Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2025-12-28 @ 9:19 PM
Study NCT ID:
NCT05580159
Status:
UNKNOWN
Last Update Posted:
2023-04-12
First Post:
2022-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
New Generation mRNA Booster Vaccine Against Emerging VOCs
Sponsor:
Stemirna Therapeutics
Organization:
Study Overview
Official Title:
A Multi-national, Randomized, Observer-blinded, Parallel Controlled Trial to Evaluate the Immunogenicity and Safety of New Generation COVID-19 mRNA Booster Vaccination Against Emerging Variants of Concern (VOC)
Status:
UNKNOWN
Status Verified Date:
2023-04
Last Known Status:
RECRUITING
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：Objectives ：SafetyTo describe the safetyprofile of all participants in each group up to 6months post-dose.Immunogenicity：To demonstrate the superiorityof neutralizing antibodyresponse in terms of geometric mean titers (GMT) of mRNA vaccine compare with inactive vaccine28 days post dose. Secondary:Immunogenicity
1. To describe binding antibodyprofile at D01,D08, D15, D29,D91 and D181 of eachstudy group.
2. To describe the neutralizing antibody profile atD08,D15,D91 and D181of 600 participants for each studyintervention group. Exploratory:Cell-mediated immunity To describe the cellular immuneresponse profile at D01, D08, D15and D29, in a subset of 30 participants for each study group.
Efficacy:To describe the occurrence of virologically-confirmed COVID-19 like illness and serologically confirmed SARS-CoV-2 infection.
1. To describe binding antibodyprofile at D01,D08, D15, D29,D91 and D181 of eachstudy group.
2. To describe the neutralizing antibody profile atD08,D15,D91 and D181of 600 participants for each studyintervention group. Exploratory:Cell-mediated immunity To describe the cellular immuneresponse profile at D01, D08, D15and D29, in a subset of 30 participants for each study group.
Efficacy:To describe the occurrence of virologically-confirmed COVID-19 like illness and serologically confirmed SARS-CoV-2 infection.
Detailed Description:
Endpoints:Safety Endpoints- Occurrence of unsolicited systemic AEs reported in the 30 minutes after each injection.
Occurrence of solicited injection site reactions and systemicreactions occurring up to 7 days post-dose.
Occurrence of unsolicited non-serious AEs reported up to 28 dayspost-dose. Occurrence of SAEs and AESIs up to 6 months throughout the study. Immunogenicity Endpoints:GMT of neutralizing antibody will be measured with the neutralization assayon D01,D29.
Binding antibody titers to full length SARS-CoV-2 Spike (S) protein will be measured for each study intervention group with the ELISA method
* Antibody titer on D01, D08, D15, D29, D91, D181
* Fold-rise in antibody titer at D08, D15, D29, D91 and D181 post vaccination relative to D01
* 4-fold-rise in antibody titer at D08, D15, D29, D91, and D181 relative to D01 Neutralizing antibody titers will be measured with the neutralization assay
* Antibody titer on D08, D15, D29, D91 and D181
* Fold-rise (fold rise in serum neutralization titer post vaccination relative to D01) at D08, D15, D29, D91 and D181
* 4-fold rise in serum neutralization titer \[post/pre\] relative to D01 at D08, D15, D29, D91 and D181
* Occurrence of neutralizing antibody seroconversion, defined as baseline values below LLOQ at baseline with detectable neutralization titer above assay lower limit of quantification at D08, D15, D29, D91 and D181INF-γ, IL-4 and IL-2 will be measured in whole blood and/or cryopreserved PBMC following stimulation with pools of S
* ExploratoryCell-mediated immunity To describe the cellular immune response profile at D01, D08, D15 and D29, in a subset of 30 participants for each study group antigen peptides.
Virologically-confirmed COVID 19 like illness as defined by specified clinical symptoms and signs and confirmed by a positive result for SARS-CoV-2 nucleic acid viral detection assay.
Occurrence of solicited injection site reactions and systemicreactions occurring up to 7 days post-dose.
Occurrence of unsolicited non-serious AEs reported up to 28 dayspost-dose. Occurrence of SAEs and AESIs up to 6 months throughout the study. Immunogenicity Endpoints:GMT of neutralizing antibody will be measured with the neutralization assayon D01,D29.
Binding antibody titers to full length SARS-CoV-2 Spike (S) protein will be measured for each study intervention group with the ELISA method
* Antibody titer on D01, D08, D15, D29, D91, D181
* Fold-rise in antibody titer at D08, D15, D29, D91 and D181 post vaccination relative to D01
* 4-fold-rise in antibody titer at D08, D15, D29, D91, and D181 relative to D01 Neutralizing antibody titers will be measured with the neutralization assay
* Antibody titer on D08, D15, D29, D91 and D181
* Fold-rise (fold rise in serum neutralization titer post vaccination relative to D01) at D08, D15, D29, D91 and D181
* 4-fold rise in serum neutralization titer \[post/pre\] relative to D01 at D08, D15, D29, D91 and D181
* Occurrence of neutralizing antibody seroconversion, defined as baseline values below LLOQ at baseline with detectable neutralization titer above assay lower limit of quantification at D08, D15, D29, D91 and D181INF-γ, IL-4 and IL-2 will be measured in whole blood and/or cryopreserved PBMC following stimulation with pools of S
* ExploratoryCell-mediated immunity To describe the cellular immune response profile at D01, D08, D15 and D29, in a subset of 30 participants for each study group antigen peptides.
Virologically-confirmed COVID 19 like illness as defined by specified clinical symptoms and signs and confirmed by a positive result for SARS-CoV-2 nucleic acid viral detection assay.
Study Oversight
Has Oversight DMC:
True
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?: