This is a phase III clinical study to assess the safety, tolerability and immunogenicity of PHH-1V as a booster dose in healthy adult subjects vaccinated against COVID-19 with the Comirnaty, Spikevax, Vaxevria or Janssen vaccine.
This is a phase III clinical study to assess the safety, tolerability and immunogenicity of PHH-1V as a booster dose in healthy adults vaccinated against COVID-19 with the Comirnaty, Spikevax, Vaxevria or Janssen vaccine at least 91 days before day 0. All the participants will receive a booster dose of the HIPRA's COVID-19 Vaccine and will be followed for 26 weeks or 52 weeks if they participate in the safety cohort, or the immunogenicity cohort, respectively.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
2,646
Intramuscular injection of 0,5 ml with 40 ug of recombinant PHH-1V
Hospital de Niguarda
Milan, Italy
Hospital Germans Trias I Pujol
Badalona, Barcelona, Spain
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability)
Number, percentage, and characteristics of solicited local and systemic reactions through Day 7 after vaccination.
Time frame: Day 7
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) (AEs)
Number, percentage, and characteristics of unsolicited local and systemic adverse events (AEs) through Day 28 after vaccination
Time frame: Day 28
Incidence of Serious Adverse Events (Safety and tolerability) (SAE)
Number and percentage of serious adverse events (SAEs) through the end of the study.
Time frame: Day 365
Incidence of Special Interest Adverse Events (Safety and tolerability) (AESI).
Number and percentage of adverse event of special interest (AESI) through the end of the study.
Time frame: Day 365
Incidence of Medically Attended Adverse Events (Safety and tolerability) (MAAEs)
Number and percentage of medically attended adverse events (MAAE) related to study vaccine through the end of the study.
Time frame: Day 365
Incidence of Adverse Events in laboratory parameters (Safety and tolerability)
Grade 3 and 4 changes from baseline in safety laboratory parameters at Days 14, 91 and 182 after vaccination. through the end of the study.
Time frame: Day 365
Changes in the immunogenicity measured by pseudovirus neutralisation
Neutralisation titre against Wuhan and Omicron strains, and any other relevant VOC in the epidemiologic moment, measured as inhibitory concentration 50 (IC50) by a pseudovirion-based neutralisation assay (PBNA) and reported as reciprocal concentration for each individual sample and geometric mean titre (GMT) for descriptive statistics analysis at Baseline and at Days 14, 91, 182 and 365.
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Hospital de Mollet
Mollet del Vallès, Barcelona, Spain
Hospital Principe de Asturias
Meco, Madrid, Spain
Hospital HM Puerta del Sur
Móstoles, Madrid, Spain
Hospital de Cruces
Barakaldo, Vizcaya, Spain
Hospital HM Delfos
Barcelona, Spain
Hospital Quironsalud Barcelona
Barcelona, Spain
Hospital Vall Hebron
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
...and 8 more locations
Time frame: Day 365
Changes in the immunogenicity measured by pseudovirus neutralisation
The geometric mean fold rise (GMFR) in neutralising antibody titre from baseline to Day 14.
Time frame: Day 14
Changes in the immunogenicity measured by means of total antibody against RBD
Binding antibodies titre measured for each individual sample and GMT for descriptive statistics analysis at Baseline and Days 14, 91, 182 and 365.
Time frame: Day 365
Changes in the immunogenicity measured by means of total antibody against RBD.
The geometric mean fold rise (GMFR) in binding antibody titre from baseline to Day 14.
Time frame: Day 14
Changes in the immunogenicity measured by means of total antibody against RBD
The percentage of subjects that after the booster dose have a ≥4-fold change in binding antibodies titre from Baseline to Day 14.
Time frame: Day 14