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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19
• Intervention / Treatment: Biological: Placebo; Biological: ABO1020

• Study Type: Interventional
• Enrollment (Actual): 14168
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Depok, Indonesia
    • RS Universitas Indonesia
  • Jakarta, Indonesia
    • RS YARSI
  • Jakarta, Indonesia
    • RSIJ Cempaka Putih
  • Jakarta, Indonesia
    • RSUP Persahabatan
  • Jakarta, Indonesia
    • Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo
• Pakistan
  • Gujranwala, Pakistan
    • Central Hospital, Gujranwala
  • Islamabad, Pakistan
    • Maroof International Hospital, Islamabad
  • Khyber, Pakistan
    • Rehman Medical Institute
  • Lahore, Pakistan
    • Akram Medical Complex
  • Lahore, Pakistan
    • National Hospital and Medical center
  • Lahore, Pakistan
    • Avicenna Medical College
  • Lahore, Pakistan
    • Central Park Teaching Hospital
  • Rawalpindi, Pakistan
    • Al-Shifa Trust Eye Hospital
• Philippines
  • Butuan, Philippines
    • Manuel J. Santos Hospita
  • Cabanatuan, Philippines
    • Premiere Medical Center
  • Cavite, Philippines
    • Silang Medical Center
  • Davao, Philippines
    • Davao Medical School Foundation
  • Iloilo, Philippines
    • St. Paul's Hospital Iloilo
  • Mandaluyong, Philippines
    • Healthcube Medical Clinic
  • Manila, Philippines
    • Philippine General Hospital
  • Manila, Philippines
    • Medical Center Manila
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Burjeel Medical City
  • Abu Dhabi, United Arab Emirates
    • Life care Hospital
  • Abu Dhabi, United Arab Emirates
    • Medeor hospital
  • Dubai, United Arab Emirates
    • AI Kuwait Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: ABO1020; Vaccine
Placebo Comparator: 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.	Biological: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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
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.
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

Collaborators and Investigators

• Sponsor: Suzhou Abogen Biosciences Co., Ltd.

Publications and helpful links

General Publications

• 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 Jul 12:S2666-6340(24)00259-9. doi: 10.1016/j.medj.2024.06.013. Online ahead of print.

Helpful 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

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2022
• Primary Completion (Actual): April 30, 2023
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: November 23, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; Omicron
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: ABO1020-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No