This is a single-center observational study, whose primary objective is to describe the immune response to Oropouche Virus (OROV) during the study period and the duration of viral RNA shedding, only for sequential samples, by RT-PCR in different matrices.
This is a study with retrospective and prospective enrollment.
Study Type
OBSERVATIONAL
Enrollment
30
IRCCS Sacro Cuore Don Calabria
Negrar, VR, Italy
RECRUITINGAnti-OROV serum antibody response
Results of the anti-OROV serum antibody response along the study period: * IgM (titer, reciprocal of dilution); * IgG (titer, reciprocal of dilution).
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
OROV viral RNA shedding in different matrices
Results of OROV viral RNA presence in different matrice along the study period: RT-PCR Ct and RNA copies/mL in different matrices: urine, whole blood, serum, vaginal swab or seminal fluid, CSF and amniotic fluid if available.
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Quality of anti-OROV humoral response
Results of the anti-OROV neutralizing antibody response along the study period: neutralizing antibodies titer (titer, reciprocal of dilution).
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO.
Quality of anti-OROV cell mediated immunity evolution
Results of the quality of anti-OROV cell mediatedimmune response along the study period: specific cell-mediated response (specific IFN producing cells/100,000).
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Quality of anti-OROV cytokine production
Results of the quality of anti-OROV cytokine production profile along the study period: cytokine analysis (pg/ml)
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO.
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Timing evolution of humoral OROV specific response
IgM and IgG kinetics (days from symptoms onset or first diagnosis).
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Time duration limits of RT-PCR-positivity persistence in different matrices
RT-PCR positivity persistence (days from symptoms onset or first diagnosis)
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Semi-quantitative OROV RNA viral loads evaluation
Results of OROV RT-PCR testing results by cycle threshold (Ct) values along the study period: RT-PCR (Ct)
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO
Quantitative OROV RNA viral load evaluation
Results of OROV RNA copies along the study period: ddPCR (copies/mL)
Time frame: Baseline, 7 days post symptoms onset (DPSO), 14 days DPSO, 21 days DPSO, 28days DPSO, 60days DPSO, 90days DPSO