A Preliminary Exploratory Cohort Study of SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine in Participants Aged 18 Years and Over in China

NCT05550142 | Unknown DMC

• 1 other identifier: LVRNA012-IIT-02
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

This is a preliminary exploratory cohort study to evaluate safety, tolerability and immunogenicity of SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine (LVRNA012) in participants aged 18 years and over in China.

Conditions

SARS-CoV-2

Outcome Measures

Primary Outcomes (3)

• Incidence of solicited adverse events

  Within 28 days after each dose/full dose

• Incidence of unsolicited adverse events

  Within 28 days after each dose/full dose

• Incidence of adverse events associated with the study vaccine

  Within 28 days after each dose/full dose

Secondary Outcomes (8)

• Incidence of grade ≥3 adverse events

  Within 28 days after each dose/full dose

• Incidence of grade ≥3 adverse events associated with the study vaccine

  Within 28 days after each dose/full dose

• Statistics of withdrawal from the study due to adverse events

  Within 28 days after each dose/full dose

• 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

Other Outcomes (13)

• The positive conversion rate of S-protein specific antibody (IgG) against Novel coronavirus 2019

  14 and 28 days after the first dose and 7, 14, 28 days, and 3, 6, and 12 months after the full course of vaccination

• The geometric mean titers (GMT) of S protein-specific antibody (IgG) against Novel coronavirus 2019

  14 and 28 days after the first dose and 7, 14, 28 days, and 3, 6, and 12 months after the full course of vaccination

• The average growth fold compared with the baseline before exemption of S protein-specific antibody (IgG) against Novel coronavirus 2019

  14 and 28 days after the first dose and 7, 14, 28 days, and 3, 6, and 12 months after the full course of vaccination

Study Arms (2)

SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine 50μg

EXPERIMENTAL

Two doses were administered by intramuscular injection, 28 days apart

Biological: SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine Low dose; Drug: Placebo

SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine 100μg

EXPERIMENTAL

Two doses were administered by intramuscular injection, 28 days apart

Biological: SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine High dose; Drug: Placebo

Interventions

SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine Low dose BIOLOGICAL

50μg/dose

SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine 50μg

SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine High dose BIOLOGICAL

100μg/dose

SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine 100μg

Placebo DRUG

Saline solution

SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine 100μg; SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine 50μg

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;
• 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;
• During the screening period, laboratory tests (blood routine, urine routine, blood biochemistry, troponin, coagulation routine, D-dimer) and electrocardiogram abnormalities were clinically significant;
• 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;

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

mRNA Vaccines

Intervention Hierarchy (Ancestors)

Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines, Acellular; Vaccines, Subunit; Vaccines; Biological Products; Complex Mixtures; Antigens; Biological Factors

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 22, 2022
• Study Start: September 16, 2022
• Primary Completion: December 19, 2022
• Study Completion: March 1, 2024
• Last Updated: February 14, 2023

Record last verified: 2022-09

Locations

CN (1)