Respiratory syncytial infection (RSV) is a major cause of morbidity for infants during the first year of life, especially among premature infants or infants with bronchopulmonary dysplasia (BPD). MEDI-493 is a humanized monoclonal antibody directed toward the fusion protein in RSV. This is a Phase III, placebo-controlled study to 1) further establish the safety of monthly MEDI-493 IM injections in the above infants; 2) determine the efficacy of prophylaxis with MEDI-493 with regard to hospitalizations in these infants. This center enrolled 12 patients into the study. All of the patients successfully completed the study. None of the infants enrolled required hospitalization for an RSV infection, and only two were hospitalized for a respiratory illness (not RSV related). The results of this multi-center study were published in a press release in July 1997. Initial analysis of results suggests that MEDI-493 reduced the incidence of RSV-associated hospitalizations by fifty-five percent. MedImmune expects to submit a Biologic License Application to the FDA requesting marketing approval of MEDI-493. Data are subject to further analysis by the company and full review by regulatory authorities before a definitive assessment of the safety and efficacy of MEDI-493 can be made.

Project Start
1997-12-01
Project End
1998-11-30
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
13
Fiscal Year
1998
Total Cost
Indirect Cost
City
Houston
State
TX
Country
United States
Zip Code
77225
Chappell, Cynthia L; Darkoh, Charles; Shimmin, Lawrence et al. (2016) Fecal Indole as a Biomarker of Susceptibility to Cryptosporidium Infection. Infect Immun 84:2299-306
Liao, George P; Harting, Matthew T; Hetz, Robert A et al. (2015) Autologous bone marrow mononuclear cells reduce therapeutic intensity for severe traumatic brain injury in children. Pediatr Crit Care Med 16:245-55
Arroyo-Ávila, Mariangelí; Santiago-Casas, Yesenia; McGwin Jr, Gerald et al. (2015) Clinical associations of anti-Smith antibodies in PROFILE: a multi-ethnic lupus cohort. Clin Rheumatol 34:1217-23
Chappell, Cynthia L; Okhuysen, Pablo C; Langer-Curry, Rebecca C et al. (2015) Cryptosporidium muris: infectivity and illness in healthy adult volunteers. Am J Trop Med Hyg 92:50-5
Reveille, John D (2014) An update on the contribution of the MHC to AS susceptibility. Clin Rheumatol 33:749-57
Bethi, Siddharth; Dasgupta, Abhijit; Weisman, Michael H et al. (2013) Functional limitations due to axial and peripheral joint impairments in patients with ankylosing spondylitis: are focused measures more informative? Arthritis Care Res (Hoboken) 65:607-14
Ward, Michael M; Learch, Thomas J; Gensler, Lianne S et al. (2013) Regional radiographic damage and functional limitations in patients with ankylosing spondylitis: differences in early and late disease. Arthritis Care Res (Hoboken) 65:257-65
Benjamin-Garner, Ruby; Stotts, Angela (2013) Impact of smoking exposure change on infant birth weight among a cohort of women in a prenatal smoking cessation study. Nicotine Tob Res 15:685-92
Ornstein, Tisha J; Max, Jeffrey E; Schachar, Russell et al. (2013) Response inhibition in children with and without ADHD after traumatic brain injury. J Neuropsychol 7:1-11
Murthy, Vijaya; Willis, Rohan; Romay-Penabad, Zurina et al. (2013) Value of isolated IgA anti-?2 -glycoprotein I positivity in the diagnosis of the antiphospholipid syndrome. Arthritis Rheum 65:3186-93

Showing the most recent 10 out of 396 publications