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

Immunogenicity & Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted With Alum+CpG 1018 Compared to Registered Covid-19 Vaccine (Covovax - Protein Subunit Vaccine) in Healthy Populations Aged 18 Years and Above in Indonesia (Phase III)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05433285

Enrollment

4050

Registered

2022-06-27

Start date

2022-06-07

Completion date

2023-08-31

Last updated

2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

COVID-19 vaccine, healthy population, naive participants

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

Interventions

BIOLOGICALCOVID-19 Protein Subunit Recombinant Vaccine

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

BIOLOGICALActive 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Masking description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Serious Adverse Event (SAE) of the vaccine	12 months after the last dose	percentage of subjects with at least 1 SAE
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)
Persistence neutralizing antibody of vaccine candidate	28 days, 3 months, 6 months and 12 months after the last dose	GMT of neutralization antibody
Safety of the candidate vaccine	28 days after each dose	percentage of subjects with solicited and unsolicited Adverse Events (AE)

Other

Measure	Time frame	Description
Cellular immunity of candidate vaccine	14 days, 6 months and 12 months after two-dose primary series.	Positive rate of specific T-cell response

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026