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Immuno-bridging Study of COVID-19 Protein Subunit Recombinant Vaccine

NCT ID: NCT05433285

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4050 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-07

Study Completion Date

2023-08-31

Brief Summary

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Observer-blind, randomized, active-controlled prospective intervention study

Detailed Description

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This trial is randomized, prospective intervention study. A total of 4,050 subjects (COVID-19 vaccine naive) who are willing to participate in the study by signing the consent form, will be involved in this trial. The subjects will be divided into three study subsets, namely Main Study I, Main Study II, and Exploratory Study: Main Study I for immunogenicity and safety evaluation, Main Study II for safety evaluation, and Exploratory Study for cellular immunity evaluation, with trial design as follow :

* Main Study I, Exploratory Study subset: Observer-blind, randomized, active-controlled prospective intervention study
* Main Study II: Open-label, randomized study to evaluate safety I

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Vaccine candidate and active comparator are masking, lot number is masking

Study Groups

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COVID-19 Protein Subunit Recombinant Vaccine

2 doses of COVID-19 Protein Subunit Recombinant Vaccine administered with 28 days interval (0.5 mL per dose)

Group Type EXPERIMENTAL

COVID-19 Protein Subunit Recombinant Vaccine

Intervention Type BIOLOGICAL

SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma

Active Comparator

2 doses of Covovax® - recombinant spike protein Nanoparticle Vaccine, administered with 28 days interval (0.5 mL per dose)

Group Type ACTIVE_COMPARATOR

Active Comparator

Intervention Type BIOLOGICAL

Covovax® COVID-19 vaccine is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of the SARS-CoV-2 betacoronavirus

Interventions

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COVID-19 Protein Subunit Recombinant Vaccine

SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma

Intervention Type BIOLOGICAL

Active Comparator

Covovax® COVID-19 vaccine is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of the SARS-CoV-2 betacoronavirus

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Clinically healthy subjects aged 18 years and above.
2. Subjects have been informed properly regarding the study and signed the informed consent form.
3. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria

1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
2. History of vaccination with any COVID-19 vaccine.
3. History of COVID-19 within 1 month (for mild-moderate disease) or 3 months (for severe disease) prior to enrollment.
4. Evolving mild, moderate, or severe illness, especially infectious disease, or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
5. Women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
6. History of uncontrolled asthma, allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
7. History of blood disorders contraindicating intramuscular injection.
8. Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc.) which according to the investigator might interfere with the assessment of the trial objectives.
9. History of confirmed or suspected immunosuppressive or immunodeficient state or in the previous 4 weeks received a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or long-term corticosteroid therapy (\> 2 weeks)).
10. History of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.
11. Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.
12. Subjects plan to move from the study area before the end of study period.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fakultas Kedokteran Universitas Indonesia

OTHER

Sponsor Role collaborator

Faculty of Medicine Universitas Diponegoro

UNKNOWN

Sponsor Role collaborator

Faculty of Medicine Universitas Andalas

UNKNOWN

Sponsor Role collaborator

Faculty of Medicine Universitas Hassanudin

UNKNOWN

Sponsor Role collaborator

PT Bio Farma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof. Dr. Soedjatmiko SpA(K), MSi, MD

Role: PRINCIPAL_INVESTIGATOR

Fakultas Kedokteran Universitas Indonesia

Locations

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Faculty of Medicine Diponegoro University

Semarang, Central Java, Indonesia

Site Status

Fakultas Kedokteran Universitas Indonesia

Jakarta, Greater Jakarta, Indonesia

Site Status

Faculty of Medicine Universitas Hassanudin

Makassar, South Sulawesi, Indonesia

Site Status

Faculty of Medicine Universitas Andalas

Padang, West Sumatera, Indonesia

Site Status

Countries

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Indonesia

References

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Nurdin A, Movieta Nency Y, Maddeppungeng M, Sekartini R, Mulia Sari R, Surachman F, Fitry Yani F, Raveinal, Anggrainy F, Hafiz A, Linosefa, Machmud R, Awaliyah Deza P, Rujiana V, Bella Rahimi M, Farhanah N, Gundi Pramudo S, Hapsari R, Tri Anantyo D, Mulyono, Mahati E, Maharani N, Darma S, Husni Esa Darussalam A, Shakinah S, Nasrum Massi M, Soedjatmiko. Immunogenicity and safety of SARS-CoV-2 recombinant protein subunit vaccine (IndoVac) adjuvanted with alum and CpG 1018 in Indonesian adults: A phase 3, randomized, active-controlled, multicenter trial. Vaccine. 2024 Apr 30;42(12):3009-3017. doi: 10.1016/j.vaccine.2024.03.077. Epub 2024 Apr 4.

Reference Type DERIVED
PMID: 38575433 (View on PubMed)

Other Identifiers

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CoV2-IB-0322

Identifier Type: -

Identifier Source: org_study_id