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Items: 45

1.

Evaluation of MEDI8852, an Anti-Influenza A Monoclonal Antibody, in Treating Acute Uncomplicated Influenza.

Ali SO, Takas T, Nyborg A, Shoemaker K, Kallewaard NL, Chiong R, Dubovsky F, Mallory RM.

Antimicrob Agents Chemother. 2018 Oct 24;62(11). pii: e00694-18. doi: 10.1128/AAC.00694-18. Print 2018 Nov.

2.

Phase 1 study of MEDI3902, an investigational anti-Pseudomonas aeruginosa PcrV and Psl bispecific human monoclonal antibody, in healthy adults.

Ali SO, Yu XQ, Robbie GJ, Wu Y, Shoemaker K, Yu L, DiGiandomenico A, Keller AE, Anude C, Hernandez-Illas M, Bellamy T, Falloon J, Dubovsky F, Jafri HS.

Clin Microbiol Infect. 2019 May;25(5):629.e1-629.e6. doi: 10.1016/j.cmi.2018.08.004. Epub 2018 Aug 11.

3.

The safety and efficacy of quadrivalent live attenuated influenza vaccine in Japanese children aged 2-18 years: Results of two phase 3 studies.

Mallory RM, Yu J, Kameo S, Tanaka M, Rito K, Itoh Y, Dubovsky F.

Influenza Other Respir Viruses. 2018 Jul;12(4):438-445. doi: 10.1111/irv.12555. Epub 2018 Apr 10.

4.

Safety, Tolerability and Pharmacokinetics of MEDI8897, an Extended Half-life Single-dose Respiratory Syncytial Virus Prefusion F-targeting Monoclonal Antibody Administered as a Single Dose to Healthy Preterm Infants.

Domachowske JB, Khan AA, Esser MT, Jensen K, Takas T, Villafana T, Dubovsky F, Griffin MP.

Pediatr Infect Dis J. 2018 Sep;37(9):886-892. doi: 10.1097/INF.0000000000001916.

5.

An Adjuvanted, Postfusion F Protein-Based Vaccine Did Not Prevent Respiratory Syncytial Virus Illness in Older Adults.

Falloon J, Yu J, Esser MT, Villafana T, Yu L, Dubovsky F, Takas T, Levin MJ, Falsey AR.

J Infect Dis. 2017 Dec 12;216(11):1362-1370. doi: 10.1093/infdis/jix503.

6.

A phase 1 study to evaluate the safety and pharmacokinetics of MEDI8852, an anti-influenza A monoclonal antibody, in healthy adult volunteers.

Mallory RM, Ali SO, Takas T, Kankam M, Dubovsky F, Tseng L.

Biologicals. 2017 Nov;50:81-86. doi: 10.1016/j.biologicals.2017.08.007. Epub 2017 Aug 23.

PMID:
28844541
7.

Dose Selection for an Adjuvanted Respiratory Syncytial Virus F Protein Vaccine for Older Adults Based on Humoral and Cellular Immune Responses.

Falloon J, Talbot HK, Curtis C, Ervin J, Krieger D, Dubovsky F, Takas T, Yu J, Yu L, Lambert SL, Villafana T, Esser MT.

Clin Vaccine Immunol. 2017 Sep 5;24(9). pii: e00157-17. doi: 10.1128/CVI.00157-17. Print 2017 Sep.

8.

Safety, Tolerability, and Pharmacokinetics of MEDI8897, the Respiratory Syncytial Virus Prefusion F-Targeting Monoclonal Antibody with an Extended Half-Life, in Healthy Adults.

Griffin MP, Khan AA, Esser MT, Jensen K, Takas T, Kankam MK, Villafana T, Dubovsky F.

Antimicrob Agents Chemother. 2017 Feb 23;61(3). pii: e01714-16. doi: 10.1128/AAC.01714-16. Print 2017 Mar.

9.

A phase 1a, first-in-human, randomized study of a respiratory syncytial virus F protein vaccine with and without a toll-like receptor-4 agonist and stable emulsion adjuvant.

Falloon J, Ji F, Curtis C, Bart S, Sheldon E, Krieger D, Dubovsky F, Lambert S, Takas T, Villafana T, Esser MT.

Vaccine. 2016 May 27;34(25):2847-54. doi: 10.1016/j.vaccine.2016.04.002. Epub 2016 Apr 19.

10.

Safety and immunogenicity of a live attenuated RSV vaccine in healthy RSV-seronegative children 5 to 24 months of age.

Malkin E, Yogev R, Abughali N, Sliman J, Wang CK, Zuo F, Yang CF, Eickhoff M, Esser MT, Tang RS, Dubovsky F.

PLoS One. 2013 Oct 29;8(10):e77104. doi: 10.1371/journal.pone.0077104. eCollection 2013.

11.

Implication of respiratory syncytial virus (RSV) F transgene sequence heterogeneity observed in Phase 1 evaluation of MEDI-534, a live attenuated parainfluenza type 3 vectored RSV vaccine.

Yang CF, Wang CK, Malkin E, Schickli JH, Shambaugh C, Zuo F, Galinski MS, Dubovsky F; Study Group, Tang RS.

Vaccine. 2013 Jun 10;31(26):2822-7. doi: 10.1016/j.vaccine.2013.04.006. Epub 2013 Apr 16.

PMID:
23602668
12.

Immunogenicity of a quadrivalent Ann Arbor strain live attenuated influenza vaccine delivered using a blow-fill-seal device in adults: a randomized, active-controlled study*.

Sheldon EA, Jeanfreau R, Sliman JA, Charenkavanich S, Rousculp MD, Dubovsky F, Mallory RM.

Influenza Other Respir Viruses. 2013 Nov;7(6):1142-50. doi: 10.1111/irv.12027. Epub 2012 Oct 14.

13.

Immunogenicity and safety of a quadrivalent live attenuated influenza vaccine in children.

Block SL, Falloon J, Hirschfield JA, Krilov LR, Dubovsky F, Yi T, Belshe RB.

Pediatr Infect Dis J. 2012 Jul;31(7):745-51. doi: 10.1097/INF.0b013e31825687b0.

PMID:
22466322
14.

The safety and efficacy of live attenuated influenza vaccine in young children with asthma or prior wheezing.

Ambrose CS, Dubovsky F, Yi T, Belshe RB, Ashkenazi S.

Eur J Clin Microbiol Infect Dis. 2012 Oct;31(10):2549-57. Epub 2012 Mar 14.

15.

A randomized, double-blind noninferiority study of quadrivalent live attenuated influenza vaccine in adults.

Block SL, Yi T, Sheldon E, Dubovsky F, Falloon J.

Vaccine. 2011 Nov 21;29(50):9391-7. doi: 10.1016/j.vaccine.2011.09.109. Epub 2011 Oct 6.

PMID:
21983154
16.

Phase 1 study of the safety and immunogenicity of a live, attenuated respiratory syncytial virus and parainfluenza virus type 3 vaccine in seronegative children.

Bernstein DI, Malkin E, Abughali N, Falloon J, Yi T, Dubovsky F; MI-CP149 Investigators.

Pediatr Infect Dis J. 2012 Feb;31(2):109-14. doi: 10.1097/INF.0b013e31823386f1.

PMID:
21926667
17.

Safety of live attenuated influenza vaccine in mild to moderately immunocompromised children with cancer.

Halasa N, Englund JA, Nachman S, Weinberg GA, Huber VC, Allison K, Dubovsky F, Yi T, McCullers JA, Flynn PM.

Vaccine. 2011 May 31;29(24):4110-5. doi: 10.1016/j.vaccine.2011.03.097. Epub 2011 Apr 13.

PMID:
21496468
18.

Safety and immunogenicity following administration of a live, attenuated monovalent 2009 H1N1 influenza vaccine to children and adults in two randomized controlled trials.

Mallory RM, Malkin E, Ambrose CS, Bellamy T, Shi L, Yi T, Jones T, Kemble G, Dubovsky F.

PLoS One. 2010 Oct 29;5(10):e13755. doi: 10.1371/journal.pone.0013755.

19.

Adenovectors induce functional antibodies capable of potent inhibition of blood stage malaria parasite growth.

Bruder JT, Stefaniak ME, Patterson NB, Chen P, Konovalova S, Limbach K, Campo JJ, Ettyreddy D, Li S, Dubovsky F, Richie TL, King CR, Long CA, Doolan DL.

