A Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS-CoV-2 Variant (COVID-19 Omicron) mRNA Vaccine (Phase 1)

NCT05433194 | Unknown Phase 1

• 1 other identifier: ABO1009-DP-005
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19

Keywords

Omicron; COVID-19

Outcome Measures

Primary Outcomes (3)

• Phase I: Incidence of solicited adverse events (AEs)

  Solicited adverse events (AEs) 0 to 7 days after vaccination with one dose of investigational product.

  0 to 7 days after vaccination with one dose of investigational product.

• Phase I: Incidence of unsolicited adverse events (AEs)

  unsolicited adverse events (AEs) 0 to 28 days after vaccination with one dose of investigational product.

  0 to 28 days after vaccination with one dose of investigational product.

• Phase I: Adverse reactions/events related to blood chemistry, blood routine, blood coagulation function and urinalysis indicators 4 days after vaccination with one dose of investigational product.

  Adverse reactions/events related to blood biochemistry, blood routine, blood coagulation function, and urinalysis indicators 4 days after vaccination with one dose of investigational product.

  4 days after vaccination with one dose of investigational product.

Secondary Outcomes (2)

• Phase I: Level of S-RBD-specific IgG antibody, titer of neutralizing antibodies, and the number of T cells

  Before Vaccination and 14 Days after Vaccination

• Phase I: Incidence of SAEs, AESIs, MAAEs

  one dose of investigational vaccine within 12 months.

Study Arms (1)

Phase I Test group 1: ABO1009-DP

EXPERIMENTAL

Intramuscularly injecting 15 μg of ABO1009-DP into lateral deltoid region of the upper arm of subjects on D0.

Biological: ABO1009-DP

Interventions

ABO1009-DP BIOLOGICAL

Vaccine

Phase I Test group 1: ABO1009-DP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.
• 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).

You may not qualify if:

• Phase I:
• Subjects should not participate in this clinical study if any of the following criteria is met:
• Positive SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) test at screening.
• Prior medical history of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS), and other human coronavirus infections or diseases.
• 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
• 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.
• Abnormal laboratory values and with clinical significance at the investigator's discretion at screening.
• 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 screening or planning to use any vaccine other than this investigational vaccine 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.
• 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.

Sponsors & Collaborators

• Suzhou Abogen Biosciences Co., Ltd.: lead

Study Sites (1)

AL Kuwait Hospital

Dubai, United Arab Emirates

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Phase I: Open-label
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase I: single-arm Phase I: 48 subjects are planned to be enrolled to receive ABO1009-DP in the test group.

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 27, 2022
• Study Start: August 22, 2022
• Primary Completion: September 26, 2022
• Study Completion: August 25, 2023
• Last Updated: February 8, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)