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

AIM Vaccine Co., Ltd.1 site in 1 country3,200 target enrollmentJanuary 4, 2023

ConditionsSARS-CoV-2

InterventionsSARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine Saline solution

DrugsSaline solution

Overview

Phase: N/A
Intervention: SARS-CoV-2 Variant (Omicron BA.5) mRNA vaccine
Conditions: SARS-CoV-2
Sponsor: AIM Vaccine Co., Ltd.
Enrollment: 3200
Locations: 1
Primary Endpoint: 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
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 4, 2023

End Date

November 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AIM Vaccine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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;
•Healthy subjects or subjects with mild underlying diseases \[stable condition with no worsening condition (no need for hospitalization or no major adjustment in treatment regimen, etc.) for at least 3 months prior to inclusion in the study\];
•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.

Exclusion Criteria

•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;

Arms & Interventions

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

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

Placebo

Intervention: Saline solution

Outcomes

Primary Outcomes

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

Time Frame: 14 days after vaccination or placebo

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

Secondary Outcomes

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)
Incidence of adverse events in people aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine(30 minutes, 0-14 days and 0-28 days after vaccination or placebo)
GMT of S protein IgG against the current major circulating strain of SARS-CoV-2 in the immunization subgroup(7 days, 14 days, 28 days, 3 months, and 6 months 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)
GMI of S protein IgG against the current major circulating strain of SARS-CoV-2 in the immunization subgroup(7 days, 14 days, 28 days, 3 months, and 6 months 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)
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)
SCR 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)
Pregnancy events among persons aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine(within 6 months 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)
SCR of S protein IgG against the current major circulating strain of SARS-CoV-2 in the immunization subgroup(7 days, 14 days, 28 days, 3 months, and 6 months after vaccination or placebo)
Incidence of serious adverse events (SAE) in people aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine(within 6 months after vaccination or placebo)
Incidence of AESI in people aged 18 years and older who had received 2 or 3 doses of inactivated COVID-19 vaccine(within 6 months after vaccination or placebo)