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

NCT05911087 | Unknown Phase 2 DMC

• 1 other identifier: SWP2023-1
• Study Type: interventional
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• Phase II :Immunogenicity

  GMTs of SARS-CoV-2 Omicron and related strain neutralizing antibody levels for SWIM816.

  15 days after study vaccination

• Phase II :Immunogenicity

  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.

  14 days post dose

Study Arms (4)

Phase II group 1 :A single 25 μg dose mRNA vaccine SWIM816

EXPERIMENTAL

Intervention Name :COVID-19 mRNA vaccine Type :Investigational Vaccine Dose :Formulation mRNA Unit Dose Strength(s) :0.5ml; Dosage Level(s) :0.25ml; Route of Administration: injection Intramuscular

Biological: Phase II:SWIM816;SARS-Cov-2;

PhaseII group 2:A single 25 μg dose mRNA vaccine SW-BIC-213

ACTIVE COMPARATOR

Intervention Name :COVID-19 mRNA vaccine Type :Control Vaccine Dose :Formulation mRNA Unit Dose Strength(s) :0.5ml; Dosage Level(s) :0.25ml; Route of Administration: injection Intramuscular

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

Phase III group 1:A single 25 μg dose mRNA vaccine SWIM816

EXPERIMENTAL

Intervention Name :COVID-19 mRNA vaccine Type :Investigational Vaccine Dose :Formulation mRNA Unit Dose Strength(s) :0.5ml; Dosage Level(s) :0.25ml; Route of Administration: injection Intramuscular

Biological: PhaseIII:SWIM816;SARS-Cov-2;

Phase III group 2:A single 30 μg dose mRNA Pfizer Bivalent vaccine

ACTIVE COMPARATOR

Intervention Name :Pfizer Bivalent Vaccine Type :Control Vaccine Dose :Formulation mRNA Unit Dose Strength(s) :0.3μg; Dosage Level(s) :0.3ml;

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

Interventions

Phase II:SWIM816;SARS-Cov-2; BIOLOGICAL

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;

Phase II group 1 :A single 25 μg dose mRNA vaccine SWIM816

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

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;

PhaseII group 2:A single 25 μg dose mRNA vaccine SW-BIC-213

PhaseIII:SWIM816;SARS-Cov-2; BIOLOGICAL

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)

Phase III group 1:A single 25 μg dose mRNA vaccine SWIM816

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

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)

Phase III group 2:A single 30 μg dose mRNA Pfizer Bivalent vaccine

Eligibility Criteria

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

You may qualify if:

• Male or female aged ≥18 years old when signing ICF.
• Participants 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.
• Those who have not been infected with the novel coronavirus or have been infected for more than 3 months.
• The participant and/or his legally acceptable representative can sign written ICF, and can fully understand the trial procedure, the risk of participating in the trial, and other interventions that can be selected if they do not participate in the trial.
• The participant and/or his legally acceptable representative have the ability to read, understand, and fill in record cards.
• Healthy participants or participants with pre-existing medical conditions who are in stable condition. The "pre-existing medical conditions" include but not limited to hypertension, diabetes, chronic cholecystitis and cholelithiasis, chronic gastritis that meet the described criteria. A stable medical condition is defined as disease not requiring significant change in therapy or no need for hospitalization as a consequence of worsening disease state for at least 3 months prior to enrollment.
• Fertile men and women of childbearing potential voluntarily agree to take effective contraceptive measures from signing ICF to 6 months after the study vaccination; the pregnancy test results of women of childbearing potential are negative on screening.

You may not qualify if:

• Presence of fever within 3 days before the study vaccination;
• A history of infection or disease related to severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), or other disease corresponding use of immunosuppressants;
• A history of allergic reactions to any vaccine or drug, such as allergy, urticaria, severe skin eczema, dyspnea, laryngeal edema, and angioneurotic edema;
• A medical or family history of seizure, epilepsy, encephalopathy and psychosis;
• Immunocompromised patients suffering from immunodeficiency diseases, important organ diseases, immune diseases (including Guillain-Barre Syndrome \[GBS\], systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy caused by any circumstances, and other immune diseases that may have an impact on immune response in the investigator's opinion), etc.
• Long-term use of immunosuppressant therapy or immunomodulatory drugs for ≥14 days within the first six months prior to enrollment. Whereas short-term (≤14 days) use of oral, inhaled and topical steroids are allowed;
• Those who are tested positive for HIV in terms of serology.
• Patients on antituberculosis therapy;
• Presence of severe or uncontrollable cardiovascular diseases, or severe or uncontrollable disorders related to endocrine system, blood and lymphatic system, liver and kidney, respiratory system, metabolic and skeletal systems, or malignancies (skin basal cell carcinoma and carcinoma in-situ of cervix are exceptions and will not be excluded), such as severe heart failure, severe pulmonary heart disease, unstable angina, liver failure, or uremia;
• Contraindications for intramuscular injection or intravenous blood sampling, including thrombocytopenia and other blood coagulation disorders;
• Participants who received any immunoglobulin or blood products in the previous 3 months before enrollment, or plan to receive similar products during the study;
• Participants who received other investigational drugs or vaccines within 1 month before the study vaccination;
• Participants who is at the acute state of disease, such as acute onset of chronic heart f ailure, acute sore throat,hypertensive encephalopathy, acute pneumonia, acute renal insufficiency, acute cholecystitis;
• Participants vaccinated with influenza vaccine within 14 days or with other vaccines within 28 days before the study vaccination;
• Those who donated blood or had blood loss (≥450 mL) within 3 months before the vaccination or plan to donate blood during the study period;

Sponsors & Collaborators

• Stemirna Therapeutics: lead

Study Officials

• Mayfong Mayxay, doctor

  National Ethics Committee for Health Research(NECHR)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yang li, doctor

CONTACT

+856 02095779465; yang.li@stemirna.com

bin luo, bachelor

CONTACT

+856 02095779465; bin.luo@stemirna.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This study uses an observer-blinded design, and the investigators and participants will all remain blinded before unblinding and do not know which group the participant belongs to.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized#double-blinded # parallel controlled trial#mRNA vaccine# and positive control group#

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: June 20, 2023
• Study Start: June 20, 2023
• Primary Completion: July 31, 2023
• Study Completion: February 1, 2024
• Last Updated: June 20, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share