Safety Clinical Trial - mRNA Booster Vaccine(SW-BIC-213) Compared With

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05686161
Study type	Interventional
Source	Stemirna Therapeutics
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	October 19, 2022
Completion date	June 27, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

mRNA Booster Vaccine(SW-BIC-213) Compared With Pfizer andSinopharm Against Emerging VOCs

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms