COVID-19 PandemicPhase 1/2NCT05226429
UNAIR Inactivated COVID-19 Vaccine
A Phase 1/2 study testing UNAIR Inactivated COVID-19 Vaccine and CoronaVac Biofarma COVID-19 Vaccine in people with COVID-19 Pandemic and Vaccine Reaction, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
Trial summary
This is a randomized, observer blind, controlled phase I/II study to evaluate the Safety, Reactogenicity, and Immunogenicity of UNAIR Inactivated Covid-19 Vaccine in Healthy Populations Aged 18 Years 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 Pandemic, Vaccine Reaction
- What is being tested?
- UNAIR Inactivated COVID-19 Vaccine and CoronaVac Biofarma COVID-19 Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 495 participants
- Where
- 1 siteIndonesia
- Study dates
- 8 Feb 2022to 6 Jul 2023
- Phase
- Phase 1/2
- 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
- Healthy adults and elderly, males and females, 18 years of age and above. Healthy status will be determined by the investigator based on medical history, clinical laboratory results, vital sign measurements, and physical examination at screening.
- Subjects have been informed properly regarding the study and signed the informed consent form
- Subject will commit to comply with the instructions of the investigator and the schedule of the trial
- Female subjects of childbearing potential must agree to consistently use any methods of contraception (except the periodic abstinence) from at least 21 days prior to enrollment and through 6 months after the last vaccination.
- Participants agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine.
- Participants must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study.
Who cannot join
- Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
- Evolving mild, moderate, and severe illness, especially infectious diseases or fever (axillary temperature 37.5 degree Celcius or more) concurrent or within 7 days prior to first study vaccination. This includes respiratory or constitutional symptoms consistent with SARS-CoV-2 (cough, sore throat, difficulty in breathing, etc)
- Known history of allergy to any component of the vaccines
- History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
- Any autoimmune or immunodeficiency disease/condition
- Subjects who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived products, long term corticosteroid - more than 2 weeks, and so on), OR anticipation of the need for immunosuppressive treatment within 6 months after last vaccination. The use of topical or nasal steroid will be permitted. Inhaled glucocorticoids is prohibited.
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- Chronic disease, inclusive of uncontrolled hypertension, congestive heart failure, chronic obstructive pulmonary disease, asthma, chronic urticaria, diabetes requiring use of medicine
- Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
- Individuals who previously receive any vaccines against Covid-19
- Subjects already immunized with any vaccine within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose
- Individuals who have a previously ascertained Covid-19 in the period of 3 months before the first recruit of this study, or in a close contact in the last 14 days with confirmed case of Covid-19
- Positive test for SARS-CoV-2 (Antigen or PCR) at screening prior to first vaccination. Testing may be repeated during the screening period if exposure to positive confirmed case of SARS-CoV-2 is suspected, at the discretion of investigator.
- History of alcohol or substance abuse
- HIV patients.
- Malignancy patients within 5 years prior to first study vaccination.
- Any neurological disease or history of significant neurological disorder such as meningitis, encephalitis, Guillain-Barre Syndrome, multiple sclerosis, etc
- Vital sign abnormalities and clinical laboratory abnormalities as decided by the investigators. Vital sign measurements and clinical laboratory testing may be repeated before the final decision.
- Women who are pregnant, breastfeeding, or who plan to become pregnant during the study.
- Participant has major psychiatric problem or illness
- Participant cannot communicate reliably with the investigator
- Participant has contraindication to intramuscular injection and blood draws, such as bleeding disorders or phobia.
- Participant had major surgery within 12 weeks before vaccination which will not be fully recovered, or has major surgery planned during the time participant is expected to participate in the study or within 6 months after the last dose of study vaccine administration.
- Any condition that in the opinion of the investigators would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine or interpretation of the study results
- Study team members.
- Subject planning to move from the study area before the end of study period.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Dr. Soetomo General Hospital
Surabaya, East Java, 67161
Dominicus Husada, MD, +6281232266377, dominicushusada@yahoo.com
Damayanti Tinduh, MD, +6281703293335, damayanti.tinduh@fk.unair.ac.id
About this study
Official title: Safety and Immunogenicity of UNAIR Inactivated COVID-19 Vaccine in Healthy Populations Aged 18 Years and Above (Phase I/II)
This is a randomized, observer blind, controlled phase I/II study to evaluate the Safety, Reactogenicity, and Immunogenicity of UNAIR Inactivated Covid-19 Vaccine in Healthy Populations Aged 18 Years and Above. UNAIR Inactivated Covid-19 Vaccine is an inactivated vaccine developed by Airlangga University (Universitas Airlangga / UNAIR) made of SARS-CoV-2 virus isolated from a patient in Surabaya, Indonesia, composed with aluminium hydroxy gel, tween 80, and L-histidine. This study will be the first in human.
