Safety and Immunogenicity Study of Recombinant Protein RBD Candidate Vaccine Against SARS-CoV-2 in Adult Healthy Volunteers (COVID-19)

Summary

This is a first-in-human, phase I/IIa, randomized, controlled, observer-blinded, dose-escalation, multicentre clinical trial to evaluate safety and immunogenicity of COVID-19 HIPRA vaccine in adult healthy volunteers.

Timeline

Start

2021-08-16

Primary completion

2021-09-30

Completion

2022-09-30

Publications

• Leal L, Pich J, Ferrer L, Nava J, Marti-Lluch R, Esteban I, Pradenas E, Raich-Regue D, Prenafeta A, Escobar K, Pastor C, Ribas-Aulinas M, Trinite B, Munoz-Basagoiti J, Domenech G, Clotet B, Corominas J, Corpes-Comes A, Garriga C, Barreiro A, Izquierdo-Useros N, Arnaiz JA, Soriano A, Rios J, Nadal M, Plana M, Blanco J, Prat T, Torroella E, Ramos R; HIPRA-HH-1 study group. Safety and immunogenicity of a recombinant protein RBD fusion heterodimer vaccine against SARS-CoV-2. NPJ Vaccines. 2023 Sep 29;8(1):147. doi: 10.1038/s41541-023-00736-5.

Drugs

Indications