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

NCT05897190 | Completed Phase 1

• 1 other identifier: CP-RBMRNA-001-01-P
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Incidence of solicited local and systemic adverse events (AE)

  Within 14 days after booster vaccination

Secondary Outcomes (3)

• Incidence of serious adverse events (SAEs)

  Within 360 days after booster vaccination

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

  The 14th day, 28th day after booster vaccination

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

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

Study Arms (4)

SARS-CoV-2 mRNA vaccine (RBMRNA-405) adult group

EXPERIMENTAL

One dose was administered by intramuscular injection on day 1

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

SARS-CoV-2 mRNA vaccine (RBMRNA-405) older adult group

EXPERIMENTAL

One dose was administered by intramuscular injection on day 1

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

CoronaVac® adult group

ACTIVE COMPARATOR

One dose was administered by intramuscular injection on day 1

Biological: CoronaVac®

CoronaVac® older adult group

ACTIVE COMPARATOR

One dose was administered by intramuscular injection on day 1

Biological: CoronaVac®

Interventions

SARS-CoV-2 mRNA vaccine (RBMRNA-405) BIOLOGICAL

Dose A

SARS-CoV-2 mRNA vaccine (RBMRNA-405) adult group; SARS-CoV-2 mRNA vaccine (RBMRNA-405) older adult group

CoronaVac® BIOLOGICAL

Dose B

CoronaVac® adult group; CoronaVac® older adult group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Argorna Pharmaceuticals Co., LTD: lead

Study Sites (1)

Chengdu Xinhua Hospital affiliated to North Sichuan Medical College

Chengdu, Sichuan, China

Location

MeSH Terms

Interventions

CVnCoV COVID-19 vaccine; sinovac COVID-19 vaccine

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2023
• First Posted: June 9, 2023
• Study Start: May 16, 2022
• Primary Completion: June 13, 2022
• Study Completion: May 12, 2023
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)