- Conditions
- COVID-19 Pandemic, Vaccine Reaction
- Being tested
- UNAIR Inactivated COVID-19 Vaccine, CoronaVac Biofarma COVID-19 Vaccine
- Keywords
- Inactivated COVID-19 Vaccine, Immunogenicity, Indonesia, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UNAIR Inactivated COVID-19 VaccineBiological
UNAIR Inactivated Covid-19 Vaccine contains S protein of SARS-CoV-2 virus, Aluminium hydroxide gel, 10 mM L-Histidine buffer, 0.005% Tween Polysorbate 80, and 0.9% Sodium chloride. Vaccine will be prepared in vial (1 ml per vial). One vial will be used for one injection only. The vial should be shaken well before injection.
CoronaVac Biofarma COVID-19 VaccineBiological
Control vaccine in this study is existing CoronaVac-BioFarma inactivated COVID-19 vaccine which has been used widely in Indonesia.
| Study group | Role | What they receive |
|---|---|---|
| UNAIR Inactivated COVID-19 Vaccine 3 microgram | Experimental | Not described Receives: Biological: UNAIR Inactivated COVID-19 Vaccine |
| UNAIR Inactivated COVID-19 Vaccine 5 microgram | Experimental | Not described Receives: Biological: UNAIR Inactivated COVID-19 Vaccine |
| CoronaVac Biofarma COVID-19 Vaccine | Active comparator | Not described Receives: Biological: CoronaVac Biofarma COVID-19 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited clinical (local and systemic), laboratory, and unsolicited adverse events
The number of adverse events occur among participants.
Measured: 7 days each vaccination
Solicited clinical (local and systemic), laboratory, and unsolicited adverse events
The number of adverse events occur among participants.
Measured: 28 days after each vaccination
SARS-CoV-2 neutralization antibodies
The level of SARS-CoV-2 neutralization antibodies in participants.
Measured: 28 days after the second vaccination
SARS-CoV-2 binding antibodies
The level of SARS-CoV-2 binding antibodies in participants.
Measured: 28 days after the second vaccination
Th1 and Th2
Th1 and Th2 levels in participants.
Measured: 28 days after the second vaccination
Secondary outcomes (4)
Solicited clinical (local and systemic), laboratory, and unsolicited adverse events
The number of adverse events occur among participants.
Measured: 3, 6, and 12 months after the first vaccination
SARS-CoV-2 neutralization antibodies
The level of SARS-CoV-2 neutralization antibodies in participants.
Measured: 3, 6, and 12 months after the first vaccination
SARS-CoV-2 binding antibodies
The level of SARS-CoV-2 binding antibodies in participants.
Measured: 3, 6, and 12 months after the first vaccination
Th1 and Th2
Th1 and Th2 levels in participants.
Measured: 3, 6, and 12 months after the first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start8 Feb 2022
- Primary completion6 Apr 2023
- Study completion6 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be 3 groups in phase I. Two adult groups (18 year old and above) with two different doses (3 and 5 μg) and 1 control group using Coronavac-BioFarma vaccine. There will be the same 3 groups in phase II. Two treatment groups of adult will use 2 kind of doses as in phase I. The other group is for control (Coronavac-BioFarma vaccine). The vaccines will be administered with 2-dose schedule, intramuscularly. All cohorts will be followed for 12 months.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 495 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Soetomo General Hospital
- Sponsor type
- Other government
- Collaborators
- Indonesia-MoH, Universitas Airlangga, Bioxis Pharmaceuticalls
- Responsible party
- Principal investigator, Dr. Dominicus Husada, dr., DTM&H, MCTM(TP), Sp.A(K), Dr. Soetomo General Hospital
- Investigators
- Dominicus Husada, MD, Principal investigator, Dr. Soetomo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226429
- Sponsor's protocol ID
- UNAIR-MP-INAKTIF-001
- Status last verified
- Jun 2023
- First submitted
- 20 Jan 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is not yet plan to share IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of UNAIR Inactivated COVID-19 Vaccine in Healthy Populations Aged 18 Years and Above (Phase I/II)
- ClinicalTrials.gov ID
- NCT05226429
- Acronym / sponsor ID
- UNAIR-MP-INAKTIF-001
- Conditions
- COVID-19 Pandemic, Vaccine Reaction
- Keywords
- Inactivated COVID-19 Vaccine, Immunogenicity, Indonesia, COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 495 participants (estimated)
- Lead sponsor
- Dr. Soetomo General HospitalOther government
- Collaborators
- Indonesia-MoH, Universitas Airlangga, Bioxis Pharmaceuticalls
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 6 Jul 2023 (estimated)
- First posted
- 7 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.
