COVID-19Phase 1NCT05228613
Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018
A Phase 1 study testing SARS-CoV-2 protein subunit recombinant vaccine and SARS-CoV-2 inactivated vaccine in people with COVID-19, run by PT Bio Farma at 2 sites 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 and immunogenicity of the SARS-CoV-2 protein subunit recombinant vaccine adjuvanted with Alum+CpG1018 Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- SARS-CoV-2 protein subunit recombinant vaccine and SARS-CoV-2 inactivated vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 2 sitesIndonesia
- Study dates
- 16 Feb 2022to 24 Jan 2023
- 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 to 70 years
- 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 investigational product against COVID-19 (based on anamnesis)
- Subjects who have history of COVID-19 (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 RT-PCR test for SARS-CoV-2 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 (for main study subset).
- 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 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
Fakultas Kedokteran Universitas Indonesia
Jakarta, Greater Jakarta
Faculty of Medicine, Diponegoro University, Semarang
Semarang, Central Java
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 (Adjuvanted With Alum+CpG 1018) 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 and immunogenicity of the SARS-CoV-2 protein subunit recombinant vaccine adjuvanted with Alum+CpG1018
Read the detailed description
This trial is observer blinded, comparative, randomized, phase I study. Approximately 175 subjects will be recruited (18 years and above).
The investigational product is 0.5 ml in two dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine). There will be 4 formula of investigational product used with different concentration of Receptor Binding Domain (RBD) antigen and adjuvant CpG 1018.
- Conditions
- COVID-19
- Being tested
- SARS-CoV-2 protein subunit recombinant vaccine, SARS-CoV-2 inactivated vaccine
- 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
SARS-CoV-2 inactivated vaccineBiological
active control manufactured by Sinovac Life Sciences Co.Ltd
| Study group | Role | What they receive |
|---|---|---|
| Vaccine Candidate Formula A | Experimental | 2 doses of vaccine candidate formula A administered with 28 days interval (0.5 mL per dose) Receives: Biological: SARS-CoV-2 protein subunit recombinant vaccine |
| Vaccine Candidate Formula B | Experimental | 2 doses of vaccine candidate formula B administered with 28 days interval (0.5 mL per dose) Receives: Biological: SARS-CoV-2 protein subunit recombinant vaccine |
| Vaccine Candidate Formula C | Experimental | 2 doses of vaccine candidate formula C administered with 28 days interval (0.5 mL per dose) Receives: Biological: SARS-CoV-2 protein subunit recombinant vaccine |
| Vaccine Candidate Formula D | Experimental | 2 doses of vaccine candidate formula D administered with 28 days interval (0.5 mL per dose) Receives: Biological: SARS-CoV-2 protein subunit recombinant vaccine |
| Active Control | Active comparator | 2 doses of active control administered with 28 days interval (0.5 mL per dose) 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 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 (9)
safety of the vaccine within 28 days after each dose
percentage of subjects with solicited and unsolicited 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
Comparison of safety between vaccine and active control
percentage of subjects with AE and SAE between vaccine and active control group
Measured: 28 days after each dose and 6 months after the last dose
Deviation of laboratory evaluation
Any deviation from routine laboratory evaluation that probably related to the dosing
Measured: 7 days after the first dose and 14 days after the last dose
Inflammatory factor evaluation
The change of interleukin-6 (IL-6) in serum
Measured: 7 days after the first dose and 14 days after the last dose
Immunogenicity profile after the last dose
GMT of IgG antibody and neutralization antibody
Measured: 14 days and 28 days after the last dose
Immunogenicity profile after the last dose
seroconversion rate of IgG antibody and neutralization antibody
Measured: 14 days and 28 days after the last dose
Comparison of immunogenicity profile
GMT of IgG antibody and neutralization antibody
Measured: 14 days and 28 days after the last dose
Comparison of immunogenicity profile
seroconversion rate of IgG antibody and neutralization antibody
Measured: 14 days and 28 days 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 posted8 Feb 2022
- Study start16 Feb 2022
- Primary completion2 Aug 2022
- Study completion24 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fakultas Kedokteran Universitas Indonesia, Faculty of Medicine, Diponegoro University, Semarang
- Responsible party
- Sponsor
- Investigators
- Prof Rini Sekartini, MD, Principal investigator, Fakultas Kedokteran Universitas IndonesiaYetty Movieta Nency, MD, Principal investigator, Faculty of Medicine, Diponegoro University, Semarang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228613
- Sponsor's protocol ID
- CoV2-0122
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2022
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nency YM, Sekartini R, Wirahmadi A, Maria S, Farhanah N, Hapsari R, Mahati E, Maharani N, Mulyono M, Anantyo DT, Pramudo SG, Yeremia GF, Setyaningsih L, Puspita M, Sari RM. Safety and immunogenicity of SARS-CoV-2 protein subunit recombinant vaccine (Indovac(R)) in healthy populations aged 18 years and above in Indonesia: A phase I, observer-blind, randomized, controlled study. Hum Vaccin Immunother. 2025 Dec;21(1):2501467. doi: 10.1080/21645515.2025.2501467. Epub 2025 May 17.
