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Immuno-bridging Study of COVID-19 Protein Subunit Recombinant Vaccine

Primary Purpose

COVID-19

Status

Active

Phase

Phase 3

Locations

Indonesia

Study Type

Interventional

Intervention

COVID-19 Protein Subunit Recombinant Vaccine

Active Comparator

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring COVID-19 vaccine, healthy population, naive participants

Eligibility Criteria

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

Inclusion Criteria:

Clinically healthy subjects aged 18 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 COVID-19 vaccine.
History of COVID-19 within 1 month (for mild-moderate disease) or 3 months (for severe disease) prior to enrollment.
Evolving mild, moderate, or severe illness, especially infectious disease, or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
Women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
History of uncontrolled asthma, allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
History of 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.
History of confirmed or suspected immunosuppressive or immunodeficient state or in the previous 4 weeks received a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or long-term corticosteroid therapy (> 2 weeks)).
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 IP immunization.
Subjects plan to move from the study area before the end of study period.

Sites / Locations

Faculty of Medicine Diponegoro University
Fakultas Kedokteran Universitas Indonesia
Faculty of Medicine Universitas Hassanudin
Faculty of Medicine Universitas Andalas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

COVID-19 Protein Subunit Recombinant Vaccine

Active Comparator

Arm Description

2 doses of COVID-19 Protein Subunit Recombinant Vaccine administered with 28 days interval (0.5 mL per dose)

2 doses of Covovax® - recombinant spike protein Nanoparticle Vaccine, administered with 28 days interval (0.5 mL per dose)

Outcomes

Primary Outcome Measures

Immunogenicity of the candidate vaccine

Geometric Mean Titers (GMT) of neutralizing antibody

Seroconversion rate of the candidate vaccine

Seroconversion rate of neutralizing antibody

Secondary Outcome Measures

Safety of the candidate vaccine

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

Serious Adverse Event (SAE) of the vaccine

percentage of subjects with at least 1 SAE

Persistence neutralizing antibody of vaccine candidate

GMT of neutralization antibody

Persistence Immunoglobulin G (IgG) antibody of vaccine candidate

GMT of IgG antibody (RBD)

Full Information

NCT ID

NCT05433285

First Posted

June 23, 2022

Last Updated

September 15, 2022

Sponsor

PT Bio Farma

Collaborators

Fakultas Kedokteran Universitas Indonesia, Faculty of Medicine Universitas Diponegoro, Faculty of Medicine Universitas Andalas, Faculty of Medicine Universitas Hassanudin

1. Study Identification

Unique Protocol Identification Number

NCT05433285

Brief Title

Immuno-bridging Study of COVID-19 Protein Subunit Recombinant Vaccine

Official Title

Immunogenicity & Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted With Alum+CpG 1018 Compared to Registered Covid-19 Vaccine (Covovax - Protein Subunit Vaccine) in Healthy Populations Aged 18 Years and Above in Indonesia (Phase III)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 7, 2022 (Actual)

Primary Completion Date

August 5, 2022 (Actual)

Study Completion Date

July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PT Bio Farma

Collaborators

Fakultas Kedokteran Universitas Indonesia, Faculty of Medicine Universitas Diponegoro, Faculty of Medicine Universitas Andalas, Faculty of Medicine Universitas Hassanudin

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

Observer-blind, randomized, active-controlled prospective intervention study

Detailed Description

This trial is randomized, prospective intervention study. A total of 4,050 subjects (COVID-19 vaccine naive) who are willing to participate in the study by signing the consent form, will be involved in this trial. The subjects will be divided into three study subsets, namely Main Study I, Main Study II, and Exploratory Study: Main Study I for immunogenicity and safety evaluation, Main Study II for safety evaluation, and Exploratory Study for cellular immunity evaluation, with trial design as follow : Main Study I, Exploratory Study subset: Observer-blind, randomized, active-controlled prospective intervention study Main Study II: Open-label, randomized study to evaluate safety I

6. Conditions and Keywords

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

COVID-19

Keywords

COVID-19 vaccine, healthy population, naive participants

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Vaccine candidate and active comparator are masking, lot number is masking

Allocation

Randomized

Enrollment

4050 (Actual)

8. Arms, Groups, and Interventions

Arm Title

COVID-19 Protein Subunit Recombinant Vaccine

Arm Type

Experimental

Arm Description

2 doses of COVID-19 Protein Subunit Recombinant Vaccine administered with 28 days interval (0.5 mL per dose)

Arm Title

Active Comparator

Arm Type

Active Comparator

Arm Description

2 doses of Covovax® - recombinant spike protein Nanoparticle Vaccine, administered with 28 days interval (0.5 mL per dose)

Intervention Type

Biological

Intervention Name(s)

COVID-19 Protein Subunit Recombinant Vaccine

Intervention Description

SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma

Intervention Type

Biological

Intervention Name(s)

Active Comparator

Intervention Description

Covovax® COVID-19 vaccine is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of the SARS-CoV-2 betacoronavirus

Primary Outcome Measure Information:

Title

Immunogenicity of the candidate vaccine

Description

Geometric Mean Titers (GMT) of neutralizing antibody

Time Frame

14 days after the last dose

Title

Seroconversion rate of the candidate vaccine

Description

Seroconversion rate of neutralizing antibody

Time Frame

14 days after the last dose

Secondary Outcome Measure Information:

Title

Safety of the candidate vaccine

Description

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

Time Frame

28 days after each dose

Title

Serious Adverse Event (SAE) of the vaccine

Description

percentage of subjects with at least 1 SAE

Time Frame

12 months after the last dose

Title

Persistence neutralizing antibody of vaccine candidate

Description

GMT of neutralization antibody

Time Frame

28 days, 3 months, 6 months and 12 months after the last dose

Title

Persistence Immunoglobulin G (IgG) antibody of vaccine candidate

Description

GMT of IgG antibody (RBD)

Time Frame

14 days, 28 days, 3 months, 6 months and 12 months after the last dose

Other Pre-specified Outcome Measures:

Title

Cellular immunity of candidate vaccine

Description

Positive rate of specific T-cell response

Time Frame

14 days, 6 months and 12 months after two-dose primary series.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinically healthy subjects aged 18 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 COVID-19 vaccine. History of COVID-19 within 1 month (for mild-moderate disease) or 3 months (for severe disease) prior to enrollment. Evolving mild, moderate, or severe illness, especially infectious disease, or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun). Women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results). History of uncontrolled asthma, allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema. History of 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. History of confirmed or suspected immunosuppressive or immunodeficient state or in the previous 4 weeks received a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or long-term corticosteroid therapy (> 2 weeks)). 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 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. Dr. Soedjatmiko SpA(K), MSi, MD

Organizational Affiliation

Fakultas Kedokteran Universitas Indonesia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine Diponegoro University

City

Semarang

State/Province

Central Java

Country

Indonesia

Facility Name

Fakultas Kedokteran Universitas Indonesia

City

Jakarta

State/Province

Greater Jakarta

Country

Indonesia

Facility Name

Faculty of Medicine Universitas Hassanudin

City

Makassar

State/Province

South Sulawesi

Country

Indonesia

Facility Name

Faculty of Medicine Universitas Andalas

City

Padang

State/Province

West Sumatera

Country

Indonesia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Immuno-bridging Study of COVID-19 Protein Subunit Recombinant Vaccine

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