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
Brief Summary

A Phase I clinical study to evaluate the safety, tolerability, and immunogenicity ofSARS-CoV-2 variant (Omicron) mRNA vaccine which is used to prevent COVID-19 caused bysevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

Detailed Description

Not Provided

Unknown status
COVID-19

Biological: ABO1009-DP

Vaccine

Eligibility Criteria

Inclusion Criteria:

- The subjects must meet all of the following inclusion criteria (Phase I):

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. 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.

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

5. 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).

Exclusion Criteria:

- Phase I:

Subjects should not participate in this clinical study if any of the following criteria
is met:

1. Positive SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) test at
screening.

2. Prior medical history of severe acute respiratory syndrome (SARS), middle east
respiratory syndrome (MERS), and other human coronavirus infections or diseases.

3. 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

4. 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.

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

6. 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.

7. Pregnant or lactating women, or those who plan to donate sperm or egg during the
trial.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. Asplenia or functional asplenia.

15. 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.

16. Having received immunoglobulins and/or blood products within 3 months prior to
administration of this investigational vaccine.

17. Suspected or known alcohol dependency or drug abuse, which may affect safety
evaluation or subject's compliance at the investigator's discretion.

18. 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.

19. Currently receiving antituberculosis treatment.

20. Staff of study site, sponsor and contract research organization (CRO) taking part in
the study.

21. Other conditions that the investigators consider unsuitable for this study.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United Arab Emirates
Locations

AL Kuwait Hospital
Dubai, United Arab Emirates

Not Provided

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