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A randomized, double-blind, controlled clinical trial to evaluate the safety and immunogenicity of an intranasally administered trivalent inactivated influenza vaccine with adjuvant LTh(αK): A phase I study

Vaccine Mar 07, 2019

Pan SC, et al. - In this randomized, double-blind, controlled phase I trial, researchers assessed a newly developed intranasal inactivated influenza vaccine with a novel adjuvant, heat-labile enterotoxin (LT) derived from E. coli (LTh(αK)). A total of 36 subjects were enrolled between November 2012 and September 2013. An adjuvant vaccine was given to 24 subjects and a control vaccine was given to 12 subjects. Mild nasal discomfort was the most common adverse event (AE), and mild fatigue and headache were systemic AEs. Overall, the investigators concluded that the intranasal inactivated influenza vaccine is generally safe and the LTh(αK)-adjuvanted vaccine is more immunogenic compared to non-adjuvanted control vaccine.
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