A Phase I/II, Randomized, Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (RBMRNA-176) in Healthy Adults Aged 18 Years and Older

Argorna Pharmaceuticals Co., LTD1 site in 1 country480 target enrollmentJanuary 8, 2022

ConditionsSARS-CoV-2

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: SARS-CoV-2
Sponsor: Argorna Pharmaceuticals Co., LTD
Enrollment: 480
Locations: 1
Primary Endpoint: Solicited local and systemic adverse reactions (AR)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The phase I/II study is to evaluate the safety and immunogenicity of SARS-COV-2 mRNA Vaccine (RBMRNA-176) at different doses in healthy subjects aged 18 years and older.

Registry

clinicaltrials.gov

Start Date

January 8, 2022

End Date

July 19, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Argorna Pharmaceuticals Co., LTD

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adults aged 18 years and older, Body Mass Index (BMI) is between 18-30, able to provide legal proof of identity
•Participants voluntarily agreed to participate in the study and signed an informed consent form
•The subject has ability to understand the research process and is willing and able to comply with all research proposals and other requirements of the study
•Axillary temperature ≤37.3°C on the day of injection
•Negative SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) test, without infective history of severe acute respiratory syndrome (SARS), coronavirus disease 2019 (COVID-19), Middle East Respiratory Syndrome (MERS)
•Female subjects of childbearing age are not at pregnant period (negative result of pregnancy test) or lactation period
•Female subjects of childbearing age had taken effective contraceptive measures 1 month before enrollment
•Female subjects of childbearing age and male subjects agree to use effective contraception for 12 months from the screening visit to the full injection
•Female subjects of childbearing age and male subjects agree that do not donate eggs (eggs, oocytes) for assisted reproduction (female subjects of childbearing age) or avoid sperm donation (male subjects) from screening period until 12 months after injection

Exclusion Criteria

•Chest x - ray is clinically significant abnormal as determined by the investigators
•The vital signs or examinations are clinically significant abnormal as determined by the investigators prior to randomization
•A history of severe allergy (including drugs, vaccines, and foods) or to any component of the experimental vaccine, e.g., allergic shock, allergic laryngeal edema, anaphylactoid purpura, dyspnea, and angioedema, etc.
•Subjects have been diagnosed with a serious disease, congenital malformation or chronic disease (including but not limited to: respiratory disease or chronic bronchitis such as asthma, serious cardiovascular disease, kidney disease, autoimmune disease, thrombocytopenic purpura, thalassemia, malignant tumor, hereditary allergic constitution, etc.) that may interfere with the conduct or completion of the study
•Diagnosed with diseases may affect immune system function, congenital or acquired immune deficiency or suppression (e.g., tuberculosis, human immunodeficiency virus (HIV)), Hepatitis B, hepatitis C, syphilis infection, uncontrollable autoimmune disease, no spleen or spleen dysfunction
•Lymph node - related diseases (such as lymphadenitis, lymph node adhesion, lymph node tuberculosis, tumor metastasis, etc.) or skin scars and fistulas at the lymph node site, or lymphadenopathy, tenderness, skin redness and swelling at the lymph node site within 7 days prior to injection
•History or family history of convulsions, epilepsy, encephalopathy, psychiatry, or history of narcolepsy
•Within 3 days prior to injection, an acute illness or attack of a chronic disease, or the use of antipyretic analgesic or anti - allergic drugs
•Subjects have contraindications to intramuscular injection, such as having been diagnosed with thrombocytopenia, any blood clotting disorder or receiving anticoagulant therapy
•Long-term use of immunopotentiator or immunosuppressant therapy within 6 months prior to the first dose injection (continuous orally or by injection for more than 14 days).

Outcomes

Primary Outcomes

Solicited local and systemic adverse reactions (AR)

Time Frame: Within 14 days after each dose

For phase I

The level of neutralizing antibody against SARS-CoV-2

Time Frame: The 28th day after the whole schedule injection

For phase II

All Adverse Events (AE) related to injection

Time Frame: From the first dose to within 28 days after the whole schedule injection

For phase I

Secondary Outcomes

The level of neutralizing antibody against SARS-CoV-2(The 21st day after the first dose, and the 7th day, 90th day, 180th day, 360th day after the whole schedule injection)
Unsolicited Adverse Events (AE)(After the first dose till before the second dose, and within 28 days after the second dose)
The level of Immunoglobulin G (IgG) antibody against SARS-CoV-2 S protein(The 21st day after the first dose, and the 7th day, 28th day, 90th day, 180th day, 360th day after the whole schedule injection)
All AEs related to injection(From the first dose to within 28 days after the whole schedule injection)
All serious adverse events (SAE)(Within 21 days after the first dose, and within 28 days after the second dose, and 90days, 180 days, 360 days after the whole schedule injection)
Solicited local and systemic ARs(Within 14 days after each dose)