Studies typically use two mice per dose level with a doubling dose-escalation or dose-halving de-escalation design.
The study was a double-blind, randomized, controlled, dose escalation phase Ib trial (www.clinicaltrials.gov NCT00452088) designed to assess the safety, reactogenicity and immunogenicity of three injections of either 15 µg or 30 µg of MSP3-LSP adsorbed on aluminum hydroxide in children 12 to 24 months of age.
The study was a double-blind, randomized, controlled, dose escalation phase Ib trial, designed to assess the safety, reactogenicity and immunogenicity of three doses of either 15 or 30 µg of MSP3-LSP adsorbed on aluminum hydroxide in 45 children 12 to 24 months of age randomized into three equal groups.
This was a double-blind, placebo-controlled, dose-escalation trial (NCT00615017) with 2 1 randomisation (active:placebo).
The latter gene therapy trial is a double-blind, randomized, placebo-controlled, dose escalation study of intra-articular administration of tgAAC94 in four cohorts of eight RA patients, each of whom will be followed for 24 weeks (protocol 13E04; Targeted Genetics Corp).
As per study design, intrapatient double dose escalation was terminated after patient #2 experienced a DLT (grade 3 PPE) at PEG-LD 24 mg m−2.
In this open-label, nonrandomised phase I study, with double dose escalation protocol, OM-174 was administered intravenously as a 15 minutes infusion twice weekly at repeated intervals of 3 and 4 days.
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.
