UNAIR Inactivated COVID-19 Vaccine Phase III (Immunobridging Study)
NCT ID: NCT05508477
Last Updated: 2022-08-29
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE3
Total Enrollment
4005 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-06-28
Study Completion Date
2023-05-28
Brief Summary
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This study is a multicenter, randomized, double blind, controlled, phase III clinical trial (Immunobridging Study) to evaluate the immunogenicity and safety of Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) in healthy populations aged 18 years and above. Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) is an inactivated vaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed with aluminium hydroxy gel, tween 80, and L-histidine, and this study will be the first phase III in human.
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Detailed Description
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This is a double blind randomized controlled trial - immunobridging study. There will be 2 groups in the study. One adult group (18 year-old and above) with 5 µg dose, and 1 control group using CoronaVac Bio Farma. Both vaccines will be administered with 2-dose schedule, intramuscularly. All cohorts will be followed for 6 months.
This study will have two interim and one full analysis The main focus is immunogenicity and safety or reactogenicity issues. Data Safety Monitoring Board will be commissioned for this study to evaluate safety data over the study period and to review any events that meet a specific study pausing rule or any other safety issue that may arise. They will review the blinded 7 and 28 days safety data following the first dose of vaccine, and then the 7 and 28 days after the second dose. The immunogenicity data will be evaluated until 6 months after the second dose
This study will have two interim and one full analysis The main focus is immunogenicity and safety or reactogenicity issues. Data Safety Monitoring Board will be commissioned for this study to evaluate safety data over the study period and to review any events that meet a specific study pausing rule or any other safety issue that may arise. They will review the blinded 7 and 28 days safety data following the first dose of vaccine, and then the 7 and 28 days after the second dose. The immunogenicity data will be evaluated until 6 months after the second dose
Conditions
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COVID-19 Pandemic
COVID-19 Vaccines
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
There will be 2 groups in the study. One adult group (18 year-old and above) with 5 µg dose, and 1 control group using CoronaVac Bio Farma. The UNAIR vaccine group will consist of 3 sub group based on different lot. Both vaccines will be administered with 2-dose schedule, intramuscularly. All cohorts will be followed for 6 months.
Primary Study Purpose
PREVENTION
Blinding Strategy
DOUBLE
Participants
Investigators
In this clinical trial, the experimental vaccine and the control vaccine will have different packages. In order to maintain the blinding process, the unblinded team will be appointed to place the vaccine in the syringe. The other team members will later inject the vaccines according to the random group that has been selected. The injection team do not know what kind of vaccine is in the syringe.
Study Groups
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Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) 5 µg
Study product are provided in the form of liquid in vial single dose (0.5 ml). The vaccine will be given twice with 28 days interval.
Group Type
EXPERIMENTAL
Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) 5 µg
Intervention Type
BIOLOGICAL
Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) contains purified S protein of SARS-CoV-2 - Dose: 5 µg, aluminium hydroxide gel, 10 mM L-Histidine buffer, 0.005%, Tween Polysorbate 80, and 0.9% Sodium chloride. Vaccine will be prepared in vial (1 ml per vial). One vial will be used for one injection only. The vial should be shaken well before injection.
CoronaVac Biofarma COVID-19 Vaccine
Control vaccine is CoronaVac Bio Farma vaccine, supplied by Ministry of Health of Indonesia, in the form of two doses vial. The vaccine will be given twice with 28 days interval.
Group Type
ACTIVE_COMPARATOR
CoronaVac Biofarma COVID-19 Vaccine
Intervention Type
BIOLOGICAL
Control vaccine in this study is existing CoronaVac-BioFarma inactivated COVID-19 vaccine which has been used widely in Indonesia
Interventions
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Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) 5 µg
Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) contains purified S protein of SARS-CoV-2 - Dose: 5 µg, aluminium hydroxide gel, 10 mM L-Histidine buffer, 0.005%, Tween Polysorbate 80, and 0.9% Sodium chloride. Vaccine will be prepared in vial (1 ml per vial). One vial will be used for one injection only. The vial should be shaken well before injection.
Intervention Type
BIOLOGICAL
CoronaVac Biofarma COVID-19 Vaccine
Control vaccine in this study is existing CoronaVac-BioFarma inactivated COVID-19 vaccine which has been used widely in Indonesia
Intervention Type
BIOLOGICAL
Eligibility Criteria
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Inclusion Criteria
1. Healthy adults and elderly, males and females, 18 years of age and above. Healthy status will be determined by the investigator based on medical history, clinical laboratory results, vital sign measurements, and physical examination at screening.
2. Subjects have been informed properly regarding the study and signed the informed consent form.
3. Subject will commit to comply with the instructions of the investigator and the schedule of the trial
4. Participants agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine.
5. Participants must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study.
2. Subjects have been informed properly regarding the study and signed the informed consent form.
3. Subject will commit to comply with the instructions of the investigator and the schedule of the trial
4. Participants agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine.
5. Participants must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study.
Exclusion Criteria
1. Subjects concomitantly enrolled or scheduled to be enrolled in another vaccine trial.
2. Evolving mild, moderate, and severe illness, especially infectious diseases or fever (axillary temperature 37.5 degree Celcius or more) concurrent or within 7 days prior to first study vaccination. This includes respiratory or constitutional symptoms consistent with SARS-CoV-2 (cough, sore throat, difficulty in breathing, etc)
3. Known history of allergy to any component of the vaccines.
4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
5. Any autoimmune or immunodeficiency disease/condition
6. Subjects who have received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived products, long term corticosteroid - more than 2 weeks, and so on), OR anticipation of the need for immunosuppressive treatment within 6 months after last vaccination. The use of topical or nasal steroid will be permitted.
