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

Phase 1 Completed 60 enrolled Providence Therapeutics Holdings Inc.

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start: 2021-01-14
Primary completion: 2022-03-30
Completion: 2022-03-30

Publications

Martin-Orozco N, Vale N, Mihic A, Amor T, Reiter L, Arita Y, Samson R, Hu Q, Gingras AC, Sorenson BT, Marcusson EG, Patel P. Phase I randomized, observer-blinded, placebo-controlled study of a SARS-CoV-2 mRNA vaccine PTX-COVID19-B. Sci Rep. 2023 May 26;13(1):8557. doi: 10.1038/s41598-023-35662-y.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PTX-COVID19-B	Messenger RNA (mRNA)	16 ug	Intramuscular
Subject	PTX-COVID19-B	Messenger RNA (mRNA)	40 ug	Intramuscular
Subject	PTX-COVID19-B	Messenger RNA (mRNA)	100 ug	Intramuscular

Indications

No indication recorded.