COVID-19Phase 3NCT05433285
Immuno-bridging Study of COVID-19 Protein Subunit Recombinant Vaccine
A Phase 3 study testing COVID-19 Protein Subunit Recombinant Vaccine and Active Comparator in people with COVID-19, run by PT Bio Farma at 4 sites in Indonesia.
Trial summary
Observer-blind, randomized, active-controlled prospective intervention study Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- COVID-19 Protein Subunit Recombinant Vaccine and Active Comparator
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,050 participants
- Where
- 4 sitesIndonesia
- Study dates
- 7 Jun 2022to 31 Aug 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
Indonesia4 sites
Fakultas Kedokteran Universitas Indonesia
Jakarta, Greater Jakarta
Faculty of Medicine Universitas Hassanudin
Makassar, South Sulawesi
Faculty of Medicine Universitas Andalas
Padang, West Sumatera
Faculty of Medicine Diponegoro University
Semarang, Central Java
About this study
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)
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
- COVID-19
- Being tested
- COVID-19 Protein Subunit Recombinant Vaccine, Active Comparator
- Keywords
- COVID-19 vaccine, healthy population, naive participants
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 Protein Subunit Recombinant VaccineBiological
SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
Active ComparatorBiological
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 group | Role | What they receive |
|---|---|---|
| COVID-19 Protein Subunit Recombinant Vaccine | Experimental | 2 doses of COVID-19 Protein Subunit Recombinant Vaccine administered with 28 days interval (0.5 mL per dose) Receives: 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) Receives: Biological: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity of the candidate vaccine
Geometric Mean Titers (GMT) of neutralizing antibody
Measured: 14 days after the last dose
Seroconversion rate of the candidate vaccine
Seroconversion rate of neutralizing antibody
Measured: 14 days after the last dose
Secondary outcomes (4)
Safety of the candidate vaccine
percentage of subjects with solicited and unsolicited Adverse Events (AE)
Measured: 28 days after each dose
Serious Adverse Event (SAE) of the vaccine
percentage of subjects with at least 1 SAE
Measured: 12 months after the last dose
Persistence neutralizing antibody of vaccine candidate
GMT of neutralization antibody
Measured: 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)
Measured: 14 days, 28 days, 3 months, 6 months and 12 months after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start7 Jun 2022
- Primary completion5 Aug 2022
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fakultas Kedokteran Universitas Indonesia, Faculty of Medicine Universitas Diponegoro, Andalas University, Faculty of Medicine Universitas Hassanudin
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. Soedjatmiko SpA(K), MSi, MD, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433285
- Sponsor's protocol ID
- CoV2-IB-0322
- Status last verified
- Nov 2023
- First submitted
- 23 Jun 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05433285
- Acronym / sponsor ID
- CoV2-IB-0322
- Conditions
- COVID-19
- Keywords
- COVID-19 vaccine, healthy population, naive participants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,050 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Collaborators
- Fakultas Kedokteran Universitas Indonesia, Faculty of Medicine Universitas Diponegoro, Andalas University, Faculty of Medicine Universitas Hassanudin
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Protein Subunit Recombinant Vaccine | Experimental | Biological: COVID-19 Protein Subunit Recombinant Vaccine2 doses of COVID-19 Protein Subunit Recombinant Vaccine administered with 28 days interval (0.5 mL per dose) |
| Active Comparator | Active comparator | Biological: Active Comparator2 doses of Covovax® - recombinant spike protein Nanoparticle Vaccine, administered with 28 days interval (0.5 mL per dose) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 Protein Subunit Recombinant VaccineSARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma | Biological | COVID-19 Protein Subunit Recombinant Vaccine |
| Active ComparatorCovovax® COVID-19 vaccine is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of the SARS-CoV-2 betacoronavirus | Biological | Active Comparator |
Primary outcome
Immunogenicity of the candidate vaccine
Time frame: 14 days after the last dose
Geometric Mean Titers (GMT) of neutralizing antibody
Seroconversion rate of the candidate vaccine
Time frame: 14 days after the last dose
Seroconversion rate of neutralizing antibody
4 secondary outcomes
Safety of the candidate vaccine
Time frame: 28 days after each dose
Serious Adverse Event (SAE) of the vaccine
Time frame: 12 months after the last dose
Persistence neutralizing antibody of vaccine candidate
Time frame: 28 days, 3 months, 6 months and 12 months after the last dose
Persistence Immunoglobulin G (IgG) antibody of vaccine candidate
Time frame: 14 days, 28 days, 3 months, 6 months and 12 months after the last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 38575433Nurdin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dr. Soedjatmiko SpA(K), MSi, MD principal investigator
Fakultas Kedokteran Universitas Indonesia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing COVID-19 Protein Subunit Recombinant Vaccine and Active Comparator in people with COVID-19, run by PT Bio Farma at 4 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity of the candidate vaccine (time frame: 14 days after the last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05433285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.