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SARS-CoV-2Phase 1NCT05599802

Clinical Study of SARS-CoV-2 Variant mRNA Vaccine in Healthy Participants

A Phase 1 study testing SARS-CoV-2 variant mRNA vaccine low dose and SARS-CoV-2 variant mRNA vaccine high dose in people with SARS-CoV-2, run by AIM Vaccine Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

An Open-Label, Phase 1 Clinical Study to Determine the Safety and Preliminary Immunogenicity of SARS-CoV-2 Variant mRNA Vaccine (LVRNA010) Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2
What is being tested?
SARS-CoV-2 variant mRNA vaccine low dose and SARS-CoV-2 variant mRNA vaccine high dose
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
No sites listed yet
Study dates
Feb 2023to May 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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 (1st dose of) vaccination and must agree to continue such precautions during the study until 3 months after (full) 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 (each dose of) vaccination in this study.
  • On the day of vaccination and 24 hours prior to (each dose of) vaccination, axillary temperatures<37.3℃/99.1°F.
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  • 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].
  • (For group 2 and group 3 only) Participants who have received full primary vaccination of licensed SARS-CoV-2 vaccine (3-8 weeks between 2 doses of COVID-19 inactivated vaccine or 2 doses of COVID-19 mRNA vaccine) and whose last dose was given >6 mony
  • (For group 1 only) Not have received any COVID-19 vaccine prior to enrollment.

Who cannot join

  • Any screening hematology and/or blood biochemistry laboratory value that meets the definition of a ≥Grade 1 abnormality,
  • (For group 1 only) Confirmed SARS-CoV-2 diagnosis within 1 years before screening visit.
  • History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), or other coronavirus infections.
  • Receipt of medications intended to treat COVID-19 with 1 year.
  • History of server adverse reaction associated with a vaccine or drug and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s).
  • SARS-CoV-2 RT-PCR positive nasopharyngeal/oropharyngeal swab specimens at screening.
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  • Positive HIV test 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 of 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 the investigational vaccination, or planned administration of vaccine(s) within 28 days after (full) vaccination.
  • Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, form 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 ≥450ml 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.
  • Women who are pregnant or breastfeeding.
  • Participants deemed unsuitable for participation in this study based on the investigator's assessment.
  • (For group 1 only: Criteria for delay of 2nd dose of vaccination) Fever within 24 hours prior to the 2nd dose of vaccination (axillary body temperature ≥37.3℃/99.1°F).
  • (For group 1 only: Criteria for delay of 2nd dose of vaccination) During treatment/recovery from illness.
  • (For group 1 only: Criteria for delay of 2nd dose of vaccination) Other conditions considered by the investigator to be unsuitable for vaccination.
  • (For group 1 only: Criteria for termination of 2nd dose of vaccination) Participants with a positive urine pregnancy or blood pregnancy test (women of childbearing age only).
  • (For group 1 only: Criteria for termination of 2nd dose of vaccination) Serious allergic reactions or serious adverse events related to vaccination (as assessed by the investigator) following a previous dose of vaccine.
  • (For group 1 only: Criteria for termination of 2nd dose of vaccination) Positive result for SARS-CoV-2 (positive RT-PCR test).
  • (For group 1 only: Criteria for termination of 2nd dose of vaccination) The investigator considers inappropriate for the participants to continue participation in the study.

Trial locations and contacts

No sites are listed yet.

Prof. Dr. M. Raza Shah contact

（92-21）37715064

razashahm@yahoo.com

About this study

Official title: An Open-Label, Phase 1 Clinical Study to Determine the Safety and Preliminary Immunogenicity of SARS-CoV-2 Variant mRNA Vaccine (LVRNA010) in Healthy Participants Aged 18 Years and Older

An Open-Label, Phase 1 Clinical Study to Determine the Safety and Preliminary Immunogenicity of SARS-CoV-2 Variant mRNA Vaccine (LVRNA010)

Conditions
SARS-CoV-2
Being tested
SARS-CoV-2 variant mRNA vaccine low dose, SARS-CoV-2 variant mRNA vaccine high dose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SARS-CoV-2 variant mRNA vaccine low doseBiological

