Nobilon's intranasal influenza vaccine begins phase I clinical development

Nobilon, the human vaccine business unit of Schering-Plough Corporation has 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.

"I am pleased to announce the start of the first clinical development program of Nobilon," said Gelmer Leibbrandt, general manager of Nobilon. "This is an important milestone in the young history of our company." Han van den Bosch, Director R&D, stated: "We are encouraged by the positive results obtained in the pre-clinical development of our candidate vaccine so far and we believe that this vaccine has the potential to become an important tool in the prevention against seasonal Influenza illness."

The initiation of the clinical development program of SCH 900795 represents Nobilon's commitment to bringing innovative vaccines for human health to the market using state-of-the-art technologies.

Influenza (flu) is a contagious disease caused by the influenza virus. Influenza is a significant cause of morbidity and mortality and seasonal epidemics are responsible for approximately 40,000 deaths and over 100,000 hospitalizations annually in the US. Influenza infection in children causes a significant increase in both medically attended illness as well as hospitalizations. Mortality due to influenza generally affects aging adults. Inactivated, parenterally administered influenza vaccines have been available since the mid-1940s and effectively prevent influenza illness in healthy adults. Vaccination of elderly generally has a lower impact on prevalence, but is up to 80% effective in preventing death. Nevertheless, current inactivated influenza vaccines have limitations and are underutilized. Intramuscular vaccination with needles is an important barrier for the acceptance of annual influenza vaccination, which may be overcome by intranasal application. Moreover, Live Attenuated Influenza Vaccine (LAIV) is expected to be more effective in inducing local and cellular immunity and as such may be more efficacious in eliciting protection.

Nobilon acquired in 2004 the majority of rights to develop, commercialize and manufacture the LAIV technology from Australian company BioDiem, which had acquired these rights from the Institute of Experimental Medicine in St. Petersburg, Russian Federation. SCH 900795 could offer several improvements over most current vaccines such as single-dose intranasal spray delivery, improved convenience and earlier and broader protection. Moreover, SCH 900795 is manufactured using state-of-the-art cell culture technology. Cell-based vaccine production offers important advantages over egg-based production such as consistency and flexibility in production, reduced risk of microbial contamination, a more homogenous viral yield, and usability for subjects with egg allergies.

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