COVID-19Phase 2NCT05727215
Heterologous Booster Study of COVID-19 Protein Subunit Recombinant Vaccine in Children 12-17 Years of Age
A Phase 2 study testing SARS-CoV-2 subunit protein recombinant vaccine in people with COVID-19, run by PT Bio Farma at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to evaluate immune response and safety of SARS-CoV-2 subunit protein recombinant vaccine (IndoVac) as a heterologous booster dose in healthy children 12-17 years of age. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- SARS-CoV-2 subunit protein recombinant 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
- 28 Feb 2023to 18 Mar 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Clinically healthy children 12-17 years of age.
- Subjects who have previously received complete primary series of inactivated (Sinovac®) COVID-19 vaccine with the last dose administered a minimum of 6 months prior to inclusion but not longer than 12 months prior to inclusion.
- Parent/legal guardian and subject has been informed properly regarding the study, and signed the informed consent form (parent/legal guardian) and assent form (subject).
- Parent and/or legal guardian will commit to comply with the instructions of the investigator and the schedule of the trial.
Who cannot join
- Subject concomitantly enrolled or scheduled to be enrolled in another trial.
- Subject who has received booster dose of COVID-19 vaccine.
- Subject who has history of COVID-19 in the last 3 months (based on anamnesis or other examinations).
- Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
- History of uncontrolled asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
- History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
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- 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.
- Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (> 2 weeks)).
- Subjects who have 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.
- Female who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
- 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 Universitas Padjadjaran
Bandung, West Java, 40161
About this study
Official title: Immunogenicity and Safety of IndoVac® as a Heterologous Booster Dose Against COVID-19 in Children 12-17 Years of Age
The goal of this clinical trial is to evaluate immune response and safety of SARS-CoV-2 subunit protein recombinant vaccine (IndoVac) as a heterologous booster dose in healthy children 12-17 years of age.
Participants who had received complete primary doses of inactivated (Sinovac®) COVID-19 Vaccine will be given IndoVac as a booster dose.
Read the detailed description
This trial is open label prospective intervention study. In this study 150 subjects who had received complete primary doses of inactivated (Sinovac®) COVID-19 Vaccine and willing to participate in the booster study by signing the consent form, will be involved in this trial.
Subject will receive one booster dose of SARS-CoV-2 subunit protein recombinant vaccine (IndoVac).
- Conditions
- COVID-19
- Being tested
- SARS-CoV-2 subunit protein recombinant vaccine
- Keywords
- COVID-19 vaccine, healthy population, Booster, Heterologous, Children
- 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 protein recombinant vaccineBiological
SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma
| Study group | Role | What they receive |
|---|---|---|
| Primary dose of inactivated (Sinovac®) vaccine | Experimental | Subject who had received a complete primary dose of inactivated (Sinovac®) vaccine Receives: Biological: SARS-CoV-2 subunit protein recombinant vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity of the candidate vaccine
Geometric Mean Titer (GMT) and GMFR of neutralizing antibody to the SARS-CoV-2
Measured: 14 days after booster vaccination
Secondary outcomes (6)
Seropositive rate of the candidate vaccine
Seropositive rate of neutralizing antibody
Measured: baseline, 14 days, 3 months, 6 months, and 12 months after booster vaccination
Seroconversion rate of the candidate vaccine
Seroconversion rate of neutralizing antibody
Measured: baseline and 14 days after booster vaccination
Seropositive rate and GMT of candidate vaccine
Seropositive rate and GMT of IgG antibody (RBD)
Measured: baseline, 14 days, 3 months, 6 months, and 12 months after booster vaccination
Seroconversion rate of candidate vaccine
Seroconversion rate of IgG antibody (RBD)
Measured: baseline and 14 days after booster vaccination
Safety of the candidate vaccine
Percentage of subjects with solicited and unsolicited Adverse Events (AE)
Measured: 30 minutes, 7 days, 28 days, and until 12 months after booster vaccination
Serious Adverse Event (SAE) of the vaccine
Percentage of subjects with at least 1 SAE
Measured: until 12 months after booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start28 Feb 2023
- Primary completion22 Feb 2024
- Study completion18 Mar 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)
- Collaborators
- Universitas Padjadjaran
- Responsible party
- Sponsor
- Investigators
- Eddy Fadlyana, MD, Principal investigator, Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727215
- Sponsor's protocol ID
- CoV2-Booster-Children-0222
- Status last verified
- Jun 2025
- First submitted
- 13 Feb 2023
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of IndoVac® as a Heterologous Booster Dose Against COVID-19 in Children 12-17 Years of Age
- ClinicalTrials.gov ID
- NCT05727215
- Acronym / sponsor ID
- CoV2-Booster-Children-0222
- Conditions
- COVID-19
- Keywords
- COVID-19 vaccine, healthy population, Booster, Heterologous, Children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Collaborators
- Universitas Padjadjaran
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 14 Feb 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.
