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
Brief Summary

This is an observer blind randomized controlled trial study to evaluate the humoralimmunogenicity profile - neutralizing antibody - after 28 days following vaccination withVaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) vaccine as heterologue boostercompared with CoronaVac administered intramuscularly in healthy adults age 18 year andabove.Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) vaccine is an inactivatedvaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed withaluminium hydroxy gel, tween 80, and L-histidine, and this will be the first boosterstudy 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.

Unknown status
COVID-19 Pandemic
COVID-19 Vaccines

Biological: 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.

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.

Eligibility Criteria

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.

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Indonesia
Locations

Dr. Soetomo General Hospital
Surabaya, East Java, Indonesia

Investigator: Dominicus Husada, MD
Contact: ‭+6281232266377‬
dominicushusada@yahoo.com

Contacts

Dominicus Husada, MD
+6281 232266377
dominicushusada@yahoo.com

Damayanti Tinduh, MD
+6281 703293335
damayanti.tinduh@fk.unair.ac.id

Dominicus Husada, MD, Principal Investigator
Dr. Soetomo General Hospital

Dr. Soetomo General Hospital
NCT Number
Keywords
Inactivated COVID-1 9 Vaccine
Inactivated COVID-1 9 Booster Vaccine
Immunogenicity
safety
Covid-19
Indonesia
Immunobridging Study
MeSH Terms
COVID-19