A Study to Evaluate the Efficacy, Safety, and Immunogenicity of SARS-CoV-2 Variant (BA.4 /5) mRNA Vaccine
NCT ID: NCT05636319
Last Updated: 2024-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
14168 participants
INTERVENTIONAL
2022-11-23
2024-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Phase3: 15000 subjects will be randomized in a ratio of 1:1 to receive ABO1020 and placebo, intramuscularly injected in the lateral deltoid region of the upper arm according to the two doses immunization schedule on Day 0 and Day 28.
PREVENTION
TRIPLE
Study Groups
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Test group 1: ABO1020
Intramuscularly inject 15 μg of ABO1020 into lateral deltoid region of the upper arm of subjects on D0 and D28, respectively.
ABO1020
Vaccine
Test group 2: Placebo
Intramuscularly inject 0 μg of placebo into lateral deltoid region of the upper arm of subjects on D0 and D28, respectively.
Placebo
Placebo
Interventions
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ABO1020
Vaccine
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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Suzhou Abogen Biosciences Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Rehman Medical Institute
Basti Khyber, , Pakistan
Central Hospital, Gujranwala
Gujranwala, , Pakistan
Maroof International Hospital, Islamabad
Islamabad, , 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 City, , Philippines
Silang Medical Center
Cavite, , Philippines
Davao Medical School Foundation
Davao City, , Philippines
St. Paul's Hospital Iloilo
Iloilo City, , 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
Countries
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References
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Hannawi S, Wu XH, Villalobos RE, Burhan E, Lallaine Borra MD, Gupta RK, Aquitania GP, Ang BWC, Mae A Zabat G, Roa CC Jr, Zoleta-De Jesus L, Yu DD, Wang M, Wu Y, Song WJ, Ying B, Qin CF. Efficacy, immunogenicity, and safety of a monovalent mRNA vaccine, ABO1020, in adults: A randomized, double-blind, placebo-controlled, phase 3 trial. Med. 2024 Oct 11;5(10):1282-1292.e3. doi: 10.1016/j.medj.2024.06.013. Epub 2024 Jul 17.
Related Links
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Efficacy, immunogenicity, and safety of a monovalent mRNA vaccine, ABO1020, in adults: A randomized, double-blind, placebo-controlled, phase 3 trial, Med (2024), https://doi.org/10.1016/j.medj.2024.06.013
Efficacy, immunogenicity, and safety of a monovalent mRNA vaccine, ABO1020, in adults: A randomized, double-blind, placebo-controlled, phase 3 trial, Med (2024), https://doi.org/10.1016/j.medj.2024.06.013
Other Identifiers
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ABO1020-301
Identifier Type: -
Identifier Source: org_study_id
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