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18 results on '"Darden, Janice M."'

1. Clinical, molecular, and drug resistance epidemiology of HIV in Jordan, 2019-2021: A national study

Author

Bakri, Faris G., Mukattash, Heyam H., Esmeiran, Hiam, Schluck, Glenna, Storme, Casey K., Broach, Erica, Mebrahtu, Tsedal, Alhawarat, Mohammad, Valencia-Ruiz, Anais, M'Hamdi, Oussama, Malia, Jennifer A., Hassen, Zebiba, Shafei, Mah'd M.S., Alkhatib, Ala Y., Gazo, Mahmoud, Jaradat, Saied A., Gomez, Yessenia, McGeehon, Samantha, McCauley, Melanie D., Moreland, Sarah C., Darden, Janice M., Amare, Mihret, Crowell, Trevor A., Vasan, Sandhya, Michael, Nelson L., Ake, Julie A., Modjarrad, Kayvon, Scott, Paul T., Peel, Sheila A., and Hakre, Shilpa

Published
2024
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2. SARS-CoV-2 recombinant spike ferritin nanoparticle vaccine adjuvanted with Army Liposome Formulation containing monophosphoryl lipid A and QS-21: a phase 1, randomised, double-blind, placebo-controlled, first-in-human clinical trial

Author

Gebrehana, Beza, Greenleaf, Melissa E, Hamer, Melinda J, Jansen, Nathan K, Jing, Xiaotang, Kagai, Jael, Kourbanova, Kamila, Koren, Michael A, Martin, Monica L, Wuertz, Kathryn McGuckin, Regules, Jason A, Sanborn, Aaron D, Wallace, David, Zhu, Lei, Gromowski, Gregory D, Corbitt, Courtney, Darden, Janice M, Dussupt, Vincent, Golub, Emily S, Headley, Jarrett A, Jarral, Umair M, King, Jocelyn, Krebs, Shelly J, Lay, Jenny, Lilly, Regina, Lynch, Jennifer, Martinez, Elizabeth J, Mayer, Sandra V, McGeehon, Samantha, Lee, Hyunna, Schech, Steven, Tadesse, Mekdi, Thomas, Paul V, Romem, Yahel, Zografos, Erifile, Lin, Bob C, Narpala, Sandeep R, Wang, Lingshu, Doria-Rose, Nicole A, Carroll, Robin E, Eaton, Amanda, Badraslioglu, Emily D, Koontz, Jason M, Nwaeze, Ugo E, Dawson, Peter, Noll, Alexander J, Orndahl, Christine M, Bray, Amy, Carrion, Ricardo, Jr., Patterson, Jean, Kulkarni, Viraj, Hallam, Cory, Gonzalez, Olga, Gazi, Michal, Ober Shepherd, Brittany L, Scott, Paul T, Hutter, Jack N, Lee, Christine, McCauley, Melanie D, Guzman, Ivelese, Bryant, Christopher, McGuire, Sarah, Kennedy, Jessie, Chen, Wei-Hung, Hajduczki, Agnes, Mdluli, Thembi, Valencia-Ruiz, Anais, Amare, Mihret F, Matyas, Gary R, Rao, Mangala, Rolland, Morgane, Mascola, John R, De Rosa, Stephen C, McElrath, M Juliana, Montefiori, David C, Serebryannyy, Leonid, McDermott, Adrian B, Peel, Sheila A, Collins, Natalie D, Joyce, M Gordon, Robb, Merlin L, Michael, Nelson L, Vasan, Sandhya, and Modjarrad, Kayvon

Published
2024
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3. SARS-CoV-2 recombinant spike ferritin nanoparticle vaccine adjuvanted with Army Liposome Formulation containing monophosphoryl lipid A and QS-21: a phase 1, randomised, double-blind, placebo-controlled, first-in-human clinical trial

