Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018

NCT ID: NCT05228613

Last Updated: 2023-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-16
• Study Completion Date: 2023-01-24

Brief Summary

The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is to evaluate the safety and immunogenicity of the SARS-CoV-2 protein subunit recombinant vaccine adjuvanted with Alum+CpG1018

Detailed Description

This trial is observer blinded, comparative, randomized, phase I study. Approximately 175 subjects will be recruited (18 years and above).

The investigational product is 0.5 ml in two dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine). There will be 4 formula of investigational product used with different concentration of Receptor Binding Domain (RBD) antigen and adjuvant CpG 1018.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vaccine Candidate Formula A

2 doses of vaccine candidate formula A administered with 28 days interval (0.5 mL per dose)

Group Type: EXPERIMENTAL

SARS-CoV-2 protein subunit recombinant vaccine

Intervention Type: BIOLOGICAL

candidate vaccine manufactured by PT. Bio Farma

Vaccine Candidate Formula B

2 doses of vaccine candidate formula B administered with 28 days interval (0.5 mL per dose)

Group Type: EXPERIMENTAL

SARS-CoV-2 protein subunit recombinant vaccine

Intervention Type: BIOLOGICAL

candidate vaccine manufactured by PT. Bio Farma

Vaccine Candidate Formula C

2 doses of vaccine candidate formula C administered with 28 days interval (0.5 mL per dose)

Group Type: EXPERIMENTAL

SARS-CoV-2 protein subunit recombinant vaccine

Intervention Type: BIOLOGICAL

candidate vaccine manufactured by PT. Bio Farma

Vaccine Candidate Formula D

2 doses of vaccine candidate formula D administered with 28 days interval (0.5 mL per dose)

Group Type: EXPERIMENTAL

SARS-CoV-2 protein subunit recombinant vaccine

Intervention Type: BIOLOGICAL

candidate vaccine manufactured by PT. Bio Farma

Active Control

2 doses of active control administered with 28 days interval (0.5 mL per dose)

Group Type: ACTIVE_COMPARATOR

SARS-CoV-2 inactivated vaccine

Intervention Type: BIOLOGICAL

active control manufactured by Sinovac Life Sciences Co.Ltd

Interventions

SARS-CoV-2 protein subunit recombinant vaccine

candidate vaccine manufactured by PT. Bio Farma

Intervention Type: BIOLOGICAL

SARS-CoV-2 inactivated vaccine

active control manufactured by Sinovac Life Sciences Co.Ltd

Intervention Type: BIOLOGICAL

Eligibility Criteria

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 investigational product against COVID-19 (based on anamnesis)

3. Subjects who have history of COVID-19 (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 RT-PCR test for SARS-CoV-2 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 main study subset).

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 IP immunization.

14. Subjects plan to move from the study area before the end of study period.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fakultas Kedokteran Universitas Indonesia

OTHER

Sponsor Role: collaborator

Faculty of Medicine, Diponegoro University, Semarang

UNKNOWN

Sponsor Role: collaborator

PT Bio Farma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof Rini Sekartini, MD

Role: PRINCIPAL_INVESTIGATOR

Fakultas Kedokteran Universitas Indonesia

Yetty Movieta Nency, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Diponegoro University, Semarang

Locations

Faculty of Medicine, Diponegoro University, Semarang

Semarang, Central Java, Indonesia

Fakultas Kedokteran Universitas Indonesia

Jakarta, Greater Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

CoV2-0122

Identifier Type: -

Identifier Source: org_study_id