The purpose of this project is to develop vaccines against otitis media and respiratory tract diseases caused by nontypeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (M. cat). For NTHi, we demonstrated earlier that detoxified lipooligosaccharide (dLOS)-protein conjugates from NTHi elicited a significant rise of anti-LOS antibodies with bactericidal activity in rabbits and conferred protection against otitis media in a chinchilla model. In the past year, a clinical batch of vaccine was produced and met all the requirements of safety and immunogenicity issued by Food and Drug Administration (FDA). As an investigational new drug (IND), this vaccine was approved by FDA to be used in humans. Currently, a Phase I clinical trial is conducted by NIDCDs scientists. The preliminary results indicate that the vaccine is safe and able to generate specific antibodies against NTHi pathogen or M. cat., we demonstrated that detoxified lipooligosaccharide (dLOS)-protein conjugate vaccines from M. cat. elicited a significant rise of anti-LOS antibodies with bactericidal activity in animal models. In addition, immunization with these conjugate vaccines conferred protection against M. cat. infection in an aerosol challenge mouse model. - Nontypeable Haemophilus influenzae, Moraxella catarrhalis, Lipooligosaccharide, Conjugate vaccine, Otitis media, Clinical trial - Human Subjects
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