COVID-19
Conditions
Interventions
Experimental group:Omicron BA.5 mRNA vaccine 100µg, Single injection
Control group:Normal saline, Single injection
Sponsors
The First Affiliated Hospital of Bengbu Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Both male and female adults aged 18 and above who can provide identification; 2.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; 3.Ability to communicate well with researchers, understand and comply with the requirements of the study; 4.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; 5.Healthy subjects or subjects with mild underlying diseases [stable condition with no worsening condition (no need for hospitalization or no major adjustment in treatment regimen, etc.) for at least 3 months prior to inclusion in the study]; 6.Women who are not possibility to have children (amenorrhea for at least 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 (lD), condoms (male), diaphragm, cervical cap, etc.) (provide negative proof of pregnancy within 48 hours); 7.SARS-CoV-2 etiology test (RT-PCR) was negative within 48 hours.
Exclusion criteria
Exclusion criteria: 1.Abnormal vital signs that are clinically significant (e.g.,abnormal controlled blood pressure); 2.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); 3.History of severe acute respiratory syndrome (SARS), Middle East Respiratory Syndrome (MERs) and other human coronavirus infection or disease history; 4.Axillary temperature =37.3? or fever within 24 hours on the day of vaccination (axillary temperature =37.3? / mouth temperature =37.5?); 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.; 6.Vaccination of any vaccine within 28 days prior to study vaccination; 7.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; 8.Have an inherited tendency to bleed or have abnormal clotting function(e.g.,cytokine deficiency, coagulation disorder or thrombocytopenia), or a history of severe bleeding; 9.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.; 10.Asplenia or functional asplenia; 11.Long-term use (continuous use=14 days) of immunosuppressants or other immunomodulatory drugs (e.g., cortisol: prednisone or similar drugs, Interferon, etc.) within 6 months prior to study vaccination, 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 theinstructions; 12.Received immunoglobulin and/or blood products within 3 months prior to study vaccination; 13.Suspected or known alcohol dependence or drug abuse; 14.Other factors considered inappropriate to be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Person-year incidence of symptomatic COVID-19 of any severity 14 days (=D14) after booster immunization with 1 dose of study vaccine or placebo in persons aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine; | — |
Secondary
| Measure | Time frame |
|---|---|
| Person-year incidence of severe and critical COVID-19 after 14 days (=D14) of booster immunization with 1 dose of study vaccine or placebo in persons aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine;Person-year incidence of COVID-19 resulting in death 14 days (=D14) after booster vaccination with 1 dose of study vaccine or placebo in persons aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine;In the immunization subgroup, true virus neutralizing antibodies GMT, GMI, and SCR against the current major circulating strain of SARS-CoV-2 were detected 7 days, 14 days, 28 days, 3 months, and 6 months after receiving one dose of study vaccine or placebo;GMT, GMI, and SCR of S protein IgG against the current major circulating strain of SARS-CoV-2 7 days, 14 days, 28 days, 3 months, and 6 months after receiving one dose of study vaccine or placebo in the immunization subgroup;Incidence of adverse events at 30 minutes, 0-14 days and 0-28 days after booster vaccination of 1 dose of study vaccine or placebo in people aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine;Incidence of serious adverse events (SAE) and AESI within 6 months after booster immunization with 1 dose of study vaccine or placebo in people aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine;Pregnancy events within 6 months after booster vaccination with 1 dose of study vaccine or placebo (including: pregnancy outcomes, delivery characteristics, delivery of newborns, and growth and development within 1 month after birth) among persons aged 18 years and older who have received 2 or 3 doses of inactivated COVID-19 vaccine; | — |
Countries
China
Contacts
Public ContactZhou Huan / Wu Qiang
The First Affiliated Hospital of Bengbu Medical College
Outcome results
None listed