NCT06181292

Safety and Immunogenicity of a Booster Vaccination With an Adapted Vaccine

Phase IIb/III, Double-Blind, Randomised, Active-Controlled, Multi-Center, Non-Inferiority Clinical Trial, to Assess the Safety and Immunogenicity of a Booster Vaccination With an Adapted Recombinant Protein RBD Fusion Homodimer Candidate Against SARS-CoV-2, in Adults Vaccinated Against COVID-19

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 913 (actual)
• Sponsor: Hipra Scientific, S.L.U · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• SARS-CoV2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	PHH-1V81	booster of PHH-1V81
BIOLOGICAL	Comirnaty Omicron XBB1.5	booster of Comirnaty Omicron XBB1.5

Timeline

• Start date: 2023-11-15
• Primary completion: 2024-06-17
• Completion: 2024-06-17
• First posted: 2023-12-26
• Last updated: 2026-03-12

Locations

10 sites across 1 country: Spain