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HIV Seropositivity: HELP
Articles by François Roman
Based on 2 articles published since 2008
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Between 2008 and 2019, François Roman wrote the following 2 articles about HIV Seropositivity.
 
+ Citations + Abstracts
1 Clinical Trial Phase 2 Placebo-Controlled Trial of Two Vaccines to Prevent Ebola in Liberia. 2017

Kennedy, Stephen B / Bolay, Fatorma / Kieh, Mark / Grandits, Greg / Badio, Moses / Ballou, Ripley / Eckes, Risa / Feinberg, Mark / Follmann, Dean / Grund, Birgit / Gupta, Swati / Hensley, Lisa / Higgs, Elizabeth / Janosko, Krisztina / Johnson, Melvin / Kateh, Francis / Logue, James / Marchand, Jonathan / Monath, Thomas / Nason, Martha / Nyenswah, Tolbert / Roman, François / Stavale, Eric / Wolfson, Julian / Neaton, James D / Lane, H Clifford / Anonymous11380923. ·From the Liberian Ministry of Health, Monrovia, Liberia (S.B.K., F.B., M.K., M.B., M.J., F.K., T.N.) · the University of Minnesota, Division of Biostatistics, Minneapolis (G.G., B.G., J.W., J.D.N.) · GlaxoSmithKline, Rockville (R.B.), and National Institutes of Health (R.E., D.F., L.H., E.H., M.N., H.C.L.) and AbViro (E.S.), Bethesda - all in Maryland · Merck, Kenilworth, NJ (M.F., S.G.) · Battelle Memorial Institute, Columbus, OH (K.J., J.L., J.M., E.S.) · International AIDS Vaccine Initiative, New York (M.F., S.G., T.M.) · and GlaxoSmithKline, Rixensart, Belgium (F.R.). ·N Engl J Med · Pubmed #29020589.

ABSTRACT: BACKGROUND: The safety and efficacy of vaccines to prevent Ebola virus disease (EVD) were unknown when the incidence of EVD was peaking in Liberia. METHODS: We initiated a randomized, placebo-controlled, phase 3 trial of the chimpanzee adenovirus 3 vaccine (ChAd3-EBO-Z) and the recombinant vesicular stomatitis virus vaccine (rVSV∆G-ZEBOV-GP) in Liberia. A phase 2 subtrial was embedded to evaluate safety and immunogenicity. Because the incidence of EVD declined in Liberia, the phase 2 component was expanded and the phase 3 component was eliminated. RESULTS: A total of 1500 adults underwent randomization and were followed for 12 months. The median age of the participants was 30 years; 36.6% of the participants were women. During the week after the administration of vaccine or placebo, adverse events occurred significantly more often with the active vaccines than with placebo; these events included injection-site reactions (in 28.5% of the patients in the ChAd3-EBO-Z group and 30.9% of those in the rVSV∆G-ZEBOV-GP group, as compared with 6.8% of those in the placebo group), headache (in 25.1% and 31.9%, vs. 16.9%), muscle pain (in 22.3% and 26.9%, vs. 13.3%), feverishness (in 23.9% and 30.5%, vs. 9.0%), and fatigue (in 14.0% and 15.4%, vs. 8.8%) (P<0.001 for all comparisons); these differences were not seen at 1 month. Serious adverse events within 12 months after injection were seen in 40 participants (8.0%) in the ChAd3-EBO-Z group, in 47 (9.4%) in the rVSV∆G-ZEBOV-GP group, and in 59 (11.8%) in the placebo group. By 1 month, an antibody response developed in 70.8% of the participants in the ChAd3-EBO-Z group and in 83.7% of those in the rVSV∆G-ZEBOV-GP group, as compared with 2.8% of those in the placebo group (P<0.001 for both comparisons). At 12 months, antibody responses in participants in the ChAd3-EBO-Z group (63.5%) and in those in the rVSV∆G-ZEBOV-GP group (79.5%) remained significantly greater than in those in the placebo group (6.8%, P<0.001 for both comparisons). CONCLUSIONS: A randomized, placebo-controlled phase 2 trial of two vaccines that was rapidly initiated and completed in Liberia showed the capability of conducting rigorous research during an outbreak. By 1 month after vaccination, the vaccines had elicited immune responses that were largely maintained through 12 months. (Funded by the National Institutes of Allergy and Infectious Diseases and the Liberian Ministry of Health; PREVAIL I ClinicalTrials.gov number, NCT02344407 .).

2 Clinical Trial Processing of blood samples influences PBMC viability and outcome of cell-mediated immune responses in antiretroviral therapy-naïve HIV-1-infected patients. 2014

Bourguignon, Patricia / Clément, Frédéric / Renaud, Frédéric / Le Bras, Vivien / Koutsoukos, Marguerite / Burny, Wivine / Moris, Philippe / Lorin, Clarisse / Collard, Alix / Leroux-Roels, Geert / Roman, François / Janssens, Michel / Vandekerckhove, Linos. ·GlaxoSmithKline Vaccines, Rue de l'institut 89, Rixensart 1330, Belgium. Electronic address: PATRICIA.BOURGUIGNON@GSK.COM. · Center for Vaccinology, Ghent University and Ghent University Hospital, De Pintelaan 185, 9000 Ghent, Belgium. Electronic address: Frederic.Clement@UGent.be. · GlaxoSmithKline Vaccines, Rue de l'institut 89, Rixensart 1330, Belgium. Electronic address: FREDERIC.X.RENAUD@GSK.COM. · GlaxoSmithKline Vaccines, Rue de l'institut 89, Rixensart 1330, Belgium. Electronic address: VIVIEN.X.LE-BRAS@GSK.COM. · GlaxoSmithKline Vaccines, Rue de l'institut 89, Rixensart 1330, Belgium. Electronic address: MARGUERITE.KOUTSOUKOS@GSK.COM. · GlaxoSmithKline Vaccines, Rue de l'institut 89, Rixensart 1330, Belgium. Electronic address: WIVINE.BURNY@GSK.COM. · GlaxoSmithKline Vaccines, Rue de l'institut 89, Rixensart 1330, Belgium. Electronic address: PHILIPPE.MORIS@GSK.COM. · GlaxoSmithKline Vaccines, Rue de l'institut 89, Rixensart 1330, Belgium. Electronic address: CLARISSE.M.LORIN@GSK.COM. · GlaxoSmithKline Vaccines, Rue de l'institut 89, Rixensart 1330, Belgium. Electronic address: ALIX.COLLARD@GSK.COM. · Center for Vaccinology, Ghent University and Ghent University Hospital, De Pintelaan 185, 9000 Ghent, Belgium. Electronic address: Geert.LerouxRoels@ugent.be. · GlaxoSmithKline Vaccines, Rue de l'institut 89, Rixensart 1330, Belgium. Electronic address: FRANCOIS.P.ROMAN@GSK.COM. · GlaxoSmithKline Vaccines, Rue de l'institut 89, Rixensart 1330, Belgium. Electronic address: MICHEL.JANSSENS@GSK.COM. · ARC (AIDS Reference Center), Department of Internal Medicine, Ghent University and Ghent University Hospital, De Pintelaan 185, 9000 Ghent, Belgium. Electronic address: Linos.Vandekerckhove@UGent.be. ·J Immunol Methods · Pubmed #25224748.

ABSTRACT: Intracellular cytokine staining (ICS) assay is increasingly used in vaccine clinical trials to measure antigen-specific T-cell mediated immune (CMI) responses in cryopreserved peripheral blood mononuclear cells (PBMCs) and whole blood. However, recent observations indicate that several parameters involved in blood processing can impact PBMC viability and CMI responses, especially in antiretroviral therapy (ART)-naïve HIV-1-infected individuals. In this phase I study (NCT01610427), we collected blood samples from 22 ART-naïve HIV-1-infected adults. PBMCs were isolated and processed for ICS assay. The individual and combined effects of the following parameters were investigated: time between blood collection and PBMC processing (time-to-process: 2, 7 or 24 h); time between PBMC thawing and initiation of in vitro stimulation with HIV-1 antigens (resting-time: 0, 2, 6 and 18 h); and duration of antigen-stimulation in PBMC cultures (stimulation-time: 6h or overnight). The cell recovery after thawing, cell viability after ICS and magnitude of HIV-specific CD8(+) T-cell responses were considered to determine the optimal combination of process conditions. The impact of time-to-process (2 or 4 h) on HIV-specific CD8(+) T-cell responses was also assessed in a whole blood ICS assay. A higher quality of cells in terms of recovery and viability (up to 81% and >80% respectively) was obtained with shorter time-to-process (less than 7 h) and resting-time (less than 2 h) intervals. Longer (overnight) rather than shorter (6 h) stimulation-time intervals increased the frequency of CD8(+)-specific T-cell responses using ICS in PBMCs without change of the functionality. The CD8(+) specific T-cell responses detected using fresh whole blood showed a good correlation with the responses detected using frozen PBMCs. Our results support the need of standardized procedures for the evaluation of CMI responses, especially in HIV-1-infected, ART-naïve patients.