COVID-19Phase 2NCT05933278
Homologous Booster Study of COVID-19 Protein Subunit Recombinant Vaccine
A Phase 2 study testing SARS-CoV-2 Subunit Recombinant Protein Vaccine in people with COVID-19, run by PT Bio Farma at 1 site in Indonesia.
Trial summary
Open-label, prospective intervention study of IndoVac® as a single, homologous booster dose 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?
- SARS-CoV-2 Subunit Recombinant Protein Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIndonesia
- Study dates
- 25 Jul 2023to 5 Sep 2024
- Phase
- Phase 2
- 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 had previously received complete primary doses of IndoVac® with the last dose administered minimum 12 months but no longer than 18 months prior to inclusion.
- 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.
- Subjects had received booster dose of COVID-19 vaccine.
- History of COVID-19 within 3 months prior to enrollment (based on anamnesis or other examinations).
- Evolving mild, moderate, or severe illness, especially infectious disease, or fever (body temperature ≥37.5°C, 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 uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension or diabetes, liver or 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 had 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 had received any vaccination (other than COVID-19 vaccine) within 1 month before IP immunization.
- Subjects plan to move from the study area before the end of study period.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Medicine Diponegoro University
Semarang, Central Java
About this study
Official title: Immunogenicity & Safety of IndoVac® as a Homologous Booster Dose Against COVID-19 in Adults Aged 18 Years and Above in Indonesia
Open-label, prospective intervention study of IndoVac® as a single, homologous booster dose
Read the detailed description
This trial is open-label, prospective intervention study. A total of 150 subjects who had previously received complete primary doses of IndoVac® in phase III and are willing to participate in the study by signing the consent form, will be involved in this trial. The regimen of the vaccine 0.5 ml injected as a single booster dose.
Evaluation will be conducted for safety and immunogenicity for all subjects. Safety evaluation include AEs until 28 days post booster dose, with AESIs and SAEs throughout the trial. Immunogenicity evaluation will compare pre-booster antibody titer (baseline) to post- booster antibody titer at 14 days, 28 days, 3 months, 6 months, and 12 months timepoint. Interim evaluation will be performed at 14 days post booster dose for Emergency Use Authorization (EUA) consideration. All subjects will be followed up until 12 months post booster dose.
- Conditions
- COVID-19
- Being tested
- SARS-CoV-2 Subunit Recombinant Protein Vaccine
- Keywords
- COVID-19 vaccine, Booster
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 Subunit Recombinant Protein VaccineBiological
SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT Bio Farma
| Study group | Role | What they receive |
|---|---|---|
| Participants who previously completed primary doses of vaccine | Experimental | Participants who previously completed primary doses of vaccine Receives: Biological: SARS-CoV-2 Subunit Recombinant Protein Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutralizing antibody before and at 14 days after booster dose
Geometric Mean Titer (GMT) and Geometric Mean Fold Ratio (GMFR) of SARS-CoV-2 neutralizing antibody against Omicron variant
Measured: Baseline, 14 days after booster dose
Secondary outcomes (4)
Neutralizing antibody at 28 days after booster dose
Geometric Mean Titer (GMT) and Geometric Mean Fold Ratio (GMFR) of SARS-CoV-2 neutralizing antibody against Omicron variant
Measured: Baseline, 14 days, 28 days after booster dose
RBD-binding IgG antibody before, at 14 days and 28 days after booster dose
Geometric Mean Titer (GMT) and Geometric Mean Fold Ratio (GMFR) of SARS-CoV-2 RBD-binding IgG antibody
Measured: Baseline, 14 days, 28 days after booster dose
Antibody persistence at 3, 6, and 12 months after booster dose
Geometric Mean Titer (GMT) and Geometric Mean Fold Ratio (GMFR) of SARS-CoV-2 RBD-binding IgG antibody
Measured: Baseline, 3 months, 6 months, 12 months after booster dose
Safety after booster dose
Number and percentage of subjects with solicited and unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs)
Measured: Baseline to 12 months after booster dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start25 Jul 2023
- Primary completion31 Aug 2024
- Study completion5 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yetty Movieta Nency, MD, Principal investigator, Faculty of Medicine Universitas Diponegoro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933278
- Sponsor's protocol ID
- CoV2-Booster 0323
- Status last verified
- Jun 2025
- First submitted
- 5 Jul 2023
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity & Safety of IndoVac® as a Homologous Booster Dose Against COVID-19 in Adults Aged 18 Years and Above in Indonesia
- ClinicalTrials.gov ID
- NCT05933278
- Acronym / sponsor ID
- CoV2-Booster 0323
- Conditions
- COVID-19
- Keywords
- COVID-19 vaccine, Booster
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 6 Jul 2023 (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.
Open-label, prospective intervention study of IndoVac® as a single, homologous booster dose
Detailed description
This trial is open-label, prospective intervention study. A total of 150 subjects who had previously received complete primary doses of IndoVac® in phase III and are willing to participate in the study by signing the consent form, will be involved in this trial. The regimen of the vaccine 0.5 ml injected as a single booster dose.
Evaluation will be conducted for safety and immunogenicity for all subjects. Safety evaluation include AEs until 28 days post booster dose, with AESIs and SAEs throughout the trial. Immunogenicity evaluation will compare pre-booster antibody titer (baseline) to post- booster antibody titer at 14 days, 28 days, 3 months, 6 months, and 12 months timepoint. Interim evaluation will be performed at 14 days post booster dose for Emergency Use Authorization (EUA) consideration. All subjects will be followed up until 12 months post booster dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants who previously completed primary doses of vaccine | Experimental | Biological: SARS-CoV-2 Subunit Recombinant Protein VaccineParticipants who previously completed primary doses of vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinically healthy subjects aged 18 years and above.
- Subjects had previously received complete primary doses of IndoVac® with the last dose administered minimum 12 months but no longer than 18 months prior to inclusion.
- 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.
- Subjects had received booster dose of COVID-19 vaccine.
- History of COVID-19 within 3 months prior to enrollment (based on anamnesis or other examinations).
- Evolving mild, moderate, or severe illness, especially infectious disease, or fever (body temperature ≥37.5°C, 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 |
|---|---|---|
| SARS-CoV-2 Subunit Recombinant Protein VaccineSARS-CoV-2 RBD subunit recombinant protein, manufactured by PT Bio Farma | Biological | Participants who previously completed primary doses of vaccine |
Primary outcome
Neutralizing antibody before and at 14 days after booster dose
Time frame: Baseline, 14 days after booster dose
Geometric Mean Titer (GMT) and Geometric Mean Fold Ratio (GMFR) of SARS-CoV-2 neutralizing antibody against Omicron variant
4 secondary outcomes
Neutralizing antibody at 28 days after booster dose
Time frame: Baseline, 14 days, 28 days after booster dose
RBD-binding IgG antibody before, at 14 days and 28 days after booster dose
Time frame: Baseline, 14 days, 28 days after booster dose
Antibody persistence at 3, 6, and 12 months after booster dose
Time frame: Baseline, 3 months, 6 months, 12 months after booster dose
Safety after booster dose
Time frame: Baseline to 12 months after booster 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 5 Jun 2025.
- 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.
Yetty Movieta Nency, MD principal investigator
Faculty of Medicine Universitas Diponegoro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SARS-CoV-2 Subunit Recombinant Protein Vaccine in people with COVID-19, run by PT Bio Farma at 1 site 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 4 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 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Neutralizing antibody before and at 14 days after booster dose (time frame: Baseline, 14 days after booster dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2025.