COVID-19Phase 1NCT05433194
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS-CoV-2 Variant (COVID-19 Omicron) mRNA Vaccine (Phase 1)
A Phase 1 study testing ABO1009-DP in people with COVID-19, run by Suzhou Abogen Biosciences Co., Ltd. at 1 site in United Arab Emirates.
Trial summary
A Phase I clinical study to evaluate the safety, tolerability, and immunogenicity of SARS-CoV-2 variant (Omicron) mRNA vaccine which is used to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. 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?
- ABO1009-DP
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 22 Aug 2022to 25 Aug 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subjects must meet all of the following inclusion criteria (Phase I):
- Voluntarily sign the ICF approved by the Ethics Committee before any study procedure and agree to participate in the study.
- Healthy male or female able to provide legal identity certificate and aged 18 years and older when signing the ICF.
- Subjects who are fully vaccinated either by 2 or 3 doses. The 2-dose immunization or the second dose of the 3-dose immunization should be from 6 to 24 months before administration of the investigational vaccine. The third dose should be >3 months before administration of the investigational vaccine.
- Be able to communicate well with the investigator, and to understand and comply with the requirements of this clinical trial.
- Males and females with childbearing potential voluntarily take effective contraceptive methods from signing ICF to 3 months after completing the vaccination, including sexual abstinence or effective contraceptive measures (e.g., intrauterine or implanted contraceptive device, oral contraceptives, injected or implanted contraceptives, sustained-release topical contraceptives, intrauterine device [IUD], condoms [male], diaphragm, and cervical cap).
Who cannot join
- Phase I:
- Subjects should not participate in this clinical study if any of the following criteria is met:
- Positive SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) test at screening.
- Prior medical history of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS), and other human coronavirus infections or diseases.
- Fever (axillary temperature or equivalent ≥ 37.3℃*) on the day of vaccination with this investigational vaccine or within recent 72 hours.
- Tympanic Temperature °C - 0.56°C = Axillary Equivalent in °C
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- Abnormal vital signs (pulse < 60 bpm or > 100 bpm, systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg when keeping awake) with clinical relevance.
- Abnormal laboratory values and with clinical significance at the investigator's discretion at screening.
- Do not remain overall healthy (i.e., has medically deteriorated significantly since receiving the two-dose vaccination, is anticipated to have fatal outcome of uncontrolled diseases within 12 months, and is not able to provide blood as specified by the trial with anticipated, deleterious medical consequences) in the clinical judgment of the investigator based on medical history and physical examination.
- Pregnant or lactating women, or those who plan to donate sperm or egg during the trial.
- Prior history of allergic reaction or anaphylaxis to any vaccine or its excipients, e.g., hypersensitivity, urticaria, serious eczema, dyspnea, laryngeal edema, and angioedema etc.
- Prior use of any other vaccine within 28 days before screening or planning to use any vaccine other than this investigational vaccine during the study period.
- Participation in the studies of any other interventional device or drug within 30 days before the screening, or current treatment with other investigational drug(s) or within 5 half-lives after taking the last dose of the study drug.
- Hereditary hemorrhagic tendency or coagulation dysfunction (e.g., cytokine defects, coagulation disorders or platelet disorder), or a history of serious bleeding, or a history of massive bleeding after intramuscular injection or intravenous puncture or ecchymosis.
- Known medical history or diagnosis confirming that subjects have diseases affecting immune system function, including cancer (except skin basal cell carcinoma), congenital or acquired immunodeficiency (e.g., infection with human immunodeficiency virus [HIV]), and uncontrolled autoimmune disease.
- Serious or uncontrolled respiratory system disorders, cardiovascular disorders, nervous system disorders, blood and lymphatic system disorders, liver and kidney disorders, metabolism and skeletal disorders, etc. influencing study results evaluation at the investigator's discretion.
- Asplenia or functional asplenia.
- Long-term use (continuous use ≥14 days) of immunosuppressants or other immunomodulators (e.g., glucocorticoids: prednisone or similar drugs) within 6 months prior to administration of this investigational vaccine, except for topical medications (e.g., ointments, eye drops, inhalants, or nasal sprays). And the topical medications should not exceed the recommended dose in the labels for use or induce any signs of systemic exposure.
- Having received immunoglobulins and/or blood products within 3 months prior to administration of this investigational vaccine.
- Suspected or known alcohol dependency or drug abuse, which may affect safety evaluation or subject's compliance at the investigator's discretion.
- Planning to permanently move from the local area before study completion or leave the local area for a long time during the period of study visits.
- Currently receiving antituberculosis treatment.
- Staff of study site, sponsor and contract research organization (CRO) taking part in the study.
- Other conditions that the investigators consider unsuitable for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS-CoV-2 Variant (Omicron) mRNA Vaccine (ABO1009-DP) for Sequential Immunization in the Population Aged 18 Years and Older Who Have Completed the Full Vaccination
A Phase I clinical study to evaluate the safety, tolerability, and immunogenicity of SARS-CoV-2 variant (Omicron) mRNA vaccine which is used to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
- Conditions
- COVID-19
- Being tested
- ABO1009-DP
- Keywords
- Omicron, 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.