PubMed 40381203
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. 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 (Adjuvanted With Alum+CpG 1018) in Healthy Populations Aged 18 Years and Above in Indonesia
- ClinicalTrials.gov ID
- NCT05228613
- Acronym / sponsor ID
- CoV2-0122
- Conditions
- COVID-19
- Keywords
- COVID-19 vaccine, healthy population
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Collaborators
- Fakultas Kedokteran Universitas Indonesia, Faculty of Medicine, Diponegoro University, Semarang
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 24 Jan 2023 (actual)
- First posted
- 8 Feb 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.
The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is to evaluate the safety and immunogenicity of the SARS-CoV-2 protein subunit recombinant vaccine adjuvanted with Alum+CpG1018
Detailed description
This trial is observer blinded, comparative, randomized, phase I study. Approximately 175 subjects will be recruited (18 years and above).
The investigational product is 0.5 ml in two dose-regimen (for all subjects) with 28 days apart between doses, compare to an active control (inactivated SARS-CoV-2 vaccine). There will be 4 formula of investigational product used with different concentration of Receptor Binding Domain (RBD) antigen and adjuvant CpG 1018.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Vaccine Candidate Formula A | Experimental | Biological: SARS-CoV-2 protein subunit recombinant vaccine2 doses of vaccine candidate formula A administered with 28 days interval (0.5 mL per dose) |
| Vaccine Candidate Formula B | Experimental | Biological: SARS-CoV-2 protein subunit recombinant vaccine2 doses of vaccine candidate formula B administered with 28 days interval (0.5 mL per dose) |
| Vaccine Candidate Formula C | Experimental | Biological: SARS-CoV-2 protein subunit recombinant vaccine2 doses of vaccine candidate formula C administered with 28 days interval (0.5 mL per dose) |
| Vaccine Candidate Formula D | Experimental | Biological: SARS-CoV-2 protein subunit recombinant vaccine2 doses of vaccine candidate formula D administered with 28 days interval (0.5 mL per dose) |
| Active Control | Active comparator | Biological: SARS-CoV-2 inactivated vaccine2 doses of active control administered with 28 days interval (0.5 mL per dose) |
Who may qualify
- Ages
- 18 to 70 years
- 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 (14 listed)
- Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
- History of vaccination with any investigational product against COVID-19 (based on anamnesis)
- Subjects who have history of COVID-19 (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 RT-PCR test for SARS-CoV-2 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 vaccinecandidate vaccine manufactured by PT. Bio Farma | Biological | Vaccine Candidate Formula A, Vaccine Candidate Formula B, Vaccine Candidate Formula C, Vaccine Candidate Formula D |
| SARS-CoV-2 inactivated vaccineactive control manufactured by Sinovac Life Sciences Co.Ltd | Biological | Active Control |
Primary outcome
Safety of the vaccine within 7 days after each dose
Time frame: 7 days after each dose
percentage of subjects with solicited and unsolicited Adverse Events (AE)
9 secondary outcomes
safety of the vaccine within 28 days after each dose
Time frame: 28 days after each dose
Serious Adverse Event (SAE) of the vaccine
Time frame: 6 months after the last dose
Comparison of safety between vaccine and active control
Time frame: 28 days after each dose and 6 months after the last dose
Deviation of laboratory evaluation
Time frame: 7 days after the first dose and 14 days after the last dose
Inflammatory factor evaluation
Time frame: 7 days after the first dose and 14 days after the last dose
Immunogenicity profile after the last dose
Time frame: 14 days and 28 days after the last dose
Immunogenicity profile after the last dose
Time frame: 14 days and 28 days after the last dose
Comparison of immunogenicity profile
Time frame: 14 days and 28 days after the last dose
Comparison of immunogenicity profile
Time frame: 14 days and 28 days 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 27 Feb 2023.
- Derived from this study: PubMed 40381203Nency YM, Sekartini R, Wirahmadi A, Maria S, Farhanah N, Hapsari R, Mahati E, Maharani N, Mulyono M, Anantyo DT, Pramudo SG, Yeremia GF, Setyaningsih L, Puspita M, Sari RM. Safety and immunogenicity of SARS-CoV-2 protein subunit recombinant vaccine (Indovac(R)) in healthy populations aged 18 years and above in Indonesia: A phase I, observer-blind, randomized, controlled study. Hum Vaccin Immunother. 2025 Dec;21(1):2501467. doi: 10.1080/21645515.2025.2501467. Epub 2025 May 17.
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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
Yetty Movieta Nency, MD principal investigator
Faculty of Medicine, Diponegoro University, Semarang
2 sites 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 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 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 27 Feb 2023. 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 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 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?
On the ClinicalTrials.gov record for NCT05228613, which also lists 1 linked publication.
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 27 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.