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

Primary Purpose

Covid19

Status

Completed

Phase

Phase 1

Locations

Indonesia

Study Type

Interventional

Intervention

SARS-CoV-2 Protein Subunit Recombinant Vaccine

SARS-CoV-2 Inactivated Vaccine

About this trial

This is an interventional treatment trial for Covid19 focused on measuring covid19 vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Clinically healthy subjects within the following age groups: adults (18-59 years) and elderly (60 years and above.
Subjects have been informed properly regarding the study and signed the informed consent form.
Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
History of vaccination with any investigational product against Covid-19 during or 6 months prior to enrollment.
Subjects who have history of Covid-19 in the last 3 months (based on anamnesis or other examinations).
Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
The result of rapid antigen test is positive.
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).
Abnormality hematology and biochemical test results.
History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
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.
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)).
Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.
Subjects receive any vaccination (other than Covid-19 vaccine) within 1 month before and after Investigational Product (IP) immunization.
Subjects plan to move from the study area before the end of study period.

Sites / Locations

Fakultas Kedokteran Universitas Indonesia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Adult - Vaccine candidate

Adult - Control

Elderly - Vaccine candidate

Elderly - Control

Arm Description

50 µg dose, adult group (18-59 years)

SARS-CoV-2 inactivated vaccine, adult group (18-59 years)

50 µg dose, elderly group (> 60 years)

SARS-CoV-2 inactivated vaccine, elderly group (> 60 years)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

safety of the SARS-CoV-2 protein subunit recombinant vaccine within 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

percentage of subjects with AE and SAE between vaccine and active control group

Deviation of laboratory evaluation

Any deviation from routine laboratory evaluation that probably related to the dosing

Deviation of laboratory evaluation

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

seropositive rate, seroconversion rate and GMT of IgG antibody and neutralization antibody

Comparison of immunogenicity between 2 and 3 doses

seropositive rate, seroconversion rate and GMT of IgG antibody and neutralization antibody

Full Information

NCT ID

NCT05067894

First Posted

October 1, 2021

Last Updated

August 8, 2022

Sponsor

PT Bio Farma

Collaborators

Fakultas Kedokteran Universitas Indonesia, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

1. Study Identification

Unique Protocol Identification Number

NCT05067894

Brief Title

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

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

December 10, 2021 (Actual)

Primary Completion Date

April 11, 2022 (Actual)

Study Completion Date

August 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PT Bio Farma

Collaborators

Fakultas Kedokteran Universitas Indonesia, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

covid19 vaccine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Observer blind: Investigational Product and Active Comparator are masking. Lot number is masking

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adult - Vaccine candidate

Arm Type

Experimental

Arm Description

50 µg dose, adult group (18-59 years)

Arm Title

Adult - Control

Arm Type

Active Comparator

Arm Description

SARS-CoV-2 inactivated vaccine, adult group (18-59 years)

Arm Title

Elderly - Vaccine candidate

Arm Type

Experimental

Arm Description

50 µg dose, elderly group (> 60 years)

Arm Title

Elderly - Control

Arm Type

Active Comparator

Arm Description

SARS-CoV-2 inactivated vaccine, elderly group (> 60 years)

Intervention Type

Biological

Intervention Name(s)

SARS-CoV-2 Protein Subunit Recombinant Vaccine

Intervention Description

intramuscular injection

Intervention Type

Biological

Intervention Name(s)

SARS-CoV-2 Inactivated Vaccine

Intervention Description

intramuscular injection

Primary Outcome Measure Information:

Title

Safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose

Description

percentage of subjects with solicited and unsolicited Adverse Events (AE)

Time Frame

7 days after each dose

Secondary Outcome Measure Information:

Title

safety of the SARS-CoV-2 protein subunit recombinant vaccine within 28 days after each dose

Description

percentage of subjects with solicited and unsolicited AE

Time Frame

28 days after each dose

Title

Comparison of AE/ Serious Adverse Events (SAE) between intervention vaccine and active control

Description

percentage of subjects with AE and SAE between vaccine and active control group

Time Frame

28 days after each dose

Title

Deviation of laboratory evaluation

Description

Any deviation from routine laboratory evaluation that probably related to the dosing

Time Frame

28 days after the first dose

Title

Deviation of laboratory evaluation

Description

Any deviation from routine laboratory evaluation that probably related to the dosing

Time Frame

7 days after whole schedule dose

Title

Immunogenicity profile of the SARS-CoV-2 protein subunit recombinant vaccine after second dose

Description

seropositive rate, seroconversion rate and GMT of IgG antibody and neutralization antibody

Time Frame

28 days after each dose

Title

Comparison of immunogenicity between 2 and 3 doses

Description

seropositive rate, seroconversion rate and GMT of IgG antibody and neutralization antibody

Time Frame

28 days after second and third dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinically healthy subjects within the following age groups: adults (18-59 years) and elderly (60 years and above. Subjects have been informed properly regarding the study and signed the informed consent form. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial. Exclusion Criteria: Subjects concomitantly enrolled or scheduled to be enrolled in another trial. History of vaccination with any investigational product against Covid-19 during or 6 months prior to enrollment. Subjects who have history of Covid-19 in the last 3 months (based on anamnesis or other examinations). Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun). The result of rapid antigen test is positive. 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). Abnormality hematology and biochemical test results. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. 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. 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)). Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome. Subjects receive any vaccination (other than Covid-19 vaccine) within 1 month before and after Investigational Product (IP) immunization. Subjects plan to move from the study area before the end of study period.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prof. Rini Sekartini, MD

Organizational Affiliation

Fakultas Kedokteran Universitas Indonesia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fakultas Kedokteran Universitas Indonesia

City

Jakarta

State/Province

Greater Jakarta

Country

Indonesia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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