Vaccine. 2010 Apr 19;28(18):3201-10. doi: 10.1016/j.vaccine.2010.02.024. Epub 2010 Feb 25.

PMID:
20188680
20.

Recombinant Liver Stage Antigen-1 (LSA-1) formulated with AS01 or AS02 is safe, elicits high titer antibody and induces IFN-gamma/IL-2 CD4+ T cells but does not protect against experimental Plasmodium falciparum infection.

Cummings JF, Spring MD, Schwenk RJ, Ockenhouse CF, Kester KE, Polhemus ME, Walsh DS, Yoon IK, Prosperi C, Juompan LY, Lanar DE, Krzych U, Hall BT, Ware LA, Stewart VA, Williams J, Dowler M, Nielsen RK, Hillier CJ, Giersing BK, Dubovsky F, Malkin E, Tucker K, Dubois MC, Cohen JD, Ballou WR, Heppner DG Jr.

Vaccine. 2010 Jul 12;28(31):5135-44. doi: 10.1016/j.vaccine.2009.08.046. Epub 2009 Sep 6.

PMID:
19737527
21.

Challenges in developing a pediatric RSV vaccine.

Schickli JH, Dubovsky F, Tang RS.

Hum Vaccin. 2009 Sep;5(9):582-91. Epub 2009 Sep 28. Review.

PMID:
19556888
22.

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.

PMID:
19483659
23.

Quantitative detection of Plasmodium falciparum DNA in saliva, blood, and urine.

Nwakanma DC, Gomez-Escobar N, Walther M, Crozier S, Dubovsky F, Malkin E, Locke E, Conway DJ.

J Infect Dis. 2009 Jun 1;199(11):1567-74. doi: 10.1086/598856.

PMID:
19432544
24.

Blood stage malaria vaccine eliciting high antigen-specific antibody concentrations confers no protection to young children in Western Kenya.

Ogutu BR, Apollo OJ, McKinney D, Okoth W, Siangla J, Dubovsky F, Tucker K, Waitumbi JN, Diggs C, Wittes J, Malkin E, Leach A, Soisson LA, Milman JB, Otieno L, Holland CA, Polhemus M, Remich SA, Ockenhouse CF, Cohen J, Ballou WR, Martin SK, Angov E, Stewart VA, Lyon JA, Heppner DG, Withers MR; MSP-1 Malaria Vaccine Working Group.

PLoS One. 2009;4(3):e4708. doi: 10.1371/journal.pone.0004708. Epub 2009 Mar 5.

25.

A phase 1 trial of PfCP2.9: an AMA1/MSP1 chimeric recombinant protein vaccine for Plasmodium falciparum malaria.

Malkin E, Hu J, Li Z, Chen Z, Bi X, Reed Z, Dubovsky F, Liu J, Wang Q, Pan X, Chen T, Giersing B, Xu Y, Kang X, Gu J, Shen Q, Tucker K, Tierney E, Pan W, Long C, Cao Z.

Vaccine. 2008 Dec 9;26(52):6864-73. doi: 10.1016/j.vaccine.2008.09.081. Epub 2008 Oct 16.

PMID:
18930094
26.

Safety of the RTS,S/AS02A malaria vaccine in Mozambican children during a Phase IIb trial.

Sacarlal J, Aponte JJ, Aide P, Mandomando I, Bassat Q, Guinovart C, Leach A, Milman J, Macete E, Espasa M, Ofori-Anyinam O, Thonnard J, Corachan S, Dubois MC, Lievens M, Dubovsky F, Ballou WR, Cohen J, Alonso PL.

Vaccine. 2008 Jan 10;26(2):174-84. Epub 2007 Nov 26.

PMID:
18069097
27.

Immunogenicity in rhesus of the Plasmodium vivax mosquito stage antigen Pvs25H with Alhydrogel and Montanide ISA 720.

Saul A, Hensmann M, Sattabongkot J, Collins WE, Barnwell JW, Langermans JA, Wu Y, Long CA, Dubovsky F, Thomas AW.

Parasite Immunol. 2007 Oct;29(10):525-33.

