2-0122
Prof. Dr.dr. Rini Sekartini, SpA (K), dr. Yetty Movieta Nency, Sp.A.(K)-IBCLC