Results demonstrated that both the procedure and personnel involved were able to maintain and guarantee aseptic conditions during all phases of manufacturing process (data not shown).
Early loosening was defined by the authors of the reports as aseptic loosening in an early phase following the initial operation.
Therefore, it is important to distinguish bacterial meningitis from aseptic meningitis during the acute phase of the disease, when clinical symptoms are often similar.
Lowest adherence was observed during the induction phase before an aseptic task (2.2%) and highest during full-length surgeries after body fluid exposure (15.9%).
During this neurologic phase, most patients have aseptic meningitis and a peripheral leukocytosis (1 ).
AN1792 was halted in phase 2 because of aseptic meningoencephalitis in 6% of the treated patients [ 22].
In 5%30%% of clinical cases, a second neurologic phase may occur with aseptic meningitis (50% of the cases), meningoencephalitis (40%), or meningoencephalomyelitis (10%) (1, 2, 7, 8 ).
The first anti-amyloid-beta (anti-Aβ) vaccine developed by Elan, AN1792, was halted in phase 2 because of aseptic meningoencephalitis.
A subsequent Phase II clinical trial was halted due to aseptic meningoencephalitis in 6% of the treated patients [8].
The investigational PfSPZ Challenge product was cryopreserved, in liquid nitrogen vapor phase at −150 to −196°C, as a suspension of aseptic, purified, replication-intact PfSPZ formulated in cryoprotectant.
After removal of HPLC mobile phase, the residue is formulated and dispensed for injection under an aseptic environment.
