25 research outputs found
Mean 3D7 growth inhibition assay results by study day and group with 95% confidence intervals.
<p>Mean 3D7 growth inhibition assay results by study day and group with 95% confidence intervals.</p
Percentage of subjects with growth inhibition assay activity ≥15% against FVO parasites, and percentage seroconverting from below up to or above threshold 30 days after last vaccination and at one and two years after enrollment, by vaccine group.
<p>Percentage of subjects with growth inhibition assay activity ≥15% against FVO parasites, and percentage seroconverting from below up to or above threshold 30 days after last vaccination and at one and two years after enrollment, by vaccine group.</p
Mean FVO growth inhibition assay results by study day and group with 95% confidence intervals.
<p>Mean FVO growth inhibition assay results by study day and group with 95% confidence intervals.</p
Percentage of subjects with growth inhibition assay activity ≥15% against 3D7 parasites, and percentage seroconverting from below up to or above threshold 30 days after last vaccination and at one and two years after enrollment, by vaccine group.
<p>Percentage of subjects with growth inhibition assay activity ≥15% against 3D7 parasites, and percentage seroconverting from below up to or above threshold 30 days after last vaccination and at one and two years after enrollment, by vaccine group.</p
Mean FVO growth inhibition assay result, and change from baseline to 30 days after last vaccination and one and two years after enrollment, with standard deviation (SD), by vaccine group.
<p>Mean FVO growth inhibition assay result, and change from baseline to 30 days after last vaccination and one and two years after enrollment, with standard deviation (SD), by vaccine group.</p
Intracellular cytokine analysis shows the presence of antigen-specific cytokine production by CD4+ cells.
<p>Peripheral blood mononuclear cells from vaccinated subjects were stimulated with VMP001 and production of IL-2, IFN-γ and TNF-α was assessed. Pie chart depicts the percentage of CD4<sup>+</sup> cytokine-producing cells for each cohort 2 weeks post 3<sup>rd</sup> vaccination (Day of challenge). G, 2 and T indicate IFN-γIL-2 and TNF-α, respectively. Cytokine producers are represented by a “+” and non-producers by a “-”.</p
Adverse events.
<p>Solicited Adverse Events (AEs) were recorded following each vaccination and are reported as the percentage of subjects in each cohort reporting the event. Pain was the most frequently reported AE, being reported by 80–100% of the subjects. A majority of the AEs presented as Grade 1 (G1, mild). Grade 2 (G2, moderate) erythema, fever, headache and Grade 3 (G3, severe) erythema were seen in a small percentage of individuals. AEs are shown post 1<sup>st</sup> (V1), 2<sup>nd</sup> (V2) and 3<sup>rd</sup> (V3) vaccine dose.</p
Fine-specificity analysis demonstrates that all domains of CSP are recognized following immunization with VMP001.
<p>Day of Challenge (DOC, or 2 weeks post-3<sup>rd</sup> vaccination) sera from all subjects were reactive to the N-term, type-1 Repeat peptide, as well as C-term region of the protein with the highest reactivity to the C-term. C- term GMTs were significantly higher in all three cohorts compared to the N- term and Type 1 repeat GMTs. Cohort 2 had significantly higher anti-Repeat antibodies compared to Cohorts 1 and 3 (p = 0.003, p = 0.01, respectively).</p
Vaccinated subjects who showed a delayed time to parasitemia had higher anti-Type 1 repeat antibodies.
<p>A. Vaccinated individuals from all three cohorts could be grouped into those that showed a delay (green, n = 16) compared to the controls, and those that did not show a delay (red, n = 11). B. Individuals with a delay in patency had higher anti-type 1 repeat antibodies compared to those with no delay (p = 0.02). Each symbol represents an individual. Cohorts 1, 2 and 3 are represented by red, blue, and green, respectively.</p
All volunteers immunized with VMP001/AS01<sub>B</sub> generated antibodies to VMP001.
<p>Anti-VMP001 antibodies were detected in 80% of vaccinated individuals starting at two weeks post-1<sup>st</sup> immunization. Titers were boosted to peak levels post-2<sup>nd</sup> immunization, with 100% of subjects developing antibodies. A decrease in antibody titers was observed on the day of third immunization (8, 6 and 4 weeks post 2<sup>nd</sup> immunization for cohorts 1, 2 and 3, respectively) followed by a slight increase post 3<sup>rd</sup> immunization. Antibody titers, defined as a serum dilution that gives an OD<sub>414</sub> of 1.0, showed a continual decline post challenge (Po Ch). Box plot represents the 25–75 percentiles and Whiskers indicate the minimum and maximum values. GMTs of anti-VMP001 antibody were significantly higher in group 1 compared to group 2 at 2 time points (2weeks post 2nd, p = 0.01, and on the day of 3rd, vaccination, p = 0.002). GMTs of anti-VMP001 antibody were significantly higher in group 2 compared to group 3 at 2 time points (4weeks post DOC, p = 0.03, and 6 months post-DOC, P = 0.04). GMTs of anti-VMP001 antibody were significantly higher in group 1 compared to group 3 at 5 time points (2 weeks post 1st vaccination, p = 0.02, on the day of 2nd vaccination, p = 0.01, 2 weeks post 2nd vaccination, p = 0.04, on the day of 3rd vaccination p = 0.002, and 6 months post DOC, p = 0.034).</p