    50μg/dose

  • SARS-CoV-2 variant mRNA vaccine high doseBiological

    100μg/dose

Study groups in NCT05599802
Study groupRoleWhat they receive
1A: 50μg SARS-CoV-2 variant mRNA vaccineExperimentalParticipants who have not received any COVID-19 vaccines will vaccinate two doses of study vaccine with 28 days apart.
Receives: Biological: SARS-CoV-2 variant mRNA vaccine low dose
1B: 100μg SARS-CoV-2 variant mRNA vaccineExperimentalParticipants who have not received any COVID-19 vaccines will vaccinate two doses of study vaccine with 28 days apart.
Receives: Biological: SARS-CoV-2 variant mRNA vaccine high dose
2A: 50μg SARS-CoV-2 variant mRNA vaccineExperimentalParticipants who have received 2 dose of COVID-19 inactivated vaccines will vaccinate 1 doses of study vaccine.
Receives: Biological: SARS-CoV-2 variant mRNA vaccine low dose
2B: 100μg SARS-CoV-2 variant mRNA vaccineExperimentalParticipants who have received 2 dose of COVID-19 inactivated vaccines will vaccinate 1 doses of study vaccine.
Receives: Biological: SARS-CoV-2 variant mRNA vaccine high dose
3A: 50μg SARS-CoV-2 variant mRNA vaccineExperimentalParticipants who have received 2 dose of COVID-19 mRNA vaccines will vaccinate 1 doses of study vaccine.
Receives: Biological: SARS-CoV-2 variant mRNA vaccine low dose
3B: 100μg SARS-CoV-2 variant mRNA vaccineExperimentalParticipants who have received 2 dose of COVID-19 mRNA vaccines will vaccinate 1 doses of study vaccine.
Receives: Biological: SARS-CoV-2 variant mRNA vaccine high dose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence, severity, and duration of each solicited (local and systemic) AE.

    Measured: Within 30 minutes and 7 days after (each dose of) vaccination

  2. Incidence, severity, and duration of each unsolicited AE.

    Measured: Within 28 days after (each dose of) vaccination

  3. The percentage of participants with abnormal hematology and chemistry laboratory values.

    Measured: 4 days after (each dose of) vaccination

Secondary outcomes (9)

  1. Geometric Mean Titer (GMT) of SARS-CoV-2 Virus Neutralizing Antibody (VNA) (live virus assay).

    Measured: Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination

  2. Seroconversion Rate (SCR) of SARS-CoV-2 Virus Neutralizing Antibody (VNA) (live virus assay).

    Measured: Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination

  3. Geometric Mean Increase (GMI) of SARS-CoV-2 Virus Neutralizing Antibody (VNA) (live virus assay).

    Measured: Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination

  4. GMT of S-protein specific IgG antibodies (ELISA)

    Measured: Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination

  5. SCR of S-protein specific IgG antibodies (ELISA)

    Measured: Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination

  6. GMI of S-protein specific IgG antibodies (ELISA)

    Measured: Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination

  7. The incidence, severity, and causality of Serious Adverse Events (SAEs)

    Measured: Within 12 months after (full) vaccination

  8. The incidence, severity, and causality of Adverse Events of Special Interest (AESI)

    Measured: Within 12 months after (full) vaccination

  9. The incidence, severity, and causality of the occurrence of pregnancy events

    Measured: Within 12 months after (full) vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2022
  2. Study startFeb 2023 (estimated)
  3. Primary completionMay 2023 (estimated)
  4. Study completionMay 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05599802
Sponsor's protocol ID
LVRNA010-I-01
Status last verified
Sep 2022
First submitted
26 Oct 2022
Last updated
1 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SARS-CoV-2 variant mRNA vaccine low dose and SARS-CoV-2 variant mRNA vaccine high dose in people with SARS-CoV-2, run by AIM Vaccine Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Prof. Dr. M. Raza Shah (（92-21）37715064, razashahm@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence, severity, and duration of each solicited (local and systemic) AE. (time frame: Within 30 minutes and 7 days after (each dose of) vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05599802.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.

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