Back to results

Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine

Primary Purpose

COVID-19

Status

Completed

Phase

Phase 2

Locations

Indonesia

Study Type

Interventional

Intervention

SARS-CoV-2 protein subunit recombinant vaccine

placebo

About this trial

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

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, history of 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 received in the previous 4 weeks a treatment likely to alter the immuneresponse (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, Semarang
Faculty of Medicine Universitas Hassanudin
Faculty of Medicine, Universitas Andalas, Padang

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Vaccine Candidate Formula 1

Vaccine Candidate Formula 2

Control

Arm Description

2 doses of vaccine candidate formula 1 administered with 28 days interval (0.5 mL per dose)

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

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

Outcomes

Primary Outcome Measures

Immunogenicity of the candidate vaccine

seroconversion rate of antibody (IgG and neutralization 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 antibody of vaccine candidate

GMT of antibody (IgG and neutralization antibody)

Persistence antibody of vaccine candidate

seropositive rate of antibody (IgG and neutralization antibody)

Full Information

NCT ID

NCT05313035

First Posted

April 5, 2022

Last Updated

April 12, 2023

Sponsor

PT Bio Farma

Collaborators

Faculty of Medicine, Universitas Indonesia, Jakarta, Faculty of Medicine, Diponegoro University, Semarang, Faculty of Medicine, Universitas Andalas, Padang, Faculty of Medicine, Universitas Hassanudin, Makassar

1. Study Identification

Unique Protocol Identification Number

NCT05313035

Brief Title

Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine

Official Title

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted With Alum+CpG 1018 in Healthy Populations Aged 18 Years and Above in Indonesia

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

April 13, 2022 (Actual)

Primary Completion Date

July 22, 2022 (Actual)

Study Completion Date

February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PT Bio Farma

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This trial is observer-blind, comparative, randomized, placebo-controlled phase 2 study. The population is healthy subjects aged 18 and above

Detailed Description

The phase 2 is dose-ranging study which will recruit 360 subjects to compare two vaccine formulas to placebo (1:1:1), to evaluate the safety and immunogenicity of the vaccine. The subjects will be given 2 doses of investigational product with 28 days interval between doses. One selected vaccine formula will be evaluated for safety and persistence antibody until 6 months after the last dose.

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Vaccine candidate and placebo are masking, lot number is masking

Allocation

Randomized

Enrollment

360 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vaccine Candidate Formula 1

Arm Type

Experimental

Arm Description

2 doses of vaccine candidate formula 1 administered with 28 days interval (0.5 mL per dose)

Arm Title

Vaccine Candidate Formula 2

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

SARS-CoV-2 protein subunit recombinant vaccine

Intervention Description

candidate vaccine manufactured by PT. Bio Farma

Intervention Type

Biological

Intervention Name(s)

placebo

Intervention Description

the placebo is NaCl injection manufactured by PT. Bio Farma

Primary Outcome Measure Information:

Title

Immunogenicity of the candidate vaccine

Description

seroconversion rate of antibody (IgG and neutralization 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

6 months after the last dose

Title

Persistence antibody of vaccine candidate

Description

GMT of antibody (IgG and neutralization antibody)

Time Frame

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

Title

Persistence antibody of vaccine candidate

Description

seropositive rate of antibody (IgG and neutralization antibody)

Time Frame

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

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, history of 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 received in the previous 4 weeks a treatment likely to alter the immuneresponse (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, Semarang

City

Semarang

State/Province

Central Java

Country

Indonesia

Facility Name

Faculty of Medicine Universitas Hassanudin

City

Makassar

State/Province

South Sulawesi

Country

Indonesia

Facility Name

Faculty of Medicine, Universitas Andalas, Padang

City

Padang

State/Province

West Sumatera

Country

Indonesia

12. IPD Sharing Statement

Learn more about this trial

Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine

We'll reach out to this number within 24 hrs