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1. Efficacy and breadth of adjuvanted SARS-CoV-2 receptor-binding domain nanoparticle vaccine in macaques

Author

King, Hannah A. D., Joyce, M. Gordon, Lakhal-Naouar, Ines, Ahmed, Aslaa, Cincotta, Camila Macedo, Subra, Caroline, Peachman, Kristina K., Hack, Holly R., Chen, Rita E., Thomas, Paul V., Chen, Wei-Hung, Sankhala, Rajeshwer S., Hajduczki, Agnes, Martinez, Elizabeth J., Peterson, Caroline E., Chang, William C., Choe, Misook, Smith, Clayton, Headley, Jarrett A., Elyard, Hanne A., Cook, Anthony, Anderson, Alexander, Wuertz, Kathryn McGuckin, Dong, Ming, Swafford, Isabella, Case, James B., Currier, Jeffrey R., Lal, Kerri G., Amare, Mihret F., Dussupt, Vincent, Molnar, Sebastian, Daye, Sharon P., Zeng, Xiankun, Barkei, Erica K., Alfson, Kendra, Staples, Hilary M., Carrion, Ricardo, Krebs, Shelly J., Paquin-Proulx, Dominic, Karasavvas, Nicos, Polonis, Victoria R., Jagodzinski, Linda L., Vasan, Sandhya, Scott, Paul T., Huang, Yaoxing, Nair, Manoj S., Ho, David D., de Val, Natalia, Diamond, Michael S., Lewisi, Mark G., Rao, Mangala, Matyas, Gary R., Gromowski, Gregory D., Peel, Sheila A., Michael, Nelson L., Modjarrad, Kayvon, and Bolton, Diane L.

Published
2021

2. Immune response profiles from humans experimentally exposed to Phlebotomus duboscqi bites

Author

de Araujo, Fernanda Fortes, primary, Abdeladhim, Maha, additional, Teixeira, Clarissa, additional, Hummer, Kelly, additional, Wilkerson, Matthew D., additional, Ressner, Roseanne, additional, Lakhal-Naouar, Ines, additional, Ellis, Michael W., additional, Meneses, Claudio, additional, Nurmukhambetova, Saule, additional, Gomes, Regis, additional, Tolbert, W. David, additional, Turiansky, George W., additional, Pazgier, Marzena, additional, Oliveira, Fabiano, additional, Valenzuela, Jesus G., additional, Kamhawi, Shaden, additional, and Aronson, Naomi, additional

Published
2024
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3. Analytical validation of quantitative SARS-CoV-2 subgenomic and viral load laboratory developed tests conducted on the Panther Fusion® (Hologic) with preliminary application to clinical samples

Author

Lakhal-Naouar, Ines, primary, Hack, Holly R., additional, Moradel, Edgar, additional, Jarra, Amie, additional, Grove, Hannah L., additional, Ismael, Rani M., additional, Padilla, Steven, additional, Coleman, Dante, additional, Ouellette, Jason, additional, Darden, Janice, additional, Storme, Casey, additional, Peachman, Kristina K., additional, Hall, Tara L., additional, Huhtanen, Mark E., additional, Scott, Paul T., additional, Hakre, Shilpa, additional, Jagodzinski, Linda L., additional, and Peel, Sheila A., additional

Published
2023
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5. 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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6. 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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7. A SARS-CoV-2 Spike Ferritin Nanoparticle Vaccine Is Protective and Promotes a Strong Immunological Response in the Cynomolgus Macaque Coronavirus Disease 2019 (COVID-19) Model

Author

Johnston, Sara C., primary, Ricks, Keersten M., additional, Lakhal-Naouar, Ines, additional, Jay, Alexandra, additional, Subra, Caroline, additional, Raymond, Jo Lynne, additional, King, Hannah A. D., additional, Rossi, Franco, additional, Clements, Tamara L., additional, Fetterer, David, additional, Tostenson, Samantha, additional, Cincotta, Camila Macedo, additional, Hack, Holly R., additional, Kuklis, Caitlin, additional, Soman, Sandrine, additional, King, Jocelyn, additional, Peachman, Kristina K., additional, Kim, Dohoon, additional, Chen, Wei-Hung, additional, Sankhala, Rajeshwer S., additional, Martinez, Elizabeth J., additional, Hajduczki, Agnes, additional, Chang, William C., additional, Choe, Misook, additional, Thomas, Paul V., additional, Peterson, Caroline E., additional, Anderson, Alexander, additional, Swafford, Isabella, additional, Currier, Jeffrey R., additional, Paquin-Proulx, Dominic, additional, Jagodzinski, Linda L., additional, Matyas, Gary R., additional, Rao, Mangala, additional, Gromowski, Gregory D., additional, Peel, Sheila A., additional, White, Lauren, additional, Smith, Jeffrey M., additional, Hooper, Jay W., additional, Michael, Nelson L., additional, Modjarrad, Kayvon, additional, Joyce, M. Gordon, additional, Nalca, Aysegul, additional, Bolton, Diane L., additional, and Pitt, Margaret L. M., additional

Published
2022
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8. A SARS-CoV-2 spike ferritin nanoparticle vaccine protects hamsters against Alpha and Beta virus variant challenge

Author

Wuertz, Kathryn McGuckin, primary, Barkei, Erica K., additional, Chen, Wei-Hung, additional, Martinez, Elizabeth J., additional, Lakhal-Naouar, Ines, additional, Jagodzinski, Linda L., additional, Paquin-Proulx, Dominic, additional, Gromowski, Gregory D., additional, Swafford, Isabella, additional, Ganesh, Akshaya, additional, Dong, Ming, additional, Zeng, Xiankun, additional, Thomas, Paul V., additional, Sankhala, Rajeshwer S., additional, Hajduczki, Agnes, additional, Peterson, Caroline E., additional, Kuklis, Caitlin, additional, Soman, Sandrine, additional, Wieczorek, Lindsay, additional, Zemil, Michelle, additional, Anderson, Alexander, additional, Darden, Janice, additional, Hernandez, Heather, additional, Grove, Hannah, additional, Dussupt, Vincent, additional, Hack, Holly, additional, de la Barrera, Rafael, additional, Zarling, Stasya, additional, Wood, James F., additional, Froude, Jeffrey W., additional, Gagne, Matthew, additional, Henry, Amy R., additional, Mokhtari, Elham Bayat, additional, Mudvari, Prakriti, additional, Krebs, Shelly J., additional, Pekosz, Andrew S., additional, Currier, Jeffrey R., additional, Kar, Swagata, additional, Porto, Maciel, additional, Winn, Adrienne, additional, Radzyminski, Kamil, additional, Lewis, Mark G., additional, Vasan, Sandhya, additional, Suthar, Mehul, additional, Polonis, Victoria R., additional, Matyas, Gary R., additional, Boritz, Eli A., additional, Douek, Daniel C., additional, Seder, Robert A., additional, Daye, Sharon P., additional, Rao, Mangala, additional, Peel, Sheila A., additional, Joyce, M. Gordon, additional, Bolton, Diane L., additional, Michael, Nelson L., additional, and Modjarrad, Kayvon, additional

Published
2021
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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. A SARS-CoV-2 spike ferritin nanoparticle vaccine protects against heterologous challenge with B.1.1.7 and B.1.351 virus variants in Syrian golden hamsters

Author

Wuertz, Kathryn McGuckin, primary, Barkei, Erica K., additional, Chen, Wei-Hung, additional, Martinez, Elizabeth J., additional, Lakhal-Naouar, Ines, additional, Jagodzinski, Linda L., additional, Paquin-Proulx, Dominic, additional, Gromowski, Gregory D., additional, Swafford, Isabella, additional, Ganesh, Akshaya, additional, Dong, Ming, additional, Zeng, Xiankun, additional, Thomas, Paul V., additional, Sankhala, Rajeshwer S., additional, Hajduczki, Agnes, additional, Peterson, Caroline E., additional, Kuklis, Caitlin, additional, Soman, Sandrine, additional, Wieczorek, Lindsay, additional, Zemil, Michelle, additional, Anderson, Alexander, additional, Darden, Janice, additional, Hernandez, Heather, additional, Grove, Hannah, additional, Dussupt, Vincent, additional, Hack, Holly, additional, de la Barrera, Rafael, additional, Zarling, Stasya, additional, Wood, James F., additional, Froude, Jeffrey W., additional, Gagne, Matthew, additional, Henry, Amy R., additional, Mokhtari, Elham Bayat, additional, Mudvari, Prakriti, additional, Krebs, Shelly J., additional, Pekosz, Andrew S., additional, Currier, Jeffrey R., additional, Kar, Swagata, additional, Porto, Maciel, additional, Winn, Adrienne, additional, Radzyminski, Kamil, additional, Lewis, Mark G., additional, Vasan, Sandhya, additional, Suthar, Mehul, additional, Polonis, Victoria R., additional, Matyas, Gary R., additional, Boritz, Eli A., additional, Douek, Daniel C., additional, Seder, Robert A., additional, Daye, Sharon P., additional, Rao, Mangala, additional, Peel, Sheila A., additional, Gordon Joyce, M., additional, Bolton, Diane L., additional, Michael, Nelson L., additional, and Modjarrad, Kayvon, additional

