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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 contrain…
What they're measuring
1
Immunogenicity against Omicron, Beta, Delta at Day 0 and Day 14