Official Title
A Multicenter, Randomized, Double Blind, Controlled, Phase III Clinical Trial (Immunobridging Study) of Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) in Healthy Population Aged 18 Years and Above
Brief Summary

This study is a multicenter, randomized, double blind, controlled, phase III clinicaltrial (Immunobridging Study) to evaluate the immunogenicity and safety of Vaksin MerahPutih - UA SARS-CoV-2 (Vero Cell Inactivated) in healthy populations aged 18 years andabove. Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) 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 study will be the first phaseIII in human.

Detailed Description

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

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
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.

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

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 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.

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

Dr. Soebandi General Hospital
Jember, East Java, Indonesia

Jember Paru Hospital
Jember, East Java, Indonesia

Dr. Saiful Anwar General Hospital
Malang, East Java, Indonesia

Airlangga University Hospital
Surabaya, East Java, Indonesia

Dr. Soetomo General Hospital
Surabaya, East Java, Indonesia

Contacts

Dominicus Husada, MD
‭+6281232266377‬
dominicushusada@yahoo.com

Damayanti Tinduh, MD
+6281703293335‬
damayanti.tinduh@fk.unair.ac.id

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

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