ImmunogenicityPhase 2/3NCT05911087
A Phase II/III Study to Evaluate the Immunogenicity and Safety and Efficacy of SWIM816 Vaccines for SARS-CoV-2
A Phase 2/3 study testing Phase II:SWIM816;SARS-Cov-2;, Phase II:SW-BIC-213;SARS-Cov-2; and PhaseIII:SWIM816;SARS-Cov-2; in people with Immunogenicity and Safety, run by Stemirna Therapeutics.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immunogenicity, Safety
- What is being tested?
- Phase II:SWIM816;SARS-Cov-2;, Phase II:SW-BIC-213;SARS-Cov-2; and PhaseIII:SWIM816;SARS-Cov-2;
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2023to 1 Feb 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 19Show fewer
- 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;
- Those who are pregnant or breast-feeding or plan to be pregnant during the study period;
- Those who plan to donate ovum or sperms during the study period;
- Those who cannot follow the trial procedures, or cannot cooperate to complete the study due to planned relocation or long-term outing;
- Those unsuitable for participating in the clinical trial as determined by the investigator because of other abnormalities that are likely to confuse the study results, or non-conformance with the maximal benefits of the participants.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase 2/3, Randomized, Double-blinded , Parallel Controlled Trial to Evaluate the Immunogenicity, Safety and Efficacy of A Heterologous Booster Dose With COVID-19 mRNA Vaccines (Bivalent) , in Previously Vaccinated Subjects Against COVID-19 With 2/3 Doses COVID-19 Vaccine Compared to a Booster Dose With mRNA COVID-19 Vaccine（Pfizer Bivalent Vaccine）in Adults.
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.
Read more
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).
Read the detailed description
Endpoints:
Cohorts 1: GMT of SARS-CoV-2 Omicron (such as BA.5, BQ.1,XBB) and reference strain neutralizing antibody(Delta and other circulating strain) levels for SWIM816 on D15 after study vaccination.
Cohorts 1: GMFR of SARS-CoV-2 Omicron (such as BA.5, BQ.1, XBB) and reference strain neutralizing.
antibody (other circulating strain) levels for SWIM816 on D15 after study vaccination.
Cohorts 1: % of participants with seroresponse to SWIM816 for GMTs of SARS-CoV-2 Omicron(such as BA.5, BQ.1, XBB) and reference strain neutralizing antibody (other circulating strain) levels on D15 after study vaccination.
Cohorts 2 (≥18 years ) Non-inferiority analysis: Geometric Mean Ratio (GMR) of SARS-CoV-2 Omicron (such as BA.5, BQ.1,XBB)-neutralizing antibody (other circulating strain) levels for SWIM816 to Pfizer Bivalent vaccine on D15 after study vaccination.
Endpoints:
Occurrence of local and systemic AEs reported within 7 days after study vaccination.
Occurrence of unsolicited AEs reported within 28 days after vaccination. Frequency, severity and relatedness of adverse events within 28 days after vaccination booster dose.
Endpoints:
Cohorts 1+2 : GMTs of Pseudovirus SARS-CoV-2 Omicron (such as BA.5, BQ.1,XBB) and reference strain neutralizing antibody levels for SWIM816 before and on D29, D91, D181 after study vaccination.
Cohorts 1+2 : GMFR of SARS-CoV-2 Omicron (such as BA.5, BQ.1,XBB) and reference strainneutralizingantibody levels for SWIM816 before and on D29, D91, D181 after study vaccination.
Cohorts 1: % of participants with seroresponse to SWIM816 for GMTs of SARS-CoV-2 Omicron(such as BA.5, BQ.1, XBB) and reference strain neutralizing antibody (other circulating strain) levels on D29, D91, D181 after study vaccination.
Cohorts 1 : GMTs and GMI of IgG profile at D01, D15, D29 , D91and D181 of each study group.
Cohorts 1: GMTs of Pseudovirus SARS-CoV-2 Omicron (such as BA.5, BQ.1,XBB) and reference strain neutralizing antibody levels for SWIM516 before and on D15, D29, D91, D181 after study vaccination.
