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First, the magnitude of elicited CD8+ T cell responses during the vaccine phase in RhCMV/SIV-vaccinated animals correlated with the protection.
All time points from the first booster through the first follow up visit after the final vaccination (week 9) was considered vaccine phase.
All adverse events were analyzed using Fisher's exact test to compare placebo and vaccine phase.
Two knots (one at the start of the vaccine phase and the other at the start of the post-vaccine phase) were used to directly quantify the differences in slopes between each phase.
Twelve patients assigned to Arm 2 received placebo (vehicle (5% DMSO in saline)) for each of four injections, were unblinded, crossed over to the vaccine phase, and received vaccine followed by 3 boosts at 2-week intervals.
Volunteers for this study were drawn from community members who: 1) had expressed interest to participate in future clinical trials, or 2) were prescreened for a previous HIV vaccine phase 1 clinical trial and were not enrolled because the trial had completed enrollment.
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The MMR vaccine phased in from the late 1980s promised relief.
There were statistically significant differences in PSADT between the pre- and post-vaccine phases (p = 0.003) and between the vaccine and post-vaccine phases (p<0.001) but not between the pre-vaccine and vaccine phases (p = 0.915).
There was no statistical difference in PSA slope between the pre-vaccine and vaccine phases (−0.018/month, p = 0.681) or the vaccine and post-vaccine phases (−0.075/month, p = 0.098).
All time points in both arms up to and including the day of the first vaccination with DC vaccine were considered pre-vaccine phase.
Scientists are using a dizzying variety of approaches to create AIDS vaccines: Phase I trials, which involve about 20 volunteers and take a year to complete, are often geared more toward judging safety than efficacy.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com