UNAIR Inactivated COVID-19 Vaccine as Heterologue Booster (Immunobridging Study)
NCT ID: NCT05918939
Last Updated: 2023-06-26
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
EARLY_PHASE1
Total Enrollment
350 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-09-05
Study Completion Date
2023-09-05
Brief Summary
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This is an observer blind randomized controlled trial study to evaluate the humoral immunogenicity profile - neutralizing antibody - after 28 days following vaccination with Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) vaccine as heterologue booster compared with CoronaVac administered intramuscularly in healthy adults age 18 year and above.
Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) vaccine 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 will be the first booster study in human.
Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) vaccine 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 will be the first booster study in human.
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Detailed Description
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This is an observer blind randomized controlled trial. There will be 2 groups in the study. First group will receive CoronaVac vaccine, manwhile the other group will receive Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) vaccine. The inclusion and exclusion criteria for the subjects were listed below. All subjects will receive either one dose of CoronaVac or Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) vaccine and be followed for 6 months. The vaccine will be administered intramuscularly.
This study will have one interim and one full analysis reports. The main focus is immunogenicity and safety 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 vaccine, and then the 3 and 6 months safety data. The immunogenicity data will be evaluated until 6 months.
This study will have one interim and one full analysis reports. The main focus is immunogenicity and safety 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 vaccine, and then the 3 and 6 months safety data. The immunogenicity data will be evaluated until 6 months.
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. First group will receive CoronaVac vaccine, manwhile the other group will receive Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) vaccine.
Primary Study Purpose
PREVENTION
Blinding Strategy
DOUBLE
Participants
Investigators
This is an observer blind randomized controlled trial. There will be 2 groups in the trial. All subjects will have either CoronaVac or Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) vaccine as booster injection. There will be 350 subjects in the study.
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 (1 ml per vial). The vaccine will be given 1 dose (0.5 ml) once.
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 SARSCoV-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). The vial should be shaken well before injection.
CoronaVac Biofarma COVID-1 9 Vaccine 3 µg
Control vaccine is CoronaVac Bio Farma vaccine, supplied by Ministry of Health of Indonesia, in the form of one dose vial (0.5 ml) once.
Group Type
ACTIVE_COMPARATOR
CoronaVac Biofarma COVID-1 9 Vaccine 3 µg
Intervention Type
BIOLOGICAL
Control vaccine in this study is existing CoronaVacBioFarma 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 SARSCoV-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). The vial should be shaken well before injection.
Intervention Type
BIOLOGICAL
CoronaVac Biofarma COVID-1 9 Vaccine 3 µg
Control vaccine in this study is existing CoronaVacBioFarma 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 already received 2 (two) doses of CoronaVac inactivated vaccines at least 6 months prior to this study.
3. Subjects have been informed properly regarding the study and signed the informed consent form
4. Subject will commit to comply with the instructions of the investigator and the schedule of the trial
5. Female subjects of childbearing potential must agree to consistently use any methods of contraception (except the periodic abstinence) from at least 21 days prior to enrollment and through 6 months after the vaccination.
6. Participants agree not to donate bone marrow, blood, and blood products from the vaccine administration until 3 months after receiving the vaccine.
7. Participants must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study.
2. Subjects already received 2 (two) doses of CoronaVac inactivated vaccines at least 6 months prior to this study.
3. Subjects have been informed properly regarding the study and signed the informed consent form
4. Subject will commit to comply with the instructions of the investigator and the schedule of the trial
5. Female subjects of childbearing potential must agree to consistently use any methods of contraception (except the periodic abstinence) from at least 21 days prior to enrollment and through 6 months after the vaccination.
6. Participants agree not to donate bone marrow, blood, and blood products from the vaccine administration until 3 months after receiving the vaccine.
7. 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 37.5oC or more) concurrent or within 7 days prior to study vaccination. This includes respiratory or constitutional symptms 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. Inhaled glucocorticoids are prohibited.
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 booster vaccine against Covid-19.
10. 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 recruit of this study, or in a close contact in the last 14 days with confirmed case of Covid-19.
11. Positive test for SARS-CoV-2 (Antigen or PCR) at screening prior to the 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.
12. History of alcohol or substance abuse
13. HIV patients.
14. Malignancy patients within 3 years prior to study vaccination.
15. Any neurological disease or history of significant neurological disorder such as meningitis, encephalitis, Guillain-Barre Syndrome, multiple sclerosis, etc
16. 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.
17. Women who are pregnant or who plan to become pregnant during the study.
18. Participant has major psychiatric problem or illness
19. Participant cannot communicate reliably with the investigator
20. Participant has contraindication to intramuscular injection and blood draws, such as bleeding disorders or phobia.
21. 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.
22. Any condition that in the opinion of the investigators would pose a helath risk to the subject if enrolled or could interfere with the evaluation of the vaccine or interpretation of the study results
23. Study team members.
24. 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 37.5oC or more) concurrent or within 7 days prior to study vaccination. This includes respiratory or constitutional symptms 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. Inhaled glucocorticoids are prohibited.
