25 research outputs found

    Adverse events.

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    <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

    All volunteers immunized with VMP001/AS01<sub>B</sub> generated antibodies to VMP001.

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    <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
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