A Study to Evaluate Safety, Tolerability, and Immunogenicity of SARS-CoV-2 Variant (COVID-19) mRNA Vaccines

NCT05434585 | Unknown Phase 1

• 1 other identifier: ABO1009-CoV.617.2-101Indonesia
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

A Phase 1 study to evaluate safety, tolerability, and immunogenicity of SARS-CoV-2 variant mRNA vaccines which are used to prevent COVID-19 caused by SARS-CoV-2 infection. this study is conducted during Indonesian subjects aged 18 years and older who have not received SARS-CoV-2 vaccines.

Conditions

COVID-19

Keywords

Delta; Omicron; COVID-19

Outcome Measures

Primary Outcomes (3)

• Incidence of solicited adverse events (AEs)

  Solicited adverse events 0 to 7 days after each injection；

  0 to 7 days after each injection

• Incidence of unsolicited AEs

  Unsolicited adverse events 0 to 28 days after each injection ； Adverse reactions/events related to blood chemistry, blood routine, blood coagulation function and urinalysis indicators 4 days after each injection

  0 to 28 days after each injection

• Changes of blood chemistry, blood routine, blood coagulation function and urinalysis indicators 4 days after each injection in comparison to pre-injection

  Adverse reactions/events related to blood chemistry, blood routine, blood coagulation function and urinalysis indicators 4 days after each injection

  4 days after each injection in comparison to pre-injection

Secondary Outcomes (2)

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

  from the first vaccination to 12 months after 2 injections

• Collection of Safety information

  through 12 months after 2 injections

Study Arms (3)

Test group 1: ABO1009-DP

EXPERIMENTAL

Intramuscularly injecting 15 μg of ABO1009-DP into lateral deltoid of the upper arm of subjects on D0 and D28, respectively.

Biological: ABO1009-DP

Test group 2: ABO-CoV.617.2

EXPERIMENTAL

Intramuscularly injecting 15 μg of ABO-CoV.617.2 into lateral deltoid of the upper arm of subjects on D0 and D28, respectively.

Biological: ABO-CoV.617.2

Control group: Placebo

PLACEBO COMPARATOR

Intramuscularly injecting placebo into lateral deltoid of the upper arm of subjects on D0 and D28, respectively

Other: Placebo

Interventions

ABO1009-DP BIOLOGICAL

Vaccine

Test group 1: ABO1009-DP

ABO-CoV.617.2 BIOLOGICAL

Vaccine

Test group 2: ABO-CoV.617.2

Placebo OTHER

Placebo

Control group: 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.
• Have not previously received any SARS-CoV-2 vaccine (marketed or investigational) before screening.
• Be able to communicate well with the investigator, and to understand and comply with the requirements of this clinical trial.
• Males or females of childbearing potential voluntarily take effective contraceptive methods from signing ICF to 3 months after the last 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:

• Subjects should not participate in this clinical study if any of the following criteria is met:
• \. Subjects who do not meet health standard upon comprehensive physical examination, mainly including:
• 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 significance.
• Body mass index (BMI) \< 18 kg/m2 or \> 30 kg/m2.
• Abnormal laboratory values and with clinical significance at the investigator's discretion at screening.
• Subjects who do not remain overall healthy (i.e., 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.
• \. SARS-CoV-2 specific antibody positive at screening. 3. Positive SARS-CoV-2 RT-PCR result at screening. 4. Prior medical history of SARS-CoV-2, severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS), or other human coronavirus infections or diseases.
• \. Fever (axillary temperature ≥ 37.3℃) on the day of vaccination with this study vaccine or within recent 72 hours.
• \. 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 vaccine within 28 days before using this study vaccine or planning to use any vaccine other than this study vaccine during the study period.
• Note: The exception is that licensed influenza vaccines can be received more than 28 days after the second dose of study injection.
• \. 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 \[HIV\]), uncontrolled autoimmune disease.

Sponsors & Collaborators

• Suzhou Abogen Biosciences Co., Ltd.: lead

Study Sites (2)

Dr. Cipto Mangunkusumo Hospital

Jakarta, Indonesia

Location

Persahabatan Hospital

Jakarta, Indonesia

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 Officials

• Dingfeng Wu

  Suzhou Abogen Biosciences Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-Blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 60 subjects will be randomized in a 2:2:1 ratio to receive ABO1009-DP, ABO-CoV.617.2, or placebo

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 28, 2022
• Study Start: July 8, 2022
• Primary Completion: October 10, 2022
• Study Completion: August 30, 2023
• Last Updated: February 8, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)