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Efficacy of motavizumab for the prevention of respiratory syncytial virus disease in healthy Native American infants: a phase 3 randomised double-blind placebo-controlled trial.

O'Brien KL, Chandran A, Weatherholtz R, Jafri HS, Griffin MP, Bellamy T, Millar EV, Jensen KM, Harris BS, Reid R, Moulton LH, Losonsky GA, Karron RA, Santosham M; Respiratory Syncytial Virus (RSV) Prevention study group.

Lancet Infect Dis. 2015 Dec;15(12):1398-408. doi: 10.1016/S1473-3099(15)00247-9. Epub 2015 Nov 4.


Randomized, Double-Blind Study of the Pharmacokinetics and Safety of Palivizumab Liquid Formulation Compared with Lyophilized Formulation.

Robbie GJ, Makari D, Harris B, Losonsky GA, Jafri HS.

Infect Dis Ther. 2014 Dec;3(2):203-14. doi: 10.1007/s40121-014-0042-x. Epub 2014 Sep 30.


Motavizumab treatment of infants hospitalized with respiratory syncytial virus infection does not decrease viral load or severity of illness.

Ramilo O, Lagos R, Sáez-Llorens X, Suzich J, Wang CK, Jensen KM, Harris BS, Losonsky GA, Griffin MP; Motavizumab Study Group.

Pediatr Infect Dis J. 2014 Jul;33(7):703-9. doi: 10.1097/INF.0000000000000240.


A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults.

Robbie GJ, Criste R, Dall'acqua WF, Jensen K, Patel NK, Losonsky GA, Griffin MP.

Antimicrob Agents Chemother. 2013 Dec;57(12):6147-53. doi: 10.1128/AAC.01285-13. Epub 2013 Sep 30.


Prevalence and Characteristics of Human Metapneumovirus Infection Among Hospitalized Children at High Risk for Severe Lower Respiratory Tract Infection.

Anderson EJ, Simões EA, Buttery JP, Dennehy PH, Domachowske JB, Jensen K, Lieberman JM, Losonsky GA, Yogev R.

J Pediatric Infect Dis Soc. 2012 Sep;1(3):212-22. doi: 10.1093/jpids/pis069. Epub 2012 Jul 3.


Population pharmacokinetics of palivizumab, a humanized anti-respiratory syncytial virus monoclonal antibody, in adults and children.

Robbie GJ, Zhao L, Mondick J, Losonsky G, Roskos LK.

Antimicrob Agents Chemother. 2012 Sep;56(9):4927-36. doi: 10.1128/AAC.06446-11. Epub 2012 Jul 16. Erratum in: Antimicrob Agents Chemother. 2012 Oct;56(10):5431.


A randomized controlled trial of motavizumab versus palivizumab for the prophylaxis of serious respiratory syncytial virus disease in children with hemodynamically significant congenital heart disease.

Feltes TF, Sondheimer HM, Tulloh RM, Harris BS, Jensen KM, Losonsky GA, Griffin MP; Motavizumab Cardiac Study Group.

Pediatr Res. 2011 Aug;70(2):186-91. doi: 10.1203/PDR.0b013e318220a553.


Analysis of respiratory syncytial virus preclinical and clinical variants resistant to neutralization by monoclonal antibodies palivizumab and/or motavizumab.

Zhu Q, McAuliffe JM, Patel NK, Palmer-Hill FJ, Yang CF, Liang B, Su L, Zhu W, Wachter L, Wilson S, MacGill RS, Krishnan S, McCarthy MP, Losonsky GA, Suzich JA.

J Infect Dis. 2011 Mar 1;203(5):674-82. doi: 10.1093/infdis/jiq100. Epub 2011 Jan 5.


A phase 2, randomized, double-blind safety and pharmacokinetic assessment of respiratory syncytial virus (RSV) prophylaxis with motavizumab and palivizumab administered in the same season.

Fernández P, Trenholme A, Abarca K, Griffin MP, Hultquist M, Harris B, Losonsky GA; Motavizumab Study Group.

