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SARS-CoV-2Phase 1NCT05897190

Evaluate the Safety and Immunogenicity of a SARS-CoV-2 mRNA Vaccine Booster

A Phase 1 study testing SARS-CoV-2 mRNA vaccine (RBMRNA-405) and CoronaVac® in people with SARS-CoV-2, run by Argorna Pharmaceuticals Co., LTD at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. 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?
SARS-CoV-2 mRNA vaccine (RBMRNA-405) and CoronaVac®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
16 May 2022to 12 May 2023
Phase
Phase 1
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 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

Who cannot join

  • 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.
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Chengdu Xinhua Hospital affiliated to North Sichuan Medical College

    Chengdu, Sichuan

Other trials in China

About this study

Official title: 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.

Conditions
SARS-CoV-2
Being tested
SARS-CoV-2 mRNA vaccine (RBMRNA-405), CoronaVac®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SARS-CoV-2 mRNA vaccine (RBMRNA-405)Biological

    Dose A

  • CoronaVac®Biological

    Dose B

Study groups in NCT05897190
Study groupRoleWhat they receive
SARS-CoV-2 mRNA vaccine (RBMRNA-405) adult groupExperimentalOne dose was administered by intramuscular injection on day 1
Receives: Biological: SARS-CoV-2 mRNA vaccine (RBMRNA-405)
SARS-CoV-2 mRNA vaccine (RBMRNA-405) older adult groupExperimentalOne dose was administered by intramuscular injection on day 1
Receives: Biological: SARS-CoV-2 mRNA vaccine (RBMRNA-405)
CoronaVac® adult groupActive comparatorOne dose was administered by intramuscular injection on day 1
Receives: Biological: CoronaVac®
CoronaVac® older adult groupActive comparatorOne dose was administered by intramuscular injection on day 1
Receives: Biological: CoronaVac®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of solicited local and systemic adverse events (AE)

    Measured: Within 14 days after booster vaccination

Secondary outcomes (3)

  1. Incidence of serious adverse events (SAEs)

    Measured: Within 360 days after booster vaccination

  2. The levels of neutralizing antibodies anti-SARS-CoV-2

    Measured: The 14th day, 28th day after booster vaccination

  3. The levels of Immunoglobulin G (IgG) antibody against the S protein of SARS-CoV-2

    Measured: The 7th day, 14th day, 28th day, 90th day, 180th day and 360th day after booster vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2023
  2. Study start16 May 2022
  3. Primary completion13 Jun 2022
  4. Study completion12 May 2023

Resources

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
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05897190
Sponsor's protocol ID
CP-RBMRNA-001-01-P
Status last verified
Mar 2024
First submitted
28 May 2023
Last updated
25 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yong X, He J, Zhang C, Wang Y, Ou Y, Zhang B. Heterologous RBMRNA-405 mRNA booster enhances humoral immunity post-inactivated COVID-19 vaccination: a randomized clinical trial in adults and older through 12 months. Sci Rep. 2026 Mar 25;16(1):14928. doi: 10.1038/s41598-026-45429-w.

    PubMed 41882056

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SARS-CoV-2 mRNA vaccine (RBMRNA-405) and CoronaVac® 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 8 inclusion and 19 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 25 Mar 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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?

Incidence of solicited local and systemic adverse events (AE) (time frame: Within 14 days after booster vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05897190, which also lists 1 linked publication.

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 25 Mar 2024.

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