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

AIM Vaccine

Status and phase: Not yet enrolling; Phase 1

Conditions: SARS-CoV-2

Treatments: Biological: SARS-CoV-2 variant mRNA vaccine low dose; Biological: SARS-CoV-2 variant mRNA vaccine high dose

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05599802

LVRNA010-I-01

Details and patient eligibility

About

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

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.
• 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.

Exclusion criteria

• 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.
• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 6 patient groups

1A: 50μg SARS-CoV-2 variant mRNA vaccine

Experimental group

Description:

Participants who have not received any COVID-19 vaccines will vaccinate two doses of study vaccine with 28 days apart.

Treatment:

Biological: SARS-CoV-2 variant mRNA vaccine low dose

1B: 100μg SARS-CoV-2 variant mRNA vaccine

Experimental group

Description:

Participants who have not received any COVID-19 vaccines will vaccinate two doses of study vaccine with 28 days apart.

Treatment:

Biological: SARS-CoV-2 variant mRNA vaccine high dose

2A: 50μg SARS-CoV-2 variant mRNA vaccine

Experimental group

Description:

Participants who have received 2 dose of COVID-19 inactivated vaccines will vaccinate 1 doses of study vaccine.

Treatment:

Biological: SARS-CoV-2 variant mRNA vaccine low dose

2B: 100μg SARS-CoV-2 variant mRNA vaccine

Experimental group

Description:

Participants who have received 2 dose of COVID-19 inactivated vaccines will vaccinate 1 doses of study vaccine.

Treatment:

Biological: SARS-CoV-2 variant mRNA vaccine high dose

3A: 50μg SARS-CoV-2 variant mRNA vaccine

Experimental group

Description:

Participants who have received 2 dose of COVID-19 mRNA vaccines will vaccinate 1 doses of study vaccine.

Treatment:

Biological: SARS-CoV-2 variant mRNA vaccine low dose

3B: 100μg SARS-CoV-2 variant mRNA vaccine

Experimental group

Description:

Participants who have received 2 dose of COVID-19 mRNA vaccines will vaccinate 1 doses of study vaccine.

Treatment:

Biological: SARS-CoV-2 variant mRNA vaccine high dose