COVID-19Phase 2/3NCT05313035
Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine
A Phase 2/3 study testing SARS-CoV-2 protein subunit recombinant vaccine in people with COVID-19, run by PT Bio Farma at 3 sites in Indonesia.
Trial summary
This trial is observer-blind, comparative, randomized, placebo-controlled phase 2 study. The population is healthy subjects aged 18 and above 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 protein subunit recombinant vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 3 sitesIndonesia
- Study dates
- 13 Apr 2022to 28 Feb 2023
- Phase
- Phase 2/3
- 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, history of 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 received in the previous 4 weeks a treatment likely to alter the immuneresponse (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
3 sites in 1 country.
Indonesia3 sites
Faculty of Medicine Universitas Hassanudin
Makassar, South Sulawesi
Faculty of Medicine, Universitas Andalas, Padang
Padang, West Sumatera
Faculty of Medicine, Diponegoro University, Semarang
Semarang, Central Java
About this study
Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted With Alum+CpG 1018 in Healthy Populations Aged 18 Years and Above in Indonesia
This trial is observer-blind, comparative, randomized, placebo-controlled phase 2 study. The population is healthy subjects aged 18 and above
Read the detailed description
The phase 2 is dose-ranging study which will recruit 360 subjects to compare two vaccine formulas to placebo (1:1:1), to evaluate the safety and immunogenicity of the vaccine. The subjects will be given 2 doses of investigational product with 28 days interval between doses.
One selected vaccine formula will be evaluated for safety and persistence antibody until 6 months after the last dose.
- Conditions
- COVID-19
- Being tested
- SARS-CoV-2 protein subunit recombinant vaccine, placebo
- Keywords
- COVID-19 vaccine, healthy population
- 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 protein subunit recombinant vaccineBiological
candidate vaccine manufactured by PT. Bio Farma
placeboBiological
the placebo is NaCl injection manufactured by PT. Bio Farma
| Study group | Role | What they receive |
|---|---|---|
| Vaccine Candidate Formula 1 | Experimental | 2 doses of vaccine candidate formula 1 administered with 28 days interval (0.5 mL per dose) Receives: Biological: SARS-CoV-2 protein subunit recombinant vaccine |
| Vaccine Candidate Formula 2 | Experimental | 2 doses of vaccine candidate formula 2 administered with 28 days interval (0.5 mL per dose) Receives: Biological: SARS-CoV-2 protein subunit recombinant vaccine |
| Control | Placebo comparator | 2 doses of placebo administered with 28 days interval (0.5 mL per dose) Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity of the candidate vaccine
seroconversion rate of antibody (IgG and neutralization 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: 6 months after the last dose
Persistence antibody of vaccine candidate
GMT of antibody (IgG and neutralization antibody)
Measured: 14 days, 28 days, 3 months, 6 months after the last dose
Persistence antibody of vaccine candidate
seropositive rate of antibody (IgG and neutralization antibody)
Measured: 14 days, 28 days, 3 months, 6 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 posted6 Apr 2022
- Study start13 Apr 2022
- Primary completion22 Jul 2022
- Study completion28 Feb 2023
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universitas Indonesia, Faculty of Medicine, Diponegoro University, Semarang, Andalas University, Faculty of Medicine, Universitas Hassanudin, Makassar
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. Soedjatmiko SpA(K), MSi, MD, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313035
- Sponsor's protocol ID
- CoV2-020322
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2022
- Last updated
- 13 Apr 2023
- 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 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine (Bio Farma) Adjuvanted With Alum+CpG 1018 in Healthy Populations Aged 18 Years and Above in Indonesia
- ClinicalTrials.gov ID
- NCT05313035
- Acronym / sponsor ID
- CoV2-020322
- Conditions
- COVID-19
- Keywords
- COVID-19 vaccine, healthy population
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Collaborators
- Universitas Indonesia, Faculty of Medicine, Diponegoro University, Semarang, Andalas University, Faculty of Medicine, Universitas Hassanudin, Makassar
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 6 Apr 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.
This trial is observer-blind, comparative, randomized, placebo-controlled phase 2 study. The population is healthy subjects aged 18 and above
Detailed description
The phase 2 is dose-ranging study which will recruit 360 subjects to compare two vaccine formulas to placebo (1:1:1), to evaluate the safety and immunogenicity of the vaccine. The subjects will be given 2 doses of investigational product with 28 days interval between doses.
One selected vaccine formula will be evaluated for safety and persistence antibody until 6 months after the last dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaccine Candidate Formula 1 | Experimental | Biological: SARS-CoV-2 protein subunit recombinant vaccine2 doses of vaccine candidate formula 1 administered with 28 days interval (0.5 mL per dose) |
| Vaccine Candidate Formula 2 | Experimental | Biological: SARS-CoV-2 protein subunit recombinant vaccine2 doses of vaccine candidate formula 2 administered with 28 days interval (0.5 mL per dose) |
| Control | Placebo comparator | Biological: placebo2 doses of placebo 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 |
|---|---|---|
| SARS-CoV-2 protein subunit recombinant vaccinecandidate vaccine manufactured by PT. Bio Farma | Biological | Vaccine Candidate Formula 1, Vaccine Candidate Formula 2 |
| placebothe placebo is NaCl injection manufactured by PT. Bio Farma | Biological | Control |
Primary outcome
Immunogenicity of the candidate vaccine
Time frame: 14 days after the last dose
seroconversion rate of antibody (IgG and neutralization 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: 6 months after the last dose
Persistence antibody of vaccine candidate
Time frame: 14 days, 28 days, 3 months, 6 months after the last dose
Persistence antibody of vaccine candidate
Time frame: 14 days, 28 days, 3 months, 6 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 13 Apr 2023.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SARS-CoV-2 protein subunit recombinant vaccine in people with COVID-19, run by PT Bio Farma at 3 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 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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). 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 13 Apr 2023.