This is a phase IIb/III, double-blind, randomised, active-controlled, multi-centre, non-inferiority clinical trial that aims to determine safety, tolerability and immunogenicity of a booster vaccination with a recombinant protein receptor binding domain (RBD) fusion homodimer of XBB.1.16 adapted candidate against SARS-CoV-2 developed by HIPRA (PHH-1V81).
This is a phase IIb/III, double-blind, randomised, active-controlled, multi-centre, non-inferiority clinical trial that aims to determine safety, tolerability and immunogenicity of a booster vaccination with a recombinant protein receptor binding domain (RBD) fusion homodimer of XBB.1.16 adapted candidate against SARS-CoV-2 developed by HIPRA (PHH-1V81). Approximately 612 participants who have received a primary scheme with an EU-approved mRNA vaccine (two doses) and at least one booster dose of an EU-approved mRNA vaccine against COVID-19, will be randomly assigned to the following two treatment arms in a PHH-1V81 : Comirnaty (Omicron XBB.1.5) 2:1 ratio: * PHH-1V81 vaccine arm: Approximately 408 adults will receive a booster dose of PHH-1V81 (HIPRA adapted vaccine). * Comirnaty vaccine arm: Approximately 204 adults will receive a booster dose of Comirnaty Omicron XBB.1.5. Participants will be stratified before randomisation by age group (approximately 10% of adults ≥60 years old), and by number of doses previously received. All participants will receive a booster dose of PHH-1V81 or Comirnaty Omicron XBB.1.5 at Day 0 and will be followed for 6 months. All subjects will be closely observed for 15 minutes after vaccination on site.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
913
booster of PHH-1V81
booster of Comirnaty Omicron XBB1.5
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital HM Delfos
Barcelona, Barcelona, Spain
CAP Centelles
Centelles, Barcelona, Spain
Hospital Josep Trueta
Girona, Girona, Spain
Number, percentage and characteristics of solicited local and systemic AEs, unsolicited AEs, SAEs, AESIs and MAAEs
To assess the safety and tolerability of a PHH-1V81 booster in adults who previously received primary vaccination and at least one booster dose of an EU-approved mRNA vaccine
Time frame: 0, 7, 14, 91 and 182 days post-vaccination
Neutralising antibody titers of PHH-1V81 booster at Day 0 and 14
To determine and compare the changes in immunogenicity measured by pseudovirus neutralisation assay (PBNA) against Omicron XBB.1.16 variant at Baseline and Day 14 in the PHH-1V81 vaccine arm versus the Comirnaty arm.
Time frame: 0 and 14 days post-vaccination
Neutralising antibody titers of PHH-1V81 booster at Day 91 and 182
To determine and compare the changes in immunogenicity measured by PBNA against Wuhan, Omicron BA.1 and Omicron XBB.1.5 at Baseline and at Days 14, 91 and 182, and Omicron XBB.1.16 at Days 91 and 182, after vaccination in the PHH-1V81 vaccine arm vs. the Comirnaty arm.
Time frame: 91 and 182 days post-vaccination
Total binding antibody titers of PHH-1V81 booster at Days 0, 14, 91 and 182
To evaluate and compare the immunogenicity measured by means of total antibody against Receptor Binding Domain of the Spike protein of SARS-CoV-2, measured by an electrochemiluminescence immunoassay (ECLIA) at Baseline and at Days 14, 91 and 182 in the PHH-1V81 vaccine arm vs the Comirnaty arm.
Time frame: 0, 14, 91 and 182 days post-vaccination
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Hospital HM Sanchinarro
Madrid, Madrid, Spain
Hospital Quironsalud Madrid
Madrid, Madrid, Spain
Hospital HM Puerta del Sur
Móstoles, Madrid, Spain
Hospital Regional de Málaga
Málaga, Málaga, Spain
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain
Hospital Universitario de Cruces
Barakaldo, Vizcaya, Spain