Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05903118
Other study ID # CP-RBMRNA-001-02
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date January 8, 2022
Est. completion date July 19, 2023

Study information

Verified date January 2024
Source Argorna Pharmaceuticals Co., LTD
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 480
Est. completion date July 19, 2023
Est. primary completion date September 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adults aged 18 years and older, Body Mass Index (BMI) is between 18-30, able to provide legal proof of identity 2. Participants voluntarily agreed to participate in the study and signed an informed consent form 3. 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 4. Axillary temperature =37.3°C on the day of injection 5. 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) 6. Female subjects of childbearing age are not at pregnant period (negative result of pregnancy test) or lactation period 7. Female subjects of childbearing age had taken effective contraceptive measures 1 month before enrollment 8. Female subjects of childbearing age and male subjects agree to use effective contraception for 12 months from the screening visit to the full injection 9. 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: 1. Chest x - ray is clinically significant abnormal as determined by the investigators 2. The vital signs or examinations are clinically significant abnormal as determined by the investigators prior to randomization 3. 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. 4. 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 5. 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 6. 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 7. History or family history of convulsions, epilepsy, encephalopathy, psychiatry, or history of narcolepsy 8. 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 9. Subjects have contraindications to intramuscular injection, such as having been diagnosed with thrombocytopenia, any blood clotting disorder or receiving anticoagulant therapy 10. 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). 11. 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 12. 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 13. Previously received any SARS-CoV-2 vaccine or plan to receive other SARS-CoV-2 vaccines 14. 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 15. 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 16. Female subjects planning to become pregnant or male subjects' partners planning to become pregnant from screening period to 12 months after whole schedule injection 17. Participating in or planning to participate in other clinical trials (drugs or vaccines) within 3 months prior to participating in this study 18. Other circumstances considered by the investigator as inappropriate to participate in the study

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
RBMRNA-176
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection
Other:
Placebo
0.9% sodium chloride (normal saline) injection

Locations

Country Name City State
China Chengdu Xinhua Hospital affiliated to North Sichuan Medical College Chengdu Sichuan

Sponsors (1)

Lead Sponsor Collaborator
Argorna Pharmaceuticals Co., LTD

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Solicited local and systemic adverse reactions (AR) For phase I Within 14 days after each dose
Primary All Adverse Events (AE) related to injection For phase I From the first dose to within 28 days after the whole schedule injection
Primary The level of neutralizing antibody against SARS-CoV-2 For phase II The 28th day after the whole schedule injection
Secondary Unsolicited Adverse Events (AE) For phase I & II After the first dose till before the second dose, and within 28 days after the second dose
Secondary All serious adverse events (SAE) 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
Secondary The level of Immunoglobulin G (IgG) antibody against SARS-CoV-2 S protein 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
Secondary The level of neutralizing antibody against SARS-CoV-2 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
Secondary The level of neutralizing antibody against SARS-CoV-2 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
Secondary Solicited local and systemic ARs For phase II Within 14 days after each dose
Secondary All AEs related to injection For phase II From the first dose to within 28 days after the whole schedule injection
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT04527471 - Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19 Phase 2
Recruiting NCT05584202 - Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants Phase 2
Completed NCT04579549 - Repeat Testing for SARS-CoV-2 N/A
Active, not recruiting NCT05547243 - A Cohort Study of COVID-19 mRNA Vaccine, Bivalent in Participants in China N/A
Recruiting NCT04747574 - Evaluation of the Safety of CD24-Exosomes in Patients With COVID-19 Infection Phase 1
Recruiting NCT04613310 - PCR and Rapid Diagnostic Test on Saliva and Nasopharyngeal Swabs for the Detection of SARS-CoV-2 (COVID-19) N/A
Terminated NCT04447404 - DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury Phase 2
Completed NCT04515147 - A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19 Phase 2
Withdrawn NCT04388709 - Interferon Lambda Therapy for COVID-19 Phase 2
Active, not recruiting NCT05550142 - A Preliminary Exploratory Cohort Study of SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine in Participants Aged 18 Years and Over in China N/A
Completed NCT04620798 - Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students N/A
Active, not recruiting NCT05547256 - A Preliminary Exploratory Cohort Study of COVID-19 mRNA Vaccine, Bivalent in Participants Aged 18 Years and Over in China N/A
Completed NCT04561102 - Evaluation of the COVIDSeq Test in Nasal Swab and Saliva From a COVID-19 Asymptomatic Population
Completed NCT04452604 - Multicentric Registry of Patients With Acute Leukemia Infected by COVID-19
Completed NCT05366322 - A Study to Compare mRNA-1273 Versus BNT162b2 COVID-19 Vaccines Among Immunocompromised Adults
Terminated NCT04958304 - Moderna COVID-19 Vaccine mRNA-1273 Observational Pregnancy Outcome Study
Completed NCT04526769 - Detecting SARS-CoV-2 in Tears
Completed NCT04690413 - NOWDx Test for the Detection of Antibodies to COVID-19 N/A