Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-30 @ 12:27 AM
Study NCT ID:
NCT05686161
Status:
UNKNOWN
Last Update Posted:
2023-01-17
First Post:
2022-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
mRNA Booster Vaccine(SW-BIC-213) Compared With Pfizer andSinopharm Against Emerging VOCs
Sponsor:
Stemirna Therapeutics
Organization:
Study Overview
Official Title:
A Randomized, Single-blind, Parallel Controlled Trial to Evaluate the Immunogenicity ,Safety,Efficacy of A Heterologous Booster Dose With SW-BIC-213, in Previously Vaccinated Subjects Against COVID-19 With Two Inactivated COVID-19 Vaccine Doses Compared to a Booster Dose With Pfizer of Sinopharmin Adults
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
ACTIVE_NOT_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 #Immunogenicity:To demonstrate the non-inferiority of binding antibody response in terms of geometric mean titers (GMT) of mRNA vaccine compare with mRNA COVID-19 vaccine(Pfizer) 14 days post dose.
Secondary#Immunogenicity:
1. To describe binding antibody profile at D01, D29 and D181 of each study group.
2. To describe the neutralizing antibody profile at D15, D29 and D181 of each study intervention group.
Secondary#Safety:
To assess the reactogenicity and safety of a booster dose in a heterologous vaccination regimen in subjects previously immunized with two Sinopharm doses.
Exploratory#Cell-mediated immunity:
To describe the cellular immune response profile at D01, D08, D15, in a subset of 30 participants for each study group.
Exploratory#Efficacy:
To describe theoccurrence ofvirologically-confirmedCOVID-19 like illness and serologicallyconfirmed SARS-CoV-2 infection.
Secondary#Immunogenicity:
1. To describe binding antibody profile at D01, D29 and D181 of each study group.
2. To describe the neutralizing antibody profile at D15, D29 and D181 of each study intervention group.
Secondary#Safety:
To assess the reactogenicity and safety of a booster dose in a heterologous vaccination regimen in subjects previously immunized with two Sinopharm doses.
Exploratory#Cell-mediated immunity:
To describe the cellular immune response profile at D01, D08, D15, in a subset of 30 participants for each study group.
Exploratory#Efficacy:
To describe theoccurrence ofvirologically-confirmedCOVID-19 like illness and serologicallyconfirmed SARS-CoV-2 infection.
Detailed Description:
Endpoint:
Immunogenicity Endpoints:
GMT of Anti-Spike IgG antibody titers will be measured with the ELISA assay on D01, D15.
Immunogenicity Endpoints:
Binding antibody titers to full length SARS-CoV-2 Spike (S) protein will be measured for each study intervention group with the ELISA method.
1. Antibody titer on D01, D29, D181.
2. Fold-rise in antibody titer at D15, D29 and D181 relative to D01Neutralizing antibody titers will be measured with the neutralization assay.
3. Antibody titer on D15, D29 and D181.
4. Fold rise in serum neutralization titer \[post/pre\] relative to D01 at D15, D29 and D181.
Safety Endpoints:
1. Occurrence of local and systemic AEs reported within 7 days after study vaccination (per group);
2. Occurrence of unsolicited AEs reported within 28 days after study vaccination (per group);
3. Occurrence of SAEs and AESIs within 28 days after study vaccination (per group).
Exploratory#Cell-mediated immunity Endpoints:
INF-γ will be measured in whole blood and/or cryopreserved PBMC following stimulation with pools of S-antigen peptides.
Exploratory#Efficacy Endpoints Occurrence of confirmed symptomatic cases during the study period
Immunogenicity Endpoints:
GMT of Anti-Spike IgG antibody titers will be measured with the ELISA assay on D01, D15.
Immunogenicity Endpoints:
Binding antibody titers to full length SARS-CoV-2 Spike (S) protein will be measured for each study intervention group with the ELISA method.
1. Antibody titer on D01, D29, D181.
2. Fold-rise in antibody titer at D15, D29 and D181 relative to D01Neutralizing antibody titers will be measured with the neutralization assay.
3. Antibody titer on D15, D29 and D181.
4. Fold rise in serum neutralization titer \[post/pre\] relative to D01 at D15, D29 and D181.
Safety Endpoints:
1. Occurrence of local and systemic AEs reported within 7 days after study vaccination (per group);
2. Occurrence of unsolicited AEs reported within 28 days after study vaccination (per group);
3. Occurrence of SAEs and AESIs within 28 days after study vaccination (per group).
Exploratory#Cell-mediated immunity Endpoints:
INF-γ will be measured in whole blood and/or cryopreserved PBMC following stimulation with pools of S-antigen peptides.
Exploratory#Efficacy Endpoints Occurrence of confirmed symptomatic cases during the study period
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?: