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COVID-19 PandemicPhase 3NCT06282692

INAVAC Vaccine Phase III (Immunobridging Study) in Healthy Population Aged 12 to 17 Years Old

A Phase 3 study testing INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg in people with COVID-19 Pandemic and COVID-19 Vaccines, run by Dr. Soetomo General Hospital at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. All subjects will be followed for 12 months. Read more about this study

Who is it for?
Ages 12 to 17 years, women onlyHealthy volunteers can take part
Conditions the study is for
COVID-19 Pandemic, COVID-19 Vaccines
What is being tested?
INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteIndonesia
Study dates
19 Jun 2023to 19 Jul 2024
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 12 to 17 years
  • Women only
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy adolescents, age 12 to 17 years old, males and females. Healthy status will be determined by the investigator based on medical history, clinical laboratory results, vital sign measurements, and physical examination at screening.
  • Subjects and the parents or guardians have been informed properly regarding the study and signed the informed consent and assent forms
  • Subject and the parents or guardians 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.
  • Subjects and the parents or guardians 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 37.5oC or more) concurrent or within 7 days prior to first 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.
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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

1 site in 1 country.

Dominicus Husada, MD contact

+6281 232266377

dominicushusada@yahoo.com

Damayanti Tinduh, MD contact

+6281 703293335

damayanti.tinduh@fk.unair.ac.id

Indonesia1 site, 1 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: An Open Label, Phase III Clinical Trial (Immunobridging Study) of INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated)) in Healthy Population Aged 12 to 17 Years Old

This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. All subjects will be followed for 12 months.

INAVAC 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 adolescents.

Read the detailed description

This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. All subjects will be followed for 12 months.

This study will have three 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 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 12 months after the second dose.

Being tested
INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg
Keywords
Inactivated COVID-1 9 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.

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

    Dose : 1 dose 0.5 ml containing 5 µg inactivated SARS-CoV-2 virus, Tween 80, histidine, Polysorbate 80, Aluminium hydroxide gel, and sodium chloride.

Study groups in NCT06282692
Study groupRoleWhat they receive
Experimental:ExperimentalINAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg Study product are provided in the form of liquid in vial single dose (0.5 ml). The vaccine will be given 1 dose (0.5 ml) twice.
Receives: Biological: INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg

What is being measured

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

  1. Vaccine Neutralizing Antibody Profile

    SARS-CoV-2 neutralizing titers in serum measured by a virus neutralization assay, at 28 days after two doses vaccination of INAVAC in healthy adolescents age 12 to 17 years old, compared with previous results in adults with two doses of similar vaccine (phase 3 in adults).

    Measured: 28 days after two doses vaccination of INAVAC.

Secondary outcomes (6)

  1. Incidence of Adverse Events

    1. Solicited - clinical (local and systemic) adverse events for 30 minutes, 24 hours, 7 and 28 days after the first and second vaccination, and then 3, 6, and 12 months after the second injection of INAVAC in healthy adolescents age 12 to 17 years old, compared with previous results in adults with two doses of similar vaccine (phase 3 in adults).
    2. Unsolicited adverse events for 30 minutes, 24 hours, 7 and 28 days after the first and second vaccination, and then 3, 6, and 12 months after the second injection of INAVAC in healthy adolescents age 12 to 17 years old, compared with previous results in adults with two doses of similar vaccine (phase 3 in adults).
    3. Serious adverse event (SAE) throughout the study (from the first vaccination).

    Measured: 30 minutes, 24 hours, 7 and 28 days following the first dose and 30 minutes, 24 hours, 7 and 28 days, 3, 6 and 12 months after the second doses of INAVAC

  2. Humoral Immunogenicity - The Neutralizing Antibody Titers in Serum

    Evaluate SARS-Cov-2 neutralizing titers in serum measured by virus neutralization assay at 3, 6, and 12 months, following vaccination with two doses of INAVAC in healthy adolescents age 12 to 17 years old, compared with previous results in adults with two doses of similar vaccine (phase 3 in adults).

    Measured: 3, 6, and 12 months, following vaccination with two doses of INAVAC

  3. Humoral Immunogenicity - Levels of SARS-CoV-2 Binding Antibodies by CLIA

    SARS-CoV-2 binding antibodies measured by CLIA: analysis of antibodies binding to the SARS-CoV-2 S-protein.

    Measured: 28 days, 3, 6, and 12 months after the second vaccination of INAVAC

  4. Cellular Immunogenicity Profile

    1. Th1 immune responses assessed by Flow cytometri
    2. Th2 immune responses assessed by Flow cytometri

    Measured: 28 days, 3, 6, and 12 months, following vaccination with two doses of INAVAC

  5. Persistence of Antibody Level

    Evaluate the persistence of antibody level over time for 12 months after second injection.

    Measured: 12 months after the second injection

  6. Whole Genome Sequencing (WGS) of SARS-CoV-2

    Whole genome sequencing (WGS) of S protein of SARS-CoV-2 virus from all positive Covid-19 cases

    Measured: Throughout the study, an average of 1 year

Timeline

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

  1. First posted28 Feb 2024
  2. Study start19 Jun 2023
  3. Primary completion19 May 2024 (estimated)
  4. Study completion19 Jul 2024 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06282692
Sponsor's protocol ID
UNAIR-MP-INAKTIF-R-005
Status last verified
Feb 2024
First submitted
21 Jun 2023
Last updated
28 Feb 2024
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 INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg in people with COVID-19 Pandemic and COVID-19 Vaccines, run by Dr. Soetomo General Hospital at 1 site 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 (+6281 232266377, dominicushusada@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vaccine Neutralizing Antibody Profile (time frame: 28 days after two doses vaccination of INAVAC.). 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 NCT06282692, which also lists 55 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 28 Feb 2024.

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