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Booster Study of COVID-19 Protein Subunit Recombinant Vaccine

Primary Purpose

COVID-19

Status

Recruiting

Phase

Phase 2

Locations

Indonesia

Study Type

Interventional

Intervention

SARS-CoV-2 subunit protein recombinant vaccine

Active Comparator

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Clinically healthy adults 18 years of age and older.
Subjects who have previously received complete primary series of authorized/approved inactivated (Sinovac®), mRNA (Pfizer®), or viral vector COVID-19 vaccine (AstraZeneca®) with the last dose administered a minimum of 6 months prior to inclusion but not longer than 12 months prior to inclusion.
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:

Subject concomitantly enrolled or scheduled to be enrolled in another trial.
Subject who has received booster dose of COVID-19 vaccine.
Subject who has 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).
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 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 IP immunization.
Subjects plan to move from the study area before the end of study period.

Sites / Locations

Faculty of Medicine Universitas UdayanaRecruiting
Faculty of Medicine Universitas PadjadjaranRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Primary dose of inactivated (Sinovac®) vaccine (1)

Primary dose of mRNA (Pfizer®) vaccine (1)

Primary dose of Viral Vector (AstraZeneca®) vaccine (1)

Primary dose of inactivated (Sinovac®) vaccine (2)

Primary dose of mRNA (Pfizer®) vaccine (2)

Primary dose of Viral Vector (AstraZeneca®) vaccine (2)

Arm Description

Subject who had received a complete primary dose of inactivated (Sinovac®) vaccine

Subject who had received a complete primary dose of mRNA (Pfizer®) vaccine

Subject who had received a complete primary dose of viral vector (AstraZeneca®) vaccine

Subject who had received a complete primary dose of inactivated (Sinovac®) vaccine

Subject who had received a complete primary dose of mRNA (Pfizer®) vaccine

Subject who had received a complete primary dose of viral vector (AstraZeneca®) vaccine

Outcomes

Primary Outcome Measures

Immunogenicity of the candidate vaccine

Geometric Mean Titer (GMT) and GMT ratio of neutralizing antibody to the SARS-CoV-2

Secondary Outcome Measures

Seropositive rate of the candidate vaccine

Seropositive rate of neutralizing antibody

Seroconversion rate of the candidate vaccine

Seroconversion rate of neutralizing antibody

Seropositive rate and GMT of candidate vaccine

Seroconversion rate of the candidate vaccine

Seroconversion rate of IgG antibody (RBD)

Comparison of immunogenicity between candidate vaccine and control group

Comparison of GMT, seroconversion rate, seropositive rate of neutralizing antibody and IgG antibody (RBD) between candidate vaccine and control group

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

Full Information

NCT ID

NCT05525208

First Posted

August 30, 2022

Last Updated

September 6, 2022

Sponsor

PT Bio Farma

Collaborators

Universitas Padjadjaran, Udayana University

1. Study Identification

Unique Protocol Identification Number

NCT05525208

Brief Title

Booster Study of COVID-19 Protein Subunit Recombinant Vaccine

Official Title

Observer-Blind, Randomized, Controlled Study of Immunogenicity and Safety of SARS-Cov-2 Protein Subunit Recombinant Vaccine (Bio Farma) as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2022 (Actual)

Primary Completion Date

February 28, 2023 (Anticipated)

Study Completion Date

March 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PT Bio Farma

Collaborators

Universitas Padjadjaran, Udayana University

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 of Immunogenicity & Safety of SARS-Cov-2 Protein Subunit Recombinant Vaccine (Bio Farma) as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older.

Detailed Description

This trial is observer-blind, randomized, prospective intervention study. In this study 900 subjects who had received complete primary doses of authorized/approved inactivated (Sinovac®), mRNA (Pfizer®), or viral vector (AstraZeneca®) COVID-19 vaccine and willing to participate in the booster study by signing the consent form, will be involved in this trial. Subject will be divided into six groups, each 150 subjects per arm who had received a complete primary dose of inactivated (Sinovac®) vaccine, mRNA (Pfizer®) vaccine, or viral vector (AstraZeneca®) vaccine will receive one booster dose of SARS-CoV-2 subunit protein recombinant vaccine or active control.

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, Booster

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Vaccine candidate and active comparator are masking.

