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1.
Clinical immunogenicity outcomes from GENEr8-1, a phase 3 study of valoctocogene roxaparvovec, an AAV5-vectored gene therapy for hemophilia A.
Mol Ther
; 2024 May 24.
Artículo
en Inglés
| MEDLINE | ID: mdl-38796703
2.
Validation of an IFN-gamma ELISpot assay to measure cellular immune responses against viral antigens in non-human primates.
Gene Ther
; 29(1-2): 41-54, 2022 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-33432123
3.
Achieving efficacy in subjects with sustained pegvaliase-neutralizing antibody responses.
Mol Genet Metab
; 134(3): 235-242, 2021 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-34716085
4.
Pegvaliase for the treatment of phenylketonuria: Results of a long-term phase 3 clinical trial program (PRISM).
Mol Genet Metab
; 124(1): 27-38, 2018 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-29653686
5.
Substitutions at amino acid positions 143, 148, and 155 of HIV-1 integrase define distinct genetic barriers to raltegravir resistance in vivo.
J Virol
; 86(13): 7249-55, 2012 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-22553340
6.
2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach).
Bioanalysis
; 15(14): 773-814, 2023 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-37526071
7.
2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness (Part 3 - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization).
Bioanalysis
; 14(11): 737-793, 2022 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-35578991
8.
Connection domain mutations in HIV-1 reverse transcriptase do not impact etravirine susceptibility and virologic responses to etravirine-containing regimens.
Antimicrob Agents Chemother
; 55(6): 2872-9, 2011 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-21464253
9.
Pharmacokinetic, pharmacodynamic, and immunogenic rationale for optimal dosing of pegvaliase, a PEGylated bacterial enzyme, in adult patients with phenylketonuria.
Clin Transl Sci
; 14(5): 1894-1905, 2021 09.
Artículo
en Inglés
| MEDLINE | ID: mdl-34057292
10.
Combinations of mutations in the connection domain of human immunodeficiency virus type 1 reverse transcriptase: assessing the impact on nucleoside and nonnucleoside reverse transcriptase inhibitor resistance.
Antimicrob Agents Chemother
; 54(5): 1973-80, 2010 May.
Artículo
en Inglés
| MEDLINE | ID: mdl-20194692
11.
Loss of raltegravir susceptibility by human immunodeficiency virus type 1 is conferred via multiple nonoverlapping genetic pathways.
J Virol
; 83(22): 11440-6, 2009 Nov.
Artículo
en Inglés
| MEDLINE | ID: mdl-19759152
12.
Comparison of human immunodeficiency virus type 1 tropism profiles in clinical samples by the Trofile and MT-2 assays.
Antimicrob Agents Chemother
; 53(11): 4686-93, 2009 Nov.
Artículo
en Inglés
| MEDLINE | ID: mdl-19687240
13.
Depletion of interfering IgG and IgM is critical to determine the role of IgE in pegvaliase-associated hypersensitivity.
J Immunol Methods
; 468: 20-28, 2019 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-30880261
14.
Beta7-integrin-independent enhancement of mucosal and systemic anti-HIV antibody responses following combined mucosal and systemic gene delivery.
Immunology
; 123(3): 378-89, 2008 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-17944930
15.
Association of immune response with efficacy and safety outcomes in adults with phenylketonuria administered pegvaliase in phase 3 clinical trials.
EBioMedicine
; 37: 366-373, 2018 Nov.
Artículo
en Inglés
| MEDLINE | ID: mdl-30366815
16.
Construction and characterization of feline immunodeficiency virus proviral mutants that coexpress interferon gamma and green fluorescent protein.
AIDS Res Hum Retroviruses
; 22(4): 342-9, 2006 Apr.
Artículo
en Inglés
| MEDLINE | ID: mdl-16623638
17.
Antibody responses against HIV in rhesus macaques following combinations of mucosal and systemic immunizations with chimeric alphavirus-based replicon particles.
AIDS Res Hum Retroviruses
; 22(10): 993-7, 2006 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-17067269
18.
Trends in darunavir resistance-associated mutations and phenotypic resistance in commercially tested United States clinical samples between 2006 and 2012.
AIDS Res Hum Retroviruses
; 31(6): 628-35, 2015 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-25684627
19.
Evolution of integrase resistance during failure of integrase inhibitor-based antiretroviral therapy.
J Acquir Immune Defic Syndr
; 54(4): 389-93, 2010 Aug.
Artículo
en Inglés
| MEDLINE | ID: mdl-20300008
20.
Vaccination of cats with attenuated feline immunodeficiency virus proviral DNA vaccine expressing gamma interferon.
J Virol
; 81(2): 465-73, 2007 Jan.
Artículo
en Inglés
| MEDLINE | ID: mdl-17079309