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http://hdl.handle.net/2445/126890
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DC Field | Value | Language |
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dc.contributor.author | Dinges, Warren | - |
dc.contributor.author | Girard, Pierre-Marie | - |
dc.contributor.author | Podzamczer Palter, Daniel | - |
dc.contributor.author | Brockmeyer, Norbert H. | - |
dc.contributor.author | García, Felipe | - |
dc.contributor.author | Harrer, Thomas | - |
dc.contributor.author | Lelievre, Jean-Daniel | - |
dc.contributor.author | Frank, Ian | - |
dc.contributor.author | Colin De Verdiere, Nathalie | - |
dc.contributor.author | Yeni, Guy-Patrick | - |
dc.contributor.author | Ortega Gonzalez, Enrique | - |
dc.contributor.author | Rubio, Rafael | - |
dc.contributor.author | Clotet, Bonaventura, 1953- | - |
dc.contributor.author | DeJesus, Edwin | - |
dc.contributor.author | Pérez Elías, María Jesús | - |
dc.contributor.author | Launay, Odile | - |
dc.contributor.author | Pialoux, Gilles | - |
dc.contributor.author | Slim, Jihad | - |
dc.contributor.author | Weiss, Laurence | - |
dc.contributor.author | Bouchaud, Olivier | - |
dc.contributor.author | Felizarta, Franco | - |
dc.contributor.author | Meurer, Anja | - |
dc.contributor.author | Raffi, François | - |
dc.contributor.author | Esser, Stefan | - |
dc.contributor.author | Katlama, Christine | - |
dc.contributor.author | Koletar, Susan L. | - |
dc.contributor.author | Mounzer, Karam | - |
dc.contributor.author | Swindells, Susan | - |
dc.contributor.author | Baxter, John | - |
dc.contributor.author | Schneider, Stefan | - |
dc.contributor.author | Chas, Julie | - |
dc.contributor.author | Molina, Jean-Michel | - |
dc.contributor.author | Koutsoukos, Marguerite | - |
dc.contributor.author | Collard, Alix | - |
dc.contributor.author | Bourguignon, Patricia | - |
dc.contributor.author | Roman, François | - |
dc.date.accessioned | 2018-12-11T11:49:55Z | - |
dc.date.available | 2018-12-11T11:49:55Z | - |
dc.date.issued | 2016-02 | - |
dc.identifier.uri | http://hdl.handle.net/2445/126890 | - |
dc.description.abstract | The impact of the investigational human immunodeficiency virus type 1 (HIV-1) F4/AS01(B) vaccine on HIV-1 viral load (VL) was evaluated in antiretroviral therapy (ART)-naive HIV-1 infected adults.This phase IIb, observer-blind study (NCT01218113), included ART-naive HIV-1 infected adults aged 18 to 55 years. Participants were randomized to receive 2 (F4/AS01(B)_2 group, N=64) or 3 (F4/AS01(B)_3 group, N=62) doses of F4/AS01(B) or placebo (control group, N=64) at weeks 0, 4, and 28. Efficacy (HIV-1 VL, CD4(+) T-cell count, ART initiation, and HIV-related clinical events), safety, and immunogenicity (antibody and T-cell responses) were evaluated during 48 weeks.At week 48, based on a mixed model, no statistically significant difference in HIV-1 VL change from baseline was demonstrated between F4/AS01(B)_2 and control group (0.073 log(10)copies/mL [97.5% confidence interval (CI): -0.088; 0.235]), or F4/AS01(B)_3 and control group (-0.096 log(10)copies/mL [97.5% CI: -0.257; 0.065]). No differences between groups were observed in HIV-1 VL change, CD4(+) T-cell count, ART initiation, or HIV-related clinical events at intermediate timepoints. Among F4/AS01(B) recipients, the most frequent solicited symptoms were pain at injection site (252/300 doses), fatigue (137/300 doses), myalgia (105/300 doses), and headache (90/300 doses). Twelve serious adverse events were reported in 6 participants; 1 was considered vaccine-related (F4/AS01(B)_2 group: angioedema). F4/AS01(B) induced polyfunctional F4-specific CD4(+) T-cells, but had no significant impact on F4-specific CD8(+) T-cell and anti-F4 antibody levels.F4/AS01(B) had a clinically acceptable safety profile, induced F4-specific CD4(+) T-cell responses, but did not reduce HIV-1 VL, impact CD4(+) T-cells count, delay ART initiation, or prevent HIV-1 related clinical events. | - |
dc.format.extent | 10 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Lippincott Williams & Wilkins | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1097/MD.0000000000002673 | - |
dc.relation.ispartof | Medicine, 2016, vol. 95, num. 6 | - |
dc.relation.uri | https://doi.org/10.1097/MD.0000000000002673 | - |
dc.rights | cc by (c) Dinges et al., 2016 | - |
dc.rights.uri | http://creativecommons.org/licenses/by/3.0/es/ | * |
dc.source | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) | - |
dc.subject.classification | VIH (Virus) | - |
dc.subject.classification | Vacunes | - |
dc.subject.other | HIV (Viruses) | - |
dc.subject.other | Vaccines | - |
dc.title | The F4/AS01B HIV-1 Vaccine Candidate Is Safe and Immunogenic, But Does Not Show Viral Efficacy in Antiretroviral Therapy-Naive, HIV-1-Infected Adults: A Randomized Controlled Trial | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.date.updated | 2018-07-25T07:52:55Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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DingesW.pdf | 636.62 kB | Adobe PDF | View/Open |
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