NCT05175742

PTX-COVID19-B, an mRNA Humoral Vaccine, Intended for Prevention of COVID-19 in a General Population. This Study is Designed to Demonstrate the Safety, Tolerability, and Immunogenicity of PTX-COVID19-B in Comparison to the Pfizer-BioNTech COVID-19 Vaccine.

A Phase 2, Randomized, Double-dummy, Observer-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of PTX-COVID19-B Compared to Pfizer-BioNTech COVID-19 Vaccine in Healthy Seronegative Adults Aged 18 to 64 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 565 (actual)
• Sponsor: Providence Therapeutics Holdings Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The Vaccine Product, PTX-COVID19-B mRNA Humoral Vaccine, is intended for prevention of COVID-19 in a general population. This study is designed to evaluate the safety, tolerability, and immunogenicity of PTX-COVID19-B compared to Pfizer-BioNTech COVID-19 vaccine in healthy seronegative adults aged 18 to 64.

Conditions

• Covid19 Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	PTX-COVID19-B	Sterile solution for injection
BIOLOGICAL	Pfizer-BioNTech COVID-19 vaccine	Sterile solution for injection
BIOLOGICAL	Placebo	0.9% sodium chloride (normal saline) injection

Timeline

• Start date: 2021-08-17
• Primary completion: 2023-03-29
• Completion: 2023-03-29
• First posted: 2022-01-04
• Last updated: 2023-04-07

Locations

11 sites across 2 countries: Canada, South Africa