28.

Evaluation of two formulations of adjuvanted RTS, S malaria vaccine in children aged 3 to 5 years living in a malaria-endemic region of Mozambique: a Phase I/IIb randomized double-blind bridging trial.

Macete EV, Sacarlal J, Aponte JJ, Leach A, Navia MM, Milman J, Guinovart C, Mandomando I, López-Púa Y, Lievens M, Owusu-Ofori A, Dubois MC, Cahill CP, Koutsoukos M, Sillman M, Thompson R, Dubovsky F, Ballou WR, Cohen J, Alonso PL.

Trials. 2007 Mar 26;8:11.

29.

Safety and immunogenicity of the RTS,S/AS02A candidate malaria vaccine in children aged 1-4 in Mozambique.

Macete E, Aponte JJ, Guinovart C, Sacarlal J, Ofori-Anyinam O, Mandomando I, Espasa M, Bevilacqua C, Leach A, Dubois MC, Heppner DG, Tello L, Milman J, Cohen J, Dubovsky F, Tornieporth N, Thompson R, Alonso PL.

Trop Med Int Health. 2007 Jan;12(1):37-46.

30.

Safety and reactogenicity of an MSP-1 malaria vaccine candidate: a randomized phase Ib dose-escalation trial in Kenyan children.

Withers MR, McKinney D, Ogutu BR, Waitumbi JN, Milman JB, Apollo OJ, Allen OG, Tucker K, Soisson LA, Diggs C, Leach A, Wittes J, Dubovsky F, Stewart VA, Remich SA, Cohen J, Ballou WR, Holland CA, Lyon JA, Angov E, Stoute JA, Martin SK, Heppner DG Jr; MSP-1 Malaria Vaccine Working Group.

PLoS Clin Trials. 2006 Nov 24;1(7):e32.

31.

Viral vectors for malaria vaccine development.

Li S, Locke E, Bruder J, Clarke D, Doolan DL, Havenga MJ, Hill AV, Liljestrom P, Monath TP, Naim HY, Ockenhouse C, Tang DC, Van Kampen KR, Viret JF, Zavala F, Dubovsky F.

Vaccine. 2007 Mar 30;25(14):2567-74. Epub 2006 Aug 1. Review.

PMID:
16914237
32.

RTS,S/AS02A malaria vaccine does not induce parasite CSP T cell epitope selection and reduces multiplicity of infection.

Enosse S, Dobaño C, Quelhas D, Aponte JJ, Lievens M, Leach A, Sacarlal J, Greenwood B, Milman J, Dubovsky F, Cohen J, Thompson R, Ballou WR, Alonso PL, Conway DJ, Sutherland CJ.

PLoS Clin Trials. 2006 May;1(1):e5. Epub 2006 May 19.

33.

Potency assay design for adjuvanted recombinant proteins as malaria vaccines.

Giersing BK, Dubovsky F, Saul A, Denamur F, Minor P, Meade B.

Vaccine. 2006 May 15;24(20):4264-70.

PMID:
16767804
34.

Progress towards the development of malaria vaccines.

Malkin E, Dubovsky F, Moree M.

Trends Parasitol. 2006 Jul;22(7):292-5. Epub 2006 May 16.

PMID:
16707275
35.

Safety, immunogenicity, and efficacy of prime-boost immunization with recombinant poxvirus FP9 and modified vaccinia virus Ankara encoding the full-length Plasmodium falciparum circumsporozoite protein.

Walther M, Thompson FM, Dunachie S, Keating S, Todryk S, Berthoud T, Andrews L, Andersen RF, Moore A, Gilbert SC, Poulton I, Dubovsky F, Tierney E, Correa S, Huntcooke A, Butcher G, Williams J, Sinden RE, Hill AV.

Infect Immun. 2006 May;74(5):2706-16.

36.

Meeting on planning Plasmodium vivax vaccine efficacy trials. July 20-21, 2004, Singapore.

Moorthy V, Dubovsky F.

Expert Rev Vaccines. 2006 Feb;5(1):21-5. No abstract available.

PMID:
16451104
37.

A clinical trial of prime-boost immunisation with the candidate malaria vaccines RTS,S/AS02A and MVA-CS.

