COVID-19 Clinical Trial
Official title:
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)
Verified date | November 2023 |
Source | PT Bio Farma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Observer-blind, randomized, active-controlled prospective intervention study
Status | Completed |
Enrollment | 4050 |
Est. completion date | August 31, 2023 |
Est. primary completion date | August 5, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Fakultas Kedokteran Universitas Indonesia | Jakarta | Greater Jakarta |
Indonesia | Faculty of Medicine Universitas Hassanudin | Makassar | South Sulawesi |
Indonesia | Faculty of Medicine Universitas Andalas | Padang | West Sumatera |
Indonesia | Faculty of Medicine Diponegoro University | Semarang | Central Java |
Lead Sponsor | Collaborator |
---|---|
PT Bio Farma | Faculty of Medicine Universitas Andalas, Faculty of Medicine Universitas Diponegoro, Faculty of Medicine Universitas Hassanudin, Fakultas Kedokteran Universitas Indonesia |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cellular immunity of candidate vaccine | Positive rate of specific T-cell response | 14 days, 6 months and 12 months after two-dose primary series. | |
Primary | Immunogenicity of the candidate vaccine | Geometric Mean Titers (GMT) of neutralizing antibody | 14 days after the last dose | |
Primary | Seroconversion rate of the candidate vaccine | Seroconversion rate of neutralizing antibody | 14 days after the last dose | |
Secondary | Safety of the candidate vaccine | percentage of subjects with solicited and unsolicited Adverse Events (AE) | 28 days after each dose | |
Secondary | Serious Adverse Event (SAE) of the vaccine | percentage of subjects with at least 1 SAE | 12 months after the last dose | |
Secondary | Persistence neutralizing antibody of vaccine candidate | GMT of neutralization antibody | 28 days, 3 months, 6 months and 12 months after the last dose | |
Secondary | Persistence Immunoglobulin G (IgG) antibody of vaccine candidate | GMT of IgG antibody (RBD) | 14 days, 28 days, 3 months, 6 months and 12 months after the last dose |
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