This is a randomized, observer blind, controlled phase I/II study to evaluate the Safety, Reactogenicity, and Immunogenicity of UNAIR Inactivated Covid-19 Vaccine in Healthy Populations Aged 18 Years and Above. UNAIR Inactivated Covid-19 Vaccine is an inactivated vaccine developed by Airlangga University (Universitas Airlangga / UNAIR) made of SARS-CoV-2 virus isolated from a patient in Surabaya, Indonesia, composed with aluminium hydroxy gel, tween 80, and L-histidine. This study will be the first in human.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- There will be 3 groups in phase I. Two adult groups (18 year old and above) with two different doses (3 and 5 μg) and 1 control group using Coronavac-BioFarma vaccine. There will be the same 3 groups in phase II. Two treatment groups of adult will use 2 kind of doses as in phase I. The other group is for control (Coronavac-BioFarma vaccine). The vaccines will be administered with 2-dose schedule, intramuscularly. All cohorts will be followed for 12 months.
| Arm | Type | Receives |
|---|---|---|
| UNAIR Inactivated COVID-19 Vaccine 3 microgram | Experimental | Biological: UNAIR Inactivated COVID-19 Vaccine |
| UNAIR Inactivated COVID-19 Vaccine 5 microgram | Experimental | Biological: UNAIR Inactivated COVID-19 Vaccine |
| CoronaVac Biofarma COVID-19 Vaccine | Active comparator | Biological: CoronaVac Biofarma COVID-19 Vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy adults and elderly, males and females, 18 years of age and above. Healthy status will be determined by the investigator based on medical history, clinical laboratory results, vital sign measurements, and physical examination at screening.
- Subjects have been informed properly regarding the study and signed the informed consent form
- Subject will commit to comply with the instructions of the investigator and the schedule of the trial
- Female subjects of childbearing potential must agree to consistently use any methods of contraception (except the periodic abstinence) from at least 21 days prior to enrollment and through 6 months after the last vaccination.
- Participants agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine.
Key exclusion criteria (25 listed)
- Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
- Evolving mild, moderate, and severe illness, especially infectious diseases or fever (axillary temperature 37.5 degree Celcius or more) concurrent or within 7 days prior to first study vaccination. This includes respiratory or constitutional symptoms consistent with SARS-CoV-2 (cough, sore throat, difficulty in breathing, etc)
- Known history of allergy to any component of the vaccines
- History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
- Any autoimmune or immunodeficiency disease/condition
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 |
|---|---|---|
| UNAIR Inactivated COVID-19 VaccineUNAIR Inactivated Covid-19 Vaccine contains S protein of SARS-CoV-2 virus, Aluminium hydroxide gel, 10 mM L-Histidine buffer, 0.005% Tween Polysorbate 80, and 0.9% Sodium chloride. Vaccine will be prepared in vial (1 ml per vial). One vial will be used for one injection only. The vial should be shaken well before injection. | Biological | UNAIR Inactivated COVID-19 Vaccine 3 microgram, UNAIR Inactivated COVID-19 Vaccine 5 microgram |
| CoronaVac Biofarma COVID-19 VaccineControl vaccine in this study is existing CoronaVac-BioFarma inactivated COVID-19 vaccine which has been used widely in Indonesia. | Biological | CoronaVac Biofarma COVID-19 Vaccine |
Primary outcome
Solicited clinical (local and systemic), laboratory, and unsolicited adverse events
Time frame: 7 days each vaccination
The number of adverse events occur among participants.
Solicited clinical (local and systemic), laboratory, and unsolicited adverse events
Time frame: 28 days after each vaccination
The number of adverse events occur among participants.
SARS-CoV-2 neutralization antibodies
Time frame: 28 days after the second vaccination
The level of SARS-CoV-2 neutralization antibodies in participants.
SARS-CoV-2 binding antibodies
Time frame: 28 days after the second vaccination
The level of SARS-CoV-2 binding antibodies in participants.
Th1 and Th2
Time frame: 28 days after the second vaccination
Th1 and Th2 levels in participants.
4 secondary outcomes
Solicited clinical (local and systemic), laboratory, and unsolicited adverse events
Time frame: 3, 6, and 12 months after the first vaccination
SARS-CoV-2 neutralization antibodies
Time frame: 3, 6, and 12 months after the first vaccination
SARS-CoV-2 binding antibodies
Time frame: 3, 6, and 12 months after the first vaccination
Th1 and Th2
Time frame: 3, 6, and 12 months after the first vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: Undecided. There is not yet plan to share IPD with other researchers.
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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.
Dominicus Husada, MD principal investigator
Dr. Soetomo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing UNAIR Inactivated COVID-19 Vaccine and CoronaVac Biofarma COVID-19 Vaccine in people with COVID-19 Pandemic and Vaccine Reaction, run by Dr. Soetomo General Hospital 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 6 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 15 Jun 2023. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominicus Husada, MD (+6281232266377, dominicushusada@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Solicited clinical (local and systemic), laboratory, and unsolicited adverse events (time frame: 7 days each vaccination). The study lists 5 primary outcomes in all. 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 15 Jun 2023.