BMC Pediatr. 2010 Jun 3;10:38. doi: 10.1186/1471-2431-10-38.


Motavizumab for prophylaxis of respiratory syncytial virus in high-risk children: a noninferiority trial.

Carbonell-Estrany X, Simões EA, Dagan R, Hall CB, Harris B, Hultquist M, Connor EM, Losonsky GA; Motavizumab Study Group.

Pediatrics. 2010 Jan;125(1):e35-51. doi: 10.1542/peds.2008-1036. Epub 2009 Dec 14.


Safety and antiviral activity of motavizumab, a respiratory syncytial virus (RSV)-specific humanized monoclonal antibody, when administered to RSV-infected children.

Lagos R, DeVincenzo JP, Muñoz A, Hultquist M, Suzich J, Connor EM, Losonsky GA.

Pediatr Infect Dis J. 2009 Sep;28(9):835-7. doi: 10.1097/INF.0b013e3181a165e4.


Phase-I study MEDI-534, of a live, attenuated intranasal vaccine against respiratory syncytial virus and parainfluenza-3 virus in seropositive children.

Gomez M, Mufson MA, Dubovsky F, Knightly C, Zeng W, Losonsky G.

Pediatr Infect Dis J. 2009 Jul;28(7):655-8. doi: 10.1097/INF.0b013e318199c3b1.


Safety, tolerability, pharmacokinetics, and immunogenicity of motavizumab, a humanized, enhanced-potency monoclonal antibody for the prevention of respiratory syncytial virus infection in at-risk children.

Abarca K, Jung E, Fernández P, Zhao L, Harris B, Connor EM, Losonsky GA; Motavizumab Study Group.

Pediatr Infect Dis J. 2009 Apr;28(4):267-72. doi: 10.1097/INF.0b013e31818ffd03.


Development of a PIV-vectored RSV vaccine: preclinical evaluation of safety, toxicity, and enhanced disease and initial clinical testing in healthy adults.

Tang RS, Spaete RR, Thompson MW, MacPhail M, Guzzetta JM, Ryan PC, Reisinger K, Chandler P, Hilty M, Walker RE, Gomez MM, Losonsky GA.

Vaccine. 2008 Nov 25;26(50):6373-82. doi: 10.1016/j.vaccine.2008.09.018. Epub 2008 Sep 24.


Immunoprophylaxis of RSV infection: advancing from RSV-IGIV to palivizumab and motavizumab.

Wu H, Pfarr DS, Losonsky GA, Kiener PA.

Curr Top Microbiol Immunol. 2008;317:103-23. Review.


Humoral, mucosal, and cellular immune responses to oral Norwalk virus-like particles in volunteers.

Tacket CO, Sztein MB, Losonsky GA, Wasserman SS, Estes MK.

Clin Immunol. 2003 Sep;108(3):241-7.


Phase I evaluation of delta virG Shigella sonnei live, attenuated, oral vaccine strain WRSS1 in healthy adults.

Kotloff KL, Taylor DN, Sztein MB, Wasserman SS, Losonsky GA, Nataro JP, Venkatesan M, Hartman A, Picking WD, Katz DE, Campbell JD, Levine MM, Hale TL.

Infect Immun. 2002 Apr;70(4):2016-21.


Safety and immunogenicity of oral inactivated whole-cell Helicobacter pylori vaccine with adjuvant among volunteers with or without subclinical infection.

Kotloff KL, Sztein MB, Wasserman SS, Losonsky GA, DiLorenzo SC, Walker RI.

Infect Immun. 2001 Jun;69(6):3581-90.


Safety and immunogenicity of increasing doses of a Clostridium difficile toxoid vaccine administered to healthy adults.

Kotloff KL, Wasserman SS, Losonsky GA, Thomas W Jr, Nichols R, Edelman R, Bridwell M, Monath TP.

Infect Immun. 2001 Feb;69(2):988-95.


Safety and immune responses to attenuated Salmonella enterica serovar typhi oral live vector vaccines expressing tetanus toxin fragment C.

