MEISSA VACCINES INC — Department of Health and Human Services SBIR Phase I: NIAID

Description

Human rhinovirus RV is the predominant etiological agent of the common cold and the leading cause of human infectious disease RV is more than a nuisance It is a major cause of community acquired pneumonia in children and adults in the United States and plays a major role in triggering exacerbations of both asthma and chronic obstructive pulmonary disease resulting in billions of dollars in medical costs every year in these high risk populations Decades ago researchers identified inactivated RV as a protective vaccine defined virus neutralizing antibodies nAb as a correlate of protection against colds and estimated duration of RV immunity using monovalent inactivated RV However co circulation of many RV types discouraged further vaccine development A valent inactivated RV vaccine was tested in people in the s but only one third of the vaccine strains induced measurable nAb reinforcing pessimism for RV vaccine development However the average amount of each input RSV type antigen in this early valent vaccine was low The Moore laboratory at Emory recently published that serum nAb against many RV types can be induced by polyvalent inactivated RV adjuvanted with alum by simply increasing the amount of each RV antigen in the vaccine Using formulations up to valent in mice and valent in non human primates inactivated RV vaccine immunogenicity was related to sufficient quantity of input antigens Serum nAb to polyvalent inactivated RV were type specific necessitating a high number of valences RV types These proof of principle data point to a tractable vaccine approach for RV vaccine product development Highly polyvalent vaccine development will require overcoming challenges in chemistry manufacturing and controls CMC such as identifying and ensuring potency and consistency of highly complex vaccine mixtures There are three RV species A B and C with and types respectively There is no evidence of RV antigenic drift Meissa Vaccines Inc and Emory University will initially focus on the most prevalent RV types the types within species A In order to balance manageable CMC research with product development our initial goal is to generate a valent recombinant RV A vaccine A valent RV A vaccine process and control can later be either scaled up and adapted to higher valency or alternatively be developed as a series of three valent vaccines to cover all RV A serotypes In Aim we will generate RV A infectious clone constructs harboring the capsid proteins of types A A A A A A A A A A A A A A A A A A A A A A A A A A A or A and evaluate their ability to produce infectious virus in a cell line suitable for cGMP manufacturing In Aim we will develop a proteomics based assay to identify and quantify unique peptides corresponding to each of the types in the valent vaccine composition This assay will be advanced for measuring potency of a highly complex vaccine mixture and be assessed for ability to be qualified for releasing lots Rhinovirus the common cold virus causes pneumonia and is an important trigger of chronic obstructive pulmonary disease COPD and asthma exacerbations In there were more than million hospitalizations due to acute exacerbations of COPD with associated costs of approximately $ billion We are advancing a high valency rhinovirus vaccine that could provide broad protection against Rhinovirus species A types