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

NCT ID: NCT05812014

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 9800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-25
• Study Completion Date: 2024-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Study Vaccine Group

Group Type: EXPERIMENTAL

SARS-CoV-2 Bivalent mRNA vaccine (LVRNA021)

Intervention Type: BIOLOGICAL

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

Control Group

Group Type: PLACEBO_COMPARATOR

0.9% sodium chloride solution

Intervention Type: DRUG

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

Interventions

SARS-CoV-2 Bivalent mRNA vaccine (LVRNA021)

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

Intervention Type: BIOLOGICAL

0.9% sodium chloride solution

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Adults aged 18 years and older;

2. 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);

3. Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures;

4. 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.);

5. 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；

6. On the day of vaccination and 24 hours prior to vaccination, axillary temperatures<37.3°C/99.1°F;

7. 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];

8. 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;

Exclusion Criteria

1. History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), or other coronavirus infections at any time;

2. History of hepatitis A, hepatitis B, hepatitis C, syphilis infection based on medical inquiry.;

3. 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);

4. Receipt of medications intended to treat COVID-19 within 6 months;

5. Virologically confirmed SARS-CoV-2 diagnosis within 6 months before screening visit;

6. Positive nasopharyngeal/oropharyngeal swab SARS-CoV-2 RT-PCR test result at screening;

7. Positive HIV test result at screening;

8. A history or family history of convulsions, epilepsy, encephalopathy and psychosis;

9. Malignant tumors in the active phase, malignant tumors not receiving adequate treatment, malignant tumors at potential risk of recurrence during the study period;

10. Asplenia or functional asplenia, complete or partial splenectomy from any cause;

11. 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;

12. 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;

13. 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;

14. Blood donation or blood loss ≥ 450 mL within 1 month prior to enrollment or planned to donate blood during the study period;

15. Participation in other studies involving study intervention within 28 days prior to study entry, and/or during the study;

16. Women who are pregnant or breastfeeding;

17. Participants deemed unsuitable for participation in this study based on the investigator's assessment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LiveRNA Therapeutics Inc.

UNKNOWN

Sponsor Role: collaborator

Ningbo Rongan Biological Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

AIM Vaccine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fan Zhang

Role: STUDY_DIRECTOR

AIM Vaccine Co., Ltd.

Locations

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

Islamabad, , Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Xinhui Chen

Role: CONTACT

xinhui.chen@aimbio.com

021-3336 ext. 0772

Facility Contacts

Muneeba Ahsan Sayeed, PHD

Role: primary

Other Identifiers

LVRNA021-III-01

Identifier Type: -

Identifier Source: org_study_id