Clinical trial NCT05067894: Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Covid19
Keywords: covid19 vaccine
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
Collaborators: name: Fakultas Kedokteran Universitas Indonesia
name: National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
First posted: 2021-10-05
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is To evaluate the safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose.

Detailed description: This trial is observer blinded, comparative, randomized, phase I study. Approximately 60 subjects will be recruited (18 years and above).

The investigational product is 0.5 ml in three dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine)

Eligibility criteria: Inclusion Criteria:

1. Clinically healthy subjects within the following age groups: adults (18-59 years) and 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.
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 immune response (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 Investigational Product (IP) immunization.
14. Subjects plan to move from the study area before the end of study period.

Primary outcomes:
measure: Safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose
timeFrame: 7 days after each dose
Secondary outcomes:
measure: safety of the SARS-CoV-2 protein subunit recombinant vaccine within 28 days after each dose
timeFrame: 28 days after each dose
measure: Comparison of AE/ Serious Adverse Events (SAE) between intervention vaccine and active control
timeFrame: 28 days after each dose
measure: Deviation of laboratory evaluation
timeFrame: 28 days after the first dose
measure: Deviation of laboratory evaluation
timeFrame: 7 days after whole schedule dose
measure: Immunogenicity profile of the SARS-CoV-2 protein subunit recombinant vaccine after second dose
timeFrame: 28 days after each dose
measure: Comparison of immunogenicity between 2 and 3 doses
timeFrame: 28 days after second and third dose
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Fakultas Kedokteran Universitas Indonesia
state: Greater Jakarta
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Prof. Rini Sekartini, MD
role: PRINCIPAL_INVESTIGATOR
References: