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1دورية أكاديمية
المؤلفون: Volk, Jonathan E, Hessol, Nancy A, Gray, Glenda E, Kublin, James G, Churchyard, Gavin J, Mlisana, Koleka, Nchabeleng, Maphoshane, Buchbinder, Susan P, Bekker, Linda-Gail
المصدر: International Journal of STD & AIDS. 25(5)
مصطلحات موضوعية: Biomedical and Clinical Sciences, Clinical Sciences, Clinical Trials and Supportive Activities, Vaccine Related, Aging, Sexually Transmitted Infections, HIV/AIDS, Infectious Diseases, Prevention, Immunization, Clinical Research, Patient Safety, Good Health and Well Being, AIDS Vaccines, Adolescent, Adult, Age Distribution, Clinical Trials as Topic, Female, HIV Infections, Humans, Male, Motivation, Patient Participation, Patient Selection, South Africa, Young Adult, HIV, AIDS, prevention, vaccination, vaccine trials, clinical trials, youth, Medical Microbiology, Public Health and Health Services, Public Health, Clinical sciences, Immunology
الوصف: By comparing younger to older participants enrolled in a HIV vaccine efficacy trial, we aimed to gain insights into the inclusion of adolescents in future trials. This was a sub-analysis of a multisite HIV vaccine randomized clinical trial in South Africa, conducted January-September 2007. Motivations for trial enrolment, social harms, adverse events and loss to follow-up were compared between younger (18-20 years old) and older participants (21-35 years old). Both younger (n = 238) and older participants (n = 563) were equally likely to report enrolling for altruistic reasons. Younger females were less likely than older participants to join for trial reimbursement (p = 0.005), while younger males were more likely to enrol because the vaccine may provide protection from HIV-acquisition (p < 0.001). There were no significant differences in the number of social harms reported. Compared to males over 20 years old, 18-20-year-old females were less likely to experience adverse events (OR = 0.1, CI 0.01-0.80) and no more likely to be lost to follow-up (OR = 0.7, CI 0.39-1.25), while 18-20-year-old males were no more likely to experience adverse events (OR = 1.3, CI 0.58-2.83) or loss to follow-up (OR = 0.8, CI 0.51-1.41). Our data support the inclusion of younger participants who are at risk for HIV in future HIV vaccine efficacy trials.
وصف الملف: application/pdf
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2دورية أكاديمية
المؤلفون: Ensoli, Barbara, Nchabeleng, Maphoshane, Ensoli, Fabrizio, Tripiciano, Antonella, Bellino, Stefania, Picconi, Orietta, Sgadari, Cecilia, Longo, Olimpia, Tavoschi, Lara, Joffe, Daniel, Cafaro, Aurelio, Francavilla, Vittorio, Moretti, Sonia, Pavone Cossut, Maria Rosaria, Collacchi, Barbara, Arancio, Angela, Paniccia, Giovanni, Casabianca, Anna, Magnani, Mauro, Buttò, Stefano, Levendal, Elise, Ndimande, John Velaphi, Asia, Bennett, Pillay, Yogan, Garaci, Enrico, Monini, Paolo
المساهمون: Ensoli, Barbara, Nchabeleng, Maphoshane, Ensoli, Fabrizio, Tripiciano, Antonella, Bellino, Stefania, Picconi, Orietta, Sgadari, Cecilia, Longo, Olimpia, Tavoschi, Lara, Joffe, Daniel, Cafaro, Aurelio, Francavilla, Vittorio, Moretti, Sonia, Pavone Cossut, Maria Rosaria, Collacchi, Barbara, Arancio, Angela, Paniccia, Giovanni, Casabianca, Anna, Magnani, Mauro, Buttò, Stefano, Levendal, Elise, Ndimande, John Velaphi, Asia, Bennett, Pillay, Yogan, Garaci, Enrico, Monini, Paolo
مصطلحات موضوعية: AIDS, CART, CD4+ T cell, Clinical trial, Cross-clade antibodie, HIV, Neutralization, Tat, Therapy intensification, Vaccine, AIDS Vaccine, Adolescent, Adult, Antibodies, Neutralizing, Antiretroviral Therapy, Highly Active, CD4-Positive T-Lymphocyte, Cross Reaction, Female, HIV Antibodie, HIV Infection, HIV-1, Human, Immunization Schedule, Immunogenicity, Male, Middle Aged, South Africa, Vaccination
الوصف: Background: Although combined antiretroviral therapy (cART) has saved millions of lives, it is incapable of full immune reconstitution and virus eradication. The transactivator of transcription (Tat) protein is a key human immunodeficiency virus (HIV) virulence factor required for virus replication and transmission. Tat is expressed and released extracellularly by infected cells also under cART and in this form induces immune dysregulation, and promotes virus reactivation, entry and spreading. Of note, anti-Tat antibodies are rare in natural infection and, when present, correlate with asymptomatic state and reduced disease progression. This suggested that induction of anti-Tat antibodies represents a pathogenesis-driven intervention to block progression and to intensify cART. Indeed Tat-based vaccination was safe, immunogenic and capable of immune restoration in an open-label, randomized phase II clinical trial conducted in 168 cART-treated volunteers in Italy. To assess whether B-clade Tat immunization would be effective also in patients with different genetic background and infecting virus, a phase II trial was conducted in South Africa. Methods: The ISS T-003 was a 48-week randomised, double-blinded, placebo-controlled trial to evaluate immunogenicity (primary endpoint) and safety (secondary endpoint) of B-clade Tat (30 μg) given intradermally, three times at 4-week intervals, in 200 HIV-infected adults on effective cART (randomised 1:1) with CD4+ T-cell counts ≥200 cells/μL. Study outcomes also included cross-clade anti-Tat antibodies, neutralization, CD4+ T-cell counts and therapy compliance. Results: Immunization was safe and well-tolerated and induced durable, high titers anti-Tat B-clade antibodies in 97 % vaccinees. Anti-Tat antibodies were cross-clade (all vaccinees tested) and neutralized Tat-mediated entry of oligomeric B-clade and C-clade envelope in dendritic cells (24 participants tested). Anti-Tat antibody titers correlated positively with neutralization. Tat vaccination increased CD4+ T-cell ...
العلاقة: info:eu-repo/semantics/altIdentifier/pmid/27277839; info:eu-repo/semantics/altIdentifier/wos/WOS:000377979100001; volume:13; issue:1; numberofpages:22; journal:RETROVIROLOGY; http://hdl.handle.net/11568/935298Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-84975138831; https://retrovirology.biomedcentral.com/articles/10.1186/s12977-016-0261-1Test