Author

Ober Shepherd, Brittany L, primary, Scott, Paul T, additional, Hutter, Jack N, additional, Lee, Christine, additional, McCauley, Melanie D, additional, Guzman, Ivelese, additional, Bryant, Christopher, additional, McGuire, Sarah, additional, Kennedy, Jessie, additional, Chen, Wei-Hung, additional, Hajduczki, Agnes, additional, Mdluli, Thembi, additional, Valencia-Ruiz, Anais, additional, Amare, Mihret F, additional, Matyas, Gary R, additional, Rao, Mangala, additional, Rolland, Morgane, additional, Mascola, John R, additional, De Rosa, Stephen C, additional, McElrath, M Juliana, additional, Montefiori, David C, additional, Serebryannyy, Leonid, additional, McDermott, Adrian B, additional, Peel, Sheila A, additional, Collins, Natalie D, additional, Joyce, M Gordon, additional, Robb, Merlin L, additional, Michael, Nelson L, additional, Vasan, Sandhya, additional, Modjarrad, Kayvon, additional, Gebrehana, Beza, additional, Greenleaf, Melissa E, additional, Hamer, Melinda J, additional, Jansen, Nathan K, additional, Jing, Xiaotang, additional, Kagai, Jael, additional, Kourbanova, Kamila, additional, Koren, Michael A, additional, Martin, Monica L, additional, Wuertz, Kathryn McGuckin, additional, Regules, Jason A, additional, Sanborn, Aaron D, additional, Wallace, David, additional, Zhu, Lei, additional, Gromowski, Gregory D, additional, Corbitt, Courtney, additional, Darden, Janice M, additional, Dussupt, Vincent, additional, Golub, Emily S, additional, Headley, Jarrett A, additional, Jarral, Umair M, additional, King, Jocelyn, additional, Krebs, Shelly J, additional, Lay, Jenny, additional, Lilly, Regina, additional, Lynch, Jennifer, additional, Martinez, Elizabeth J, additional, Mayer, Sandra V, additional, McGeehon, Samantha, additional, Lee, Hyunna, additional, Schech, Steven, additional, Tadesse, Mekdi, additional, Thomas, Paul V, additional, Romem, Yahel, additional, Zografos, Erifile, additional, Lin, Bob C, additional, Narpala, Sandeep R, additional, Wang, Lingshu, additional, Doria-Rose, Nicole A, additional, Carroll, Robin E, additional, Eaton, Amanda, additional, Badraslioglu, Emily D, additional, Koontz, Jason M, additional, Nwaeze, Ugo E, additional, Dawson, Peter, additional, Noll, Alexander J, additional, Orndahl, Christine M, additional, Bray, Amy, additional, Carrion, Ricardo, additional, Patterson, Jean, additional, Kulkarni, Viraj, additional, Hallam, Cory, additional, Gonzalez, Olga, additional, and Gazi, Michal, additional

Published
2024
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4. Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial

Author

Modjarrad, Kayvon, Roberts, Christine C, Mills, Kristin T, Castellano, Amy R, Paolino, Kristopher, Muthumani, Kar, Reuschel, Emma L, Robb, Merlin L, Racine, Trina, Oh, Myoung-don, Lamarre, Claude, Zaidi, Faraz I, Boyer, Jean, Kudchodkar, Sagar B, Jeong, Moonsup, Darden, Janice M, Park, Young K, Scott, Paul T, Remigio, Celine, Parikh, Ajay P, Wise, Megan C, Patel, Ami, Duperret, Elizabeth K, Kim, Kevin Y, Choi, Hyeree, White, Scott, Bagarazzi, Mark, May, Jeanine M, Kane, Deborah, Lee, Hyojin, Kobinger, Gary, Michael, Nelson L, Weiner, David B, Thomas, Stephen J, and Maslow, Joel N

Published
2019
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5. Prospective screening for sexually transmitted infections among US service members with Chlamydia trachomatis or Neisseria gonorrhoeae infection

Author

Bedno, Sheryl, primary, Hakre, Shilpa, additional, Clark, Shannon, additional, Dear, Nicole, additional, Milazzo, Mark, additional, McCoart, Amy, additional, Hassen, Zebiba, additional, Liu, Heather, additional, Bianchi, Elizabeth J., additional, Darden, Janice M., additional, Paudel, Misti, additional, Malia, Jennifer A., additional, Peel, Sheila A., additional, Scott, Paul T., additional, and Petruccelli, Bruno, additional