7. Unstable chronic disease, inclusive of uncontrolled hypertension, congestive heart failure, chronic obstructive pulmonary disease, asthma, chronic urticaria, diabetes requiring use of medicine. The final decision regarding this condition will be decided by the attending field clinicians or investigator.
8. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
9. Individuals who previously receive any vaccines against Covid-19.
10. Subjects already immunized with any vaccine within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose.
11. Individuals who have a previously ascertained Covid-19 in the period of 1 month (for mild, moderate, or asymptomatic people) or 3 months (for severe Covid-19) before the first recruit of this study, or in a close contact in the last 14 days with confirmed case of Covid-19.
12. Positive test for SARS-CoV-2 (Antigen test or, if necessary, PCR test) at screening prior to first vaccination. Testing may be repeated during the screening period if exposure to positive confirmed case of SARS-CoV-2 is suspected, at the discretion of investigator.
13. Alcohol or substance abuse
14. HIV patients.
15. Malignancy patients within 2 years prior to first study vaccination.
16. Any neurological disease or history of significant neurological disorder such as meningitis, encephalitis, Guillain-Barre Syndrome, multiple sclerosis, etc
17. Vital sign abnormalities and clinical laboratory abnormalities as decided by the investigators. Vital sign measurements and clinical laboratory testing may be repeated before the final decision.
18. Women who are pregnant or who plan to become pregnant during the study.
19. Participant has major psychiatric problem or illness
20. Participant cannot communicate reliably with the investigator
21. Participant has contraindication to intramuscular injection and blood draws, such as bleeding disorders or phobia.
22. Participant had major surgery within 12 weeks before vaccination which will not be fully recovered, or has major surgery planned during the time participant is expected to participate in the study or within 6 months after the last dose of study vaccine administration.
23. Any condition that in the opinion of the investigators would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine or interpretation of the study results
24. Study team members.
25. Subject planning to move from the study area before the end of study period.
2. Evolving mild, moderate, and severe illness, especially infectious diseases or fever (axillary temperature 37.5 degree Celcius or more) concurrent or within 7 days prior to first study vaccination. This includes respiratory or constitutional symptoms consistent with SARS-CoV-2 (cough, sore throat, difficulty in breathing, etc)
3. Known history of allergy to any component of the vaccines.
4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
5. Any autoimmune or immunodeficiency disease/condition
6. Subjects who have received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived products, long term corticosteroid - more than 2 weeks, and so on), OR anticipation of the need for immunosuppressive treatment within 6 months after last vaccination. The use of topical or nasal steroid will be permitted.
7. Unstable chronic disease, inclusive of uncontrolled hypertension, congestive heart failure, chronic obstructive pulmonary disease, asthma, chronic urticaria, diabetes requiring use of medicine. The final decision regarding this condition will be decided by the attending field clinicians or investigator.
8. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
9. Individuals who previously receive any vaccines against Covid-19.
10. Subjects already immunized with any vaccine within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose.
11. Individuals who have a previously ascertained Covid-19 in the period of 1 month (for mild, moderate, or asymptomatic people) or 3 months (for severe Covid-19) before the first recruit of this study, or in a close contact in the last 14 days with confirmed case of Covid-19.
12. Positive test for SARS-CoV-2 (Antigen test or, if necessary, PCR test) at screening prior to first vaccination. Testing may be repeated during the screening period if exposure to positive confirmed case of SARS-CoV-2 is suspected, at the discretion of investigator.
13. Alcohol or substance abuse
14. HIV patients.
15. Malignancy patients within 2 years prior to first study vaccination.
16. Any neurological disease or history of significant neurological disorder such as meningitis, encephalitis, Guillain-Barre Syndrome, multiple sclerosis, etc
17. Vital sign abnormalities and clinical laboratory abnormalities as decided by the investigators. Vital sign measurements and clinical laboratory testing may be repeated before the final decision.
18. Women who are pregnant or who plan to become pregnant during the study.
19. Participant has major psychiatric problem or illness
20. Participant cannot communicate reliably with the investigator
21. Participant has contraindication to intramuscular injection and blood draws, such as bleeding disorders or phobia.
22. Participant had major surgery within 12 weeks before vaccination which will not be fully recovered, or has major surgery planned during the time participant is expected to participate in the study or within 6 months after the last dose of study vaccine administration.
23. Any condition that in the opinion of the investigators would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine or interpretation of the study results
24. Study team members.
25. Subject planning to move from the study area before the end of study period.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Indonesia-MoH
OTHER_GOV
Sponsor Role
collaborator
Universitas Airlangga
OTHER
Sponsor Role
collaborator
Bioxis Pharmaceuticalls
INDUSTRY
Sponsor Role
collaborator
Dr. Soetomo General Hospital
OTHER_GOV
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Dominicus Husada, MD
Role: PRINCIPAL_INVESTIGATOR
Dr. Soetomo General Hospital
Locations
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Dr. Soebandi General Hospital
Jember, East Java, Indonesia
Site Status
RECRUITING
Jember Paru Hospital
Jember, East Java, Indonesia
Site Status
RECRUITING
Dr. Saiful Anwar General Hospital
Malang, East Java, Indonesia
Site Status
RECRUITING
Airlangga University Hospital
Surabaya, East Java, Indonesia
Site Status
RECRUITING
Dr. Soetomo General Hospital
Surabaya, East Java, Indonesia
Site Status
RECRUITING
Countries
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Indonesia
Central Contacts
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Facility Contacts
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Retna D Puspita, MD
Role: primary
+62813-3118-0432
Sigit K Jati, MD
Role: primary
+6281233843628
Cesarius S Wahono, MD
Role: primary
+6281344110967
Brian E Rahman, MD
Role: primary
+628123005886
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UNAIR-MP-INAKTIF-III-01
Identifier Type: -
Identifier Source: org_study_id
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