ARVAC - A New Recombinant Coronavirus Disease 2019 (COVID-19) Vaccine

Phase 1 Completed 80 enrolled Laboratorio Pablo Cassará S.R.L. National Council of Scientific and Technical Research, Argentina · collab Universidad Nacional de San Martín (UNSAM) · collab

Non-randomizedSingle-groupOpen-labelPrevention

Summary

The objective of this clinical trial is to test a new vaccine against SARS-CoV-2 (ARVAC-CG) in healthy adult volunteers, previously vaccinated against the SARS-CoV-2 virus. The main questions it aims to answer are: * What is the safety and tolerability profile of the two-dose schedule of this new vaccine? * What is the immune response after each dose of vaccine Participants will receive two doses of the study vaccine 28 days apart. They will be required to complete a total of 7 safety and immunogenicity follow-up visits over a 1-year period.

Timeline

Start: 2022-04-20
Primary completion: 2022-09-30
Completion: 2023-10-29

Publications

Pasquevich KA, Coria LM, Ceballos A, Mazzitelli B, Rodriguez JM, Demaria A, Pueblas Castro C, Bruno L, Saposnik L, Salvatori M, Varese A, Gonzalez S, Gonzalez Martinez VV, Geffner J, Alvarez D; Laboratorio Pablo Cassara R&D and CMC for ARVAC CG consortium; Feleder E, Halabe K, Perez Lera PE, de Oca FM, Vega JC, Lombardo M, Yerino GA, Flo J, Cassataro J. Safety and immunogenicity of a SARS-CoV-2 Gamma variant RBD-based protein adjuvanted vaccine used as booster in healthy adults. Nat Commun. 2023 Jul 28;14(1):4551. doi: 10.1038/s41467-023-40272-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ARVAC CG	Vaccine	25 ug	Intramuscular
Subject	ARVAC CG	Vaccine	50 ug	Intramuscular

Indications

No indication recorded.