Published
2023
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6. Validation of SARS-CoV-2 pooled testing for surveillance using the Panther Fusion® system: Impact of pool size, automation, and assay chemistry

Author

Park, Rudolph, primary, Chandrasekaran, Prabha, additional, Hernandez, Heather, additional, Lakhal-Naouar, Ines, additional, Peachman, Kristina K., additional, Hack, Holly R., additional, Coleman, Dante, additional, Ouellette, Jason, additional, Darden, Janice M., additional, M’hamdi, Oussama, additional, Sugiharto, Victor A., additional, Chen, Hua-Wei, additional, Schilling, Megan A., additional, Simons, Mark P., additional, Collins, Natalie D., additional, Johnson, Yuliya S., additional, Jagodzinski, Linda L., additional, and Peel, Sheila A., additional

Published
2022
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7. Evaluation of Antibody-Dependent Fc-Mediated Viral Entry, as Compared With Neutralization, in SARS-CoV-2 Infection

Author

Wieczorek, Lindsay, primary, Zemil, Michelle, additional, Merbah, Mélanie, additional, Dussupt, Vincent, additional, Kavusak, Erin, additional, Molnar, Sebastian, additional, Heller, Jonah, additional, Beckman, Bradley, additional, Wollen-Roberts, Suzanne, additional, Peachman, Kristina K., additional, Darden, Janice M., additional, Krebs, Shelly, additional, Rolland, Morgane, additional, Peel, Sheila A., additional, and Polonis, Victoria R., additional

Published
2022
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8. Virological and Serological Assessment of US Army Trainees Isolated for Coronavirus Disease 2019

Author

Hakre, Shilpa, primary, Lakhal-Naouar, Ines, additional, King, David B, additional, Burns, Jennifer L, additional, Jackson, Kenya N, additional, Krauss, Stephen W, additional, Chandrasekaran, Prabha, additional, McCauley, Melanie D, additional, Ober Shepherd, Brittany L, additional, McHenry, Samantha, additional, Bianchi, Elizabeth J, additional, Ouellette, Jason, additional, Darden, Janice M, additional, Sanborn, Aaron D, additional, Daye, Sharon P, additional, Kwon, Paul O, additional, Stubbs, Jeremiah, additional, Brigantti, Crystal L, additional, Hall, Tara L, additional, Beagle, Milford H, additional, Pieri, Jason A, additional, Frambes, Timothy R, additional, O’Connell, Robert J, additional, Modjarrad, Kayvon, additional, Murray, Clinton K, additional, Jagodzinski, Linda L, additional, Scott, Paul T, additional, and Peel, Sheila A, additional

Published
2022
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9. Validation of SARS-CoV-2 pooled testing for surveillance using the Panther Fusion® system: Impact of pool size, automation, and assay chemistry.

Author

Park, Rudolph, Chandrasekaran, Prabha, Hernandez, Heather, Lakhal-Naouar, Ines, Peachman, Kristina K., Hack, Holly R., Coleman, Dante, Ouellette, Jason, Darden, Janice M., M'hamdi, Oussama, Sugiharto, Victor A., Chen, Hua-Wei, Schilling, Megan A., Simons, Mark P., Collins, Natalie D., Johnson, Yuliya S., Jagodzinski, Linda L., and Peel, Sheila A.

Subjects
AUTOMATION, DIAGNOSTIC specimens, OCHRATOXINS, TURNAROUND time, NUCLEIC acids, SARS-CoV-2, DETECTION limit
Abstract

