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Status unknownNCT05428592Updated Feb 2, 2023

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

A Phase 3 interventional study of LVRNA009 and CoronaVac® in SARS-CoV-2, sponsored by AIM Vaccine Co., Ltd.. Status unknown at 1 site in Pakistan. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-02.

Sponsored by AIM Vaccine Co., Ltd. · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
1,100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • SARS-CoV-2
03

In context

Lead sponsor

AIM Vaccine Co., Ltd. is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
1,100 participants (estimated)

Study arms

  • Experimental
    LVRNA009 study group

    Biological: LVRNA009

  • Active comparator
    CoronaVac® control group

    Biological: CoronaVac®

Interventions

  • BiologicalLVRNA009

    50μg /0.5 mL/Vial/person

  • BiologicalCoronaVac®

    0.5 mL/Vial, 0.5mL per human dose containing 600SU of inactivated SARS-CoV-2 antigen

06

What researchers measure

Primary outcomes

  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)

    Seroconversion is defined as: GMT post vaccination≥ 4-fold rise from baseline GMT value

    Time frame: 14 days after vaccination for all participants

  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 outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Clinical Trial Unit, National Institute of Health
    Islamabad, 45500, Pakistan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05428592
Lead sponsor
AIM Vaccine Co., Ltd.
Responsible party
Sponsor
First posted
Jun 23, 2022
Start date
Apr 2023 (estimated)
Primary completion
Oct 2023 (estimated)
Completion
Oct 2024 (estimated)
Last update
Feb 2, 2023

Study contacts

Fan Zhang
Contact
fan.zhang@aimbio.com
021-33360772 ext. 8066
Wumei Han
Contact
wumei.han@aimbio.com
021-33360772 ext. 8021
Aamer Ikram
principal investigator · National Institute of Health, Islamabad

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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