CompletedNCT05433285Updated Nov 29, 2023

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

A Phase 3 interventional study of COVID-19 Protein Subunit Recombinant Vaccine and Active Comparator in COVID-19, sponsored by PT Bio Farma. Completed at 4 sites in Indonesia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by PT Bio Farma · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 4,050
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

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

Read the 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

Conditions studied

COVID-19

Browse trials for

COVID-19 7,774

Keywords

COVID-19 vaccine
healthy population
naive participants

In context

COVID-19

7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 4,050 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

PT Bio Farma is the lead sponsor of 46 studies on the registry; 6 are open to participants now.

Browse PT Bio Farma studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
History of vaccination with any COVID-19 vaccine.
History of COVID-19 within 1 month (for mild-moderate disease) or 3 months (for severe disease) prior to enrollment.
Evolving mild, moderate, or severe illness, especially infectious disease, or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
Women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
History of uncontrolled asthma, allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
History of blood disorders contraindicating intramuscular injection.
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.
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)).
History of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.
Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.
Subjects plan to move from the study area before the end of study period.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 4,050 participants (actual)

Study arms

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

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

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Study locations

4 sites

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

References and documents

Publications

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. PubMed 38575433 ↗

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2022 to primary completion in Aug 2022, 1 month.

Of 157 industry-sponsored phase 3 interventional studies under COVID-19, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 15. This study's 1 month is below that.

Counting every sponsor, half of 436 studies reached it within 9 months; a quarter within 5 and three quarters within 17.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 23, 2022
First posted: Jun 27, 2022
StartActual: Jun 7, 2022
Primary completionActual: Aug 5, 2022
CompletionActual: Aug 31, 2023
Last update: Nov 29, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Nov 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05433285
Lead sponsor: PT Bio Farma
Collaborators: Fakultas Kedokteran Universitas Indonesia, Faculty of Medicine Universitas Diponegoro, Andalas University, Faculty of Medicine Universitas Hassanudin
Responsible party: Sponsor
First posted: Jun 27, 2022
Start date: Jun 7, 2022
Primary completion: Aug 5, 2022
Completion: Aug 31, 2023
Last update: Nov 29, 2023

Study contacts

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

principal investigator · Fakultas Kedokteran Universitas Indonesia

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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