A Phase IIb/III, Open Label, Single Arm, Multi-centre, Trial to Assess the Immunogenicity and Safety of an Additional Dose Vaccination With a Recombinant Protein RBD Fusion Heterodimer Candidate (PHH-1V) Against SARS-CoV-2, in Adults With Pre-existing Immunosuppressive Conditions Vaccinated Against COVID-19

Hipra Scientific, S.L.U6 sites in 2 countries241 target enrollmentMay 12, 2022

ConditionsSARS CoV 2 Infection

InterventionsPHH-1V

Overview

Phase: Phase 2
Intervention: PHH-1V
Conditions: SARS CoV 2 Infection
Sponsor: Hipra Scientific, S.L.U
Enrollment: 241
Locations: 6
Primary Endpoint: Immunogenicity against Omicron, Beta, Delta at Day 0 and Day 14
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A phase IIb/III, open label, single arm, multi-centre, trial to assess the immunogenicity and safety of an additional dose vaccination with a recombinant protein RBD fusion heterodimer candidate (PHH-1V) against SARS-CoV-2, in adults with pre-existing immunosuppressive conditions vaccinated against COVID-19

Registry

clinicaltrials.gov

Start Date

May 12, 2022

End Date

December 1, 2023

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hipra Scientific, S.L.U

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male, female or transgender, ≥ 18 years old at Day
•Provide inform consent form
•Participant who has:
•3 doses of mRNA vaccines
•2 doses of mRNA vaccines and previous COVID-19 infection
•2 doses of Coronavac and 1 Comirnaty, or, 1 Coronavac and 2 Comirnaty
•Participant who has:
•HIV infection with CD4 Tcells counts \<400
•Primary antibody deficiency disorders
•Kidney disease on dialysis

Exclusion Criteria

•History of anaphylaxis to any prior vaccine
•Participants has received or plans to receive live attenuated vaccines, other not live vaccines, or Vaxzevria or Janssen vaccines.
•Pregnant or breast-feeding at Day
•A confirmed COVID-19 diagnose \<90 days prior to vaccination day
•A clinically significant acute illness or fever at screening or 48h before day
•Participant had a surgery requiring hospitalisation and has not received the hospital discharge.
•Participant has an ongoing severe and non-stable psychiatric condition
•Participant has a problematic or risky use of substances including alcohol
•Participant has a bleeding disorder that contraindicates intramuscular injection
•Participant suffering from post-acute COVID-19 syndrome / long COVID

Arms & Interventions

Experimental: COVID-19 Vaccine HIPRA 40 mcg/dose

Intramuscular injection of HIPRA's COVID-19 vaccine, consisting of 40 mcg/dose.

Intervention: PHH-1V

Outcomes

Primary Outcomes

Immunogenicity against Omicron, Beta, Delta at Day 0 and Day 14

Time Frame: Day 0 and Day 14

Changes in neutralising antibodies measured by pseudovirus (or live virus for the HIV cohort\*) neutralization against Omicron, Beta and Delta any other relevant Variants of Concern (VOC) in the epidemiologic moment, at Baseline and at Day 14 after administration of HIPRA's vaccine (PHH-1V).

Secondary Outcomes

Safety and tolerability of the booster vaccine(Day 0, Day 14, Day 91, Day 182, Day 365)
Total antibodies(Day 0, Day 14, Day 91, Day 182, Day 365)
Immunogenicity against Omicron, Beta, Delta at Day 91, Day 182 and Day 365(Day 91, Day 182 and Day 365)