Allocation

Randomized

Enrollment

900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Primary dose of inactivated (Sinovac®) vaccine (1)

Arm Type

Experimental

Arm Description

Subject who had received a complete primary dose of inactivated (Sinovac®) vaccine

Arm Title

Primary dose of mRNA (Pfizer®) vaccine (1)

Arm Type

Experimental

Arm Description

Subject who had received a complete primary dose of mRNA (Pfizer®) vaccine

Arm Title

Primary dose of Viral Vector (AstraZeneca®) vaccine (1)

Arm Type

Experimental

Arm Description

Subject who had received a complete primary dose of viral vector (AstraZeneca®) vaccine

Arm Title

Primary dose of inactivated (Sinovac®) vaccine (2)

Arm Type

Experimental

Arm Description

Subject who had received a complete primary dose of inactivated (Sinovac®) vaccine

Arm Title

Primary dose of mRNA (Pfizer®) vaccine (2)

Arm Type

Experimental

Arm Description

Subject who had received a complete primary dose of mRNA (Pfizer®) vaccine

Arm Title

Primary dose of Viral Vector (AstraZeneca®) vaccine (2)

Arm Type

Experimental

Arm Description

Subject who had received a complete primary dose of viral vector (AstraZeneca®) vaccine

Intervention Type

Biological

Intervention Name(s)

SARS-CoV-2 subunit protein 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

The Pfizer-BioNTech® COVID-19 vaccine or BNT162b2, is an mRNA vaccine encoding a P2 mutant spike protein (PS 2) and formulated as an RNA-lipid nanoparticle of nucleoside-modified mRNA (modRNA).

Primary Outcome Measure Information:

Title

Immunogenicity of the candidate vaccine

Description

Geometric Mean Titer (GMT) and GMT ratio of neutralizing antibody to the SARS-CoV-2

Time Frame

14 days after booster vaccination

Secondary Outcome Measure Information:

Title

Seropositive rate of the candidate vaccine

Description

Seropositive rate of neutralizing antibody

Time Frame

Baseline, 14 days and 6 months after booster vaccination

Title

Seroconversion rate of the candidate vaccine

Description

Seroconversion rate of neutralizing antibody

Time Frame

Baseline and 14 days after booster vaccination

Title

Seropositive rate and GMT of candidate vaccine

Description

Seropositive rate and GMT of candidate vaccine

Time Frame

Baseline, 14 days, and 6 months after booster vaccination

Title

Seroconversion rate of the candidate vaccine

Description

Seroconversion rate of IgG antibody (RBD)

Time Frame

baseline and 14 days after booster vaccination

Title

Comparison of immunogenicity between candidate vaccine and control group

Description

Comparison of GMT, seroconversion rate, seropositive rate of neutralizing antibody and IgG antibody (RBD) between candidate vaccine and control group

Time Frame

Baseline, 14 days, and 6 months after booster vaccination

Title

Safety of the candidate vaccine

Description

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

Time Frame

28 days after booster vaccination

Title

Serious Adverse Event (SAE) of the vaccine

Description

Percentage of subjects with at least 1 SAE

Time Frame

6 months after booster vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinically healthy adults 18 years of age and older. Subjects who have previously received complete primary series of authorized/approved inactivated (Sinovac®), mRNA (Pfizer®), or viral vector COVID-19 vaccine (AstraZeneca®) with the last dose administered a minimum of 6 months prior to inclusion but not longer than 12 months prior to inclusion. 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: Subject concomitantly enrolled or scheduled to be enrolled in another trial. Subject who has received booster dose of COVID-19 vaccine. Subject who has 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). 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 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 IP immunization. Subjects plan to move from the study area before the end of study period.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rini M. Sari, MD

Phone

+6222-2033755

rini.mulia@biofarma.co.id

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kusnandi Rusmil, Prof, MD

Organizational Affiliation

Faculty of Medicine Universitas Padjadjaran

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Medicine Universitas Udayana

City

Denpasar

State/Province

Bali

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

I Gusti Ayu T. Wardani, MD

Phone

081338799222

First Name & Middle Initial & Last Name & Degree

I Gusti Ayu T. Wardani, MD

Facility Name

Faculty of Medicine Universitas Padjadjaran

City

Bandung

State/Province

West Java

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kusnandi Rusmil, Prof, MD

Phone

0811232774

First Name & Middle Initial & Last Name & Degree

Kusnandi Rusmil, Prof, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Booster Study of COVID-19 Protein Subunit Recombinant Vaccine

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