Status:
COMPLETED
A Phase IIb/III Clinical Trial to Assess Safety and Immunogenicity of a COVID-19 Vaccine Booster Dose in Immunosupressed Adults.
Lead Sponsor:
Hipra Scientific, S.L.U
Collaborating Sponsors:
Veristat, Inc.
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Conditions:
SARS CoV 2 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT05303402
Start Date
May 12 2022
End Date
December 1 2023
Last Update
September 16 2025
Active Locations (6)
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1
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
2
Hospital Clínic de Barcelona
Barcelona, Barcelona, Spain, 08036
3
Hospital Josep Trueta
Girona, Girona, Spain, 17001
4
Hacettepe University Medical Faculty Hospitals
Ankara, Ankara, Turkey (Türkiye), 06230