Cohorts 1: GMFR of SARS-CoV-2 Omicron (such as BA.5, BQ.1,XBB) and reference strain neutralizing antibody levels for SW-BIC-213 before and on D15, D181 after study vaccination.
Endpoints:
Serious AEs (SAEs), AEs leading to withdrawal and AEs of special interest (AESIs) within 180 days.
Endpoints:
Occurrence of confirmed symptomatic cases during the study period. Number of confirmed SARS-CoV-2 symptomatic cases; Severity of confirmed cases of SARS-CoV-2 infection(WHO scale). Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on D8 and Day 15 [ Time Frame: Day 8 and Day 15 after the study vaccination .]
- Conditions
- Immunogenicity, Safety
- Being tested
- Phase II:SWIM816;SARS-Cov-2;, Phase II:SW-BIC-213;SARS-Cov-2;, PhaseIII:SWIM816;SARS-Cov-2;, PhaseIII:Pfizer(Pfizer Bivalent vaccine);SARS-Cov-2；
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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: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;
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)
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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; Receives: Biological: PhaseIII:Pfizer(Pfizer Bivalent vaccine);SARS-Cov-2； |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II :Immunogenicity
GMTs of SARS-CoV-2 Omicron and related strain neutralizing antibody levels for SWIM816.
Measured: 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.
Measured: 14 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start20 Jun 2023 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunogenicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized#double-blinded # parallel controlled trial#mRNA vaccine# and positive control group#
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stemirna Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mayfong Mayxay, doctor, Principal investigator, National Ethics Committee for Health Research(NECHR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911087
- Sponsor's protocol ID
- SWP2023-1
- Status last verified
- Jun 2023
- First submitted
- 18 Jun 2023
- Last updated
- 20 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Randomized, Double-blinded , Parallel Controlled Trial to Evaluate the Immunogenicity, Safety and Efficacy of A Heterologous Booster Dose With COVID-19 mRNA Vaccines (Bivalent) , in Previously Vaccinated Subjects Against COVID-19 With 2/3 Doses COVID-19 Vaccine Compared to a Booster Dose With mRNA COVID-19 Vaccine（Pfizer Bivalent Vaccine）in Adults.
- ClinicalTrials.gov ID
- NCT05911087
- Acronym / sponsor ID
- SWP2023-1
- Conditions
- Immunogenicity, Safety
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Stemirna TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2023 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 20 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Endpoints:
Cohorts 1: GMT of SARS-CoV-2 Omicron (such as BA.5, BQ.1,XBB) and reference strain neutralizing antibody(Delta and other circulating strain) levels for SWIM816 on D15 after study vaccination.
Cohorts 1: GMFR of SARS-CoV-2 Omicron (such as BA.5, BQ.1, XBB) and reference strain neutralizing.
antibody (other circulating strain) levels for SWIM816 on D15 after study vaccination.
Cohorts 1: % of participants with seroresponse to SWIM816 for GMTs of SARS-CoV-2 Omicron(such as BA.5, BQ.1, XBB) and reference strain neutralizing antibody (other circulating strain) levels on D15 after study vaccination.
Cohorts 2 (≥18 years ) Non-inferiority analysis: Geometric Mean Ratio (GMR) of SARS-CoV-2 Omicron (such as BA.5, BQ.1,XBB)-neutralizing antibody (other circulating strain) levels for SWIM816 to Pfizer Bivalent vaccine on D15 after study vaccination.
Endpoints:
Occurrence of local and systemic AEs reported within 7 days after study vaccination.
Occurrence of unsolicited AEs reported within 28 days after vaccination. Frequency, severity and relatedness of adverse events within 28 days after vaccination booster dose.
Endpoints:
Cohorts 1+2 : GMTs of Pseudovirus SARS-CoV-2 Omicron (such as BA.5, BQ.1,XBB) and reference strain neutralizing antibody levels for SWIM816 before and on D29, D91, D181 after study vaccination.
Cohorts 1+2 : GMFR of SARS-CoV-2 Omicron (such as BA.5, BQ.1,XBB) and reference strainneutralizingantibody levels for SWIM816 before and on D29, D91, D181 after study vaccination.
