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
Brief Summary

A Phase 1 study to evaluate safety, tolerability, and immunogenicity of SARS-CoV-2variant 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 notreceived SARS-CoV-2 vaccines.

Detailed Description

Not Provided

Unknown status
COVID-19

Biological: ABO1009-DP

Vaccine

Biological: ABO-CoV.617.2

Vaccine

Other: Placebo

Placebo

Eligibility Criteria

Inclusion Criteria:

1. Voluntarily sign the ICF approved by the Ethics Committee before any study procedure
and agree to participate in the study.

2. Healthy male or female able to provide legal identity certificate and aged 18 years
and older when signing the ICF.

3. Have not previously received any SARS-CoV-2 vaccine (marketed or investigational)
before screening.

4. Be able to communicate well with the investigator, and to understand and comply with
the requirements of this clinical trial.

5. 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).

Exclusion Criteria:

Exclusion criteria for the first dose

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:

1. 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.

2. Body mass index (BMI) < 18 kg/m2 or > 30 kg/m2.

3. Abnormal laboratory values and with clinical significance at the investigator's
discretion at screening.

4. 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.

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.

Exclusion Criteria for the second dose

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:

1. Positive pregnancy test for female subjects of childbearing potential.

2. Positive SARS-CoV-2 RT-PCR result.

3. Serious hypersensitivity or serious adverse event causally related to vaccination
has occurred following the first dose.

4. Other circumstances considered by the investigator as inappropriate to receive the
second dose of the vaccine

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Indonesia
Locations

Dr. Cipto Mangunkusumo Hospital
Jakarta, Indonesia

Persahabatan Hospital
Jakarta, Indonesia

Dingfeng Wu, Study Director
Suzhou Abogen Biosciences Co., Ltd.

Suzhou Abogen Biosciences Co., Ltd.
NCT Number
Keywords
Delta
Omicron
Covid-19
MeSH Terms
COVID-19