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

NCT05547243 | Unknown DMC

• 1 other identifier: LVRNA021-IIT-03
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

SARS-CoV-2

Outcome Measures

Primary Outcomes (3)

• SARS-CoV-2 Novel coronavirus S protein antibody (IgG) level

  At 28 days after full immunization

• The levels of neutralizing antibodies of SARS-CoV-2 anti-Novel coronavirus 2019 (Omicron BA.2, BA.4, BA.5 and Delta strains) true virus

  At 28 days after full immunization

• The levels of neutralizing antibodies of SARS-CoV-2 anti-Novel coronavirus 2019 (Omicron BA.2, BA.4, BA.5 and Delta strains) pseudovirus

  At 28 days after full immunization

Secondary Outcomes (20)

• Incidence of adverse events

  Within 14 days and 28 days after each dose of immunization

• Incidence of adverse events associated with the study vaccine

  Within 14 days and 28 days after each dose of immunization

• Incidence of SAE

  Within 28 days, 3 months, 6 months, and 12 months after the first dose of immunization to full immunization

• Incidence of AESI

  Within 28 days, 3 months, 6 months, and 12 months after the first dose of immunization to full immunization

• Incidence of SAE associated with the study vaccine

  Within 28 days, 3 months, 6 months, and 12 months after the first dose of immunization to full immunization

Study Arms (3)

Low dose

EXPERIMENTAL

Two doses were administered by intramuscular injection, 28 days apart

Biological: SARS-CoV-2 mRNA Vaccine, Bivalent Low dose

High dose

EXPERIMENTAL

Two doses were administered by intramuscular injection, 28 days apart

Biological: SARS-CoV-2 mRNA Vaccine, Bivalent High dose

Placebo

PLACEBO COMPARATOR

Two doses were administered by intramuscular injection, 28 days apart

Drug: Placebo

Interventions

SARS-CoV-2 mRNA Vaccine, Bivalent Low dose BIOLOGICAL

50μg/dose

Low dose

SARS-CoV-2 mRNA Vaccine, Bivalent High dose BIOLOGICAL

100μg/dose

High dose

Placebo DRUG

Saline solution

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Smokers (≥20 cigarettes per day on average in the past 30 days), alcoholics (≥61 grams of pure alcohol per day on average for men and ≥41 grams of pure alcohol per day for women in the past 30 days) and drug abuse;
• 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;

Sponsors & Collaborators

• AIM Vaccine Co., Ltd.: lead
• Ningbo Rongan Biological Pharmaceutical Co., Ltd.: collaborator
• The First Affiliated Hospital of Bengbu Medical University: collaborator

Study Sites (1)

First Affiliated Hospital Bengbu Medical College

Bengbu, Anhui, China

Location

MeSH Terms

Interventions

CVnCoV COVID-19 vaccine

Study Officials

• Huan Zhou

  The First Affiliated Hospital of Bengbu Medical University

  PRINCIPAL INVESTIGATOR

• Qiang Wu

  The First Affiliated Hospital of Bengbu Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2022
• First Posted: September 21, 2022
• Study Start: September 26, 2022
• Primary Completion: December 23, 2022
• Study Completion: March 1, 2024
• Last Updated: February 14, 2023

Record last verified: 2022-09

Locations

CN (1)