Cohorts 1: % of participants with seroresponse to SWIM816 for GMTs of SARS-CoV-2 Omicron(such as BA.5, BQ.1, XBB) and reference strain neutralizing antibody (other circulating strain) levels on D29, D91, D181 after study vaccination.
Cohorts 1 : GMTs and GMI of IgG profile at D01, D15, D29 , D91and D181 of each study group.
Cohorts 1: GMTs of Pseudovirus SARS-CoV-2 Omicron (such as BA.5, BQ.1,XBB) and reference strain neutralizing antibody levels for SWIM516 before and on D15, D29, D91, D181 after study vaccination.
Cohorts 1: GMFR of SARS-CoV-2 Omicron (such as BA.5, BQ.1,XBB) and reference strain neutralizing antibody levels for SW-BIC-213 before and on D15, D181 after study vaccination.
Endpoints:
Serious AEs (SAEs), AEs leading to withdrawal and AEs of special interest (AESIs) within 180 days.
Endpoints:
Occurrence of confirmed symptomatic cases during the study period. Number of confirmed SARS-CoV-2 symptomatic cases; Severity of confirmed cases of SARS-CoV-2 infection(WHO scale). Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on D8 and Day 15 [ Time Frame: Day 8 and Day 15 after the study vaccination .]
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- randomized#double-blinded # parallel controlled trial#mRNA vaccine# and positive control group#
| Arm | Type | Receives |
|---|---|---|
| Phase II group 1 :A single 25 μg dose mRNA vaccine SWIM816 | Experimental | Biological: Phase II:SWIM816;SARS-Cov-2;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 |
| PhaseII group 2:A single 25 μg dose mRNA vaccine SW-BIC-213 | Active comparator | Biological: Phase II:SW-BIC-213;SARS-Cov-2;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 |
| Phase III group 1:A single 25 μg dose mRNA vaccine SWIM816 | Experimental | Biological: PhaseIII:SWIM816;SARS-Cov-2;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 |
| Phase III group 2:A single 30 μg dose mRNA Pfizer Bivalent vaccine | Active comparator | Biological: PhaseIII:Pfizer(Pfizer Bivalent vaccine);SARS-Cov-2；Intervention Name :Pfizer Bivalent Vaccine Type :Control Vaccine Dose :Formulation mRNA Unit Dose Strength(s) :0.3μg; Dosage Level(s) :0.3ml; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 group 1 :A single 25 μg dose mRNA vaccine SWIM816 |
| 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 | PhaseII group 2:A single 25 μg dose mRNA vaccine SW-BIC-213 |
| 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 | Phase III group 1:A single 25 μg dose mRNA vaccine SWIM816 |
| 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) | Biological | Phase III group 2:A single 30 μg dose mRNA Pfizer Bivalent vaccine |
Primary outcome
Phase II :Immunogenicity
Time frame: 15 days after study vaccination
GMTs of SARS-CoV-2 Omicron and related strain neutralizing antibody levels for SWIM816.
Phase II :Immunogenicity
Time frame: 14 days post dose
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Immunogenicity
RecruitingPhase 2
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 in Participants ≥6 Months to <12 Years of Age
SARS-CoV-2
Active, not recruitingPhase 2
A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living in a TB Endemic Region.
Tuberculosis (TB)
RecruitingPhase 1
A Study of HL40626S Tablets in Healthy Adults
Skin Disease, Immune System Disease
RecruitingPhase 1
NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease
Graves Disease
Active, not recruitingPhase 1/2
A Study to Characterize the Safety and Immunogenicity of AZD6489 in Participants 60 Years of Age and Older (ARIES)
RSV Respiratory Syncytial Virus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mayfong Mayxay, doctor principal investigator
National Ethics Committee for Health Research(NECHR)
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Phase II:SWIM816;SARS-Cov-2;, Phase II:SW-BIC-213;SARS-Cov-2; and PhaseIII:SWIM816;SARS-Cov-2; in people with Immunogenicity and Safety, run by Stemirna Therapeutics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yang li, doctor (+856 02095779465, yang.li@stemirna.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase II :Immunogenicity (time frame: 15 days after study vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2023.