Nobilon advances first vaccine into human trials
Intranasal influenza vaccine begins Phase I clinical development
Nobilon, the human vaccine business unit of Schering-Plough Corporation, announced that it has reached an important milestone with the initiation of its first-in-human clinical development program for SCH 900795, a new intranasal Live Attenuated Influenza Vaccine (LAIV) for annual seasonal use.
The candidate vaccine is composed of the three attenuated Influenza viruses recommended by the World Health Organization (WHO) for seasonal vaccine, in an intranasal device. The LAIV differs from most existing influenza vaccines, because it has been designed to offer (1) single-dose intranasal delivery, (2) advanced cell culture manufacturing technology and (3) potential earlier and broader protection against infection by influenza viruses.
The Phase I study consists of a randomized, double-blind, placebo-controlled, rising single-dose design and will include a total of 120 healthy volunteers. The primary objective of the Phase I program is to investigate the safety, tolerability and immunogenicity of escalating doses of SCH 900795 in adult men and women.
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