This is a first-in-human, phase I/IIa, randomized, controlled, observer-blinded, dose-escalation, multicentre clinical trial to evaluate safety and immunogenicity of COVID-19 HIPRA vaccine in adult healthy volunteers.
The study population includes 30 healthy adults aged 18-39 which will be distributed in 3 cohorts, receiving three different doses of antigen, 10 µg, 20 µg and 40 µg. In each cohort, patients will be randomized in ratio of 10:2 test:commercial vaccine, following an staggered enrolment with a sentinel subject in each cohort. Each participant will receive 2 immunisations separated by 21 days, and will be followed for 48 weeks after the second dose
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
30
One sentinel subject and 4 additional subjects will be assigned to COVID-19 vaccine HIPRA 10 µg
One sentinel subject and 9 additional subjects will be assigned to COVID-19 vaccine HIPRA 20 µg
One sentinel subject and 9 additional subjects will be assigned to COVID-19 vaccine HIPRA 40 µg
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Universitari Dr. Josep Trueta
Girona, Spain
Number and percentage of solicited local and systemic reactogenicity adverse events for 7 days following each vaccination.
Time frame: 7 days
Number and percentage of unsolicited local and systemic reactogenicity adverse events for 28 days following each vaccination.
Time frame: 28 days
Change from baseline in hematology and biochemistry laboratory values at 7 days following each vaccination
Time frame: 7 days
Number and percentage of serious adverse events throughout the study duration.
Time frame: 357 days
Number and percentage of adverse events of special interest (AESI) throughout the study
Time frame: 357 days
Number and percentage of medically attended adverse events (MAAE) related to study vaccine throughout the study duration
Time frame: 357 days
Neutralization titer measured as Inhibitory concentration 50 (IC50) for each individual sample and geometric mean titer (GMT) for group comparison at Day 21 and 35
Time frame: Day 21 and 35
Geometric mean fold rise (GMFR) in neutralizing antibodies titers from baseline at Day 21 and 35.
Time frame: Day 21 and 35
Neutralization titer measured as IC50 for each individual sample and GMT for group comparison at 24 and 48 weeks after the second dose
Time frame: week 27 and week 51
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One subject in cohort 1 and 2 subjects in Cohort 2 and 3 will be assigned to Commercial COVID-19 vaccine
GMFR in neutralizing antibodies titers from baseline at 24 and 48 weeks after the second dose.
Time frame: week 27 and week 51
Binding antibody IgG titer measured for each individual sample and GMT for group comparison at Day 21 and 35
Time frame: Day 21 and 35
GMFR in IgG titer from baseline at Day 21 and 35
Time frame: Day 21 and 35
Binding antibody IgG titer measured for each individual sample and GMT for group comparison at 24 and 48 weeks after the second dose.
Time frame: week 27 and week 51
GMFR in IgG titer from baseline at 24 and 48 weeks after the second dose
Time frame: week 27 and week 51
T-cell-mediated response to the SARS-CoV-2 S protein as measured by whole PBMC stimulation by ELISpot at baseline and at Day 35.
Time frame: Day 35
CD4+/CD8+ T-cell response to the SARS-CoV-2 S protein as measured by in vitro PBMC stimulation by cytokine staining assays at baseline and at Day 35
Time frame: Day 35