A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy,Safety, and Immunogenicity of SARS-CoV-2 Variant (BA.4 /5) mRNA Vaccine (ABO1020) inHealthy Subjects Aged 18 Years and Older Who Have Completed the Full Vaccination
Not Provided
Biological: ABO1020
Vaccine
Biological: Placebo
Placebo
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. Subjects who have previously been fully vaccinated either by 2 or 3 doses of
SARS-CoV-2 inactivated vaccine. The last dose of immunization should be >6 months
before administration of the investigational products.
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:
1. Positive SARS-CoV-2 rapid test at screening.
2. Prior medical history of severe acute respiratory syndrome (SARS), middle east
respiratory syndrome (MERS).
3. Fever (axillary temperature or equivalent ≥ 37.3℃*) on the day of vaccination with
this investigational vaccine or within recent 72 hours.
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. 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.
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 other vaccine within 28 days before using the investigational
products or planning to use any vaccine other than the investigational products
during the study period.
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]), and 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 study site, sponsor and contract research organization (CRO) taking part in
the study.
20. Other conditions that the investigators consider unsuitable for this study.
RS Universitas Indonesia
Depok, Indonesia
RS YARSI
Jakarta, Indonesia
RSIJ Cempaka Putih
Jakarta, Indonesia
RSUP Persahabatan
Jakarta, Indonesia
Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo
Jakarta, Indonesia
Central Hospital, Gujranwala
Gujranwala, Pakistan
Maroof International Hospital, Islamabad
Islamabad, Pakistan
Rehman Medical Institute
Khyber, Pakistan
Akram Medical Complex
Lahore, Pakistan
Avicenna Medical College
Lahore, Pakistan
Central Park Teaching Hospital
Lahore, Pakistan
National Hospital and Medical center
Lahore, Pakistan
Al-Shifa Trust Eye Hospital
Rawalpindi, Pakistan
Manuel J. Santos Hospita
Butuan, Philippines
Premiere Medical Center
Cabanatuan, Philippines
Silang Medical Center
Cavite, Philippines
Davao Medical School Foundation
Davao, Philippines
St. Paul's Hospital Iloilo
Iloilo, Philippines
Healthcube Medical Clinic
Mandaluyong, Philippines
Medical Center Manila
Manila, Philippines
Philippine General Hospital
Manila, Philippines
Burjeel Medical City
Abu Dhabi, United Arab Emirates
Life Care Hospital
Abu Dhabi, United Arab Emirates
Medeor hospital
Abu Dhabi, United Arab Emirates
AI Kuwait Hospital
Dubai, United Arab Emirates
Not Provided