Combining diagnostic specimens into pools has been considered as a strategy to augment throughput, decrease turnaround time, and leverage resources. This study utilized a multi-parametric approach to assess optimum pool size, impact of automation, and effect of nucleic acid amplification chemistries on the detection of SARS-CoV-2 RNA in pooled samples for surveillance testing on the Hologic Panther Fusion® System. Dorfman pooled testing was conducted with previously tested SARS-CoV-2 nasopharyngeal samples using Hologic's Aptima® and Panther Fusion® SARS-CoV-2 Emergency Use Authorization assays. A manual workflow was used to generate pool sizes of 5:1 (five samples: one positive, four negative) and 10:1. An automated workflow was used to generate pool sizes of 3:1, 4:1, 5:1, 8:1 and 10:1. The impact of pool size, pooling method, and assay chemistry on sensitivity, specificity, and lower limit of detection (LLOD) was evaluated. Both the Hologic Aptima® and Panther Fusion® SARS-CoV-2 assays demonstrated >85% positive percent agreement between neat testing and pool sizes ≤5:1, satisfying FDA recommendation. Discordant results between neat and pooled testing were more frequent for positive samples with CT>35. Fusion® CT (cycle threshold) values for pooled samples increased as expected for pool sizes of 5:1 (CT increase of 1.92–2.41) and 10:1 (CT increase of 3.03–3.29). The Fusion® assay demonstrated lower LLOD than the Aptima® assay for pooled testing (956 vs 1503 cp/mL, pool size of 5:1). Lowering the cut-off threshold of the Aptima® assay from 560 kRLU (manufacturer's setting) to 350 kRLU improved the assay sensitivity to that of the Fusion® assay for pooled testing. Both Hologic's SARS-CoV-2 assays met the FDA recommended guidelines for percent positive agreement (>85%) for pool sizes ≤5:1. Automated pooling increased test throughput and enabled automated sample tracking while requiring less labor. The Fusion® SARS-CoV-2 assay, which demonstrated a lower LLOD, may be more appropriate for surveillance testing. [ABSTRACT FROM AUTHOR]

Published
2022
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10. Serological profiles of pan-coronavirus-specific responses in COVID-19 patients using a multiplexed electro-chemiluminescence-based testing platform

Author

Chaudhury, Sidhartha, primary, Hutter, Jack, additional, Bolton, Jessica S., additional, Hakre, Shilpa, additional, Mose, Evelyn, additional, Wooten, Amy, additional, O’Connell, William, additional, Hudak, Joseph, additional, Krebs, Shelly J., additional, Darden, Janice M., additional, Regules, Jason A., additional, Murray, Clinton K., additional, Modjarrad, Kayvon, additional, Scott, Paul, additional, Peel, Sheila, additional, and Bergmann-Leitner, Elke S., additional

Published
2021
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11. A Double-Blind Randomized Phase I Clinical Trial Targeting ALVAC-HIV Vaccine to Human Dendritic Cells

Author

Eller, Michael A., primary, Slike, Bonnie M., additional, Cox, Josephine H., additional, Lesho, Emil, additional, Wang, Zhining, additional, Currier, Jeffrey R., additional, Darden, Janice M., additional, Polonis, Victoria R., additional, Vahey, Maryanne T., additional, Peel, Sheila, additional, Robb, Merlin L., additional, Michael, Nelson L., additional, and Marovich, Mary A., additional

Published
2011
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13. Biologic and Genetic Characterization of a Panel of 60 Human Immunodeficiency Virus Type 1 Isolates, Representing Clades A, B, C, D, CRF01_AE, and CRF02_AG, for the Development and Assessment of Candidate Vaccines

Author

Brown, Bruce K., primary, Darden, Janice M., additional, Tovanabutra, Sodsai, additional, Oblander, Tamara, additional, Frost, Julie, additional, Sanders-Buell, Eric, additional, de Souza, Mark S., additional, Birx, Deborah L., additional, McCutchan, Francine E., additional, and Polonis, Victoria R., additional

Published
2005
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14. Human Immunodeficiency Virus Type 1 Primary Isolate Neutralization Resistance Is Associated with the Syncytium-Inducing Phenotype and Lower CD4 Cell Counts in Subtype CRF01_AE-Infected Patients

Author

Polonis, Victoria R., primary, Souza, Mark S. de, additional, Darden, Janice M., additional, Chantakulkij, Somsak, additional, Chuenchitra, Thippawan, additional, Nitayaphan, Sorachai, additional, Brown, Arthur E., additional, Robb, Merlin L., additional, and Birx, Deborah L., additional

Published
2003
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18. Safety and immunogenicity of a next-generation live-attenuated yellow fever vaccine produced in a Vero cell line in the USA: a phase 1 randomised, observer-blind, active-controlled, dose-ranging clinical trial.

