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

Suzhou Abogen Biosciences Co., Ltd.25 sites in 4 countries14,168 target enrollmentNovember 23, 2022

ConditionsCOVID-19

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: COVID-19
Sponsor: Suzhou Abogen Biosciences Co., Ltd.
Enrollment: 14168
Locations: 25
Primary Endpoint: In Phase 3, efficacy after the second dose
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

November 23, 2022

End Date

July 31, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Suzhou Abogen Biosciences Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntarily sign the ICF approved by the Ethics Committee before any study procedure and agree to participate in the study.
•Healthy male or female able to provide legal identity certificate and aged 18 years and older when signing the ICF.
•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.
•Be able to communicate well with the investigator, and to understand and comply with the requirements of this clinical trial.
•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

•Positive SARS-CoV-2 rapid test at screening.
•Prior medical history of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS).
•Fever (axillary temperature or equivalent ≥ 37.3℃\*) on the day of vaccination with this investigational vaccine or within recent 72 hours.
•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.
•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.
•Pregnant or lactating women, or those who plan to donate sperm or egg during the trial.
•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.
•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.
•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.
•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.

Outcomes

Primary Outcomes

In Phase 3, efficacy after the second dose

Time Frame: 14 days after second dose

Confirmed COVID-19 cases occurring from 14 days after the second dose

In Phase 1/2, Incidence of unsolicited adverse events

Time Frame: 0 to 28 days after each dose

Unsolicited adverse events 0 to 28 days after each dose

In Phase 1/2, Incidence of solicited adverse events

Time Frame: 0 to 14 days after each dose

Solicited adverse events 0 to 14 days after each dose

Secondary Outcomes

In Phase 1/2, titer of Anti-SARS-CoV-2 live virus neutralizing antibody(28 days after each dose and the corresponding ratio against Day 0 before the vaccination.)
In Phase 3, titer of Anti-SARS-CoV-2 live virus neutralizing antibody(28 days after each dose, 90 days and 180 days after the second dose and the corresponding ratio against Day 0 before the vaccination.)
In Phase 3, Observation of long-term Safety(12 months after each dose)
In Phase 1/2, Observation of Long-term Safety(12 months after each dose)