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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
241
COVID-19 Vaccine HIPRA, 40 mcg/dose
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Clínic de Barcelona
Barcelona, Barcelona, Spain
Hospital Josep Trueta
Girona, Girona, Spain
Hacettepe University Medical Faculty Hospitals
Ankara, Ankara, Turkey (Türkiye)
Immunogenicity against Omicron, Beta, Delta at Day 0 and Day 14
Changes in neutralising antibodies measured by pseudovirus (or live virus for the HIV cohort\*) neutralization against Omicron, Beta and Delta any other relevant Variants of Concern (VOC) in the epidemiologic moment, at Baseline and at Day 14 after administration of HIPRA's vaccine (PHH-1V).
Time frame: Day 0 and Day 14
Immunogenicity against Omicron, Beta, Delta at Day 91, Day 182 and Day 365
1\. To determine and compare the changes of the immunogenicity measured by pseudovirus (or live virus for the HIV cohort) neutralization against Omicron, Beta and Delta and any other relevant Variants of Concern (VOC) in the epidemiologic moment at Days, 91, 182 and 365, after administration of HIPRA's vaccine (PHH-1V).
Time frame: Day 91, Day 182 and Day 365
Total antibodies
To evaluate the immunogenicity measured by means of total antibody against Receptor Binding Domain of the Spike protein of SARS-CoV-2 quantification, measured by an electrochemiluminescence immunoassay (ECLIA) at Baseline and at Days 14, 91, 182 and 365 after administration of HIPRA's vaccine (PHH-1V).
Time frame: Day 0, Day 14, Day 91, Day 182, Day 365
Safety and tolerability of the booster vaccine
To assess the safety and tolerability of PHH-1V as an additional dose in adult individuals with pre-existing immunosuppressive conditions
Time frame: Day 0, Day 14, Day 91, Day 182, Day 365
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ankara University Medical Faculty Hospitals
Ankara, Ankara, Turkey (Türkiye)
Koc University Hospital
Istanbul, Istanbul, Turkey (Türkiye)