Immunogenicity and Safety of a Booster Vaccination With a Recombinant Protein RBD Candidate Vaccine Against SARS-CoV-2 in Healthy Adults Volunteers Fully Vaccinated Followed by an Extension Period to Study a Fourth Dose Administration.

Summary

This Phase IIb clinical study aims to compare the immunogenicity and safety of a booster dose of recombinant protein RBD fusion dimer vaccine as a heterologous booster (to subjects who have received the second dose of the Pfizer-BioNTech (Comirnaty) COVID-19 vaccine at least 182 days prior to the booster dose in this study) versus a homologous booster (subjects who received the second dose of the Comirnaty COVID-19 vaccine at least 182 days prior to the booster dose in this study) will receive a third dose of the Comirnaty vaccine). The extension part of the study aims to compare the immunogenicity and safety of a fourth dose of PHH-1V in subjects with a primovaccination with Pfizer-BioNTech (Comirnaty) COVID-19 vaccine plus either a booster dose of Comirnaty or PHH-1V versus those with three vaccinations of Comirnaty.

Timeline

Start

2021-11-16

Primary completion

2023-05-29

Completion

2023-05-29

Publications

• Corominas J, Garriga C, Prenafeta A, Moros A, Canete M, Barreiro A, Gonzalez-Gonzalez L, Madrenas L, Guell I, Clotet B, Izquierdo-Useros N, Raich-Regue D, Gallemi M, Blanco J, Pradenas E, Trinite B, G Prado J, Perez-Caballero R, Bernad L, Plana M, Esteban I, Aurrecoechea E, Taleb RA, McSkimming P, Soriano A, Nava J, Anagua JO, Ramos R, Marti Lluch R, Corpes Comes A, Otero Romero S, Martinez-Gomez X, Camacho-Arteaga L, Molto J, Benet S, Bailon L, Arribas JR, Borobia AM, Queiruga Parada J, Navarro-Perez J, Forner Giner MJ, Lucas RO, Vazquez Jimenez MDM, Lopez Fernandez MJ, Alvarez-Mon M, Troncoso D, Arana-Arri E, Meijide S, Imaz-Ayo N, Garcia PM, de la Villa S, Rodriguez Fernandez S, Prat T, Torroella E, Ferrer L. Humoral and cellular immune responses after 6 months of a heterologous SARS-CoV-2 booster with the protein-based PHH-1V vaccine in a phase IIb trial. Vaccine. 2025 Feb 15;47:126685. doi: 10.1016/j.vaccine.2024.126685. Epub 2025 Jan 13.
• Moros A, Prenafeta A, Barreiro A, Perozo E, Fernandez A, Canete M, Gonzalez L, Garriga C, Pradenas E, Marfil S, Blanco J, Cebollada Rica P, Sistere-Oro M, Meyerhans A, Prat Cabanas T, March R, Ferrer L. Immunogenicity and safety in pigs of PHH-1V, a SARS-CoV-2 RBD fusion heterodimer vaccine candidate. Vaccine. 2023 Aug 7;41(35):5072-5078. doi: 10.1016/j.vaccine.2023.07.008. Epub 2023 Jul 16.
• Corominas J, Garriga C, Prenafeta A, Moros A, Canete M, Barreiro A, Gonzalez-Gonzalez L, Madrenas L, Guell I, Clotet B, Izquierdo-Useros N, Raich-Regue D, Gallemi M, Blanco J, Pradenas E, Trinite B, Prado JG, Blanch-Lombarte O, Perez-Caballero R, Plana M, Esteban I, Pastor-Quinones C, Nunez-Costa X, Taleb RA, McSkimming P, Soriano A, Nava J, Anagua JO, Ramos R, Lluch RM, Comes AC, Romero SO, Gomez XM, Sans-Pola C, Molto J, Benet S, Bailon L, Arribas JR, Borobia AM, Parada JQ, Navarro-Perez J, Forner Giner MJ, Lucas RO, Jimenez MDMV, Compan SO, Alvarez-Mon M, Troncoso D, Arana-Arri E, Meijide S, Imaz-Ayo N, Garcia PM, de la Villa Martinez S, Fernandez SR, Prat T, Torroella E, Ferrer L. Safety and immunogenicity of the protein-based PHH-1V compared to BNT162b2 as a heterologous SARS-CoV-2 booster vaccine in adults vaccinated against COVID-19: a multicentre, randomised, double-blind, non-inferiority phase IIb trial. Lancet Reg Health Eur. 2023 May;28:100613. doi: 10.1016/j.lanepe.2023.100613. Epub 2023 Apr 14.

Drugs

Indications