> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/immuno-bridging-study-of-covid-19-protein-subunit-e639a40d-e64b-4b72-891d-b9e289fa4d37
> Record changed: 2026-10-13

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

NCT05433285

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

Phase

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

Recruitment status

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

Participants

4,050

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

Lead sponsor

PT Bio Farma

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

Start date

2022-06-07

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

Number of sites

4

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

## Title and summary

**Summary**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

**Short title**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

**Official title**

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)

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

## Status and phase

**Control arm**

Active comparator

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

**Recruitment status**

Completed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

**Phase**

Phase 3

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

## Dates

**Completion date**

2023-08-31

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

**First posted**

2022-06-27

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

**Registry last updated**

2023-11-29

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

**Primary completion date**

2022-08-05

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

**Start date**

2022-06-07

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

## Size and sites

**Actual participants**

4,050

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

**Participants**

4,050

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

**Participant count basis**

Actual

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

**Protocol amendments**

2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

**Number of sites**

4

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

## Sponsor and oversight

**Data monitoring committee**

Yes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

**Lead sponsor**

PT Bio Farma

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

## Identifiers

**Registry ID**

NCT05433285

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

**ClinicalTrials.gov ID**

NCT05433285

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Prevention

**Masking**

Double masking

**Masking description**

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

**Masked roles**

Participants, Investigators

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

## Outcomes

### Primary outcomes

1. Immunogenicity of the candidate vaccine  
Timeframe: 14 days after the last dose  
Geometric Mean Titers (GMT) of neutralizing antibody
2. Seroconversion rate of the candidate vaccine  
Timeframe: 14 days after the last dose  
Seroconversion rate of neutralizing antibody

### Secondary outcomes

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

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**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.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

## Sites

- Faculty of Medicine Diponegoro UniversitySemarang, Indonesia
- Fakultas Kedokteran Universitas IndonesiaJakarta, Indonesia
- Faculty of Medicine Universitas HassanudinMakassar, Indonesia
- Faculty of Medicine Universitas AndalasPadang, Indonesia

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

## References

- PubMed 38575433  
Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/38575433/)
Related publication

Sources for references

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05433285)

## Related records

### Drugs (2)

- [Ecallantide](https://trialight.com/data/asset/ecallantide-69df0662-e2f8-453e-a613-6a9a354e572a.md)
- [Meropenem](https://trialight.com/data/asset/meropenem-a90880e5-37b0-473b-bf12-d5f0de7894c2.md)

### Collaborators (4)

- Andalas University
- Faculty of Medicine Universitas Diponegoro
- Faculty of Medicine Universitas Hassanudin
- Fakultas Kedokteran Universitas Indonesia

### Lead sponsors (1)

- [PT Bio Farma](https://trialight.com/data/company/pt-bio-farma-42be2c17-f22a-46e5-8a73-fb239c6d39df.md)

### Conditions (1)

- [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Primary condition

### Targets (1)

- [KLKB1](https://trialight.com/data/target/klkb1-1b5f36f0-03d2-539a-a1ff-0cb816e42034.md)

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