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In each study, a double-blind, randomised controlled, staggered, dose-escalation design was used to evaluate 10 μg RTS,S dose (10 μg RTS,S in 0.1 mL AS02A), 25 μg dose (25 μg RTS,S in 0.25 mL AS02A) and finally a 50 μg dose (50 μg RTS,S in 0.5 mL AS02A) of the RTS,S/AS02A candidate malaria vaccine administered according to a 0-, 1- and 3-month vaccination schedule.
Thus, no further dose escalation was performed.
Provide slow dose escalation to minimise any side effects.
Design: Randomized, controlled, single-blind phase II dose escalation trial.
A 3 + 3 dose escalation design was employed.
The study plan employed randomized, open label, dose escalation design.
While etanercept had lower dose escalation rates than adalimumab, this is consistent with their labelling which advises against dose escalation.
Dose escalation proceeded without dose-limiting toxicities to a maximum feasible dose of 3 × 109 pfu.
Doses were better tolerated when intra-animal or intra-patient dose escalation was used.
While etanercept had lower dose escalation rates than adalimumab, this could probably be explained by labelling which advises against dose escalation.
All the previous mentioned studies have evaluated TNF inhibitor dose escalation, but there is no standard analytic method for the calculation of dose escalation.
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