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

Last updated: February 23, 2024
Sponsor: Hipra Scientific, S.L.U
Overall Status: Completed

Phase

3

Condition

Covid-19

Treatment

PHH1-V

Clinical Study ID

NCT05303402
HIPRA-HH-4
  • Ages > 18
  • All Genders

Study Summary

A phase 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

Eligibility Criteria

Inclusion

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, sexualabstinence, condom.
  • Male: Vasectomized participant, sexual abstinence, condom.

Exclusion

Exclusion Criteria:

  • History of anaphylaxis to any prior vaccine
  • Participants has received or plans to receive live attenuated vaccines, other not livevaccines, 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 hospitaldischarge.
  • 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 ordevice
  • 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 opinionmight increase participant risk, interfere with the study or impair interpretation ofstudy data.

Study Design

Total Participants: 241
Treatment Group(s): 1
Primary Treatment: PHH1-V
Phase: 3
Study Start date:
May 12, 2022
Estimated Completion Date:
December 01, 2023

Connect with a study center

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Josep Trueta

    Girona, 17001
    Spain

    Site Not Available

  • Ankara University Medical Faculty Hospitals

    Ankara, 06620
    Turkey

    Site Not Available

  • Hacettepe University Medical Faculty Hospitals

    Ankara, 06230
    Turkey

    Site Not Available

  • Koc University Hospital

    Istanbul, 34010
    Turkey

    Site Not Available

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