Randomized, Blinded, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021) in Participants Aged 18 Years and Older Who Have Received SARS-CoV-2 Vaccine

AIM Vaccine Co., Ltd.1 site in 1 country60 target enrollmentAugust 10, 2023

ConditionsSARS-CoV-2

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: SARS-CoV-2
Sponsor: AIM Vaccine Co., Ltd.
Enrollment: 60
Locations: 1
Primary Endpoint: Incidence of solicited and unsolicited adverse events
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This trial is a phase I clinical trial of a SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021). The trial used a randomized, blinded, placebo-controlled design to evaluate the safety, tolerability, and preliminary immunogenicity of the trial vaccine in participants Aged 18 Years and Older who had received SARS-CoV-2 Vaccine.

Registry

clinicaltrials.gov

Start Date

August 10, 2023

End Date

August 25, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AIM Vaccine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy adults aged 18 years and older, both male and female, who can provide legal identity certificate of participants;
•The subject understands the contents of the Informed Consent Form and the vaccination situation of this vaccination, voluntarily signs the Informed Consent Form, and has the ability to use the thermometer, scale and fill in the Diary Card and Contact Card as required (if the subject is unable to sign the Informed Consent Form by himself/herself due to limited reading and writing ability, the informed consent form and signature of the Informed Consent Form can be completed under the witness' s witness);
•Able to communicate well with investigators and understand and comply with the requirements of this trial;
•Completion of basic immunization with SARS-CoV-2 vaccine ≥ 6 months;
•Negative nucleic acid test for SARS-CoV-2 within 3 days prior to vaccination;
•Women who have used effective contraception within 2 weeks prior to inclusion in this trial, have a negative pregnancy test (pregnancy test can be exempted for those who have been amenorrheic for at least 1 year or have a documented history of surgical sterilization), and voluntarily agree to continue using at least 1 effective contraception within 6 months after vaccination \[effective contraception includes: oral contraceptives, injected or implanted contraception, sustained-release local contraceptives, hormonal patches, intrauterine device (IUD), sterilization, abstinence, condoms (men), diaphragms, cervical caps, etc.\];
•Healthy participants or participants with mild underlying disease \[stable condition without worsening (requiring no hospitalization or major modification of treatment regimen, etc.) for at least 3 months prior to inclusion in this trial\].

Exclusion Criteria

•Abnormal blood routine, blood biochemistry, coagulation routine, D-dimer, troponin, urine routine and other clinical test indicators during the screening period, and the investigator judges that the health condition is uncertain and further diagnosis is required, or the investigator judges that the patient is not suitable for vaccination in combination with the medical history and clinical manifestations;
•Body mass index (BMI) \<18 kg/m 2 or \>30 kg/m 2;
•Individuals with any infectious disease, acute infection, acute phase of chronic infection (such as active untreated pulmonary tuberculosis, etc.) or any advanced immune disease (inquiry);
•Infected within last 6 months or likely infected with SARS-CoV-2;
•Positive HIV test result at screening;
•Fever on the day of investigational vaccination (axillary temperature ≥ 37.3℃) or within 3 days, or use of antipyretic and analgesic drugs within 3 days;
•Women with a positive pregnancy test (surgical sterilizers who are menstruating or amenorrheic for at least 1 year or have medical records may be exempted from pregnancy testing), or breastfeeding women, or women planning to become pregnant from screening through 6 months after booster vaccination, men whose partners plan to become pregnant, or plan to donate sperm and eggs;
•Previous history of allergic or allergic reactions to vaccines or drugs, such as urticaria, severe skin eczema, dyspnea, laryngeal edema, angioneurotic edema, etc.;
•Administration of any vaccine within 28 days prior to booster vaccination with investigational vaccine;
•Have participated within 28 days prior to booster vaccination with investigational vaccine or plan to participate in other drug clinical trials within 12 months after booster vaccination;

Outcomes

Primary Outcomes

Incidence of solicited and unsolicited adverse events

Time Frame: 0-28 days after booster vaccination.

Incidence of solicited and unsolicited adverse events 0-28 days after booster vaccination in all participants.

Secondary Outcomes

Incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs)(Within 12 months after booster vaccination.)
Incidence of abnormal laboratory-related parameters(3 days after booster vaccination)
GMT, SCR, and GMI of neutralizing antibodies against SARS-CoV-2 (Delta, Omicron BA.5, XBB, and current major circulating strains)(7, 14, 28 days after booster vaccination.)
GMC, SCR, and GMI of IgG antibodies against S proteins of SARS-CoV-2 (Delta, Omicron BA.5, XBB, and current major circulating strains)(7, 14, 28 days after booster vaccination.)
GMT of neutralizing antibodies against SARS-CoV-2 (Delta, Omicron BA.5, XBB, and current major circulating strains)(3, 6, 12 months after booster vaccination.)
GMC of IgG antibodies against S proteins of SARS-CoV-2 (Delta, Omicron BA.5, XBB, and current major circulating strains)(3, 6, 12 months after booster vaccination.)