Tacket CO, Galen J, Sztein MB, Losonsky G, Wyant TL, Nataro J, Wasserman SS, Edelman R, Chatfield S, Dougan G, Levine MM.

Clin Immunol. 2000 Nov;97(2):146-53.


Albendazole treatment of children with ascariasis enhances the vibriocidal antibody response to the live attenuated oral cholera vaccine CVD 103-HgR.

Cooper PJ, Chico ME, Losonsky G, Sandoval C, Espinel I, Sridhara R, Aguilar M, Guevara A, Guderian RH, Levine MM, Griffin GE, Nutman TB.

J Infect Dis. 2000 Oct;182(4):1199-206. Epub 2000 Sep 8.


Human immune responses to a novel norwalk virus vaccine delivered in transgenic potatoes.

Tacket CO, Mason HS, Losonsky G, Estes MK, Levine MM, Arntzen CJ.

J Infect Dis. 2000 Jul;182(1):302-5. Epub 2000 Jul 6.


Diminution of the anti-polyribosylribitol phosphate response to a combined diphtheria-tetanus-acellular pertussis/Haemophilus influenzae type b vaccine by concurrent inactivated poliovirus vaccination.

Rennels MB, Englund JA, Bernstein DI, Losonsky GA, Anderson EL, Pichichero ME, Munoz FM, Wolff MC.

Pediatr Infect Dis J. 2000 May;19(5):417-23.


Role of EspB in experimental human enteropathogenic Escherichia coli infection.

Tacket CO, Sztein MB, Losonsky G, Abe A, Finlay BB, McNamara BP, Fantry GT, James SP, Nataro JP, Levine MM, Donnenberg MS.

Infect Immun. 2000 Jun;68(6):3689-95.


Phase 2 clinical trial of attenuated Salmonella enterica serovar typhi oral live vector vaccine CVD 908-htrA in U.S. volunteers.

Tacket CO, Sztein MB, Wasserman SS, Losonsky G, Kotloff KL, Wyant TL, Nataro JP, Edelman R, Perry J, Bedford P, Brown D, Chatfield S, Dougan G, Levine MM.

Infect Immun. 2000 Mar;68(3):1196-201.


Shigella flexneri 2a strain CVD 1207, with specific deletions in virG, sen, set, and guaBA, is highly attenuated in humans.

Kotloff KL, Noriega FR, Samandari T, Sztein MB, Losonsky GA, Nataro JP, Picking WD, Barry EM, Levine MM.

Infect Immun. 2000 Mar;68(3):1034-9.


Production of IFN-gamma and IL-10 to Shigella invasins by mononuclear cells from volunteers orally inoculated with a Shiga toxin-deleted Shigella dysenteriae type 1 strain.

Samandari T, Kotloff KL, Losonsky GA, Picking WD, Sansonetti PJ, Levine MM, Sztein MB.

J Immunol. 2000 Feb 15;164(4):2221-32.


Extensive swelling after booster doses of acellular pertussis-tetanus-diphtheria vaccines.

Rennels MB, Deloria MA, Pichichero ME, Losonsky GA, Englund JA, Meade BD, Anderson EL, Steinhoff MC, Edwards KM.

Pediatrics. 2000 Jan;105(1):e12.


Validation and characterization of a human volunteer challenge model for cholera by using frozen bacteria of the new Vibrio cholerae epidemic serotype, O139.

Cohen MB, Giannella RA, Losonsky GA, Lang DR, Parker S, Hawkins JA, Gunther C, Schiff GA.

Infect Immun. 1999 Dec;67(12):6346-9.


Validation of a gastrointestinal explant system for measurement of mucosal antibody production.

Losonsky GA, Fantry GT, Reymann M, Lim Y.

Clin Diagn Lab Immunol. 1999 Nov;6(6):803-7.


Effect of small bowel bacterial overgrowth on the immunogenicity of single-dose live oral cholera vaccine CVD 103-HgR.

