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

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)

Study Overview

• Status: Not yet recruiting
• Conditions: SARS-CoV-2
• Intervention / Treatment: Biological: SARS-CoV-2 variant mRNA vaccine low dose; Biological: SARS-CoV-2 variant mRNA vaccine high dose

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Prof. Dr. M. Raza Shah; Phone Number: （92-21）37715064; Email: razashahm@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1A: 50μg SARS-CoV-2 variant mRNA vaccine; 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; 50μg/dose
Experimental: 1B: 100μg SARS-CoV-2 variant mRNA vaccine; 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; 100μg/dose
Experimental: 2A: 50μg SARS-CoV-2 variant mRNA vaccine; 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; 50μg/dose
Experimental: 2B: 100μg SARS-CoV-2 variant mRNA vaccine; 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; 100μg/dose
Experimental: 3A: 50μg SARS-CoV-2 variant mRNA vaccine; 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; 50μg/dose
Experimental: 3B: 100μg SARS-CoV-2 variant mRNA vaccine; 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; 100μg/dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
GMI of S-protein specific IgG antibodies (ELISA)	Before (each dose of) vaccination, 14 days and 28 days after (each dose of) vaccination
The incidence, severity, and causality of Serious Adverse Events (SAEs)	Within 12 months after (full) vaccination
The incidence, severity, and causality of Adverse Events of Special Interest (AESI)	Within 12 months after (full) vaccination
The incidence, severity, and causality of the occurrence of pregnancy events	Within 12 months after (full) vaccination

Other Outcome Measures

Outcome Measure	Time Frame
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
GMT of S-protein specific IgG antibodies (ELISA)	3 months and 6 months after (full) vaccination
SCR of S-protein specific IgG antibodies (ELISA)	3 months and 6 months after (full) vaccination
GMI of S-protein specific IgG antibodies (ELISA)	3 months and 6 months after (full) vaccination

Collaborators and Investigators

• Sponsor: AIM Vaccine Co., Ltd.
• Collaborators: Ningbo Rongan Biological Pharmaceutical Co. Ltd.; LiveRNA Therapeutics Inc.
• Investigators: Principal Investigator: Prof. Dr. M. Raza Shah, Center for Bioequivalence Studies and clinical research

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: LVRNA010-I-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No