NCT05305573

Assessing the Immunogenicity and Safety of a HIPRA's Candidate Booster Vaccination in Adults Fully Vaccinated With Adenovirus Vaccine Against COVID-19.

A Phase IIb, Double-Blind, Randomized, Active Controlled, Multi-center, Non-inferiority Trial to Assess Immunogenicity and Safety of a Booster Vaccination With a Recombinant Protein RBD Fusion Dimer Candidate (PHH-1V) Against SARS-CoV-2, in Adults Fully Vaccinated With Adenovirus Vaccine Against COVID-19

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Hipra Scientific, S.L.U · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Phase IIb clinical trial to assess the Immunogenicity and Safety of a HIPRA's Candidate Booster vaccination (PHH-1V) in adults fully vaccinated with the adenovirus vaccine Vaxevria against COVID-19.

Detailed description

The study population includes healthy adults aged above 18 years old who have received two doses of the Vaxevria vaccine, and are at least 91 days and less than 365 days after their second dose. Participants will be randomly assigned into two treatment arms. In each arm, volunteers will be randomized in a ratio Test vaccine:Comirnaty of 2:1. Each participant will receive one booster immunisation and will be followed for 6 months to evaluate immunogenicity response and assess the safety of the test vaccine in comparison to Comirnaty.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 Vaccine HIPRA 40 ug/dose	Subjects will receive one injection of COVID-19 Vaccine HIPRA (PHH-1V)
BIOLOGICAL	Comirnaty (Pfizer-BioNtech) 30 ug/dose concentrate for dispersion for injection	Subjects will receive one injection of Comirnaty Vaccine

Timeline

• Start date: 2022-03-25
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2022-03-31
• Last updated: 2023-03-01

Locations

7 sites across 1 country: Spain