Clinical Trail of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021) in Participants Aged 18 Years and Older

NCT05812014 | Unknown Phase 3

• 1 other identifier: LVRNA021-III-01
• Study Type: interventional
• Target: 9,800
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center, randomized, blinded, placebo-controlled, phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of SARS-CoV-2 bivalent mRNA vaccine (LVRNA021) as booster in participants aged 18 years and older who completed primary/1 booster dose(s) of SARS-CoV-2 vaccination.

Conditions

SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19

  The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity meeting the case definition for the primary efficacy analysis occurring from 14 days after booster vaccination.

  14 days after vaccination or placebo

Secondary Outcomes (23)

• Person-year incidence density of first episodes of virologically-confirmed moderate to severe cases of COVID-19

  14 days after vaccination or placebo

• Person-year incidence density of first episodes of virologically-confirmed severe cases of COVID-19

  14 days after vaccination or placebo

• Person-year incidence density of first episodes of virologically-confirmed cases of COVID-19

  14 days after vaccination or placebo

• Person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 for participants in different age strata (18-59 years, ≥ 60 years)

  14 days after vaccination or placebo

• Incidence of each solicited (local and systemic) AE in all participants.

  within 14 days after vaccination or placebo

Other Outcomes (7)

• Person-year incidence density of first episodes of virologically-confirmed cases of COVID-19 of any severity caused by individual VOCs.

  14 days after vaccination or placebo

• Cellular immune subgroup:viral antigen IL-2 levels

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

• Cellular immune subgroup:viral antigen IL-4 levels

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

Study Arms (2)

Study Vaccine Group

EXPERIMENTAL

Biological: SARS-CoV-2 Bivalent mRNA vaccine (LVRNA021)

Control Group

PLACEBO COMPARATOR

Drug: 0.9% sodium chloride solution

Interventions

SARS-CoV-2 Bivalent mRNA vaccine (LVRNA021) BIOLOGICAL

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

Study Vaccine Group

0.9% sodium chloride solution DRUG

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

Control Group

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years and older;
• Understand the content of the ICF, and voluntarily sign the ICF (If the participant is unable to sign the ICF on his/her own due to illiteracy, an impartial witness is needed);
• Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures;
• Female participants of childbearing potential or partners of male participants: voluntarily agree to use effective contraception with their partners prior to the first vaccination and must agree to continue such precautions during the study until 3 months after booster vaccination \[Effective contraception includes oral contraceptives, injectable or implantable contraception, extended-release topical contraceptives, hormonal patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (for male), diaphragms, cervical caps, etc.);
• For female participants: without childbearing potential (amenorrhea for at least 1 year or documented surgical sterilization) or have used effective contraception with a negative pregnancy test before booster vaccination in this study；
• On the day of vaccination and 24 hours prior to vaccination, axillary temperatures\<37.3°C/99.1°F;
• Healthy participants or participants with mild underlying disease \[in a stable state without exacerbation (no admission to hospital or no major adjustment to treatment regimen, etc.) for at least 3 months prior to enrollment in this study\];
• Participants who have received primary/1 booster dose(s) of SARS-CoV-2 vaccination (including primary series of inactivated vaccine, mRNA vaccine, adenovirus vaccine or 1 homologous/heterologous booster), with the last dose received at least 6 months before enrolment. Documented confirmation of prior SARS-CoV-2 vaccination receipt must be obtained prior to randomization;

You may not qualify if:

• History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), or other coronavirus infections at any time;
• History of hepatitis A, hepatitis B, hepatitis C, syphilis infection based on medical inquiry.;
• History of severe adverse reaction associated with a vaccine or drug and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s);
• Receipt of medications intended to treat COVID-19 within 6 months;
• Virologically confirmed SARS-CoV-2 diagnosis within 6 months before screening visit;
• Positive nasopharyngeal/oropharyngeal swab SARS-CoV-2 RT-PCR test result at screening;
• Positive HIV test result at screening;
• A history or family history of convulsions, epilepsy, encephalopathy and psychosis;
• Malignant tumors in the active phase, malignant tumors not receiving adequate treatment, malignant tumors at potential risk of recurrence during the study period;
• Asplenia or functional asplenia, complete or partial splenectomy from any cause;
• Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, epidural, or topical (skin or eyes) corticosteroids are permitted;
• Any other licensed vaccines given within 28 days prior to vaccination, planned administration of any other vaccines within 28 days after vaccination, or planned administration of other COVID-19 vaccines during the entire study duration;
• Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before vaccine administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before vaccine administration, or planned receipt throughout the study;
• Blood donation or blood loss ≥ 450 mL within 1 month prior to enrollment or planned to donate blood during the study period;
• Participation in other studies involving study intervention within 28 days prior to study entry, and/or during the study;

Sponsors & Collaborators

• AIM Vaccine Co., Ltd.: lead
• LiveRNA Therapeutics Inc.: collaborator
• Ningbo Rongan Biological Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Sindh Infectious Diseases Hospital & Research Center Dow University of Health Sciences

Islamabad, 9216793, Pakistan

RECRUITING

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Fan Zhang

  AIM Vaccine Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Xinhui Chen

CONTACT

021-3336; xinhui.chen@aimbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 13, 2023
• Study Start: March 25, 2023
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 19, 2023

Record last verified: 2023-01

Locations

PA (1)