ABO1009-DPBiological
Vaccine
| Study group | Role | What they receive |
|---|---|---|
| Phase I Test group 1: ABO1009-DP | Experimental | Intramuscularly injecting 15 μg of ABO1009-DP into lateral deltoid region of the upper arm of subjects on D0. Receives: Biological: ABO1009-DP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Incidence of solicited adverse events (AEs)
Solicited adverse events (AEs) 0 to 7 days after vaccination with one dose of investigational product.
Measured: 0 to 7 days after vaccination with one dose of investigational product.
Phase I: Incidence of unsolicited adverse events (AEs)
unsolicited adverse events (AEs) 0 to 28 days after vaccination with one dose of investigational product.
Measured: 0 to 28 days after vaccination with one dose of investigational product.
Phase I: Adverse reactions/events related to blood chemistry, blood routine, blood coagulation function and urinalysis indicators 4 days after vaccination with one dose of investigational product.
Adverse reactions/events related to blood biochemistry, blood routine, blood coagulation function, and urinalysis indicators 4 days after vaccination with one dose of investigational product.
Measured: 4 days after vaccination with one dose of investigational product.
Secondary outcomes (2)
Phase I: Level of S-RBD-specific IgG antibody, titer of neutralizing antibodies, and the number of T cells
Collect venous blood to get data such as S-RBD-specific IgG antibody level and neutralizing antibodies and number of T cells to evaluate the immunogenicity of ABO1009-DP against SARS CoV-2 Omicron variant.
Measured: Before Vaccination and 14 Days after Vaccination
Phase I: Incidence of SAEs, AESIs, MAAEs
Serious adverse events (SAEs), adverse events of special interest (AESIs), and other medically attended adverse events (MAAEs) after vaccination with one dose of investigational vaccine within 12 months.
Measured: one dose of investigational vaccine within 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start22 Aug 2022
- Primary completion26 Sep 2022
- Study completion25 Aug 2023 (estimated)
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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase I: single-arm Phase I: 48 subjects are planned to be enrolled to receive ABO1009-DP in the test group.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Abogen Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433194
- Sponsor's protocol ID
- ABO1009-DP-005
- Status last verified
- Aug 2022
- First submitted
- 16 Jun 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS-CoV-2 Variant (Omicron) mRNA Vaccine (ABO1009-DP) for Sequential Immunization in the Population Aged 18 Years and Older Who Have Completed the Full Vaccination
- ClinicalTrials.gov ID
- NCT05433194
- Acronym / sponsor ID
- ABO1009-DP-005
- Conditions
- COVID-19
- Keywords
- Omicron, COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Suzhou Abogen Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 26 Sep 2022 (actual)
- Study completion
- 25 Aug 2023 (estimated)
- First posted
- 27 Jun 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.
A Phase I clinical study to evaluate the safety, tolerability, and immunogenicity of SARS-CoV-2 variant (Omicron) mRNA vaccine which is used to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase I: single-arm Phase I: 48 subjects are planned to be enrolled to receive ABO1009-DP in the test group.
| Arm | Type | Receives |
|---|---|---|
| Phase I Test group 1: ABO1009-DP | Experimental | Biological: ABO1009-DPIntramuscularly injecting 15 μg of ABO1009-DP into lateral deltoid region of the upper arm of subjects on D0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subjects must meet all of the following inclusion criteria (Phase I):
Key exclusion criteria (24 listed)
- Phase I:
- Subjects should not participate in this clinical study if any of the following criteria is met:
- Positive SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) test at screening.
- Prior medical history of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS), and other human coronavirus infections or diseases.
- Fever (axillary temperature or equivalent ≥ 37.3℃*) on the day of vaccination with this investigational vaccine or within recent 72 hours.
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 |
|---|---|---|
| ABO1009-DPVaccine | Biological | Phase I Test group 1: ABO1009-DP |
Primary outcome
Phase I: Incidence of solicited adverse events (AEs)
Time frame: 0 to 7 days after vaccination with one dose of investigational product.
Solicited adverse events (AEs) 0 to 7 days after vaccination with one dose of investigational product.
Phase I: Incidence of unsolicited adverse events (AEs)
Time frame: 0 to 28 days after vaccination with one dose of investigational product.
unsolicited adverse events (AEs) 0 to 28 days after vaccination with one dose of investigational product.
Phase I: Adverse reactions/events related to blood chemistry, blood routine, blood coagulation function and urinalysis indicators 4 days after vaccination with one dose of investigational product.
Time frame: 4 days after vaccination with one dose of investigational product.
Adverse reactions/events related to blood biochemistry, blood routine, blood coagulation function, and urinalysis indicators 4 days after vaccination with one dose of investigational product.
2 secondary outcomes
Phase I: Level of S-RBD-specific IgG antibody, titer of neutralizing antibodies, and the number of T cells
Time frame: Before Vaccination and 14 Days after Vaccination
Phase I: Incidence of SAEs, AESIs, MAAEs
Time frame: one dose of investigational vaccine within 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 ABO1009-DP in people with COVID-19, run by Suzhou Abogen Biosciences Co., Ltd. at 1 site in United Arab Emirates.
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 24 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 8 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 1 site in United Arab Emirates. 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?
Results are not available in the source record.
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?
Phase I: Incidence of solicited adverse events (AEs) (time frame: 0 to 7 days after vaccination with one dose of investigational product.). The study lists 3 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 8 Feb 2023; AzTrials last refreshed its copy on 31 Oct 2026.