A Study to Evaluate the Efficacy, Safety, and Immunogenicity of SARS-CoV-2 Variant (BA.4 /5) mRNA Vaccine

COVID-19 Clinical Trial

Official title:

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) in Healthy Subjects Aged 18 Years and Older Who Have Completed the Full Vaccination

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05636319
• Other study ID #: ABO1020-301
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: November 23, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: September 2023
• Source: Suzhou Abogen Biosciences Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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) in Healthy Subjects Aged 18 Years and Older Who Have Completed the Full Vaccination

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14168
• Est. completion date: July 31, 2024
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• ABO1020
Vaccine
• Placebo
Placebo

Locations

Country	Name	City	State
Indonesia	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
Pakistan	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
Philippines	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
United Arab Emirates	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

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Abogen Biosciences Co., Ltd.

Countries where clinical trial is conducted

Indonesia,  Pakistan,  Philippines,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In Phase 1/2, Incidence of solicited adverse events	Solicited adverse events 0 to 14 days after each dose	0 to 14 days after each dose
Primary	In Phase 1/2, Incidence of unsolicited adverse events	Unsolicited adverse events 0 to 28 days after each dose	0 to 28 days after each dose
Primary	In Phase 3, efficacy after the second dose	Confirmed COVID-19 cases occurring from 14 days after the second dose	14 days after second dose
Secondary	In Phase 1/2, titer of Anti-SARS-CoV-2 live virus neutralizing antibody	Evaluate the immunogenicity of ABO1020	28 days after each dose and the corresponding ratio against Day 0 before the vaccination.
Secondary	In Phase 1/2, Observation of Long-term Safety	Serious adverse events, adverse events of special interest and other medically attended adverse events through 12 months after each dose.	12 months after each dose
Secondary	In Phase 3, titer of Anti-SARS-CoV-2 live virus neutralizing antibody	Evaluate the immunogenicity of ABO1020	28 days after each dose, 90 days and 180 days after the second dose and the corresponding ratio against Day 0 before the vaccination.
Secondary	In Phase 3, Observation of long-term Safety	Serious adverse events, adverse events of special interest through 12 months after each dose.	12 months after each dose