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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05428592
Recruitment Status : Not yet recruiting
First Posted : June 23, 2022
Last Update Posted : February 2, 2023
Sponsor:
Information provided by (Responsible Party):
AIM Vaccine Co., Ltd.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Biological: LVRNA009 Biological: CoronaVac® Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, blinded, parallel-controlled design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Estimated Study Start Date : April 2023
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: LVRNA009 study group Biological: LVRNA009
50μg /0.5 mL/Vial/person
Active Comparator: CoronaVac® control group Biological: CoronaVac®
0.5 mL/Vial, 0.5mL per human dose containing 600SU of inactivated SARS-CoV-2 antigen


Outcome Measures
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Primary Outcome Measures :
  1. Geometric mean titer (GMT) of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay) [ Time Frame: 14 days after vaccination for all participants ]
  2. Seroconversion Rate (SCR) of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay) [ Time Frame: 14 days after vaccination for all participants ]
    Seroconversion is defined as: GMT post vaccination≥ 4-fold rise from baseline GMT value

  3. Incidence of each solicited (local and systemic) AE and each unsolicited AE [ Time Frame: AE within 14 days, unsolicited AE within 28 days after vaccination for all participants ]
  4. Intensity of each solicited (local and systemic) AE and each unsolicited AE [ Time Frame: AE within 14 days, unsolicited AE within 28 days after vaccination for all participants ]
  5. Duration of each solicited (local and systemic) AE and each unsolicited AE [ Time Frame: AE within 14 days, unsolicited AE within 28 days after vaccination for all participants ]

Secondary Outcome Measures :
  1. Geometric mean increase (GMI) of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay) [ Time Frame: 14 days after vaccination for all participants ]
  2. GMT of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay) [ Time Frame: 28 days, 3 months, 6 months, and 12 months after vaccination for all participants ]
  3. SCR of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay) [ Time Frame: 28 days, 3 months, 6 months, and 12 months after vaccination for all participants ]
  4. GMI of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay) [ Time Frame: 28 days, 3 months, 6 months, and 12 months after vaccination for all participants ]
  5. GMT of SARS-CoV-2 (Wild-type strain) VNA (pseudo-virus neutralizing assay) [ Time Frame: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants ]
  6. SCR of SARS-CoV-2 (Wild-type strain) VNA (pseudo-virus neutralizing assay) [ Time Frame: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants ]
  7. GMI of SARS-CoV-2 (Wild-type strain) VNA (pseudo-virus neutralizing assay) [ Time Frame: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants ]
  8. GMT of S-protein specific IgG antibodies (ELISA) [ Time Frame: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants ]
  9. SCR of S-protein specific IgG antibodies (ELISA) [ Time Frame: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants ]
  10. GMI of S-protein specific IgG antibodies (ELISA) [ Time Frame: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants ]
  11. Incidence of serious adverse events (SAEs), adverse events of special interest (AESI), and the occurrence of pregnancy events [ Time Frame: within 12 months after vaccination for all participants ]
  12. Intensity of serious adverse events (SAEs), adverse events of special interest (AESI), and the occurrence of pregnancy events [ Time Frame: within 12 months after vaccination for all participants ]
  13. Causality of serious adverse events (SAEs), adverse events of special interest (AESI), and the occurrence of pregnancy events [ Time Frame: within 12 months after vaccination for all participants ]

Other Outcome Measures:
  1. Cellular immune subgroup: virus antigen-specific IL-2, IL-4, IL-13, IFN-γ cytokine titers (ELISpot) [ Time Frame: 7 days, 14 days, and 28 days after vaccination ]
  2. Cross-neutralization subgroup: cross-neutralizing ability of VNA (live virus neutralizing assay) against other VOCs of SARS-CoV-2 [ Time Frame: 14 and 28 days after vaccination ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  11. Any other licensed vaccines given within 28 days prior to the study vaccination, or planned administration of vaccine(s) within 28 days after vaccination.
  12. Have received immunoglobulin or other blood products within 3 months prior to enrollment or plan to receive them during the study period.
  13. Blood donation or blood loss ≥ 450 mL within 1 month prior to enrolment, or planned donation during the study period.
  14. Participants who have received any other investigational product within 1 month prior to enrollment or intent to participate in another clinical study at any time during the conduct of this study.
  15. Female participants who are pregnant or breastfeeding.
  16. Participants deemed unsuitable for participation in this study based on the investigator's assessment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05428592


Contacts
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Contact: Fan Zhang 021-33360772 ext 8066 fan.zhang@aimbio.com
Contact: Wumei Han 021-33360772 ext 8021 wumei.han@aimbio.com

Locations
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Pakistan
Clinical Trial Unit, National Institute of Health
Islamabad, Pakistan, 45500
Contact: Omera Naseer, Dr    03005302095    omerashuaib@hotmail.com   
Principal Investigator: Aamer Ikram, Dr         
Sponsors and Collaborators
AIM Vaccine Co., Ltd.
Investigators
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Principal Investigator: Aamer Ikram National Institute of Health, Islamabad
More Information
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Responsible Party: AIM Vaccine Co., Ltd.
ClinicalTrials.gov Identifier: NCT05428592    
Other Study ID Numbers: LVRNA009-Ⅲ-02
First Posted: June 23, 2022    Key Record Dates
Last Update Posted: February 2, 2023
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No