COVID-19 PandemicEarly Phase 1NCT06272253

UNAIR Inactivated COVID-19 Vaccine INAVAC as Heterologue Booster (Immunobridging Study) in Adolescent Subjects

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is an open label trial. There will only be 1 group in the study. All subjects will receive INAVAC vaccine and be followed for 6 months. The vaccine will be administered intramuscularly. This study will be started after the interim analysis of the phase III INAVAC trial in adolescent. Read more about this study

Who is it for?: Ages 12 to 17 yearsHealthy 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: 250 participants
Where: 1 siteIndonesia
Study dates: 19 Sep 2023to 19 Jul 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 12 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy males and females, adolescents age 12-17 years old. 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 Coronavac (Sinovac) vaccines at least 3 months prior to this study.
Subjects and the parents or guardian have been informed properly regarding the study and signed the informed consent form
Subject and the parents or guardian 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 vaccine.
Participants and the parents or guardian 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 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. Inhaled glucocorticoids are prohibited.

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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
Subjects already immunized with any other vaccines 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 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.
History of alcohol or substance abuse
HIV patients.
Malignancy patients within 3 years prior to 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 vaccination.
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.

Indonesia1 site

Dr. Soetomo General Hospital
Surabaya, East Java, 67161

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)) as Heterologue Booster in Adolescent Subjects in Indonesia

This is an open label trial. There will only be 1 group in the study. All subjects will receive INAVAC vaccine and be followed for 6 months.

The vaccine will be administered intramuscularly. This study will be started after the interim analysis of the phase III INAVAC trial in adolescent. This study will have two interim and one full analysis reports.

Read the detailed description

This is an open label trial. There will only be 1 group in the study. All subjects will receive INAVAC vaccine and be followed for 6 months.

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 vaccine, and then the 3 and 6 months safety data. The immunogenicity data will be evaluated until 6 months.

Conditions: COVID-19 Pandemic, COVID-19 Vaccines
Being tested: INAVAC (Vaksin Merah Putih - UA- SARS CoV-2 (Vero Cell Inactivated) 5 μg
Keywords: Inactivated COVID-1 9 Vaccine, Immunobridging Study, Immunogenicity, Safety, COVID-19, Indonesia
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 NCT06272253
Study group	Role	What they receive
INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 μg	Experimental	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) 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 Response (Neutralizing antibody)
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 heterologue booster in healthy adolescents age 12-17 years old.
Measured: 28 days after the booster vaccination

Secondary outcomes (3)

Incidence of Adverse Events
1. Solicited - clinical (local and systemic) adverse events for 7 and 28 days, 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster administered intramuscularly in healthy adolescents age 12-17 years old.
2. Unsolicited adverse events for 7 and 28 days, 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster administered intramuscularly in healthy adolescents age 12-17 years old.
3. Serious adverse events (SAE) throughout the study.
Measured: 7 and 28 days, 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster.
Humoral Immune Response - The neutralizing antibody
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 heterologue booster administered intramuscularly in healthy Adolescent subjects.
Measured: 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster
Humoral Immune Response-IgG SARS-CoV-2 neutralizing titer by CLIA
IgG RBD SARS-CoV-2 (CLIA): analysis of IgG RBD SARS-CoV-2 antibodies for 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster administered intramuscularly in healthy Adolescent subjects.
Measured: 28 days, 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster

Timeline

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

19 Sep 202319 Jul 2024

First posted22 Feb 2024
Study start19 Sep 2023
Primary completion19 Mar 2024 (estimated)
Study completion19 Jul 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)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: 250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06272253
Sponsor's protocol ID: UNAIR-MP-INAKTIF-R-010
Status last verified: Feb 2024
First submitted: 18 Feb 2024
Last updated: 22 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
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
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
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?

The sponsor has not listed a contact. The official record may have more details.

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 22 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)) as Heterologue Booster in Adolescent Subjects in Indonesia
ClinicalTrials.gov ID: NCT06272253
Acronym / sponsor ID: UNAIR-MP-INAKTIF-R-010
Conditions: COVID-19 Pandemic, COVID-19 Vaccines
Keywords: Inactivated COVID-1 9 Vaccine, Immunobridging Study, Immunogenicity, Safety, COVID-19, Indonesia
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 250 participants (actual)
Lead sponsor: Dr. Soetomo General HospitalOther government
Collaborators: Indonesia-MoH, Universitas Airlangga, PT Biotis Pharmaceuticals, Indonesia
Study start: 19 Sep 2023 (actual)
Primary completion: 19 Mar 2024 (estimated)
Study completion: 19 Jul 2024 (estimated)
First posted: 22 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.

This is an open label trial. There will only be 1 group in the study. All subjects will receive INAVAC vaccine and be followed for 6 months.

Detailed description

This is an open label trial. There will only be 1 group in the study. All subjects will receive INAVAC vaccine and be followed for 6 months.

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 μgStudy 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) once.

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

Healthy males and females, adolescents age 12-17 years old. 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 Coronavac (Sinovac) vaccines at least 3 months prior to this study.
Subjects and the parents or guardian have been informed properly regarding the study and signed the informed consent form
Subject and the parents or guardian 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 vaccine.

Key exclusion criteria (24 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) 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)
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 μgDose : 1 dose 0.5 ml containing 5 μg inactivated SARS-CoV-2 virus, 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 Response (Neutralizing antibody)
Time frame: 28 days after the booster vaccination
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 heterologue booster in healthy adolescents age 12-17 years old.

3 secondary outcomes

Incidence of Adverse Events
Time frame: 7 and 28 days, 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster.
Humoral Immune Response - The neutralizing antibody
Time frame: 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster
Humoral Immune Response-IgG SARS-CoV-2 neutralizing titer by CLIA
Time frame: 28 days, 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
Results publication: 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.
Results publication: 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.
Results publicationBadan 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.
Results publication: 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.
Results publication: 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.
Results publication: 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.
Results publication: 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.
Results publication: 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.
Results publication: 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.
Results publication: 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.
Results publication: PubMed 34246358Tanriover 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.
Results publication: PubMed 34037666Al 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.
New York Vaccine Tracker. Downloaded from https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine- tracker.html. Accessed 30 April 2022.Link provided by the sponsor.
Badan POM Republik Indonesia. Dowloaded from https://www.pom.go.id/siaran-pers/pastikan-keamanan-dan-mutu-vaksin-badan-pom-kawal-uji-klinik-vaksin-merah-putih. Accessed 11 October 2021.Link provided by the sponsor.
Worldometer coronavirus cases. Downloaded from https://www.worldometers.info/coronavirus/. Accessed 30 April 2022.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.

The record lists no contact. Use the official record to reach the sponsor.

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 6 inclusion and 24 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 22 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Humoral Immune Response (Neutralizing antibody) (time frame: 28 days after the booster 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 NCT06272253, which also lists 24 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 22 Feb 2024.