PHASE 1 SARS-COV-2-Spike-Ferritin-Nanoparticle (SpFN) Vaccine With ALFQ Adjuvant for Prevention of COVID-19

Phase 1 Completed 29 enrolled U.S. Army Medical Research and Development Command Henry M. Jackson Foundation for the Advancement of Military Medicine · collab Walter Reed Army Institute of Research (WRAIR) · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to evaluate the safety, reactogenicity, and immune response of the SpFN COVID-19 vaccine with Army Liposomal Formulation QS21 (ALFQ) adjuvant in healthy adults ages 18-55.

Timeline

Start: 2021-04-05
Primary completion: 2023-03-31
Completion: 2023-10-30

Publications

Ober Shepherd BL, Scott PT, Hutter JN, Lee C, McCauley MD, Guzman I, Bryant C, McGuire S, Kennedy J, Chen WH, Hajduczki A, Mdluli T, Valencia-Ruiz A, Amare MF, Matyas GR, Rao M, Rolland M, Mascola JR, De Rosa SC, McElrath MJ, Montefiori DC, Serebryannyy L, McDermott AB, Peel SA, Collins ND, Joyce MG, Robb ML, Michael NL, Vasan S, Modjarrad K; EID-030 Study Group. SARS-CoV-2 recombinant spike ferritin nanoparticle vaccine adjuvanted with Army Liposome Formulation containing monophosphoryl lipid A and QS-21: a phase 1, randomised, double-blind, placebo-controlled, first-in-human clinical trial. Lancet Microbe. 2024 Jun;5(6):e581-e593. doi: 10.1016/S2666-5247(23)00410-X. Epub 2024 May 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SpFN_1B-06-PL	Vaccine	25 ug	Intramuscular
Subject	SpFN_1B-06-PL	Vaccine	50 ug	Intramuscular
Background	Army Liposomal Formulation QS21	Other / unclassified	0.5 ml	Intramuscular

PHASE 1 SARS-COV-2-Spike-Ferritin-Nanoparticle (SpFN) Vaccine With ALFQ Adjuvant for Prevention of COVID-19

Summary

Timeline

Publications

Drugs

Indications