Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine

Phase 1

Completed

• Conditions: Covid19
• Interventions: Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine; Biological: SARS-CoV-2 Inactivated Vaccine

• Registration Number: NCT05067894
• Lead Sponsor: PT Bio Farma

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)

Study Timeline

• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2021-10-01
• Study First Posted: 2021-10-05
• Study Start: 2021-12-10
• Primary Completion: 2022-04-11
• Status Verified: 2022-08
• Study Completion: 2022-08-06
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adult - Vaccine candidate	SARS-CoV-2 Protein Subunit Recombinant Vaccine	50 µg dose, adult group (18-59 years)
Elderly - Control	SARS-CoV-2 Inactivated Vaccine	SARS-CoV-2 inactivated vaccine, elderly group (\> 60 years)
Adult - Control	SARS-CoV-2 Inactivated Vaccine	SARS-CoV-2 inactivated vaccine, adult group (18-59 years)
Elderly - Vaccine candidate	SARS-CoV-2 Protein Subunit Recombinant Vaccine	50 µg dose, elderly group (\> 60 years)

Primary Outcome Measures

Name	Time	Method
Safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose	7 days after each dose	percentage of subjects with solicited and unsolicited Adverse Events (AE)

Secondary Outcome Measures

Name	Time	Method
safety of the SARS-CoV-2 protein subunit recombinant vaccine within 28 days after each dose	28 days after each dose	percentage of subjects with solicited and unsolicited AE
Comparison of AE/ Serious Adverse Events (SAE) between intervention vaccine and active control	28 days after each dose	percentage of subjects with AE and SAE between vaccine and active control group
Deviation of laboratory evaluation	7 days after whole schedule dose	Any deviation from routine laboratory evaluation that probably related to the dosing
Immunogenicity profile of the SARS-CoV-2 protein subunit recombinant vaccine after second dose	28 days after each dose	seropositive rate, seroconversion rate and GMT of IgG antibody and neutralization antibody
Comparison of immunogenicity between 2 and 3 doses	28 days after second and third dose	seropositive rate, seroconversion rate and GMT of IgG antibody and neutralization antibody

Trial Locations

Locations (1)

Fakultas Kedokteran Universitas Indonesia; 🇮🇩 Jakarta, Greater Jakarta, Indonesia