NasVax Commences a Phase I/ IIa Dose-Optimization Clinical Study of VaxiSome-Adjuvanted Influenza Vaccine
NasVax announced the commencement of a second Phase I/IIa clinical study with VaxiSome-adjuvanted Influenza vaccine, following positive results demonstrated in their final analysis of data from its initial clinical study using VaxiSome when given as a single intramuscular dose.
The immunogenicity and safety profile in NasVax's initial clinical study with the adjuvant (VaxiSome) is positive and supports further development of its novel product, according to the company. NasVax received Ethical Committee approval and has initiated administration of vaccine in a follow-on dosage-optimization study in elderly subjects.
In the initial study conducted from mid-2007 into 2008, 97 adult subjects and 60 elderly subjects received commercial influenza vaccine either alone or adjuvanted with VaxiSome in a double-blinded, randomized, dose-ranging study design with 6-month follow-up. The VaxiSome-adjuvanted vaccine was observed to be generally well tolerated in all study arms. The overall profile of systemic adverse events (AEs) was similar in the VaxiSome-Influenza vaccine and commercial Influenza vaccine groups, with no serious AEs and no significant systemic AEs attributable to the adjuvant. As is observed with other vaccine adjuvants, there were VaxiSome-related transient local effects that were generally mild to moderate in intensity.
The adjuvant effect was readily apparent in both elderly and adult subjects. The adjuvanted vaccine, compared to unadjuvanted vaccine, induced generally higher fold-increases over pre-vaccination levels in titers of protective Hemagglutination Inhibition (HI) antibodies for vaccine virus strains. As readout in elderly subjects for the adjuvant effect, the HI antibody titers for all vaccine strains elicited by the adjuvanted vaccine, compared to titers elicited by unadjuvanted vaccine, showed superior persistence from 1 month post-vaccination onwards – superior persistence would better assure more prolonged protection against clinical influenza during the flu season that follows the vaccination season.
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Topic world Antibodies
Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous
