A Phase IIb/III Clinical Trial to Assess Safety and Immunogenicity of a COVID-19 Vaccine Booster Dose in Immunosupressed Adults.

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

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

Study Overview

• Status: Completed
• Conditions: SARS CoV 2 Infection
• Intervention / Treatment: Biological: PHH-1V

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Germans Trias i Pujol
    • Barcelona, Barcelona, Spain, 08036
      • Hospital Clinic de Barcelona
  • Girona
    • Girona, Girona, Spain, 17001
      • Hospital Josep Trueta
• Turkey (Türkiye)
  • Ankara
    • Ankara, Ankara, Turkey (Türkiye), 06230
      • Hacettepe University Medical Faculty Hospitals
    • Ankara, Ankara, Turkey (Türkiye), 06620
      • Ankara University Medical Faculty Hospitals
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34010
      • Koc University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male, female or transgender, ≥ 18 years old at Day 0.
• 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
• Kidney transplant at least >1 year
• Auto Immune Disease (AID) in treatment with rituximab
• For a female of childbearing potential, to have a negative pregnancy test at Day 0
• Use of any of these contraception:
• Female: hormonal contraception, intrauterine device, vasectomized partner, sexual abstinence, condom.
• Male: Vasectomized participant, sexual abstinence, condom.

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 0.
• A confirmed COVID-19 diagnose <90 days prior to vaccination day 0.
• A clinically significant acute illness or fever at screening or 48h before day 0.
• 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
• Participant received any immunotherapy to prevent/treat COVID-19 in the last 90 days
• Participant is already participating in another research involving drug, biologics or device
• Participant has donated ≥450 ml of blood products within 12 weeks before screening
• Participant has any medical condition and/or finding that in the investigator opinion might increase participant risk, interfere with the study or impair interpretation of study data.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: COVID-19 Vaccine HIPRA 40 mcg/dose; Intramuscular injection of HIPRA's COVID-19 vaccine, consisting of 40 mcg/dose.	Biological: PHH-1V; COVID-19 Vaccine HIPRA, 40 mcg/dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity against Omicron, Beta, Delta at 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).	Day 0 and Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity against Omicron, Beta, Delta at Day 91, Day 182 and Day 365	1. To determine and compare the changes of the immunogenicity measured by pseudovirus (or live virus for the HIV cohort) neutralization against Omicron, Beta and Delta and any other relevant Variants of Concern (VOC) in the epidemiologic moment at Days, 91, 182 and 365, after administration of HIPRA's vaccine (PHH-1V).	Day 91, Day 182 and Day 365
Total antibodies	To evaluate the immunogenicity measured by means of total antibody against Receptor Binding Domain of the Spike protein of SARS-CoV-2 quantification, measured by an electrochemiluminescence immunoassay (ECLIA) at Baseline and at Days 14, 91, 182 and 365 after administration of HIPRA's vaccine (PHH-1V).	Day 0, Day 14, Day 91, Day 182, Day 365
Safety and tolerability of the booster vaccine	To assess the safety and tolerability of PHH-1V as an additional dose in adult individuals with pre-existing immunosuppressive conditions	Day 0, Day 14, Day 91, Day 182, Day 365

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of SARS-CoV-2 infections	Number of participants with SARS-CoV-2 infections ≥14 days after PHH-1V administration.	Day 0, Day 14, Day 91, Day 182, Day 365
Number of SARS-CoV-2 severe infections (Severe cases are considered as any episode of COVID-19 requiring ≥ 24hrs of hospitalization.)	Number of COVID-19 severe infections ≥14 days after PHH-1V administration.	Day 0, Day 14, Day 91, Day 182, Day 365
Celular immunity	Antibody IgG subclasses titre usage and avidity of humoral immunity at Baseline and Days 14, 91, 182 and 365.	Day 0, Day 14, Day 91, Day 182, Day 365
T-cell cellullar immunity	T-cell mediated phenotype polyclonality with potential cross-reactivity capacity and gene-expression profiles against the SARS-CoV-2 Spike & RBD proteins at Baseline and at Days 14, 91, 182 and 365 in a subset of 50% of participants.	Day 0, Day 14, Day 91, Day 182, Day 365

Collaborators and Investigators

• Sponsor: Hipra Scientific, S.L.U
• Collaborators: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta; Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia; Veristat, Inc.; Asphalion

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2022
• Primary Completion (Actual): July 29, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; HIPRA COVID-19 vaccine
• Other Study ID Numbers: HIPRA-HH-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No