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COVID-19 PandemicPhase 3NCT05508477

UNAIR Inactivated COVID-19 Vaccine Phase III (Immunobridging Study)

A Phase 3 study testing Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) 5 µg and CoronaVac Biofarma COVID-19 Vaccine in people with COVID-19 Pandemic and COVID-19 Vaccines, run by Dr. Soetomo General Hospital at 5 sites in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19 Pandemic, COVID-19 Vaccines
What is being tested?
Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) 5 µg and CoronaVac Biofarma COVID-19 Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,005 participants
Where
5 sitesIndonesia
Study dates
28 Jun 2022to 28 May 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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 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
  • 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.
  • Participants must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study.

Who cannot join

  • 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 37.5 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)
  • 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.
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  • 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 vaccines against Covid-19.
  • Subjects already immunized with any vaccine within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose.
  • 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.
  • 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.
  • Alcohol or substance abuse
  • HIV patients.
  • Malignancy patients within 2 years prior to first 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 health 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.

Trial locations and contacts

5 sites in 1 country.

Dominicus Husada, MD contact

‭+6281232266377‬

dominicushusada@yahoo.com

Damayanti Tinduh, MD contact

+6281703293335‬

damayanti.tinduh@fk.unair.ac.id

5 sites in 1 country

Indonesia5 sites, 5 recruiting

  • Dr. Soebandi General Hospital

    Jember, East Java, 68111

    Retna D Puspita, MD, +62813-3118-0432

    Recruiting

  • Jember Paru Hospital

    Jember, East Java, 68118

    Sigit K Jati, MD, +6281233843628

    Recruiting

  • Dr. Saiful Anwar General Hospital

    Malang, East Java, 65112

    Cesarius S Wahono, MD, +6281344110967

    Recruiting

  • Airlangga University Hospital

    Surabaya, East Java, 60115

    Brian E Rahman, MD, +628123005886

    Recruiting

  • Dr. Soetomo General Hospital

    Surabaya, East Java, 67161

    Dominicus Husada, MD, ‭+6281232266377‬, dominicushusada@yahoo.com

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

    Recruiting

Other trials in Indonesia

About this study

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

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.

Read the 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

Being tested
Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) 5 µg, CoronaVac Biofarma COVID-19 Vaccine
Keywords
Inactivated COVID-19 Vaccine, Immunogenicity, Safety, COVID-19, Indonesia, Immunobridging study
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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 VaccineBiological

    Control vaccine in this study is existing CoronaVac-BioFarma inactivated COVID-19 vaccine which has been used widely in Indonesia

Study groups in NCT05508477
Study groupRoleWhat they receive
Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) 5 µgExperimentalStudy 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.
Receives: Biological: Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) 5 µg
CoronaVac Biofarma COVID-19 VaccineActive comparatorControl 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.
Receives: Biological: CoronaVac Biofarma COVID-19 Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Humoral Immunogenicity Profile

    The level of SARS-CoV-2 neutralizing and non neutralizing antibody among participants

    Measured: 28 days after the second vaccination

Secondary outcomes (3)

  1. The Safety Profile

    Evaluate number of adverse events occur among participants

    Measured: Within 30 minutes, 24 hours, 7 and 28 days following each dose and 3 and 6 months after the second doses of vaccination

  2. The Humoral Immunogenicity Profile

    The level of SARS-CoV-2 neutralizing and non neutralizing antibody among participants

    Measured: 3 and 6 months following the second vaccination

  3. The Cellular Immunogenicity Profile

    Evaluate Th1 and Th2 immune responses including CD4+/CD8+. IL-2, IL-4, TNF alpha, IFN gamma, and other markers after stimulation of PBMC with SARS-CoV-2 protein peptides and Interferon gamma release assay (IGRA) to assess the production of IFN-γ from stimulated CD4+ and CD8+ with antigen peptides specific to SARS-CoV-2 among participants

    Measured: 3 and 6 months after the second vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2022
  2. Study start28 Jun 2022
  3. Primary completion28 Mar 2023 (estimated)
  4. Study completion28 May 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
4,005 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05508477
Sponsor's protocol ID
UNAIR-MP-INAKTIF-III-01
Status last verified
Jun 2022
First submitted
18 Aug 2022
Last updated
29 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang C, Wang Z, Wang G, Lau JY, Zhang K, Li W. COVID-19 in early 2021: current status and looking forward. Signal Transduct Target Ther. 2021 Mar 8;6(1):114. doi: 10.1038/s41392-021-00527-1.

