Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05911087
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-20
First Post:
2023-06-18
Brief Title:
A Phase IIIII Study to Evaluate the Immunogenicity and Safety and Efficacy of SWIM816 Vaccines for SARS-CoV-2
Sponsor:
Stemirna Therapeutics
Organization:
Stemirna Therapeutics
Study Overview
Official Title:
A Phase 23 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 23 Doses COVID-19 Vaccine Compared to a Booster Dose With mRNA COVID-19 VaccinePfizer Bivalent Vaccinein Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Immunogenicity ObjectiveCohort 1 GMTs of SARS-CoV-2 Omicron and related strain neutralizing antibody levels for SWIM816Cohort 2 To demonstrate the non- inferiority of neutralizing antibody response in terms of geometric mean titers GMT of COVID-19 mRNA vaccineSWIM816 compare with mRNA COVID-19 vaccinePfizer Bivalent vaccine 14 days post dose
Primary Safety ObjectiveTo assess the reactogenicity and safety of a booster dose in a heterologous vaccination regimen in subjects previously immunized with 23 doses of COVID-19 vaccine with or without previously diagnosed with COVID-19
Secondary Immunogenicity ObjectivesTo describe the neutralizing antibody response at D29 D91 and D181To describe binding antibody profile at D01 D15 D29 D91 and D181 of each study group
Secondary Safety ObjectiveTo assess the reactogenicity and safety of third or fourth booster dose in a heterologous vaccination regimen in subjects previously immunized with 23 COVID-19 vaccine doses
Exploratory Objective1Documented confirmed SARS-CoV-2 symptomatic infection2Todemonstrate the cellular immune response profile at study group 30 subjects per each group for cellular immune testing
Primary Safety ObjectiveTo assess the reactogenicity and safety of a booster dose in a heterologous vaccination regimen in subjects previously immunized with 23 doses of COVID-19 vaccine with or without previously diagnosed with COVID-19
Secondary Immunogenicity ObjectivesTo describe the neutralizing antibody response at D29 D91 and D181To describe binding antibody profile at D01 D15 D29 D91 and D181 of each study group
Secondary Safety ObjectiveTo assess the reactogenicity and safety of third or fourth booster dose in a heterologous vaccination regimen in subjects previously immunized with 23 COVID-19 vaccine doses
Exploratory Objective1Documented confirmed SARS-CoV-2 symptomatic infection2Todemonstrate 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 BA5 BQ1XBB and reference strain neutralizing antibodyDelta and other circulating strain levels for SWIM816 on D15 after study vaccination
Cohorts 1 GMFR of SARS-CoV-2 Omicron such as BA5 BQ1 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 Omicronsuch as BA5 BQ1 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 BA5 BQ1XBB-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 12 GMTs of Pseudovirus SARS-CoV-2 Omicron such as BA5 BQ1XBB and reference strain neutralizing antibody levels for SWIM816 before and on D29 D91 D181 after study vaccination
Cohorts 12 GMFR of SARS-CoV-2 Omicron such as BA5 BQ1XBB 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 Omicronsuch as BA5 BQ1 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 BA5 BQ1XBB 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 BA5 BQ1XBB 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 infectionWHO 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
Cohorts 1 GMT of SARS-CoV-2 Omicron such as BA5 BQ1XBB and reference strain neutralizing antibodyDelta and other circulating strain levels for SWIM816 on D15 after study vaccination
Cohorts 1 GMFR of SARS-CoV-2 Omicron such as BA5 BQ1 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 Omicronsuch as BA5 BQ1 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 BA5 BQ1XBB-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 12 GMTs of Pseudovirus SARS-CoV-2 Omicron such as BA5 BQ1XBB and reference strain neutralizing antibody levels for SWIM816 before and on D29 D91 D181 after study vaccination
Cohorts 12 GMFR of SARS-CoV-2 Omicron such as BA5 BQ1XBB 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 Omicronsuch as BA5 BQ1 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 BA5 BQ1XBB 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 BA5 BQ1XBB 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 infectionWHO 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None