The goal of this clinical trial is to evaluate immune response and safety of SARS-CoV-2 subunit protein recombinant vaccine (IndoVac) as a heterologous booster dose in healthy children 12-17 years of age.
Participants who had received complete primary doses of inactivated (Sinovac®) COVID-19 Vaccine will be given IndoVac as a booster dose.
Detailed description
This trial is open label prospective intervention study. In this study 150 subjects who had received complete primary doses of inactivated (Sinovac®) COVID-19 Vaccine and willing to participate in the booster study by signing the consent form, will be involved in this trial.
Subject will receive one booster dose of SARS-CoV-2 subunit protein recombinant vaccine (IndoVac).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary dose of inactivated (Sinovac®) vaccine | Experimental | Biological: SARS-CoV-2 subunit protein recombinant vaccineSubject who had received a complete primary dose of inactivated (Sinovac®) vaccine |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Clinically healthy children 12-17 years of age.
- Subjects who have previously received complete primary series of inactivated (Sinovac®) COVID-19 vaccine with the last dose administered a minimum of 6 months prior to inclusion but not longer than 12 months prior to inclusion.
- Parent/legal guardian and subject has been informed properly regarding the study, and signed the informed consent form (parent/legal guardian) and assent form (subject).
- Parent and/or legal guardian will commit to comply with the instructions of the investigator and the schedule of the trial.
Key exclusion criteria (12 listed)
- Subject concomitantly enrolled or scheduled to be enrolled in another trial.
- Subject who has received booster dose of COVID-19 vaccine.
- Subject who has history of COVID-19 in the last 3 months (based on anamnesis or other examinations).
- Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
- History of uncontrolled asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
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 protein recombinant vaccineSARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma | Biological | Primary dose of inactivated (Sinovac®) vaccine |
Primary outcome
Immunogenicity of the candidate vaccine
Time frame: 14 days after booster vaccination
Geometric Mean Titer (GMT) and GMFR of neutralizing antibody to the SARS-CoV-2
6 secondary outcomes
Seropositive rate of the candidate vaccine
Time frame: baseline, 14 days, 3 months, 6 months, and 12 months after booster vaccination
Seroconversion rate of the candidate vaccine
Time frame: baseline and 14 days after booster vaccination
Seropositive rate and GMT of candidate vaccine
Time frame: baseline, 14 days, 3 months, 6 months, and 12 months after booster vaccination
Seroconversion rate of candidate vaccine
Time frame: baseline and 14 days after booster vaccination
Safety of the candidate vaccine
Time frame: 30 minutes, 7 days, 28 days, and until 12 months after booster vaccination
Serious Adverse Event (SAE) of the vaccine
Time frame: until 12 months after booster vaccination
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 3 Jun 2025.
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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.
Eddy Fadlyana, MD principal investigator
Universitas Padjadjaran
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 protein recombinant 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 3 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?
Immunogenicity of the candidate vaccine (time frame: 14 days after booster vaccination). 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 3 Jun 2025.