NCT04765436

PTX-COVID19-B, an mRNA Humoral Vaccine, is Intended for Prevention of COVID-19 in a General Population. This Study is Designed to Evaluate Safety, Tolerability, and Immunogenicity of PTX-COVID19-B Vaccine in Healthy Seronegative Adults Aged 18-64

A Phase I, First-in-Human, Observer-Blinded, Randomized, Placebo Controlled, Ascending Dose Study to Evaluate the Safety, Tolerability, and Immunogenicity of PTX-COVID19-B Vaccine in Healthy Seronegative Adults Aged 18-64

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (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 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	Placebo	0.9% sodium chloride (normal saline) injection

Timeline

• Start date: 2021-01-14
• Primary completion: 2022-03-30
• Completion: 2022-03-30
• First posted: 2021-02-21
• Last updated: 2022-04-25

Locations

1 site across 1 country: Canada