Clinical Trial of COVID-19 Vaccine（SARS-CoV-2 Variant(Omicron BA.5) mRNA Vaccine） in Participants Aged 18 Years and Over

NCT05745545 | Unknown

• 1 other identifier: LVRNA012-IIT-04
• Study Type: interventional
• Target: 3,200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, randomized, blinded, placebo-controlled clinical trial to evaluate the protective efficacy, safety and immunogenicity of one dose of the SARS-CoV-2 variant (Omicron BA.5) mRNA vaccine in people aged 18 years and older who had received two or three doses of inactivated COVID-19 vaccine.

Conditions

SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Person-year incidence of symptomatic COVID-19 of any severity among persons 18 years of age and older who had received 2 or 3 doses of inactivated COVID-19 vaccine

  Person-year incidence of symptomatic COVID-19 of any severity 14 days after vaccination (≥D14) with a booster dose of study vaccine or placebo among persons 18 years of age and older who had received 2 or 3 doses of inactivated COVID-19 vaccine

  14 days after vaccination or placebo

Secondary Outcomes (13)

• Person-year incidence of severe and critical COVID-19 in persons aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine

  14 days after vaccination or placebo

• Person-year incidence of COVID-19 resulting in death in persons aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine

  14 days after vaccination or placebo

• Person-year incidence of symptomatic COVID-19 of any severity among persons aged 18-59 years and ≥60 years who had received 2 or 3 doses of inactivated COVID-19 vaccine

  14 days after vaccination or placebo

• GMT of true virus neutralizing antibodies against the current major circulating strain of SARS-CoV-2 in subjects in the immunization subgroup

  7 days, 14 days, 28 days, 3 months, and 6 months after vaccination or placebo

• GMI of true virus neutralizing antibodies against the current major circulating strain of SARS-CoV-2 in subjects in the immunization subgroup

  7 days, 14 days, 28 days, 3 months, and 6 months after vaccination or placebo

Other Outcomes (6)

• Person-year incidence of COVID-19 of any severity in persons aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine

  7 days after vaccination or placebo

• Immune subgroup: viral antigen IL-2 levels

  7 days, 14 days, 28 days and 3 months after vaccination or placebo

• Immune subgroup: viral antigen IL-4 levels

  7 days, 14 days, 28 days and 3 months after vaccination or placebo

Study Arms (2)

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

EXPERIMENTAL

Biological: SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine

Placebo

PLACEBO COMPARATOR

Drug: Saline solution

Interventions

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

One dose was administered by intramuscular injection, 100μg，1.0ml/dose

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

Saline solution DRUG

One dose was administered by intramuscular injection, 0.5ml/vial

Placebo

Eligibility Criteria

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

You may qualify if:

• Both male and female adults aged 18 and above who can provide identification;
• Know the contents of the informed consent form and the situation of the vaccination, sign the informed consent form voluntarily, and have the ability to use the thermometer, scale and fill in the diary card and contact card as required;
• Ability to communicate well with researchers, understand and comply with the requirements of the study;
• Two or three doses of COVID-19 inactivated vaccine have been completed and ≥6 months have passed since the last dose of COVID-19 inactivated vaccine;
• Women who are not possibility to have children (amenorrhea for at least 1 year or surgical sterilization with medical records) or who are known not to be pregnant or lactating and who have used effective contraception for nearly 14 days before vaccination (e.g., Intrauterine or implantable contraceptive devices,oral contraceptives, injected or embedded contraceptives, slow-release topical contraceptives, intrauterine devices (IUD), condoms (male), diaphragm, cervical cap, etc.) (provide negative proof of pregnancy within 48 hours);
• SARS-CoV-2 etiology test (RT-PCR) was negative within 48 hours.

