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Clinical Trial of SARS-CoV-2 mRNA Vaccine(LVRNA009) as Heterologous Booster in Islamabad | Clinical Trials | Clareo Health

UNKNOWNPHASE3

Clinical Trial of SARS-CoV-2 mRNA Vaccine(LVRNA009) as Heterologous Booster in Islamabad

A Randomized, Blinded, Parallel-controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of SARS-CoV-2 mRNA Vaccine (LVRNA009) as Heterologous Booster in Participants Aged 18 Years and Older Vaccinated 2 Doses Inactivated SARS-CoV-2 Vaccine

NCT05428592•AIM Vaccine Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a randomized, blinded, parallel-controlled phase 3 clinical trial. The study intent to evaluate the immunogenicity and safety of SARS-CoV-2 mRNA Vaccine (LVRNA009) as heterologous booster in participants aged 18 years and older vaccinated 2 doses Inactivated SARS-CoV-2 Vaccine.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Adults aged 18 years and older.
•2. Understand the contents of the ICF and voluntarily sign it (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 study requirements, including all scheduled visits, vaccinations, laboratory tests, and other study procedures.
•4. Female participants of childbearing potential or partners of male participants: voluntarily agree to use effective contraception with their partners 14 days prior to the vaccination and must agree to continue such precautions during the study until 3 months after vaccination. \[Effective contraception includes oral contraceptives, injectable or implantable contraception, extended-release topical contraceptives, hormonal patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (for males), diaphragms, cervical caps, etc.\].
•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 vaccination in this study.
•6. Axillary temperature \<37.3°C/99.1°F at screening visit and 72 hours prior to vaccination.
•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 vaccinated 2 doses of CoronaVac® (with an interval of 3-8 weeks between 2 doses), for 6-12 months prior to enrollment.

Exclusion Criteria

•1. Previous medications intervention for the prophylaxis or prevention of COVID-19 (Including vaccination with any licensed SARS-CoV-2 vaccines other than 2 doses of CoronaVac® ).
•2. History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS) or other coronavirus infections.
•3. History of a previous laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19.
•4. History of allergy to any component of the study vaccine or history of severe allergic reaction to the vaccine or drug (including but not limited to anaphylaxis, allergic laryngeal oedema, anaphylactic purpura, thrombocytopenic purpura, or localized allergic necrosis (Arthus reaction)).
•5. Positive nucleic acid for SARS-CoV-2 in nasopharyngeal/oropharyngeal swab specimens.
•6. Positive HIV test result.
•7. A history or family history of convulsions, epilepsy, encephalopathy and psychosis.
•8. Malignant tumors in the active phase, malignant tumors not receiving adequate treatment, malignant tumors at potential risk of recurrence during the study period.
•9. Congenital or functional splenic deficiency, complete or partial splenectomy for any reason.
•10. Prolonged (defined as more than 14 days) use of immunosuppressive or other immunomodulatory drugs (e.g., corticosteroids, ≥20 mg/d prednisone or equivalent; however, inhaled and topical steroids are permitted) within 6 months prior to the vaccine.
+6 more criteria

Locations (1)

Clinical Trial Unit, National Institute of Health

Islamabad, Pakistan

Key Dates

Start Date

April 1, 2023

Primary Completion Date

October 1, 2023

Completion Date

October 1, 2024

Last Updated

February 2, 2023

Enrollment

1,100

ESTIMATED participants

Conditions

SARS-CoV-2

Interventions

LVRNA009

BIOLOGICAL

CoronaVac®

BIOLOGICAL

Contacts

Fan Zhang

CONTACT

021-33360772 fan.zhang@aimbio.com

Wumei Han

CONTACT

021-33360772 wumei.han@aimbio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Trial of SARS-CoV-2 mRNA Vaccine(LVRNA009) as Heterologous Booster in Islamabad

Inclusion Criteria

Exclusion Criteria

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