Covid19Phase 1NCT05067894
Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine
A Phase 1 study testing SARS-CoV-2 Protein Subunit Recombinant Vaccine and SARS-CoV-2 Inactivated Vaccine in people with Covid19, run by PT Bio Farma at 1 site in Indonesia.
Trial summary
The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is To evaluate the safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- SARS-CoV-2 Protein Subunit Recombinant Vaccine and SARS-CoV-2 Inactivated Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Dec 2021to 6 Aug 2022
- Phase
- Phase 1
- 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 within the following age groups: adults (18-59 years) and elderly (60 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 investigational product against Covid-19 during or 6 months prior to enrollment.
- Subjects who have 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).
- The result of rapid antigen test is positive.
- Women who are lactating, pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
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- Abnormality hematology and biochemical 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.
- 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 Investigational Product (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
Fakultas Kedokteran Universitas Indonesia
Jakarta, Greater Jakarta
About this study
Official title: A Phase I, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Populations Aged 18 Years and Above in Indonesia
The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is To evaluate the safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose.
Read the detailed description
This trial is observer blinded, comparative, randomized, phase I study. Approximately 60 subjects will be recruited (18 years and above).
The investigational product is 0.5 ml in three dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine)
- Conditions
- Covid19
- Being tested
- SARS-CoV-2 Protein Subunit Recombinant Vaccine, SARS-CoV-2 Inactivated Vaccine
- Keywords
- covid19 vaccine
- 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
intramuscular injection
SARS-CoV-2 Inactivated VaccineBiological
intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Adult - Vaccine candidate | Experimental | 50 µg dose, adult group (18-59 years) Receives: Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine |
| Adult - Control | Active comparator | SARS-CoV-2 inactivated vaccine, adult group (18-59 years) Receives: Biological: SARS-CoV-2 Inactivated Vaccine |
| Elderly - Vaccine candidate | Experimental | 50 µg dose, elderly group (> 60 years) Receives: Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine |
| Elderly - Control | Active comparator | SARS-CoV-2 inactivated vaccine, elderly group (> 60 years) Receives: Biological: SARS-CoV-2 Inactivated Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose
percentage of subjects with solicited and unsolicited Adverse Events (AE)
Measured: 7 days after each dose
Secondary outcomes (6)
safety of the SARS-CoV-2 protein subunit recombinant vaccine within 28 days after each dose
percentage of subjects with solicited and unsolicited AE
Measured: 28 days after each dose
Comparison of AE/ Serious Adverse Events (SAE) between intervention vaccine and active control
percentage of subjects with AE and SAE between vaccine and active control group
Measured: 28 days after each dose
Deviation of laboratory evaluation
Any deviation from routine laboratory evaluation that probably related to the dosing
Measured: 28 days after the first dose
Deviation of laboratory evaluation
Any deviation from routine laboratory evaluation that probably related to the dosing
Measured: 7 days after whole schedule dose
Immunogenicity profile of the SARS-CoV-2 protein subunit recombinant vaccine after second dose
seropositive rate, seroconversion rate and GMT of IgG antibody and neutralization antibody
Measured: 28 days after each dose
Comparison of immunogenicity between 2 and 3 doses
seropositive rate, seroconversion rate and GMT of IgG antibody and neutralization antibody
Measured: 28 days after second and third dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start10 Dec 2021
- Primary completion11 Apr 2022
- Study completion6 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fakultas Kedokteran Universitas Indonesia, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
- Responsible party
- Sponsor
- Investigators
- Prof. Rini Sekartini, MD, Principal investigator, Fakultas Kedokteran Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067894
- Sponsor's protocol ID
- CoV2-010221
- Status last verified
- Aug 2022
- First submitted
- 1 Oct 2021
- Last updated
- 9 Aug 2022
- 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 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Populations Aged 18 Years and Above in Indonesia
- ClinicalTrials.gov ID
- NCT05067894
- Acronym / sponsor ID
- CoV2-010221
- Conditions
- Covid19
- Keywords
- covid19 vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Collaborators
- Fakultas Kedokteran Universitas Indonesia, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 6 Aug 2022 (actual)
- First posted
- 5 Oct 2021 (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 study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is To evaluate the safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose.
Detailed description
This trial is observer blinded, comparative, randomized, phase I study. Approximately 60 subjects will be recruited (18 years and above).
The investigational product is 0.5 ml in three dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adult - Vaccine candidate | Experimental | Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine50 µg dose, adult group (18-59 years) |
| Adult - Control | Active comparator | Biological: SARS-CoV-2 Inactivated VaccineSARS-CoV-2 inactivated vaccine, adult group (18-59 years) |
| Elderly - Vaccine candidate | Experimental | Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine50 µg dose, elderly group (> 60 years) |
| Elderly - Control | Active comparator | Biological: SARS-CoV-2 Inactivated VaccineSARS-CoV-2 inactivated vaccine, elderly group (> 60 years) |
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 within the following age groups: adults (18-59 years) and elderly (60 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 (14 listed)
- Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
- History of vaccination with any investigational product against Covid-19 during or 6 months prior to enrollment.
- Subjects who have 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).
- The result of rapid antigen test is positive.
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 Vaccineintramuscular injection | Biological | Adult - Vaccine candidate, Elderly - Vaccine candidate |
| SARS-CoV-2 Inactivated Vaccineintramuscular injection | Biological | Adult - Control, Elderly - Control |
Primary outcome
Safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose
Time frame: 7 days after each dose
percentage of subjects with solicited and unsolicited Adverse Events (AE)
6 secondary outcomes
safety of the SARS-CoV-2 protein subunit recombinant vaccine within 28 days after each dose
Time frame: 28 days after each dose
Comparison of AE/ Serious Adverse Events (SAE) between intervention vaccine and active control
Time frame: 28 days after each dose
Deviation of laboratory evaluation
Time frame: 28 days after the first dose
Deviation of laboratory evaluation
Time frame: 7 days after whole schedule dose
Immunogenicity profile of the SARS-CoV-2 protein subunit recombinant vaccine after second dose
Time frame: 28 days after each dose
Comparison of immunogenicity between 2 and 3 doses
Time frame: 28 days after second and third 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 9 Aug 2022.
- 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. Rini Sekartini, MD principal investigator
Fakultas Kedokteran Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SARS-CoV-2 Protein Subunit Recombinant Vaccine and SARS-CoV-2 Inactivated Vaccine in people with Covid19, 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 3 inclusion and 14 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 9 Aug 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose (time frame: 7 days after each 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 9 Aug 2022.