NCT05686161

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Stemirna Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Conditions

• Immunogenicity
• Safety
• Efficacy

Interventions

Type	Name	Description
BIOLOGICAL	SW-BIC-213;SARS-Cov-2.	The study will be performed in people receiving two doses of Sinopharm vaccine over 180 days (± 30 days) after the second dose prior to enrollment. The three study groups who will receive the booster dose will be assigned as follows: Subjects (N≈600) Group 1: (N≈200) - Stemirna(SW-BIC-213) Group 2: (N≈200) - Pfizer(BNT162b2) Group 3: (N≈200) -Sinopharm (BIBP) Study groups: There will be three study groups. Study Group Assignment: Randomization (1:1:1) will be applied for subjects to account for the different number of doses per vial for different vaccines and short shelf life.
BIOLOGICAL	Sinopharm (BIBP);SARS-Cov-2.	The study will be performed in people receiving two doses of Sinopharm vaccine over 180 days (± 30 days) after the second dose prior to enrollment. The three study groups who will receive the booster dose will be assigned as follows: Subjects (N≈600) Group 1: (N≈200) - Stemirna(SW-BIC-213) Group 2: (N≈200) - Pfizer(BNT162b2) Group 3: (N≈200) -Sinopharm (BIBP) Study groups: There will be three study groups. Study Group Assignment: Randomization (1:1:1) will be applied for subjects to account for the different number of doses per vial for different vaccines and short shelf life.
BIOLOGICAL	Pfizer(BNT162b2);SARS-Cov-2.	The study will be performed in people receiving two doses of Sinopharm vaccine over 180 days (± 30 days) after the second dose prior to enrollment. The three study groups who will receive the booster dose will be assigned as follows: Subjects (N≈600) Group 1: (N≈200) - Stemirna(SW-BIC-213) Group 2: (N≈200) - Pfizer(BNT162b2) Group 3: (N≈200) -Sinopharm (BIBP) Study groups: There will be three study groups. Study Group Assignment: Randomization (1:1:1) will be applied for subjects to account for the different number of doses per vial for different vaccines and short shelf life.

Timeline

• Start date: 2022-10-19
• Primary completion: 2022-12-07
• Completion: 2023-06-27
• First posted: 2023-01-17
• Last updated: 2023-01-17

Locations

1 site across 1 country: Laos