COVID-19 PandemicEarly Phase 1NCT06259578

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

A Early Phase 1 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COVID-19 Pandemic, COVID-19 Vaccines, COVID-19 Virus Disease
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: 29 Jan 2024to 29 Dec 2024
Phase: Early Phase 1
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 already received 2 (two) doses of INAVAC vaccines (5 ug), mostly during the phase I/II/III clinical trial of this vaccine. The interval between the second primary injection and the booster is 12-18 months.
Subjects have been informed properly regarding the study and signed the informed consent form
Subjects will commit to comply with the instructions of the investigator and the schedule of the trial
Female subjects of childbearing potential must agree to postpone pregnancy from at least 21 days before enrollment and through 6 months after the vaccination.
Participants agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the vaccine.
Participants must be willing to provide verifiable identification, have 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) concurrently or within 7 days before 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 steroids will be permitted. Inhaled glucocorticoids are prohibited.

Show all 25Show fewer

Unstable chronic disease, inclusive of uncontrolled hypertension, congestive heart failure, chronic obstructive pulmonary disease, asthma, chronic urticaria, and diabetes requiring the use of medicine. The final decision regarding this condition will be made by the attending field clinicians or investigators.
Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
Individuals who previously received any vaccines against Covid-19, other than INAVAC.
Subjects already immunized with any other vaccines within 4 weeks prior and expect to receive other vaccines within 60 days following the booster dose
Individuals who have a previously ascertained COVID-19 in 1 month (for mild, moderate, or asymptomatic people) or 3 months (for severe COVID-19) before the first recruit of this study, or in close contact in the last 14 days with a confirmed case of Covid-19.
Positive test for SARS-CoV-2 (Antigen or PCR) at screening before the vaccination. Testing may be repeated during the screening period if exposure to a positive confirmed case of SARS-CoV-2 is suspected, at the discretion of the investigator.
History of alcohol or substance abuse
HIV patients.
Malignancy patients within 3 years before 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 a major psychiatric problem or illness
Participant cannot communicate reliably with the investigator
Participant has contraindications to intramuscular injection and blood draws, such as bleeding disorders or phobia.
The participant had major surgery within 12 weeks before vaccination which will not be fully recovered, or has major surgery planned during the time the 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 the study period.

Trial locations and contacts

1 site in 1 country.

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: Immunobridging Study: Immunogenicity and Safety of INAVAC (Vaksin Merah Putih - UNAIR SARS-CoV-2 (Vero Cell Inactivated)) Vaccine as Homologue Booster in Adult Subjects in Indonesia

The goal of this open-label clinical trial is to evaluate the safety and immunogenicity of INAVAC (Vaksin Merah Putih - UNAIR SARS-CoV-2 (Vero Cell Inactivated)) Vaccine as Homologue Booster in Adult Subjects in Indonesia. The main question it aims to answer is: "To evaluate the humoral immunogenicity profile at 28 days following vaccination with INAVAC vaccine as homolog booster administered intramuscularly in healthy adults age 18 years and above". Participants will be administered one dose of vaccination for the third dose (booster vaccination) intramuscularly.

Read the detailed description

This is an open-label trial. There will be only one group in the study. This group will receive the INAVAC vaccine as a booster. The inclusion and exclusion criteria for the subjects are listed below. All subjects will be followed for 6 months. The vaccine will be administered intramuscularly. This study will have one interim and one full analysis report. A 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-day safety data following the vaccine, and then the 3 and 6-month safety data. The immunogenicity data will be evaluated for 6 months.

Conditions: COVID-19 Pandemic, COVID-19 Vaccines, COVID-19 Virus Disease
Being tested: INAVAC (Vaksin Merah Putih - UA- SARS CoV-2 (Vero Cell Inactivated) 5 μg
Keywords: Inactivated COVID-19 Vaccine, Immunogenicity, Safety, COVID-19, Indonesia, Immunobridging study, Booster, INAVAC
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
1 dose of 0.5 ml containing inactivated SARS-CoV-2 virus (5 μg ), Tween 80, histidine, Polysorbate 80, Aluminium hydroxide gel, and sodium chloride

Study groups in NCT06259578
Study group	Role	What they receive
INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 μg	Experimental	The study product is provided in the form of liquid in vial single dose (0.5 ml). The vaccine will be given 1 dose (0.5 ml) once. 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.

Humoral Immune Reponse
1. SARS-CoV-2 Neutralization: SARS-CoV-2 neutralizing titers in serum measured by a virus neutralization assay, at 28 days following vaccination with INAVAC vaccine as homologue booster administered intramuscularly in healthy adults age 18 year and above
2. IgG RBD SARS-CoV-2 antibodies measured by CLIA: analysis of antibodies binding to the SARS-CoV-2 S-protein, at 28 days following vaccination with INAVAC vaccine as homologue booster administered intramuscularly in healthy adults age 18 year and above
Measured: 28 days following vaccination

Secondary outcomes (3)

Incidence of Adverse Events
1. Solicited - clinical (local and systemic) adverse events for 7 and 28 days, 3 and 6 month following vaccination with INAVAC vaccine as homologue booster administered intramuscularly in healthy adults age 18 year and above
2. Unsolicited adverse events for 7 and 28 days, 3 and 6 months following vaccination with INAVAC vaccine as homologue booster administered intramuscularly in healthy adults age 18 year and above
3. Serious adverse event (SAE) throughout the study
Measured: 7 days, 28 days, 3 months and 6 months following vaccination
Humoral Immune Reponse
1. SARS-CoV-2 Neutralization: SARS-CoV-2 neutralizing titers in serum measured by a virus neutralization assay, for 3 and 6 months following vaccination with INAVAC vaccine as homolog booster administered intramuscularly in healthy adults age 18 years and above
2. IgG RBD SARS-CoV-2 antibodies measured by CLIA: analysis of antibodies binding to the SARS-CoV-2 S-protein, for 3 and 6 months following vaccination with INAVAC vaccine as homolog booster administered intramuscularly in healthy adults age 18 years and above
Measured: 3 and 6 months following vaccination
Exploratory Endpoints
Whole genome sequencing (WGS) of S protein of SARS-CoV-2 virus from positive Covid-19 cases during the study
Measured: Through study completion, an average of 6 months after the study product administration

Timeline

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

29 Jan 202429 Dec 2024

First posted14 Feb 2024
Study start29 Jan 2024
Primary completion29 Aug 2024 (estimated)
Study completion29 Dec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (25)Papers the sponsor has linked to this study.
Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Early Phase 1
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: NCT06259578
Sponsor's protocol ID: UNAIR-MP-INAKTIF-BO-009
Status last verified: Feb 2024
First submitted: 5 Feb 2024
Last updated: 14 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
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
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
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
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
Palacios R, Patino EG, de Oliveira Piorelli R, Conde MTRP, Batista AP, Zeng G, Xin Q, Kallas EG, Flores J, Ockenhouse CF, Gast C. Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Oct 15;21(1):853. doi: 10.1186/s13063-020-04775-4.
PubMed 33059771
Tanriover MD, Doganay HL, Akova M, Guner HR, Azap A, Akhan S, Kose S, Erdinc FS, Akalin EH, Tabak OF, Pullukcu H, Batum O, Simsek Yavuz S, Turhan O, Yildirmak MT, Koksal I, Tasova Y, Korten V, Yilmaz G, Celen MK, Altin S, Celik I, Bayindir Y, Karaoglan I, Yilmaz A, Ozkul A, Gur H, Unal S; CoronaVac Study Group. Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey. Lancet. 2021 Jul 17;398(10296):213-222. doi: 10.1016/S0140-6736(21)01429-X. Epub 2021 Jul 8.
PubMed 34246358
Al Kaabi N, Zhang Y, Xia S, Yang Y, Al Qahtani MM, Abdulrazzaq N, Al Nusair M, Hassany M, Jawad JS, Abdalla J, Hussein SE, Al Mazrouei SK, Al Karam M, Li X, Yang X, Wang W, Lai B, Chen W, Huang S, Wang Q, Yang T, Liu Y, Ma R, Hussain ZM, Khan T, Saifuddin Fasihuddin M, You W, Xie Z, Zhao Y, Jiang Z, Zhao G, Zhang Y, Mahmoud S, ElTantawy I, Xiao P, Koshy A, Zaher WA, Wang H, Duan K, Pan A, Yang X. Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults: A Randomized Clinical Trial. JAMA. 2021 Jul 6;326(1):35-45. doi: 10.1001/jama.2021.8565.
PubMed 34037666
Kyriakidis NC, Lopez-Cortes A, Gonzalez EV, Grimaldos AB, Prado EO. SARS-CoV-2 vaccines strategies: a comprehensive review of phase 3 candidates. NPJ Vaccines. 2021 Feb 22;6(1):28. doi: 10.1038/s41541-021-00292-w.
PubMed 33619260
Mendonca SA, Lorincz R, Boucher P, Curiel DT. Adenoviral vector vaccine platforms in the SARS-CoV-2 pandemic. NPJ Vaccines. 2021 Aug 5;6(1):97. doi: 10.1038/s41541-021-00356-x.
PubMed 34354082
Yadav T, Srivastava N, Mishra G, Dhama K, Kumar S, Puri B, Saxena SK. Recombinant vaccines for COVID-19. Hum Vaccin Immunother. 2020 Dec 1;16(12):2905-2912. doi: 10.1080/21645515.2020.1820808. Epub 2020 Nov 24.
PubMed 33232211

Want to know more?

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Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunobridging Study: Immunogenicity and Safety of INAVAC (Vaksin Merah Putih - UNAIR SARS-CoV-2 (Vero Cell Inactivated)) Vaccine as Homologue Booster in Adult Subjects in Indonesia
ClinicalTrials.gov ID: NCT06259578
Acronym / sponsor ID: UNAIR-MP-INAKTIF-BO-009
Conditions: COVID-19 Pandemic, COVID-19 Vaccines, COVID-19 Virus Disease
Keywords: Inactivated COVID-19 Vaccine, Immunogenicity, Safety, COVID-19, Indonesia, Immunobridging study, Booster, INAVAC
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 400 participants (estimated)
Lead sponsor: Dr. Soetomo General HospitalOther government
Collaborators: Universitas Airlangga, Bioxis Pharmaceuticalls, Indonesia-MoH
Study start: 29 Jan 2024 (actual)
Primary completion: 29 Aug 2024 (estimated)
Study completion: 29 Dec 2024 (estimated)
First posted: 14 Feb 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 μg	Experimental	Biological: INAVAC (Vaksin Merah Putih - UA- SARS CoV-2 (Vero Cell Inactivated) 5 μgThe study product is provided in the form of liquid in vial single dose (0.5 ml). The vaccine will be given 1 dose (0.5 ml) once.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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 INAVAC vaccines (5 ug), mostly during the phase I/II/III clinical trial of this vaccine. The interval between the second primary injection and the booster is 12-18 months.
Subjects have been informed properly regarding the study and signed the informed consent form
Subjects will commit to comply with the instructions of the investigator and the schedule of the trial
Female subjects of childbearing potential must agree to postpone pregnancy from at least 21 days before enrollment and through 6 months after the vaccination.

Key exclusion criteria (25 listed)

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) concurrently or within 7 days before 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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
INAVAC (Vaksin Merah Putih - UA- SARS CoV-2 (Vero Cell Inactivated) 5 μg1 dose of 0.5 ml containing inactivated SARS-CoV-2 virus (5 μg ), Tween 80, histidine, Polysorbate 80, Aluminium hydroxide gel, and sodium chloride	Biological	INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 μg

Primary outcome

Humoral Immune Reponse
Time frame: 28 days following vaccination
1. SARS-CoV-2 Neutralization: SARS-CoV-2 neutralizing titers in serum measured by a virus neutralization assay, at 28 days following vaccination with INAVAC vaccine as homologue booster administered intramuscularly in healthy adults age 18 year and above 2. IgG RBD SARS-CoV-2 antibodies measured by CLIA: analysis of antibodies binding to the SARS-CoV-2 S-protein, at 28 days following vaccination with INAVAC vaccine as homologue booster administered intramuscularly in healthy adults age 18 year and above

3 secondary outcomes

Incidence of Adverse Events
Time frame: 7 days, 28 days, 3 months and 6 months following vaccination
Humoral Immune Reponse
Time frame: 3 and 6 months following vaccination
Exploratory Endpoints
Time frame: Through study completion, an average of 6 months after the study product administration

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
Background: PubMed 33686059Wang 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.
Background: PubMed 32619759Noh 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.
Background: PubMed 33767468Irwin 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.
Background: PubMed 33323376So 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.
Background: PubMed 33296901Biswas 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.
BackgroundCirrincione 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
Background: PubMed 33301246Polack 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.
Background: PubMed 33378609Baden 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.
Background: PubMed 33306989Voysey 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.
Background: PubMed 33059771Palacios R, Patino EG, de Oliveira Piorelli R, Conde MTRP, Batista AP, Zeng G, Xin Q, Kallas EG, Flores J, Ockenhouse CF, Gast C. Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Oct 15;21(1):853. doi: 10.1186/s13063-020-04775-4.
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New York Vaccine Tracker. Accessed 30 April 2022.Link provided by the sponsor.
Badan POM Republik Indonesia. Accessed 11 October 2021.Link provided by the sponsor.
Worldometer coronavirus cases. Accessed 30 March 2023.Link provided by the sponsor.
Our world in Data. Accessed 30 April 2022.Link provided by the sponsor.
CNN. Accessed 11 October 2021.Link provided by the sponsor.
World Health Organization. Accessed 11 October 2021.Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dr. Soetomo General Hospital

Surabaya, Indonesia

‭+6281232266377‬

dominicushusada@yahoo.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 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 14 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Humoral Immune Reponse (time frame: 28 days following 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 NCT06259578, which also lists 25 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 14 Feb 2024.