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

NCT05636319 | Unknown Phase 2 DMC

• 1 other identifier: ABO1020-301
• Study Type: interventional
• Target: 14,168
• Locations: 4 countries
• Sites: 25

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

Conditions

COVID-19

Keywords

COVID-19; Omicron

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• 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 1/2, Observation of Long-term Safety

  12 months after each dose

• 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

Study Arms (2)

Test group 1: ABO1020

EXPERIMENTAL

Intramuscularly inject 15 μg of ABO1020 into lateral deltoid region of the upper arm of subjects on D0 and D28, respectively.

Biological: ABO1020

Test group 2: Placebo

PLACEBO COMPARATOR

Intramuscularly inject 0 μg of placebo into lateral deltoid region of the upper arm of subjects on D0 and D28, respectively.

Biological: Placebo

Interventions

ABO1020 BIOLOGICAL

Vaccine

Test group 1: ABO1020

Placebo BIOLOGICAL

Placebo

Test group 2: Placebo

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 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).

You may not qualify if:

• 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.
• 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.
• 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.
• Asplenia or functional asplenia.
• 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.
• Having received immunoglobulins and/or blood products within 3 months prior to administration of this investigational vaccine.

Sponsors & Collaborators

• Suzhou Abogen Biosciences Co., Ltd.: lead

Study Sites (25)

RS Universitas Indonesia

Depok, Indonesia

Location

RS YARSI

Jakarta, Indonesia

Location

RSIJ Cempaka Putih

Jakarta, Indonesia

Location

RSUP Persahabatan

Jakarta, Indonesia

Location

Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo

Jakarta, Indonesia

Location

Central Hospital, Gujranwala

Gujranwala, Pakistan

Location

Maroof International Hospital, Islamabad

Islamabad, Pakistan

Location

Rehman Medical Institute

Khaibar, Pakistan

Location

Akram Medical Complex

Lahore, Pakistan

Location

Avicenna Medical College

Lahore, Pakistan

Location

Central Park Teaching Hospital

Lahore, Pakistan

Location

National Hospital and Medical center

Lahore, Pakistan

Location

Al-Shifa Trust Eye Hospital

Rawalpindi, Pakistan

Location

Manuel J. Santos Hospita

Butuan, Philippines

Location

Premiere Medical Center

Cabanatuan City, Philippines

Location

Silang Medical Center

Cavite, Philippines

Location

Davao Medical School Foundation

Davao City, Philippines

Location

St. Paul's Hospital Iloilo

Iloilo City, Philippines

Location

Healthcube Medical Clinic

Mandaluyong, Philippines

Location

Medical Center Manila

Manila, Philippines

Location

Philippine General Hospital

Manila, Philippines

Location

Burjeel Medical City

Abu Dhabi, United Arab Emirates

Location

Life Care Hospital

Abu Dhabi, United Arab Emirates

Location

Medeor hospital

Abu Dhabi, United Arab Emirates

Location

AI Kuwait Hospital

Dubai, United Arab Emirates

Location

Related Publications (1)

• 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.

  PMID: 39025066 RESULT

Related Links

• 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

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 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase1/2: 30 subjects will be randomized in a ratio of 2:1 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. 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.

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 5, 2022
• Study Start: November 23, 2022
• Primary Completion: April 30, 2023
• Study Completion: July 31, 2024
• Last Updated: August 7, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (5); PH (8); AE (4); PA (8)