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
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
SpainSite Not Available
Hospital Clínic de Barcelona
Barcelona, 08036
SpainSite Not Available
Hospital Josep Trueta
Girona, 17001
SpainSite Not Available
Ankara University Medical Faculty Hospitals
Ankara, 06620
TurkeySite Not Available
Hacettepe University Medical Faculty Hospitals
Ankara, 06230
TurkeySite Not Available
Koc University Hospital
Istanbul, 34010
TurkeySite Not Available
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