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COVID-19Phase 2NCT05525208

Booster Study of COVID-19 Protein Subunit Recombinant Vaccine

A Phase 2 study testing SARS-CoV-2 subunit protein recombinant vaccine and Active Comparator in people with COVID-19, run by PT Bio Farma at 2 sites in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Observer-blind, randomized, active-controlled prospective intervention study of Immunogenicity \& Safety of SARS-Cov-2 Protein Subunit Recombinant Vaccine (Bio Farma) as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older. 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 protein recombinant vaccine and Active Comparator
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
696 participants
Where
2 sitesIndonesia
Study dates
1 Sep 2022to 4 Aug 2023
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 adults 18 years of age and older.
  • Subjects who have previously received complete primary series of authorized/approved inactivated (Sinovac®), mRNA (Pfizer®), or viral vector COVID-19 vaccine (AstraZeneca®) with the last dose administered a minimum of 6 months prior to inclusion but not longer than 12 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

  • 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).
  • 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 asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
Show all 12Show fewer
  • History of uncontrolled coagulopathy or 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.
  • 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.
  • Subjects plan to move from the study area before the end of study period.

Trial locations and contacts

2 sites in 1 country.

Indonesia2 sites

  • Faculty of Medicine Universitas Padjadjaran

    Bandung, West Java

  • Faculty of Medicine Universitas Udayana

    Denpasar, Bali

Other trials in Indonesia

About this study

Official title: Observer-Blind, Randomized, Controlled Study of Immunogenicity and Safety of SARS-Cov-2 Protein Subunit Recombinant Vaccine (Bio Farma) as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older

Observer-blind, randomized, active-controlled prospective intervention study of Immunogenicity \& Safety of SARS-Cov-2 Protein Subunit Recombinant Vaccine (Bio Farma) as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older.

Read the detailed description

This trial is observer-blind, randomized, prospective intervention study. In this study 900 subjects who had received complete primary doses of authorized/approved inactivated (Sinovac®), mRNA (Pfizer®), or viral vector (AstraZeneca®) COVID-19 vaccine and willing to participate in the booster study by signing the consent form, will be involved in this trial.

Subject will be divided into six groups, each 150 subjects per arm who had received a complete primary dose of inactivated (Sinovac®) vaccine, mRNA (Pfizer®) vaccine, or viral vector (AstraZeneca®) vaccine will receive one booster dose of SARS-CoV-2 subunit protein recombinant vaccine or active control.

Conditions
COVID-19
Being tested
SARS-CoV-2 subunit protein recombinant vaccine, Active Comparator
Keywords
COVID-19 vaccine, healthy population, 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 protein recombinant vaccineBiological

    SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma

  • Active ComparatorBiological

    The Pfizer-BioNTech® COVID-19 vaccine or BNT162b2, is an mRNA vaccine encoding a P2 mutant spike protein (PS 2) and formulated as an RNA-lipid nanoparticle of nucleoside-modified mRNA (modRNA).

Study groups in NCT05525208
Study groupRoleWhat they receive
Primary dose of inactivated (Sinovac®) vaccine (1)ExperimentalSubject who had received a complete primary dose of inactivated (Sinovac®) vaccine
Receives: Biological: SARS-CoV-2 subunit protein recombinant vaccine
Primary dose of mRNA (Pfizer®) vaccine (1)ExperimentalSubject who had received a complete primary dose of mRNA (Pfizer®) vaccine
Receives: Biological: SARS-CoV-2 subunit protein recombinant vaccine
Primary dose of Viral Vector (AstraZeneca®) vaccine (1)ExperimentalSubject who had received a complete primary dose of viral vector (AstraZeneca®) vaccine
Receives: Biological: SARS-CoV-2 subunit protein recombinant vaccine
Primary dose of inactivated (Sinovac®) vaccine (2)ExperimentalSubject who had received a complete primary dose of inactivated (Sinovac®) vaccine
Receives: Biological: Active Comparator
Primary dose of mRNA (Pfizer®) vaccine (2)ExperimentalSubject who had received a complete primary dose of mRNA (Pfizer®) vaccine
Receives: Biological: Active Comparator
Primary dose of Viral Vector (AstraZeneca®) vaccine (2)ExperimentalSubject who had received a complete primary dose of viral vector (AstraZeneca®) vaccine
Receives: Biological: Active Comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immunogenicity of the candidate vaccine

    Geometric Mean Titer (GMT) and GMT ratio of neutralizing antibody to the SARS-CoV-2

    Measured: 14 days after booster vaccination

Secondary outcomes (7)

  1. Seropositive rate of the candidate vaccine

    Seropositive rate of neutralizing antibody

    Measured: Baseline, 14 days and 6 months after booster vaccination

  2. Seroconversion rate of the candidate vaccine

    Seroconversion rate of neutralizing antibody

    Measured: Baseline and 14 days after booster vaccination

  3. Seropositive rate and GMT of candidate vaccine

    Seropositive rate and GMT of candidate vaccine

    Measured: Baseline, 14 days, and 6 months after booster vaccination

  4. Seroconversion rate of the candidate vaccine

    Seroconversion rate of IgG antibody (RBD)

    Measured: baseline and 14 days after booster vaccination

  5. Comparison of immunogenicity between candidate vaccine and control group

    Comparison of GMT, seroconversion rate, seropositive rate of neutralizing antibody and IgG antibody (RBD) between candidate vaccine and control group

    Measured: Baseline, 14 days, and 6 months after booster vaccination

  6. Safety of the candidate vaccine

    Percentage of subjects with solicited and unsolicited Adverse Events (AE)

    Measured: 28 days after booster vaccination

  7. Serious Adverse Event (SAE) of the vaccine

    Percentage of subjects with at least 1 SAE

    Measured: 6 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.

  1. First posted1 Sep 2022
  2. Study start1 Sep 2022
  3. Primary completion2 Jul 2023
  4. Study completion4 Aug 2023

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
696 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05525208
Sponsor's protocol ID
CoV2-Booster-0222
Status last verified
Jun 2025
First submitted
30 Aug 2022
Last updated
3 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SARS-CoV-2 subunit protein recombinant vaccine and Active Comparator in people with COVID-19, run by PT Bio Farma at 2 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 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 2 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 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?

On the ClinicalTrials.gov record for NCT05525208.

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.

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