A Phase I, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Populations Aged 18 Years and Above in Indonesia

Tahapan Penelitian : Awal
Sponsor:
Mitra Pelaksana:
Fakultas Kedokteran Universitas Indonesia
No Registry
INA-ZTGW21
Tanggal Input Registry : 07-12-2021

10-12-2021
Number and percentage of subjects with solicited and unsolicited adverse events within 7 days after each dose
Safety: - Number and percentage of subjects with solicited and unsolicited adverse events within 28 days after each dose. - Comparison of number and percentage of subjects with adverse events and serious adverse events between vaccine and active control group within 28 days after each dose. - Any deviation from laboratory evaluation of SGOT/SGPT and Albumin that probably related to the dosing 28 days after the first dose for liver function evaluation. - Any deviation from routine laboratory evaluation that probably related to the dosing 7 days after the whole schedule dose. Immunogenicity: - Seropositive rate and GMT anti-RBD antibody IgG titer (ELISA) at baseline, day 28, 56, 84. - Seroconversion of anti-RBD antibody IgG titer (ELISA) at day 28, 56, 84 - Seropositive rate and GMT of neutralizing antibody titer at baseline, day 28, 56, 84 - Seroconversion of neutralizing antibody titer at day 28, 56, 84 - Comparison of seropositive rate, seroconversion and GMT anti-RBD antibody IgG titer (ELISA) between two-dose and three-dose regimen of dosing. - Comparison of seropositive rate, seroconversion and GMT of neutralizing antibody between two-dose and three-dose regimen of dosing.
 
A Phase I, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Populations Aged 18 Years and Above in Indonesia
A Phase I, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Populations Aged 18 Years and Above in Indonesia
Eksperimental
This trial is observer blinded, comparative, randomized, phase I. Approximately 60 subjects will be recruited in this study. The safety and immunogenicity result of the Phase I study will determine the continuation of the next phase clinical trial. The vaccine candidate (SARS-CoV-2 protein subunit recombinant vaccine) will be compared to active control. The regimen of the investigational product is 0.5 ml injected 50 μg in three dose-regimen (for all subjects) with 28 days apart between doses. Antibody testing after each dose will be conducted to evaluate the immunogenicity profile after vaccination.
60
 

Inclusion Criteria:

1. Clinically healthy subjects within the following age groups: adults (18-59 years), elderly (60 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 investigational product against COVID-19 during or 6 months prior to enrollment. 3. Subjects who have 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. The result of rapid antigen test 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 phase I). 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.
 
845/UN2.F1/ETIK/PPM.00.02/2021
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RG.01.06.1.2.12.21.462
COV2-010221
Prof. Dr.dr. Rini Sekartini, SpA (K)