NCT05246137

A Phase III Trial to Assess the Safety and Immunogenicity of a HIPRA's Candidate Booster Vaccination Against COVID-19.

A Phase III, Open Label, Single Arm, Multi-centre, Trial to Assess the Safety and Immunogenicity of a Booster Vaccination With a Recombinant Protein RBD Fusion Heterodimer Candidate (PHH-1V) Against SARS-CoV-2, in Adults Vaccinated Against COVID-19.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,646 (actual)
• Sponsor: Hipra Scientific, S.L.U · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

This is a phase III clinical study to assess the safety, tolerability and immunogenicity of PHH-1V as a booster dose in healthy adult subjects vaccinated against COVID-19 with the Comirnaty, Spikevax, Vaxevria or Janssen vaccine.

Detailed description

This is a phase III clinical study to assess the safety, tolerability and immunogenicity of PHH-1V as a booster dose in healthy adults vaccinated against COVID-19 with the Comirnaty, Spikevax, Vaxevria or Janssen vaccine at least 91 days before day 0. All the participants will receive a booster dose of the HIPRA's COVID-19 Vaccine and will be followed for 26 weeks or 52 weeks if they participate in the safety cohort, or the immunogenicity cohort, respectively.

Conditions

• COVID-19
• SARS-CoV-2 Acute Respiratory Disease

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 Vaccine 40 ug/dose	Intramuscular injection of 0,5 ml with 40 ug of recombinant PHH-1V

Timeline

• Start date: 2022-02-03
• Primary completion: 2022-03-03
• Completion: 2023-03-03
• First posted: 2022-02-18
• Last updated: 2023-03-15

Locations

18 sites across 2 countries: Italy, Spain