Overview

A Cohort Study of COVID-19 mRNA Vaccine, Bivalent in Participants in China

Status:
Not yet recruiting
Trial end date:
2024-03-01
Target enrollment:
0
Participant gender:
All
Summary
This is a cohort study to evaluate safety and immunogenicity of COVID-19 mRNA Vaccine, Bivalent (LVRNA021) in participants aged 18 years and over in China
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
AIM Vaccine Co., Ltd.
Collaborators:
First Affiliated Hospital Bengbu Medical College
Ningbo Rongan Biological Pharmaceutical Co. Ltd
Treatments:
Vaccines
Criteria
Inclusion Criteria:

- Age at the time of first dose of vaccine: adults aged 18-59 years (including boundary
values), elderly ≥60 years, both sexes;

- Armpit temperature <37.3℃ on the day of enrollment;

- Based on the medical history and relevant physical examination and laboratory
examination results, the investigator clinically determined that the patient was in
good health;

- Subjects have independent judgment ability, can read, understand and complete
vaccination diary cards, and they participate voluntarily and sign an informed consent
form.

Exclusion Criteria:

- The subject has a history of SARS-CoV-2 or SARS infection, or has a history of contact
with SARS-CoV-2 infected persons (nucleic acid test positive) or suspected infected
persons within 30 days before screening, or living abroad within 30 days before
screening history, or a positive SARS-CoV-2 nucleic acid test or a positive SARS-CoV-2
IgM or IgG test before the first dose of vaccine;

- History of allergy to any component of the study vaccine or a history of a severe
allergic reaction to the vaccine or drug (including but not limited to anaphylactic
shock, anaphylactic laryngeal edema, anaphylactic purpura, thrombocytopenic purpura,
or local anaphylactic necrosis [Arthus reaction]);

- Upon questioning, have a history of COVID-19 vaccination, or have received other
inactivated vaccines within 14 days before screening, and received live attenuated
vaccines within 28 days;

- Patients have a medical history or family history of epilepsy, convulsions,
neurological diseases and mental diseases;

- There are contraindications for intramuscular injection, such as: thrombocytopenia
that has been diagnosed, any coagulation disorder or receiving anticoagulant
treatment, etc.;

- The investigator judges that he is known or suspected of having more serious diseases
at the same time, including but not limited to: respiratory diseases (tuberculosis,
lung failure, etc.), liver and kidney diseases, cardiovascular diseases (heart
failure, severe hypertension, etc.), Malignant tumor, infection or allergic skin
disease, HIV infection (test report can be provided), or during the active period of
acute infection or chronic disease (within 3 days before vaccination);

- Congenital malformations, developmental disorders, or chronic diseases that the
investigator judges are not suitable for participating in this study (such as Downs
syndrome, sickle cell anemia or neurological disorders, Guillain-Barre syndrome,
etc.), excluding stable diabetes/hypertension );

- Patients with known immunological impairment or low immunological function diagnosed
by the hospital before enrollment, or functional asplenia or splenectomy caused by any
situation;

- During the screening period, laboratory tests (ALT, AST, troponin, D-dimer) and
electrocardiogram abnormalities were clinically significant;

- Those with evidence of tobacco, alcohol, and drug abuse, and those who did not agree
to abstain from smoking and drinking during the study period;

- Female: those who have a positive blood pregnancy test, are pregnant, breastfeeding,
or have a pregnancy plan within one year; men: whose spouse has a pregnancy plan
within one year;

- Patients have participated in other clinical trials (drugs, biological products or
devices) within 3 months before the first dose of vaccine, or plan to participate in
other clinical trials during the research period;

- Patients received immune enhancement or immunosuppressive therapy within 6 months
before the first dose of vaccine (continuous oral or instillation for more than 14
days);

- Patients donated blood ≥400 ml within 28 days before screening, or received whole
blood, plasma and immunoglobulin therapy within 6 months before screening;

- Currently receiving research drug treatment to prevent COVID-19;

- Patients are taking antipyretic, analgesic and anti-allergic drugs within 3 days
before enrollment;

- The investigator judges that the subjects cannot follow the research procedures,
comply with the agreement, or plan to permanently relocate from the area before the
end of the research, or plan to leave the local area for a long time during the
scheduled visit period;

- The relevant staff involved in this study or their immediate family members (such as
spouses, parents, siblings or children);

- According to the investigator's judgment, there are other situations that are not
suitable for participating in this clinical trial.