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Heterologous Booster Study of COVID-19 Protein Subunit Recombinant Vaccine in Children 12-17 Years of Age

Primary Purpose

COVID-19

Status
Active
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
SARS-CoV-2 subunit protein recombinant vaccine
Sponsored by
PT Bio Farma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

12 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Clinically healthy children 12-17 years of age. Subjects who have previously received complete primary series of inactivated (Sinovac®) COVID-19 vaccine with the last dose administered a minimum of 6 months prior to inclusion but not longer than 12 months prior to inclusion. Parent/legal guardian and subject has been informed properly regarding the study, and signed the informed consent form (parent/legal guardian) and assent form (subject). Parent and/or legal guardian 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). 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 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. Female who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results). Subjects plan to move from the study area before the end of study period.

Sites / Locations

  • Faculty of Medicine Universitas Padjadjaran

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Primary dose of inactivated (Sinovac®) vaccine

Arm Description

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

Outcomes

Primary Outcome Measures

Immunogenicity of the candidate vaccine
Geometric Mean Titer (GMT) and GMFR 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
Seropositive rate and GMT of IgG antibody (RBD)
Seroconversion rate of candidate vaccine
Seroconversion rate of IgG antibody (RBD)
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

First Posted
February 13, 2023
Last Updated
August 23, 2023
Sponsor
PT Bio Farma
Collaborators
Universitas Padjadjaran
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1. Study Identification

Unique Protocol Identification Number
NCT05727215
Brief Title
Heterologous Booster Study of COVID-19 Protein Subunit Recombinant Vaccine in Children 12-17 Years of Age
Official Title
Immunogenicity and Safety of IndoVac® as a Heterologous Booster Dose Against COVID-19 in Children 12-17 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
June 22, 2023 (Actual)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PT Bio Farma
Collaborators
Universitas Padjadjaran

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to evaluate immune response and safety of SARS-CoV-2 subunit protein recombinant vaccine (IndoVac) as a heterologous booster dose in healthy children 12-17 years of age. Participants who had received complete primary doses of inactivated (Sinovac®) COVID-19 Vaccine will be given IndoVac as a booster dose.
Detailed Description
This trial is open label prospective intervention study. In this study 150 subjects who had received complete primary doses of inactivated (Sinovac®) COVID-19 Vaccine and willing to participate in the booster study by signing the consent form, will be involved in this trial. Subject will receive one booster dose of SARS-CoV-2 subunit protein recombinant vaccine (IndoVac).

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, Heterologous, Children

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Primary dose of inactivated (Sinovac®) vaccine
Arm Type
Experimental
Arm Description
Subject who had received a complete primary dose of inactivated (Sinovac®) 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
Primary Outcome Measure Information:
Title
Immunogenicity of the candidate vaccine
Description
Geometric Mean Titer (GMT) and GMFR 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, 3 months, 6 months, and 12 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 IgG antibody (RBD)
Time Frame
baseline, 14 days, 3 months, 6 months, and 12 months after booster vaccination
Title
Seroconversion rate of candidate vaccine
Description
Seroconversion rate of IgG antibody (RBD)
Time Frame
baseline and 14 days after booster vaccination
Title
Safety of the candidate vaccine
Description
Percentage of subjects with solicited and unsolicited Adverse Events (AE)
Time Frame
30 minutes, 7 days, 28 days, and until 12 months after booster vaccination
Title
Serious Adverse Event (SAE) of the vaccine
Description
Percentage of subjects with at least 1 SAE
Time Frame
until 12 months after booster vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinically healthy children 12-17 years of age. Subjects who have previously received complete primary series of inactivated (Sinovac®) COVID-19 vaccine with the last dose administered a minimum of 6 months prior to inclusion but not longer than 12 months prior to inclusion. Parent/legal guardian and subject has been informed properly regarding the study, and signed the informed consent form (parent/legal guardian) and assent form (subject). Parent and/or legal guardian 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). 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 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. Female who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results). Subjects plan to move from the study area before the end of study period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eddy Fadlyana, MD
Organizational Affiliation
Universitas Padjadjaran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Universitas Padjadjaran
City
Bandung
State/Province
Jawa Barat
ZIP/Postal Code
40161
Country
Indonesia

12. IPD Sharing Statement

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Heterologous Booster Study of COVID-19 Protein Subunit Recombinant Vaccine in Children 12-17 Years of Age

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