- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05897190
Evaluate the Safety and Immunogenicity of a SARS-CoV-2 mRNA Vaccine Booster
March 21, 2024 updated by: Argorna Pharmaceuticals Co., LTD
Evaluate the Safety and Immunogenicity of a SARS-CoV-2 mRNA Vaccine (RBMRNA-405) as a Booster in Chinese Adults & Older
This study is to evaluate the safety and immunogenicity of a SARS-CoV-2 mRNA Vaccine as a heterologous booster dose in adults who completed 2 doses of inactivated vaccination through 12 months in China.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- 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 the ability to understand the study process and is willing and able to comply with all study proposals and other requirements of the study
- Be willing and able to comply with protocol and complete 12-month study follow-up
- Have received 2 doses of inactivated SARS-CoV-2 vaccine for 6 months and less than 12 months before enrollment
- Male and female subjects of childbearing age agree to use effective contraception from screening period until 12 months after vaccination; female subjects of childbearing age have taken effective contraceptive measures 1 month before enrollment
- Female subjects of childbearing age are not at pregnant period (negative result of pregnancy test) or lactation period
- Male and female subjects of child-bearing age agree that do not donate eggs (eggs, oocytes) for assisted reproduction (female subjects of reproductive age) or avoid sperm donation (male subjects) from screening period until 12 months after vaccination
Exclusion Criteria:
- Have received any SARS-CoV-2 vaccines other than 2 doses of the inactivated vaccine
- History of Severe Acute Respiratory Syndrome (SARS), Coronavirus disease 2019 (COVID-19), Middle East Respiratory Syndrome (MERS) and other human coronavirus infections or disease
- Positive SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) test
- The vital signs or physical examination are clinically significant abnormal as determined by the investigators in screening
- Fever (axillary temperature≥37.3°C) on the day of the vaccination
- A history of severe allergy (including drugs, vaccines, and foods) or to any component of the experimental vaccine, e.g., allergic shock, laryngeal edema, anaphylactoid purpura, dyspnea, and angioedema, etc.
- Subjects have contraindications to intramuscular injection, such as having been diagnosed with thrombocytopenia, any blood clotting disorder, or receiving anticoagulant therapy
- Subjects have been diagnosed with a serious disease, congenital malformation or chronic disease (including but not limited to respiratory disease or bronchitis such as asthma, serious cardiovascular disease, serious cerebrovascular disease, kidney disease, serious or uncontrollable diabetes, 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, including malignant tumor, 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
- History or family history of central nervous system disease, convulsions or tics, epilepsy, meningitis, neurological disorders, mental disorders, cerebritis, myelitis, Guillain-Barre syndrome, etc
- Long-term use of immunopotentiator or immunosuppressant therapy within 6 months prior to vaccination (continuous oral or 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.) or have received solid organ or bone marrow transplantation within 3 months prior to vaccination
- 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 vaccination
- Within 3 days prior to vaccination, an acute illness or attack of a chronic disease, or the use of antipyretic analgesic or anti - allergic drugs
- Other vaccines have been administered within 4 weeks prior to the trial vaccination or other vaccination schedule (except for emergency vaccinations such as Rabies vaccine and Tetanus vaccine) between the screening period and 28 days after the vaccination
- Participating in or planning to participate in other clinical trials (drugs or vaccines) within 3 months prior to participating in this study
- Any blood loss >400 mL (e.g., donation of blood or blood components or injury) within 28 days prior to the screening visit, or plans to donate blood or blood components between the screening visit and 28 days post-vaccination
- Any abnormal or permanent body art (such as tattoos) at the site of the vaccination, which the researchers think to interfere with observing local reactions at the site of the vaccination
- 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 |
---|---|
Active Comparator: CoronaVac® adult group
One dose was administered by intramuscular injection on day 1
|
Dose B
|
Experimental: SARS-CoV-2 mRNA vaccine (RBMRNA-405) adult group
One dose was administered by intramuscular injection on day 1
|
Dose A
|
Experimental: SARS-CoV-2 mRNA vaccine (RBMRNA-405) older adult group
One dose was administered by intramuscular injection on day 1
|
Dose A
|
Active Comparator: CoronaVac® older adult group
One dose was administered by intramuscular injection on day 1
|
Dose B
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of solicited local and systemic adverse events (AE)
Time Frame: Within 14 days after booster vaccination
|
Within 14 days after booster vaccination
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The levels of Immunoglobulin G (IgG) antibody against the S protein of SARS-CoV-2
Time Frame: The 7th day, 14th day, 28th day, 90th day, 180th day and 360th day after booster vaccination
|
The 7th day, 14th day, 28th day, 90th day, 180th day and 360th day after booster vaccination
|
Incidence of serious adverse events (SAEs)
Time Frame: Within 360 days after booster vaccination
|
Within 360 days after booster vaccination
|
The levels of neutralizing antibodies anti-SARS-CoV-2
Time Frame: The 14th day, 28th day after booster vaccination
|
The 14th day, 28th day after booster vaccination
|
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)
May 16, 2022
Primary Completion (Actual)
June 13, 2022
Study Completion (Actual)
May 12, 2023
Study Registration Dates
First Submitted
May 28, 2023
First Submitted That Met QC Criteria
May 31, 2023
First Posted (Actual)
June 9, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- CP-RBMRNA-001-01-P
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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