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 booster vaccine against Covid-19.
10. 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 recruit of this study, or in a close contact in the last 14 days with confirmed case of Covid-19.
11. Positive test for SARS-CoV-2 (Antigen or PCR) at screening prior to the 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.
12. History of alcohol or substance abuse
13. HIV patients.
14. Malignancy patients within 3 years prior to study vaccination.
15. Any neurological disease or history of significant neurological disorder such as meningitis, encephalitis, Guillain-Barre Syndrome, multiple sclerosis, etc
16. 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.
17. Women who are pregnant or who plan to become pregnant during the study.
18. Participant has major psychiatric problem or illness
19. Participant cannot communicate reliably with the investigator
20. Participant has contraindication to intramuscular injection and blood draws, such as bleeding disorders or phobia.
21. 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.
22. Any condition that in the opinion of the investigators would pose a helath risk to the subject if enrolled or could interfere with the evaluation of the vaccine or interpretation of the study results
23. Study team members.
24. 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. 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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References
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Reference Type
BACKGROUND
Other Identifiers
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UNAIR-MP-INAKTIF-BO-007
Identifier Type: -
Identifier Source: org_study_id
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NCT05330871
UNKNOWN
PHASE2
New Generation mRNA Booster Vaccine Against Emerging VOCs
NCT05580159
UNKNOWN
PHASE3
Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018
NCT05228613
COMPLETED
PHASE1
Booster Study of COVID-19 Protein Subunit Recombinant Vaccine
NCT05525208
COMPLETED
PHASE2
Safety and Immunogenicity Study of Booster Vaccination With Medium-dosage or High-dosage SARS-CoV-2 Inactivated Vaccine for Prevention of COVID-19
NCT05079217
UNKNOWN
PHASE4
Study on Sequential Immunization of Omicron Inactivated COVID-19 Vaccine and Prototype Inactivated COVID-19 Vaccine in Population Aged 18 Years Old and Above
NCT05374954
UNKNOWN
PHASE3
Study on Sequential Immunization of Inactivated SARS-CoV-2 Vaccine and Recombinant SARS-CoV-2 Vaccine (Ad5 Vector)
NCT04892459
COMPLETED
PHASE4
Dendritic Cell Vaccine, AV-COVID-19, to Prevent COVID-19 Infection
NCT04690387
COMPLETED
PHASE1
Heterologous Prime-boost Immunization with an Aerosolised Adenovirus Type-5 Vector-based COVID-19 Vaccine (Ad5-nCoV) After Priming with an Inactivated SARS-CoV-2 Vaccine
NCT05043259
COMPLETED
PHASE1/PHASE2
Immunogenicity and Safety of ChulaCov19 BNA159 and ChulaCov19 BNA159.2 Vaccines as a Booster Dose in Adults
NCT05605470
COMPLETED
PHASE2
The Efficacy, Safety and Immunogenicity Study of Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19
NCT04659239
UNKNOWN
PHASE3
Immunogenicity and Safety of Comvigen (Bivalent) Vaccine
NCT05930730
UNKNOWN
PHASE2
A Study to Evaluate Dose Levels of Ad26.COV2.S Administered as a Two-dose Schedule in Healthy Adults
NCT04908722
COMPLETED
PHASE3
Safety and Immunogenicity Study of Inactivated Vaccine for Prophylaxis of SARS CoV-2 Infection (COVID-19)
NCT04352608
COMPLETED
PHASE1/PHASE2
Randomized, Single-blinded, Multicenter Trial Comparing the Immune Response to a 2nd Booster Dose of COVID-19 mRNA Vaccine (Pfizer-BioNTech) or Sanofi /GSK B.1.351 Adjuvanted Vaccine in Adults
NCT05405283
UNKNOWN
PHASE3
A Study to Evaluate the Safety and Immunogenicity of Omicron COVID-19 Vaccine (Vero Cell), Inactivated in Population 18 Years Old of Age and Above
NCT05365724
UNKNOWN
PHASE1/PHASE2
Immunogenicity and Safety Study of Monovalent Omicron XBB.1.5 Vaccine as a Booster in Adults
NCT06567457
WITHDRAWN
PHASE3
A Study to Evaluate Safety, Tolerability, and Immunogenicity of SARS-CoV-2 Variant (COVID-19) mRNA Vaccines
NCT05434585
UNKNOWN
PHASE1
The Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (SYS6006) as Heterologous Booster in Participants Aged 18 Years and Older Vaccinated With Inactivated SARS-CoV-2 Vaccine
NCT05492643
UNKNOWN
NA
A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Compared With AZD1222 in Adults Aged 18 Years and Above
NCT05198596
COMPLETED
PHASE3
A Study to Understand is the COVID-19 Vaccine BNT162b2 is Safe in Indonesia People
NCT05621239
COMPLETED