A Phase II/III Study to Evaluate the Immunogenicity and Safety and Efficacy of SWIM816 Vaccines for SARS-CoV-2

Summary

Primary Immunogenicity Objective：Cohort 1: GMTs of SARS-CoV-2 Omicron and related strain neutralizing antibody levels for SWIM816.Cohort 2: To demonstrate the non- inferiority of neutralizing antibody response in terms of geometric mean titers (GMT) of COVID-19 mRNA vaccine(SWIM816) compare with mRNA COVID-19 vaccine(Pfizer Bivalent vaccine) 14 days post dose.

Primary Safety Objective：To assess the reactogenicity and safety of a booster dose in a heterologous vaccination regimen in subjects previously immunized with 2/3 doses of COVID-19 vaccine with or without previously diagnosed with COVID-19.

Secondary Immunogenicity Objectives：To describe the neutralizing antibody response at D29, D91 and D181.To describe binding antibody profile at D01, D15, D29, D91 and D181 of each study group.

Secondary Safety Objective：To assess the reactogenicity and safety of third or fourth booster dose in a heterologous vaccination regimen in subjects previously immunized with 2/3 COVID-19 vaccine doses.

Exploratory Objective：1.Documented confirmed SARS-CoV-2 symptomatic infection；2.Todemonstrate the cellular immune response profile at study group (30 subjects per each group for cellular immune testing).

Conditions

• Immunogenicity
• Safety

Interventions

BIOLOGICAL

Phase II:SWIM816;SARS-Cov-2;

The study will be performed in people who were previously vaccinated with 2/3 doses of COVID-19 vaccine, with or without previously diagnosed with COVID-19. The interval between the date of last dose and the date of this study vaccination should be 6 to 24 months. There are 2 groups in phase 2 stage, total number 200 subjects who are ≥18 years old. Details as below: Group 1: (N=100) - SWIM816 25 μg; Group 2: (N=100) - SW-BIC-213 25 μg;

BIOLOGICAL

Phase II:SW-BIC-213;SARS-Cov-2;

The study will be performed in people who were previously vaccinated with 2/3 doses of COVID-19 vaccine, with or without previously diagnosed with COVID-19. The interval between the date of last dose and the date of this study vaccination should be 6 to 24 months. There are 2 groups in phase 2 stage, total number 200 subjects who are ≥18 years old. Details as below: Group 1: (N=100) - SWIM816 25 μg; Group 2: (N=100) - SW-BIC-213 25 μg;

BIOLOGICAL

PhaseIII:SWIM816;SARS-Cov-2;

The study will be performed in people who were previously vaccinated with 2/3 doses of COVID-19 vaccine, with or without previously diagnosed with COVID-19. The interval between the date of last dose and the date of this study vaccination should be 6 to 24 months. There are two groups in phase 3 stage., total number 600 subjects who are ≥18 years old. Details as below: Group 1: (N=300) - SWIM816 (≥18 years old ) Group 2: (N=300) -Pfizer Bivalent vaccine (≥18 years old)

BIOLOGICAL

PhaseIII:Pfizer(Pfizer Bivalent vaccine);SARS-Cov-2；

The study will be performed in people who were previously vaccinated with 2/3 doses of COVID-19 vaccine, with or without previously diagnosed with COVID-19. The interval between the date of last dose and the date of this study vaccination should be 6 to 24 months. There are two groups in phase 3 stage., total number 600 subjects who are ≥18 years old. Details as below: Group 1: (N=300) - SWIM816 (≥18 years old ) Group 2: (N=300) -Pfizer Bivalent vaccine (≥18 years old)

Sponsors & Collaborators

• Stemirna Therapeutics

  lead INDUSTRY

Principal Investigators

• Mayfong Mayxay, doctor · National Ethics Committee for Health Research(NECHR)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-06-20

Primary Completion

2023-07-31

Completion

2024-02-01