Back to resultsSafety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
SARS-CoV-2 protein subunit recombinant vaccine
SARS-CoV-2 inactivated vaccine
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19 vaccine, healthy population
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 investigational product against COVID-19 (based on anamnesis)
- Subjects who have history of COVID-19 (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 RT-PCR test for SARS-CoV-2 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 (for main study subset).
- 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, Diponegoro University, Semarang
- Fakultas Kedokteran Universitas Indonesia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Vaccine Candidate Formula A
Vaccine Candidate Formula B
Vaccine Candidate Formula C
Vaccine Candidate Formula D
Active Control
Arm Description
2 doses of vaccine candidate formula A administered with 28 days interval (0.5 mL per dose)
2 doses of vaccine candidate formula B administered with 28 days interval (0.5 mL per dose)
2 doses of vaccine candidate formula C administered with 28 days interval (0.5 mL per dose)
2 doses of vaccine candidate formula D administered with 28 days interval (0.5 mL per dose)
2 doses of active control administered with 28 days interval (0.5 mL per dose)
Outcomes
Primary Outcome Measures
Safety of the vaccine within 7 days after each dose
percentage of subjects with solicited and unsolicited Adverse Events (AE)
Secondary Outcome Measures
safety of the vaccine within 28 days after each dose
percentage of subjects with solicited and unsolicited AE
Serious Adverse Event (SAE) of the vaccine
percentage of subjects with at least 1 SAE
Comparison of safety between 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
Inflammatory factor evaluation
The change of interleukin-6 (IL-6) in serum
Immunogenicity profile after the last dose
GMT of IgG antibody and neutralization antibody
Immunogenicity profile after the last dose
seroconversion rate of IgG antibody and neutralization antibody
Comparison of immunogenicity profile
GMT of IgG antibody and neutralization antibody
Comparison of immunogenicity profile
seroconversion rate of IgG antibody and neutralization antibody
Full Information
NCT ID
NCT05228613
First Posted
February 7, 2022
Last Updated
February 23, 2023
Sponsor
PT Bio Farma
Collaborators
Fakultas Kedokteran Universitas Indonesia, Faculty of Medicine, Diponegoro University, Semarang
1. Study Identification
Unique Protocol Identification Number
NCT05228613
Brief Title
Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018
Official Title
A Phase I, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Adjuvanted With Alum+CpG 1018) in Healthy Populations Aged 18 Years and Above in Indonesia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 16, 2022 (Actual)
Primary Completion Date
August 2, 2022 (Actual)
Study Completion Date
January 24, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PT Bio Farma
Collaborators
Fakultas Kedokteran Universitas Indonesia, Faculty of Medicine, Diponegoro University, Semarang
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 study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is to evaluate the safety and immunogenicity of the SARS-CoV-2 protein subunit recombinant vaccine adjuvanted with Alum+CpG1018
Detailed Description
This trial is observer blinded, comparative, randomized, phase I study. Approximately 175 subjects will be recruited (18 years and above).
The investigational product is 0.5 ml in two dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine). There will be 4 formula of investigational product used with different concentration of Receptor Binding Domain (RBD) antigen and adjuvant CpG 1018.
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 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
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaccine Candidate Formula A
Arm Type
Experimental
Arm Description
2 doses of vaccine candidate formula A administered with 28 days interval (0.5 mL per dose)
Arm Title
Vaccine Candidate Formula B
Arm Type
Experimental
Arm Description
2 doses of vaccine candidate formula B administered with 28 days interval (0.5 mL per dose)
Arm Title
Vaccine Candidate Formula C
Arm Type
Experimental
Arm Description
2 doses of vaccine candidate formula C administered with 28 days interval (0.5 mL per dose)
Arm Title
Vaccine Candidate Formula D
Arm Type
Experimental
Arm Description
2 doses of vaccine candidate formula D administered with 28 days interval (0.5 mL per dose)
Arm Title
Active Control
Arm Type
Active Comparator
Arm Description
2 doses of active control 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)
SARS-CoV-2 inactivated vaccine
Intervention Description
active control manufactured by Sinovac Life Sciences Co.Ltd
Primary Outcome Measure Information:
Title
Safety of the 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 vaccine within 28 days after each dose
Description
percentage of subjects with solicited and unsolicited 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
Comparison of safety between 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 and 6 months after the last dose
Title
Deviation of laboratory evaluation
Description
Any deviation from routine laboratory evaluation that probably related to the dosing
Time Frame
7 days after the first dose and 14 days after the last dose
Title
Inflammatory factor evaluation
Description
The change of interleukin-6 (IL-6) in serum
Time Frame
7 days after the first dose and 14 days after the last dose
Title
Immunogenicity profile after the last dose
Description
GMT of IgG antibody and neutralization antibody
Time Frame
14 days and 28 days after the last dose
Title
Immunogenicity profile after the last dose
Description
seroconversion rate of IgG antibody and neutralization antibody
Time Frame
14 days and 28 days after the last dose
Title
Comparison of immunogenicity profile
Description
GMT of IgG antibody and neutralization antibody
Time Frame
14 days and 28 days after the last dose
Title
Comparison of immunogenicity profile
Description
seroconversion rate of IgG antibody and neutralization antibody
Time Frame
14 days and 28 days after the last dose
Other Pre-specified Outcome Measures:
Title
Cellular immunity evaluation
Description
Positive rate of specific T-cell response
Time Frame
14 days after the last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
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 investigational product against COVID-19 (based on anamnesis)
Subjects who have history of COVID-19 (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 RT-PCR test for SARS-CoV-2 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 (for main study subset).
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.
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
First Name & Middle Initial & Last Name & Degree
Yetty Movieta Nency, MD
Organizational Affiliation
Faculty of Medicine, Diponegoro University, Semarang
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
Fakultas Kedokteran Universitas Indonesia
City
Jakarta
State/Province
Greater Jakarta
Country
Indonesia
12. IPD Sharing Statement
Learn more about this trial
Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018
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