NCT05930730

Immunogenicity and Safety of Comvigen (Bivalent) Vaccine

A Phase 2, Non-inferiority, Open-label, Randomized Controlled Study to Evaluate the Immunogenicity and Safety of Comvigen (Bivalent) Vaccine as a Booster Dose in Adults Who Have Received a Previous Booster Dose of an Approved COVID-19 Vaccine

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This study will assess the safety, reactogenicity and immunogenicity of a single dose of Comvigen (Bivalent, ChulaCov19 BNA159.2) vaccine or BIVALENT Pfizer/BNT vaccine as a booster among healthy males and non-pregnant females aged 18-64 years after receiving a previous booster dose of any approved mRNA COVID-19 vaccine for more than 3 months. The results of Combiven will be compared to BIVALENT Pfizer/BNT vaccine.

Detailed description

This is a phase II, non-inferiority, multicenter randomized open-label trial in which 450 healthy males and non-pregnant females, aged 18-64 years, will be recruited from multi-sites in Thailand. The randomization will be a 2:1 design to receive either Comvigen (Bivalent, ChulaCov19 BNA159.2) vaccine or BIVALENT Pfizer/BNT vaccine. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of a single dose of COMVIGEN at 50 ug, as a booster dose, given at 3 months and above after receipt of a previous booster dose of any approved mRNA COVID-19 vaccine. The estimated sample size would also allow a comparison between a booster dose, Comvigen (Bivalent, ChulaCov19 BNA159.2) vaccine at 50 ug to Comirnaty, BIVALENT of Pfizer/BNT Bivalent vaccine at 30 ug dose.

Conditions

• Safety of a Single Dose of COMVIGEN Vaccine
• Reactogenicity of a Single Dose of COMVIGEN Vaccine
• Immunogenicity of a Single Dose of COMVIGEN Vaccine
• Safety of a Single Dose of BIVALENT Pfizer/BNT Vaccine
• Reactogenicity of a Single Dose of BIVALENT Pfizer/BNT Vaccine
• Immunogenicity of a Single Dose of BIVALENT Pfizer/BNT Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Comvigen (Bivalent, ChulaCov19 BNA159.2)	single dose of COMVIGEN at 50 ug, as a booster dose, given at 3 months and above after receipt of a previous booster dose of any approved mRNA COVID-19 vaccine
BIOLOGICAL	BIVALENT Pfizer/BNT vaccine	single dose of BIVALENT of Pfizer/BNT Bivalent vaccine at 30 ug, as a booster dose, given at 3 months and above after receipt of a previous booster dose of any approved mRNA COVID-19 vaccine

Timeline

• Start date: 2023-10-09
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2023-07-05
• Last updated: 2023-10-18

Locations

2 sites across 1 country: Thailand