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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05067894
• Other study ID #: CoV2-010221
• Status: Completed
• Phase: Phase 1
• Start date: December 10, 2021
• Est. completion date: August 6, 2022

Study information

• Verified date: August 2022
• Source: PT Bio Farma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 6, 2022
• Est. primary completion date: April 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Biological:
• SARS-CoV-2 Protein Subunit Recombinant Vaccine
intramuscular injection
• SARS-CoV-2 Inactivated Vaccine
intramuscular injection

Locations

Country	Name	City	State
Indonesia	Fakultas Kedokteran Universitas Indonesia	Jakarta	Greater Jakarta

Sponsors (3)

Lead Sponsor	Collaborator
PT Bio Farma	Fakultas Kedokteran Universitas Indonesia, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

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