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COVID-19Phase 1NCT05434585

A Study to Evaluate Safety, Tolerability, and Immunogenicity of SARS-CoV-2 Variant (COVID-19) mRNA Vaccines

A Phase 1 study testing ABO1009-DP and ABO-CoV.617.2 in people with COVID-19, run by Suzhou Abogen Biosciences Co., Ltd. at 2 sites in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

A Phase 1 study to evaluate safety, tolerability, and immunogenicity of SARS-CoV-2 variant mRNA vaccines which are used to prevent COVID-19 caused by SARS-CoV-2 infection. this study is conducted during Indonesian subjects aged 18 years and older who have not received SARS-CoV-2 vaccines. 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 and ABO-CoV.617.2
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
2 sitesIndonesia
Study dates
8 Jul 2022to 30 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

  • 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.
  • Have not previously received any SARS-CoV-2 vaccine (marketed or investigational) before screening.
  • Be able to communicate well with the investigator, and to understand and comply with the requirements of this clinical trial.
  • Males or females of childbearing potential voluntarily take effective contraceptive methods from signing ICF to 3 months after the last 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

  • Subjects should not participate in this clinical study if any of the following criteria is met:
  • 1. Subjects who do not meet health standard upon comprehensive physical examination, mainly including:
  • 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 significance.
  • Body mass index (BMI) < 18 kg/m2 or > 30 kg/m2.
  • Abnormal laboratory values and with clinical significance at the investigator's discretion at screening.
  • Subjects who do not remain overall healthy (i.e., 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.
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  • 2. SARS-CoV-2 specific antibody positive at screening. 3. Positive SARS-CoV-2 RT-PCR result at screening. 4. Prior medical history of SARS-CoV-2, severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS), or other human coronavirus infections or diseases.
  • 5. Fever (axillary temperature ≥ 37.3℃) on the day of vaccination with this study vaccine or within recent 72 hours.
  • 6. Pregnant or lactating women, or those who plan to donate sperm or egg during the trial.
  • 7. 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.
  • 8. Prior use of any vaccine within 28 days before using this study vaccine or planning to use any vaccine other than this study vaccine during the study period.
  • Note: The exception is that licensed influenza vaccines can be received more than 28 days after the second dose of study injection.
  • 9. 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.
  • 10. 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.
  • 11. 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]), uncontrolled autoimmune disease.
  • 12. 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.
  • 13. Asplenia or functional asplenia. 14. 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.
  • 15. Having received immunoglobulins and/or blood products within 3 months prior to administration of this investigational vaccine.
  • 16. Suspected or known alcohol dependency or drug abuse, which may affect safety evaluation or subject's compliance at the investigator's discretion.
  • 17. 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.
  • 18. Receiving antituberculosis treatment. 19. Staff of test site, sponsor and contract research organization (CRO) taking part in the study.
  • If the subjects have any of the followings prior to the second dose, vaccination will be terminated. However, other study procedures can be continued at the discretion of the investigators:
  • Positive pregnancy test for female subjects of childbearing potential.
  • Positive SARS-CoV-2 RT-PCR result.
  • Serious hypersensitivity or serious adverse event causally related to vaccination has occurred following the first dose.
  • Other circumstances considered by the investigator as inappropriate to receive the second dose of the vaccine

Trial locations and contacts

2 sites in 1 country.

Indonesia2 sites

  • Dr. Cipto Mangunkusumo Hospital

    Jakarta

  • Persahabatan Hospital

    Jakarta

Other trials in Indonesia

About this study

Official title: A Randomized, Double-Blind, and Placebo-Controlled Phase 1 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS-CoV-2 Variant mRNA Vaccines (ABO1009-DP and ABO-CoV.617.2) in Indonesian Subjects Aged 18 Years and Older Who Have Not Received SARS-CoV-2 Vaccines

A Phase 1 study to evaluate safety, tolerability, and immunogenicity of SARS-CoV-2 variant mRNA vaccines which are used to prevent COVID-19 caused by SARS-CoV-2 infection. this study is conducted during Indonesian subjects aged 18 years and older who have not received SARS-CoV-2 vaccines.

Conditions
COVID-19
Being tested
ABO1009-DP, ABO-CoV.617.2, Placebo
Keywords
Delta, 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

  • ABO-CoV.617.2Biological

    Vaccine

  • PlaceboOther

    Placebo

Study groups in NCT05434585
Study groupRoleWhat they receive
Test group 1: ABO1009-DPExperimentalIntramuscularly injecting 15 μg of ABO1009-DP into lateral deltoid of the upper arm of subjects on D0 and D28, respectively.
Receives: Biological: ABO1009-DP
Test group 2: ABO-CoV.617.2ExperimentalIntramuscularly injecting 15 μg of ABO-CoV.617.2 into lateral deltoid of the upper arm of subjects on D0 and D28, respectively.
Receives: Biological: ABO-CoV.617.2
Control group: PlaceboPlacebo comparatorIntramuscularly injecting placebo into lateral deltoid of the upper arm of subjects on D0 and D28, respectively
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of solicited adverse events (AEs)

    Solicited adverse events 0 to 7 days after each injection；

    Measured: 0 to 7 days after each injection

  2. Incidence of unsolicited AEs

    Unsolicited adverse events 0 to 28 days after each injection ； Adverse reactions/events related to blood chemistry, blood routine, blood coagulation function and urinalysis indicators 4 days after each injection

    Measured: 0 to 28 days after each injection

  3. Changes of blood chemistry, blood routine, blood coagulation function and urinalysis indicators 4 days after each injection in comparison to pre-injection

    Adverse reactions/events related to blood chemistry, blood routine, blood coagulation function and urinalysis indicators 4 days after each injection

    Measured: 4 days after each injection in comparison to pre-injection

Secondary outcomes (2)

  1. Level of S-RBD-specific IgG antibody, titer of neutralizing antibodies, and the number of T cells

    Evaluate the immunogenicity of ABO1009-DP and ABO-CoV.617.2 against SARS-CoV-2 (original strain, Delta variant and Omicron variant)

    Measured: from the first vaccination to 12 months after 2 injections

  2. Collection of Safety information

    Serious adverse events (SAEs), adverse events of special interest (AESIs) and other medically attended adverse events (MAAEs) through 12 months after 2 injections

    Measured: through 12 months after 2 injections

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2022
  2. Study start8 Jul 2022
  3. Primary completion10 Oct 2022
  4. Study completion30 Aug 2023 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
60 subjects will be randomized in a 2:2:1 ratio to receive ABO1009-DP, ABO-CoV.617.2, or placebo
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05434585
Sponsor's protocol ID
ABO1009-CoV.617.2-101Indonesia
Status last verified
Aug 2022
First submitted
20 Jun 2022
Last updated
8 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABO1009-DP and ABO-CoV.617.2 in people with COVID-19, run by Suzhou Abogen Biosciences Co., Ltd. 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 5 inclusion and 26 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 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. 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 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?

Incidence of solicited adverse events (AEs) (time frame: 0 to 7 days after each injection). 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?

On the ClinicalTrials.gov record for NCT05434585.

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.

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