Lagos R, Fasano A, Wasserman SS, Prado V, San Martin O, Abrego P, Losonsky GA, Alegria S, Levine MM.

J Infect Dis. 1999 Nov;180(5):1709-12.


Palatability, reactogenicity and immunogenicity of engineered live oral cholera vaccine CVD 103-HgR in Chilean infants and toddlers.

Lagos R, San Martin O, Wasserman SS, Prado V, Losonsky GA, Bustamante C, Levine MM.

Pediatr Infect Dis J. 1999 Jul;18(7):624-30.


Oral immunization with urease and Escherichia coli heat-labile enterotoxin is safe and immunogenic in Helicobacter pylori-infected adults.

Michetti P, Kreiss C, Kotloff KL, Porta N, Blanco JL, Bachmann D, Herranz M, Saldinger PF, Corthésy-Theulaz I, Losonsky G, Nichols R, Simon J, Stolte M, Ackerman S, Monath TP, Blum AL.

Gastroenterology. 1999 Apr;116(4):804-12.


Expanded safety and immunogenicity of a bivalent, oral, attenuated cholera vaccine, CVD 103-HgR plus CVD 111, in United States military personnel stationed in Panama.

Taylor DN, Sanchez JL, Castro JM, Lebron C, Parrado CM, Johnson DE, Tacket CO, Losonsky GA, Wasserman SS, Levine MM, Cryz SJ.

Infect Immun. 1999 Apr;67(4):2030-4.


Hepatitis B vaccination of premature infants: a reassessment of current recommendations for delayed immunization.

Losonsky GA, Wasserman SS, Stephens I, Mahoney F, Armstrong P, Gumpper K, Dulkerian S, West DJ, Gewolb IH.

Pediatrics. 1999 Feb;103(2):E14.


A single dose of live oral cholera vaccine CVD 103-HgR is safe and immunogenic in HIV-infected and HIV-noninfected adults in Mali.

Perry RT, Plowe CV, Koumaré B, Bougoudogo F, Kotloff KL, Losonsky GA, Wasserman SS, Levine MM.

Bull World Health Organ. 1998;76(1):63-71.


Economisation of vaccination against Haemophilus influenzae type b: a randomised trial of immunogenicity of fractional-dose and two-dose regimens.

Lagos R, Valenzuela MT, Levine OS, Losonsky GA, Erazo A, Wasserman SS, Levine MM.

Lancet. 1998 May 16;351(9114):1472-6.


Immunogenicity in humans of a recombinant bacterial antigen delivered in a transgenic potato.

Tacket CO, Mason HS, Losonsky G, Clements JD, Levine MM, Arntzen CJ.

Nat Med. 1998 May;4(5):607-9.


Validation of a volunteer model of cholera with frozen bacteria as the challenge.

Sack DA, Tacket CO, Cohen MB, Sack RB, Losonsky GA, Shimko J, Nataro JP, Edelman R, Levine MM, Giannella RA, Schiff G, Lang D.

Infect Immun. 1998 May;66(5):1968-72.


Investigation of the roles of toxin-coregulated pili and mannose-sensitive hemagglutinin pili in the pathogenesis of Vibrio cholerae O139 infection.

Tacket CO, Taylor RK, Losonsky G, Lim Y, Nataro JP, Kaper JB, Levine MM.

Infect Immun. 1998 Feb;66(2):692-5.


Effect of prior experimental human enteropathogenic Escherichia coli infection on illness following homologous and heterologous rechallenge.

Donnenberg MS, Tacket CO, Losonsky G, Frankel G, Nataro JP, Dougan G, Levine MM.

Infect Immun. 1998 Jan;66(1):52-8.


Evaluation of a bivalent (CVD 103-HgR/CVD 111) live oral cholera vaccine in adult volunteers from the United States and Peru.

Taylor DN, Tacket CO, Losonsky G, Castro O, Gutierrez J, Meza R, Nataro JP, Kaper JB, Wasserman SS, Edelman R, Levine MM, Cryz SJ.

Infect Immun. 1997 Sep;65(9):3852-6.

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