    PubMed 33686059

  • Noh JY, Song JY, Yoon JG, Seong H, Cheong HJ, Kim WJ. Safe hospital preparedness in the era of COVID-19: The Swiss cheese model. Int J Infect Dis. 2020 Sep;98:294-296. doi: 10.1016/j.ijid.2020.06.094. Epub 2020 Jun 30.

    PubMed 32619759

  • New York Vaccine Tracker. Downloaded from https://www.nytimes.com/interactive/2020/science/coronavirus-vaccinetracker.html. Accessed 11 April 2022

  • Badan POM Republik Indonesia. Dowloaded from https://www.pom.go.id/new/view/more/pers/605/Pastikan-Keamanan-danMutu-Vaksin---Badan-POM-Kawal-Uji-Klinik-Vaksin-Merah-Putih.html. Accessed 11 October 2021.

  • Irwin A. What it will take to vaccinate the world against COVID-19. Nature. 2021 Apr;592(7853):176-178. doi: 10.1038/d41586-021-00727-3. No abstract available.

    PubMed 33767468

  • So AD, Woo J. Reserving coronavirus disease 2019 vaccines for global access: cross sectional analysis. BMJ. 2020 Dec 15;371:m4750. doi: 10.1136/bmj.m4750.

    PubMed 33323376

  • Worldometer coronavirus cases. Downloaded from https://www.worldometers.info/coronavirus/. Accessed 11 October 2021

  • Biswas M, Rahaman S, Biswas TK, Haque Z, Ibrahim B. Association of Sex, Age, and Comorbidities with Mortality in COVID-19 Patients: A Systematic Review and Meta-Analysis. Intervirology. 2020 Dec 9:1-12. doi: 10.1159/000512592. Online ahead of print.

    PubMed 33296901

  • Satuan Tugas Penanganan Covid-19. Downloaded from https://covid19.go.id/petasebaran. Accessed 11 October 2021

  • Cirrincione L, Plescia F, Ledda C, Rapisarda V, Martorana D, Moldovan RE, Theodoridou K, Cannizzaro E. COVID-19 Pandemic: Prevention and Protection Measures to Be Adopted at the Workplace. Sustainability 2020; 12: 3603

  • Bloomberg. Downloaded from https://www.bloomberg.com/graphics/covidresilience-ranking/. Accessed 11 October 2021

  • Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Perez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Tureci O, Nell H, Schaefer A, Unal S, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10.

    PubMed 33301246

  • Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Mascola J, Polakowski L, Ledgerwood J, Graham BS, Bennett H, Pajon R, Knightly C, Leav B, Deng W, Zhou H, Han S, Ivarsson M, Miller J, Zaks T; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384(5):403-416. doi: 10.1056/NEJMoa2035389. Epub 2020 Dec 30.

    PubMed 33378609

  • Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O'Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Torok ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8.

    PubMed 33306989

  • Our world in Data. Downloaded from https://ourworldindata.org/covidvaccinations. Accessed 11 April 2022.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vaksin Merah Putih - UA SARS-CoV-2 (Vero Cell Inactivated) 5 µg and CoronaVac Biofarma COVID-19 Vaccine in people with COVID-19 Pandemic and COVID-19 Vaccines, run by Dr. Soetomo General Hospital at 5 sites in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dominicus Husada, MD (‭+6281232266377‬, dominicushusada@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Humoral Immunogenicity Profile (time frame: 28 days after the second vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05508477, which also lists 48 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.

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