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

Phase 3

Completed

• Conditions: COVID-19
• Interventions: Biological: COVID-19 Protein Subunit Recombinant Vaccine; Biological: Active Comparator

• Registration Number: NCT05433285
• Lead Sponsor: PT Bio Farma

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2022-06-07
• Study First Submitted: 2022-06-23
• Study First Submitted QC: 2022-06-23
• Study First Posted: 2022-06-27
• Primary Completion: 2022-08-05
• Study Completion: 2023-08-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4050

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COVID-19 Protein Subunit Recombinant Vaccine	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)
Active Comparator	Active Comparator	2 doses of Covovax® - recombinant spike protein Nanoparticle Vaccine, administered with 28 days interval (0.5 mL per dose)

Primary Outcome Measures

Name	Time	Method
Immunogenicity of the candidate vaccine	14 days after the last dose	Geometric Mean Titers (GMT) of neutralizing antibody
Seroconversion rate of the candidate vaccine	14 days after the last dose	Seroconversion rate of neutralizing antibody

Secondary Outcome Measures

Name	Time	Method
Safety of the candidate vaccine	28 days after each dose	percentage of subjects with solicited and unsolicited Adverse Events (AE)
Serious Adverse Event (SAE) of the vaccine	12 months after the last dose	percentage of subjects with at least 1 SAE
Persistence neutralizing antibody of vaccine candidate	28 days, 3 months, 6 months and 12 months after the last dose	GMT of neutralization antibody
Persistence Immunoglobulin G (IgG) antibody of vaccine candidate	14 days, 28 days, 3 months, 6 months and 12 months after the last dose	GMT of IgG antibody (RBD)

Trial Locations

Locations (4)

Faculty of Medicine Diponegoro University; 🇮🇩 Semarang, Central Java, Indonesia

Fakultas Kedokteran Universitas Indonesia; 🇮🇩 Jakarta, Greater Jakarta, Indonesia

Faculty of Medicine Universitas Hassanudin; 🇮🇩 Makassar, South Sulawesi, Indonesia

Faculty of Medicine Universitas Andalas; 🇮🇩 Padang, West Sumatera, Indonesia