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

H

Hipra

Status and phase

Completed
Phase 3

Conditions

SARS CoV 2 Infection

Treatments

Biological: PHH1-V

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05303402
HIPRA-HH-4

Details and patient eligibility

About

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

Enrollment

241 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

241 participants in 1 patient group

Experimental: COVID-19 Vaccine HIPRA 40 mcg/dose
Experimental group
Description:
Intramuscular injection of HIPRA's COVID-19 vaccine, consisting of 40 mcg/dose.
Treatment:
Biological: PHH1-V

Trial contacts and locations

6

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Central trial contact

Teresa Prat, Dr.

Data sourced from clinicaltrials.gov

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