Author

Modjarrad K, Scott PT, McCauley M, Ober-Shepherd B, Sondergaard E, Amare MF, Parikh AP, Omar B, Minutello AM, Adhikarla H, Wu Y, P AR, Delore V, Mantel N, Morrison MN, Kourbanova KS, Martinez ME, Guzman I, Greenleaf ME, Darden JM, Koren MA, Hamer MJ, Lee CE, Hutter JN, Peel SA, Robb ML, Vangelisti M, and Feroldi E

Abstract

Background: Recent outbreaks between 2015-17 and production delays have led to a yellow fever vaccine shortage. Therefore, there is an urgent need for new yellow fever vaccines with improved production scalability. A next-generation live-attenuated yellow fever vaccine candidate (vYF), produced in a Vero cell line has shown similar immunogenicity to licensed yellow fever vaccines in preclinical studies. In this study, we aimed to report the safety and immunogenicity of vYF in human clinical trial participants., Methods: In this first in-human, phase 1 randomised, observer-blind, active-controlled, dose-ranging clinical trial conducted at a single centre in the USA (Walter Reed Army Institute of Research, Silver Spring, MD, USA), 72 healthy adults (aged 18-60 years), without a known history of flavivirus infection or vaccination were randomly assigned (1:1:1:1) using interactive response technology to receive one dose of either vYF at 4, 5 or 6 Log CCID 50 or the licensed YF-VAX (18 individuals per group). The primary outcomes were safety, neutralising antibody (NAb) titres through D180 post-vaccination in the per-protocol analysis set (comprised of yellow fever-naive participants who received their intended vaccine and provided a valid post-vaccination blood sample), and occurrence, and level of yellow fever viraemia in each vaccine group through D14 post-vaccination., Findings: All vYF doses had a safety and tolerability profile similar to YF-VAX. The most frequently reported solicited injection site reactions (vYF groups vs YF-VAX group) were pain (22% [12 of 54 participants, 95% CI 12-36] vs 28% [five of 18 participants, 10-54]), and erythema (13% [seven of 54 participants, 5-25] vs 39% [seven of 18 participants, 17-64]), with headache (32% [17 of 54 participants, 20-46] vs 44% [eight of 18 participants, 22-69]) and malaise (26% [14 of 54 participants, 15-40] vs 33% [six of 18 participants, 13-59]) as the most frequently reported solicited systemic reactions. One grade 3 solicited reaction (erythema) reported in the YF-VAX group resolved spontaneously. No serious unsolicited adverse events or deaths were reported. Viraemia was transiently detected in 50 participants between D4 and D10 in all groups and was observed in more participants or for a longer time in the vYF 6 Log CCID 50 and YF-VAX groups. All yellow fever-naive vaccine recipients across the study groups seroconverted yielding four-fold increase from baseline in yellow fever NAb titres measured by yellow fever microneutralisation assay by D28 and were seroprotected with yellow fever NAb titres of at least 10 [1/dil]). Overall, 100% (18 of 18 participants, 95% CI 82-100), 89% (16 participants, 65-99), 100% (18 participants, 82-100), and 94% (17 participants, 73-100) of participants in the vYF 4 Log, vYF 5 Log, vYF 6 Log CCID 50 groups, and YF-VAX group, respectively, remained seroprotected through D180., Interpretation: vYF has a similar safety and immunogenicity profile to YF-VAX. In general, the vYF 5 Log CCID 50 dose appeared to show optimal viraemia, safety, and immunogenicity, and was chosen for subsequent development., Funding: Sanofi., Competing Interests: Declaration of interests A-MM, HA, YW, ARP, VD, NM, MV, and EF are Sanofi employees and hold shares and stock options in the company. KM and PTS were employed by the Walter Reed Army Institute of Research at the time of this study. MM, BO-S, ES, MFA, APP, BO, MNM, KSK, MEM, IG, MEG, JMD, MAK, MJH, CEL, JNH, SAP, and MLR received funds from Sanofi through their institutions to support their work in the VYF01 trial (NCT04142086)., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)

Published
2024
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