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Completed

NCT Number: NCT05303402

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

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Key information

Conditions

SARS CoV 2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PHH-1V

Biological

COVID-19 Vaccine HIPRA, 40 mcg/dose

Primary outcomes

  1. 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

  1. Immunogenicity against Omicron, Beta, Delta at Day 91, Day 182 and Day 365

    Time frame: Day 91, Day 182 and Day 365

    • 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).

  2. Total antibodies

    Time frame: Day 0, Day 14, Day 91, Day 182, Day 365

    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).

  3. Safety and tolerability of the booster vaccine

    Time frame: Day 0, Day 14, Day 91, Day 182, Day 365

    To assess the safety and tolerability of PHH-1V as an additional dose in adult individuals with pre-existing immunosuppressive conditions

Other outcomes

  1. Number of SARS-CoV-2 infections

    Time frame: Day 0, Day 14, Day 91, Day 182, Day 365

    Number of participants with SARS-CoV-2 infections ≥14 days after PHH-1V administration.

  2. Number of SARS-CoV-2 severe infections (Severe cases are considered as any episode of COVID-19 requiring ≥ 24hrs of hospitalization.)

    Time frame: Day 0, Day 14, Day 91, Day 182, Day 365

    Number of COVID-19 severe infections ≥14 days after PHH-1V administration.

  3. Celular immunity

    Time frame: Day 0, Day 14, Day 91, Day 182, Day 365

    Antibody IgG subclasses titre usage and avidity of humoral immunity at Baseline and Days 14, 91, 182 and 365.

  4. T-cell cellullar immunity

    Time frame: Day 0, Day 14, Day 91, Day 182, Day 365

    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.

Sponsors and collaborators

Lead sponsor

Hipra Scientific, S.L.U

Industry

Collaborators

  • Asphalion
  • Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
  • Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
  • Veristat, Inc.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 31, 2022
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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