COVID-19 Clinical Trial
Official title:
A Phase 2, Double-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
Verified date | April 2023 |
Source | PT Bio Farma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial is observer-blind, comparative, randomized, placebo-controlled phase 2 study. The population is healthy subjects aged 18 and above
Status | Completed |
Enrollment | 360 |
Est. completion date | February 28, 2023 |
Est. primary completion date | July 22, 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, history of 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 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)). 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 | Faculty of Medicine Universitas Hassanudin | Makassar | South Sulawesi |
Indonesia | Faculty of Medicine, Universitas Andalas, Padang | Padang | West Sumatera |
Indonesia | Faculty of Medicine, Diponegoro University, Semarang | Semarang | Central Java |
Lead Sponsor | Collaborator |
---|---|
PT Bio Farma | Faculty of Medicine, Diponegoro University, Semarang, Faculty of Medicine, Universitas Andalas, Padang, Faculty of Medicine, Universitas Hassanudin, Makassar, Faculty of Medicine, Universitas Indonesia, Jakarta |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immunogenicity of the candidate vaccine | seroconversion rate of antibody (IgG and neutralization 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 | 6 months after the last dose | |
Secondary | Persistence antibody of vaccine candidate | GMT of antibody (IgG and neutralization antibody) | 14 days, 28 days, 3 months, 6 months after the last dose | |
Secondary | Persistence antibody of vaccine candidate | seropositive rate of antibody (IgG and neutralization antibody) | 14 days, 28 days, 3 months, 6 months after the last dose |
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