Dunachie SJ, Walther M, Vuola JM, Webster DP, Keating SM, Berthoud T, Andrews L, Bejon P, Poulton I, Butcher G, Watkins K, Sinden RE, Leach A, Moris P, Tornieporth N, Schneider J, Dubovsky F, Tierney E, Williams J, Heppner DG Jr, Gilbert SC, Cohen J, Hill AV.

Vaccine. 2006 Apr 5;24(15):2850-9. Epub 2006 Jan 6.

PMID:
16434127
38.

Duration of protection with RTS,S/AS02A malaria vaccine in prevention of Plasmodium falciparum disease in Mozambican children: single-blind extended follow-up of a randomised controlled trial.

Alonso PL, Sacarlal J, Aponte JJ, Leach A, Macete E, Aide P, Sigauque B, Milman J, Mandomando I, Bassat Q, Guinovart C, Espasa M, Corachan S, Lievens M, Navia MM, Dubois MC, Menendez C, Dubovsky F, Cohen J, Thompson R, Ballou WR.

Lancet. 2005 Dec 10;366(9502):2012-8.

PMID:
16338450
39.

Effect of adjuvant on reactogenicity and long-term immunogenicity of the malaria Vaccine ICC-1132 in macaques.

Langermans JA, Schmidt A, Vervenne RA, Birkett AJ, Calvo-Calle JM, Hensmann M, Thornton GB, Dubovsky F, Weiler H, Nardin E, Thomas AW.

Vaccine. 2005 Sep 30;23(41):4935-43.

PMID:
15998554
40.

Safety and enhanced immunogenicity of a hepatitis B core particle Plasmodium falciparum malaria vaccine formulated in adjuvant Montanide ISA 720 in a phase I trial.

Oliveira GA, Wetzel K, Calvo-Calle JM, Nussenzweig R, Schmidt A, Birkett A, Dubovsky F, Tierney E, Gleiter CH, Boehmer G, Luty AJ, Ramharter M, Thornton GB, Kremsner PG, Nardin EH.

Infect Immun. 2005 Jun;73(6):3587-97.

41.

Safety, immunogenicity and efficacy of a pre-erythrocytic malaria candidate vaccine, ICC-1132 formulated in Seppic ISA 720.

Walther M, Dunachie S, Keating S, Vuola JM, Berthoud T, Schmidt A, Maier C, Andrews L, Andersen RF, Gilbert S, Poulton I, Webster D, Dubovsky F, Tierney E, Sarpotdar P, Correa S, Huntcooke A, Butcher G, Williams J, Sinden RE, Thornton GB, Hill AV.

Vaccine. 2005 Jan 4;23(7):857-64.

PMID:
15603885
42.

Efficacy of the RTS,S/AS02A vaccine against Plasmodium falciparum infection and disease in young African children: randomised controlled trial.

Alonso PL, Sacarlal J, Aponte JJ, Leach A, Macete E, Milman J, Mandomando I, Spiessens B, Guinovart C, Espasa M, Bassat Q, Aide P, Ofori-Anyinam O, Navia MM, Corachan S, Ceuppens M, Dubois MC, Demoitié MA, Dubovsky F, Menéndez C, Tornieporth N, Ballou WR, Thompson R, Cohen J.

Lancet. 2004 Oct 16-22;364(9443):1411-20.

PMID:
15488216
43.

Malaria vaccines: orphans in transition.

Dubovsky F, Moree M, Rabinovich R.

Dev Biol (Basel). 2002;110:47-53. No abstract available.

PMID:
12477306
44.

Heterogeneous virulence of enteroaggregative Escherichia coli strains isolated from children in Southwest Nigeria.

Okeke IN, Lamikanra A, Czeczulin J, Dubovsky F, Kaper JB, Nataro JP.

J Infect Dis. 2000 Jan;181(1):252-60.

PMID:
10608774
45.

Identification and cloning of a novel plasmid-encoded enterotoxin of enteroinvasive Escherichia coli and Shigella strains.

Nataro JP, Seriwatana J, Fasano A, Maneval DR, Guers LD, Noriega F, Dubovsky F, Levine MM, Morris JG Jr.

Infect Immun. 1995 Dec;63(12):4721-8.

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