SARS-CoV-2Phase 1/2NCT05903118
A Phase I/II Study to Evaluate a SARS-CoV-2 mRNA Vaccine in Healthy Adults
A Phase 1/2 study testing RBMRNA-176 in people with SARS-CoV-2, run by Argorna Pharmaceuticals Co., LTD at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- RBMRNA-176
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2022to 19 Jul 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Chengdu Xinhua Hospital affiliated to North Sichuan Medical College
Chengdu, Sichuan
About this study
Official title: 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.
- Conditions
- SARS-CoV-2
- Being tested
- RBMRNA-176, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RBMRNA-176Biological
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection
PlaceboOther
0.9% sodium chloride (normal saline) injection
| Study group | Role | What they receive |
|---|---|---|
| Participants aged 18 to 59 years. | Experimental | Escalating dose levels Receives: Biological: RBMRNA-176 |
| Participants aged 60 years and older. | Experimental | Escalating dose levels Receives: Biological: RBMRNA-176 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited local and systemic adverse reactions (AR)
For phase I
Measured: Within 14 days after each dose
All Adverse Events (AE) related to injection
For phase I
Measured: From the first dose to within 28 days after the whole schedule injection
The level of neutralizing antibody against SARS-CoV-2
For phase II
Measured: The 28th day after the whole schedule injection
Secondary outcomes (7)
Unsolicited Adverse Events (AE)
For phase I \& II
Measured: After the first dose till before the second dose, and within 28 days after the second dose
All serious adverse events (SAE)
For phase I \& II
Measured: 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
For phase I \& II
Measured: 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
For phase I
Measured: 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
For phase II
Measured: 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
For phase II
Measured: Within 14 days after each dose
All AEs related to injection
For phase II
Measured: From the first dose to within 28 days after the whole schedule injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start8 Jan 2022
- Primary completion1 Sep 2022
- Study completion19 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Argorna Pharmaceuticals Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903118
- Sponsor's protocol ID
- CP-RBMRNA-001-02
- Status last verified
- Jan 2024
- First submitted
- 12 Jun 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05903118
- Acronym / sponsor ID
- CP-RBMRNA-001-02
- Conditions
- SARS-CoV-2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Argorna Pharmaceuticals Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 8 Jan 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Participants aged 18 to 59 years. | Experimental | Biological: RBMRNA-176Escalating dose levels |
| Participants aged 60 years and older. | Experimental | Biological: RBMRNA-176Escalating dose levels |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RBMRNA-176Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection | Biological | Participants aged 18 to 59 years., Participants aged 60 years and older. |
| Placebo0.9% sodium chloride (normal saline) injection | Other | Placebo |
Primary outcome
Solicited local and systemic adverse reactions (AR)
Time frame: Within 14 days after each dose
For phase I
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
The level of neutralizing antibody against SARS-CoV-2
Time frame: The 28th day after the whole schedule injection
For phase II
7 secondary outcomes
Unsolicited Adverse Events (AE)
Time frame: 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
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
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
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
Solicited local and systemic ARs
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for SARS-CoV-2
RecruitingPhase 2
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age
SARS-CoV-2
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Active, not recruitingObservational study
Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)
COVID-19 Vaccination
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RBMRNA-176 in people with SARS-CoV-2, run by Argorna Pharmaceuticals Co., LTD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Solicited local and systemic adverse reactions (AR) (time frame: Within 14 days after each dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.