- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05903118
A Phase I/II Study to Evaluate a SARS-CoV-2 mRNA Vaccine in Healthy Adults
January 9, 2024 updated by: Argorna Pharmaceuticals Co., LTD
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
480
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China
- Chengdu Xinhua Hospital affiliated to North Sichuan Medical College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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).
- Use of any blood or blood - related products (e.g., blood transfusion, use of human albumin, human immunoglobulin, etc.) within 6 months prior to the first dose injection
- Any blood lost > 400 mL within 28 days prior to the screening visit (e.g., donate blood or component blood, or injured), or plan to donate blood or component blood between the screening visit and 28 days after the last dose injection
- Previously received any SARS-CoV-2 vaccine or plan to receive other SARS-CoV-2 vaccines
- Other vaccines have been administered within 4 weeks prior to the first dose injection or other injection schedule (except for emergency injections such as Rabies vaccine and Tetanus vaccine) between the screening period and 28 days after the injection
- Any abnormal or permanent body art (such as tattoos) at the site of the injection, which the researchers think to interfere with observing local reactions at the site of the injection
- Female subjects planning to become pregnant or male subjects' partners planning to become pregnant from screening period to 12 months after whole schedule injection
- Participating in or planning to participate in other clinical trials (drugs or vaccines) within 3 months prior to participating in this study
- Other circumstances considered by the investigator as inappropriate to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
0.9% sodium chloride (normal saline) injection
|
Experimental: Participants aged 18 to 59 years.
Escalating dose levels
|
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection
|
Experimental: Participants aged 60 years and older.
Escalating dose levels
|
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Solicited local and systemic adverse reactions (AR)
Time Frame: Within 14 days after each dose
|
For phase I
|
Within 14 days after each dose
|
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
|
From the first dose to within 28 days after the whole schedule injection
|
The level of neutralizing antibody against SARS-CoV-2
Time Frame: The 28th day after the whole schedule injection
|
For phase II
|
The 28th day after the whole schedule injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unsolicited Adverse Events (AE)
Time Frame: After the first dose till before the second dose, and within 28 days after the second dose
|
For phase I & II
|
After the first dose till before the second dose, and within 28 days after the second dose
|
All serious adverse events (SAE)
Time Frame: 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
|
For phase I & II
|
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
|
The level of Immunoglobulin G (IgG) antibody against SARS-CoV-2 S protein
Time Frame: The 21st day after the first dose, and the 7th day, 28th day, 90th day, 180th day, 360th day after the whole schedule injection
|
For phase I & II
|
The 21st day after the first dose, and the 7th day, 28th day, 90th day, 180th day, 360th day after the whole schedule injection
|
The level of neutralizing antibody against SARS-CoV-2
Time Frame: The 21st day after the first dose, and the 7th day, 28th day, 90th day, 180th day, 360th day after the whole schedule injection
|
For phase I
|
The 21st day after the first dose, and the 7th day, 28th day, 90th day, 180th day, 360th day after the whole schedule injection
|
The level of neutralizing antibody against SARS-CoV-2
Time Frame: The 21st day after the first dose, and the 7th day, 90th day, 180th day, 360th day after the whole schedule injection
|
For phase II
|
The 21st day after the first dose, and the 7th day, 90th day, 180th day, 360th day after the whole schedule injection
|
Solicited local and systemic ARs
Time Frame: Within 14 days after each dose
|
For phase II
|
Within 14 days after each dose
|
All AEs related to injection
Time Frame: From the first dose to within 28 days after the whole schedule injection
|
For phase II
|
From the first dose to within 28 days after the whole schedule injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 8, 2022
Primary Completion (Actual)
September 1, 2022
Study Completion (Actual)
July 19, 2023
Study Registration Dates
First Submitted
June 12, 2023
First Submitted That Met QC Criteria
June 12, 2023
First Posted (Actual)
June 15, 2023
Study Record Updates
Last Update Posted (Actual)
January 10, 2024
Last Update Submitted That Met QC Criteria
January 9, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- CP-RBMRNA-001-02
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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