You may not qualify if:

• Abnormal vital signs that are clinically significant (e.g. abnormal controlled blood pressure);
• Have been infected with COVID-19 or used any COVID-19 prophylactic medication other than 3 doses of COVID-19 inactivated vaccine within the last 6 months (for example, a history of any other non-COVID-19 inactivated vaccine on or off the market, or 1 or 4 doses of COVID-19 inactivated vaccine);
• History of severe acute respiratory syndrome (SARS), Middle East Respiratory Syndrome (MERS) and other human coronavirus infection or disease history;
• Axillary temperature ≥37.3℃ or fever within 24 hours on the day of vaccination (axillary temperature ≥37.3℃/ mouth temperature ≥37.5℃);
• A history of severe allergic reactions or allergic reactions to vaccines or drugs, such as urticaria, severe eczema, dyspnea, laryngeal edema, angioneurotic edema, etc.;
• Vaccination of any vaccine within 28 days prior to study vaccination;
• Enrolled in a clinical study of another drug within 28 days before vaccination or planned to participate in a clinical study of another drug within 6 months after vaccination;
• Have a genetic tendency to bleed or abnormal coagulation function (e.g. cytokine deficiency, coagulation disorder or thrombocytopenia), or a history of severe bleeding;
• A known history or diagnosis of a disease affecting immune system function, such as cancer (other than basal cell carcinoma of the skin), congenital or acquired immunodeficiency (e.g., HIV infection), uncontrolled autoimmune disease, etc.;
• Asplenia or functional asplenia;
• Long-term use (continuous use ≥14 days) of immunosuppressants or other immunomodulatory drugs (e.g., cortisol: prednisone or similar drugs) within 6 months prior to study vaccination; Interferon, etc.), but topical use (such as ointments, eye drops, inhalants or nasal sprays) is permitted, and the dose of topical use shall not exceed that recommended in the instructions;
• Received immunoglobulin and/or blood products within 3 months prior to study vaccination;
• Suspected or known alcohol dependence or drug abuse;
• Other factors considered inappropriate to be included in the study.

Sponsors & Collaborators

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

Study Sites (1)

First Affiliated Hospital Bengbu Medical College

Bengbu, Anhui, China

RECRUITING

Related Publications (3)

• Vetter VM, Kurth T, Konigorski S. Evaluation of easy-to-implement anti-stress interventions in a series of N-of-1 trials: study protocol of the anti-stress intervention among physicians study. Front Psychiatry. 2024 Aug 23;15:1420097. doi: 10.3389/fpsyt.2024.1420097. eCollection 2024.

  PMID: 39247614 DERIVED

• Emadi Torghabeh A, Aledavood SA, Soltani E, Akbari Oryani M, Akhlaghi S, Hosseini S, Fani Pakdel A, Taghizadeh Kermani A, Anvari K, Shahidsales S, Bahadorian S, Mashreghi Moghaddam S. Pathologic response evaluation of localized or locally advanced esophageal carcinoma to induction chemotherapy followed by preoperative concurrent chemotherapy and hypofractionated radiotherapy: a clinical trial. Front Oncol. 2024 Aug 19;14:1439730. doi: 10.3389/fonc.2024.1439730. eCollection 2024.

  PMID: 39224811 DERIVED

• Zhou H, Zheng H, Peng Y, Su Y, Yu X, Wang W, Li S, Ding Y, Jiao S, Wang Y, Zhu X, Luo L, Dong Z, Liu L, Zhang F, Wu Q, Li J, Zhu F. Efficacy, safety, and immunogenicity of SARS-CoV-2 mRNA vaccine (Omicron BA.5) LVRNA012: a randomized, double-blind, placebo-controlled phase 3 trial. Front Immunol. 2024 Jun 6;15:1407826. doi: 10.3389/fimmu.2024.1407826. eCollection 2024.

  PMID: 38903523 DERIVED

MeSH Terms

Interventions

mRNA Vaccines; Saline Solution

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; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

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

Central Study Contacts

Huan Zhou

CONTACT

13665527160; zhouhuanbest@163.com

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: February 16, 2023
• First Posted: February 27, 2023
• Study Start: January 4, 2023
• Primary Completion: September 1, 2023
• Study Completion: November 1, 2023
• Last Updated: February 28, 2023

Record last verified: 2022-12

Locations

CN (1)