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

NCT05599802 | Unknown Phase 1

• 1 other identifier: LVRNA010-I-01
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Outcome Measures

Primary Outcomes (3)

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

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

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

  Within 28 days after (each dose of) vaccination

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

  4 days after (each dose of) vaccination

Secondary Outcomes (9)

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

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

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

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

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

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

• GMT of S-protein specific IgG antibodies (ELISA)

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

• SCR of S-protein specific IgG antibodies (ELISA)

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

Other Outcomes (6)

• GMT of SARS-CoV-2 VNA (live virus assay).

  3 months and 6 months after (full) vaccination

• SCR of SARS-CoV-2 VNA (live virus assay).

  3 months and 6 months after (full) vaccination

• GMI of SARS-CoV-2 VNA (live virus assay).

  3 months and 6 months after (full) vaccination

Study Arms (6)

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

Interventions

SARS-CoV-2 variant mRNA vaccine low dose BIOLOGICAL

50μg/dose

1A: 50μg SARS-CoV-2 variant mRNA vaccine; 2A: 50μg SARS-CoV-2 variant mRNA vaccine; 3A: 50μg SARS-CoV-2 variant mRNA vaccine

SARS-CoV-2 variant mRNA vaccine high dose BIOLOGICAL

100μg/dose

1B: 100μg SARS-CoV-2 variant mRNA vaccine; 2B: 100μg SARS-CoV-2 variant mRNA vaccine; 3B: 100μg SARS-CoV-2 variant mRNA vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AIM Vaccine Co., Ltd.: lead
• Ningbo Rongan Biological Pharmaceutical Co., Ltd.: collaborator
• LiveRNA Therapeutics Inc.: collaborator

Study Officials

• Prof. Dr. M. Raza Shah

  Center for Bioequivalence Studies and Clinical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof. Dr. M. Raza Shah

CONTACT

（92-21）37715064; razashahm@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: February 1, 2023
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2024
• Last Updated: November 1, 2022

Record last verified: 2022-09