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UNAIR Inactivated COVID-19 Vaccine as Heterologue Booster (Immunobridging Study)

Primary Purpose

COVID-19 Pandemic, COVID-19 Vaccines

Status
Recruiting
Phase
Early Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) 5 µg
CoronaVac Biofarma COVID-1 9 Vaccine 3 µg
Sponsored by
Dr. Soetomo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 Pandemic focused on measuring Inactivated COVID-1 9 Vaccine, Inactivated COVID-1 9 Booster Vaccine, Immunogenicity, Safety, COVID-19, Indonesia, Immunobridging Study

Eligibility Criteria

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

Inclusion Criteria: 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. Subjects already received 2 (two) doses of CoronaVac inactivated vaccines at least 6 months prior to this study. Subjects have been informed properly regarding the study and signed the informed consent form Subject will commit to comply with the instructions of the investigator and the schedule of the trial 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. Participants agree not to donate bone marrow, blood, and blood products from the vaccine administration until 3 months after receiving the vaccine. Participants must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study. Exclusion Criteria: Subjects concomitantly enrolled or scheduled to be enrolled in another vaccine trial 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) Known history of allergy to any component of the vaccines History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection Any autoimmune or immunodeficiency disease/condition 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. 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. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives Individuals who previously receive any booster vaccine against Covid-19. 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. 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. History of alcohol or substance abuse HIV patients. Malignancy patients within 3 years prior to study vaccination. Any neurological disease or history of significant neurological disorder such as meningitis, encephalitis, Guillain-Barre Syndrome, multiple sclerosis, etc 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. Women who are pregnant or who plan to become pregnant during the study. Participant has major psychiatric problem or illness Participant cannot communicate reliably with the investigator Participant has contraindication to intramuscular injection and blood draws, such as bleeding disorders or phobia. 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. 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 Study team members. Subject planning to move from the study area before the end of study period.

Sites / Locations

  • Dr. Soetomo General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) 5 µg

CoronaVac Biofarma COVID-1 9 Vaccine 3 µg

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The Humoral Immunogenicity Profile
The level of 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

Secondary Outcome Measures

Full Information

First Posted
June 21, 2023
Last Updated
June 21, 2023
Sponsor
Dr. Soetomo General Hospital
Collaborators
Indonesia-MoH, Universitas Airlangga, Biotis Pharmaceuticals, Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT05918939
Brief Title
UNAIR Inactivated COVID-19 Vaccine as Heterologue Booster (Immunobridging Study)
Official Title
Immunobridging Study: Immunogenicity and Safety of Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) Vaccine as Heterologue Booster in Adult Subjects in Indonesia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
August 5, 2023 (Anticipated)
Study Completion Date
September 5, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Soetomo General Hospital
Collaborators
Indonesia-MoH, Universitas Airlangga, Biotis Pharmaceuticals, Indonesia

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
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Pandemic, COVID-19 Vaccines
Keywords
Inactivated COVID-1 9 Vaccine, Inactivated COVID-1 9 Booster Vaccine, Immunogenicity, Safety, COVID-19, Indonesia, Immunobridging Study

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) 5 µg
Arm Type
Experimental
Arm Description
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.
Arm Title
CoronaVac Biofarma COVID-1 9 Vaccine 3 µg
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) 5 µg
Intervention Description
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
Intervention Name(s)
CoronaVac Biofarma COVID-1 9 Vaccine 3 µg
Intervention Description
Control vaccine in this study is existing CoronaVacBioFarma inactivated COVID-19 vaccine which has been used widely in Indonesia.
Primary Outcome Measure Information:
Title
The Humoral Immunogenicity Profile
Description
The level of 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
Time Frame
28 days after the booster vaccination
Other Pre-specified Outcome Measures:
Title
Safety and reactogenicity
Description
Evaluate number of adverse events occur among participants
Time Frame
Within 7 and 28 days, 3 and 6 months following vaccination
Title
The Humoral Immune Response - Neutralizing Antibody
Description
The level of neutralizing antibody after 3 and 6 months following vacciation 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.
Time Frame
3 and 6 months following the booster vaccination
Title
The Humoral Immune Response - Non Neutralizing Antibody
Description
The level of non neutralizing titers in serum following vaccination with Vaksin Merah Putih - UA SARSCoV-2 (Vero Cell Inactivated) vaccine as heterologue booster compared with CoronaVac administered intramuscularly in healthy adults age 18 year and above
Time Frame
at 28 days, 3 and 6 months following vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Subjects already received 2 (two) doses of CoronaVac inactivated vaccines at least 6 months prior to this study. Subjects have been informed properly regarding the study and signed the informed consent form Subject will commit to comply with the instructions of the investigator and the schedule of the trial 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. Participants agree not to donate bone marrow, blood, and blood products from the vaccine administration until 3 months after receiving the vaccine. Participants must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study. Exclusion Criteria: Subjects concomitantly enrolled or scheduled to be enrolled in another vaccine trial 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) Known history of allergy to any component of the vaccines History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection Any autoimmune or immunodeficiency disease/condition 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. 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. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives Individuals who previously receive any booster vaccine against Covid-19. 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. 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. History of alcohol or substance abuse HIV patients. Malignancy patients within 3 years prior to study vaccination. Any neurological disease or history of significant neurological disorder such as meningitis, encephalitis, Guillain-Barre Syndrome, multiple sclerosis, etc 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. Women who are pregnant or who plan to become pregnant during the study. Participant has major psychiatric problem or illness Participant cannot communicate reliably with the investigator Participant has contraindication to intramuscular injection and blood draws, such as bleeding disorders or phobia. 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. 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 Study team members. Subject planning 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
Dominicus Husada, MD
Phone
+6281 232266377
Email
dominicushusada@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Damayanti Tinduh, MD
Phone
+6281 703293335
Email
damayanti.tinduh@fk.unair.ac.id
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominicus Husada, MD
Organizational Affiliation
Dr. Soetomo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Soetomo General Hospital
City
Surabaya
State/Province
East Java
ZIP/Postal Code
67161
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominicus Husada, MD
Phone
‭+6281232266377‬
Email
dominicushusada@yahoo.com
First Name & Middle Initial & Last Name & Degree
Damayanti Tinduh, MD
Phone
‭+6281703293335‬
Email
damayanti.tinduh@fk.unair.ac.id
First Name & Middle Initial & Last Name & Degree
Dominicus Husada, MD
First Name & Middle Initial & Last Name & Degree
Damayanti Tinduh, MD
First Name & Middle Initial & Last Name & Degree
Gatot Soegiarto, MD
First Name & Middle Initial & Last Name & Degree
Leny Kartina, MD
First Name & Middle Initial & Last Name & Degree
Aryati Aryati, MD
First Name & Middle Initial & Last Name & Degree
Jusak Nugraha, MD
First Name & Middle Initial & Last Name & Degree
Munawaroh Fitriah, MD
First Name & Middle Initial & Last Name & Degree
Maria I Lusida, MD
First Name & Middle Initial & Last Name & Degree
Eko B Khoendori, MD
First Name & Middle Initial & Last Name & Degree
Neneng D Kurniati, MD
First Name & Middle Initial & Last Name & Degree
Fierly Hayati, MD
First Name & Middle Initial & Last Name & Degree
Budi Utomo, MD
First Name & Middle Initial & Last Name & Degree
Novira Widajanti, MD
First Name & Middle Initial & Last Name & Degree
Yudi H Oktaviono, MD
First Name & Middle Initial & Last Name & Degree
Deasy Fetarayani, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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UNAIR Inactivated COVID-19 Vaccine as Heterologue Booster (Immunobridging Study)

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