Published
2021
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11. The human immune response to saliva of Phlebotomus alexandri, the vector of visceral leishmaniasis in Iraq, and its relationship to sand fly exposure and infection

Author

Lakhal-Naouar, Ines, primary, Mukbel, Rami, additional, DeFraites, Robert F., additional, Mody, Rupal M., additional, Massoud, Lina N., additional, Shaw, Dutchabong, additional, Co, Edgie M., additional, Sherwood, Jeffrey E., additional, Kamhawi, Shaden, additional, and Aronson, Naomi E., additional

Published
2021
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13. Asymptomatic Visceral Leishmania infantum Infection in US Soldiers Deployed to Iraq

Author

Mody, Rupal M, primary, Lakhal-Naouar, Ines, additional, Sherwood, Jeffrey E, additional, Koles, Nancy L, additional, Shaw, Dutchabong, additional, Bigley, Daniel P, additional, Co, Edgie-Mark A, additional, Copeland, Nathanial K, additional, Jagodzinski, Linda L, additional, Mukbel, Rami M, additional, Smiley, Rebecca A, additional, Duncan, Robert C, additional, Kamhawi, Shaden, additional, Jeronimo, Selma M B, additional, DeFraites, Robert F, additional, and Aronson, Naomi E, additional

Published
2018
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14. Asymptomatic Visceral Leishmania infantum Infection in US Soldiers Deployed to Iraq.

Author

Mody, Rupal M, Lakhal-Naouar, Ines, Sherwood, Jeffrey E, Koles, Nancy L, Shaw, Dutchabong, Bigley, Daniel P, Co, Edgie-Mark A, Copeland, Nathanial K, Jagodzinski, Linda L, Mukbel, Rami M, Smiley, Rebecca A, Duncan, Robert C, Kamhawi, Shaden, Jeronimo, Selma M B, DeFraites, Robert F, and Aronson, Naomi E

Subjects
*LEISHMANIASIS diagnosis, *SALIVA analysis, *IMMUNOGLOBULIN analysis, *BLOOD collection, *CHI-squared test, *CONFIDENCE intervals, *STATISTICAL correlation, *DEPLOYMENT (Military strategy), *ENZYME-linked immunosorbent assay, *ETHNIC groups, *FISHER exact test, *LEISHMANIASIS, *POLYMERASE chain reaction, *SOCIAL problems, *MILITARY personnel, *SURVEYS, *VETERANS' hospitals, *LOGISTIC regression analysis, *SYMPTOMS, *DISEASE prevalence, *INTERFERON gamma release tests, *MANN Whitney U Test, *DISEASE risk factors
Abstract

Background Visceral leishmaniasis (VL), due to Leishmania infantum, is a persistent intracellular parasitic infection transmitted by the bite of infected sand flies. Symptomatic VL has been reported in U.S. soldiers with Iraq deployment. Untreated symptomatic VL can be fatal; asymptomatic VL (AVL) may establish a lifelong risk of reactivation. We report prevalence and AVL risk factors in Operation Iraqi Freedom (OIF) deployers during 2002–11. Methods Healthy soldiers exposed to VL endemic areas in Iraq and 50 controls who never traveled to endemic regions were recruited through military healthcare facilities (2015–17). Responses to a risk factor survey and blood samples were obtained. Leishmania research diagnostics utilized included enzyme-linked immunosorbent assay (ELISA), rk39 test strips, quantitative polymerase chain reaction (PCR), and interferon gamma release (IGRA) assays. Statistical analyses included Fisher exact test, Pearson χ2 test, Mann-Whitney U test, and logistic regression. Results 200 deployed subjects were enrolled, mostly males (84.0%), of white ethnicity (79.0%), and median age 41 (range 24–61) years. 64% were seropositive for Phlebotomus alexandri saliva antibodies. Prevalence of AVL (any positive test result) was 39/200 (19.5%, 95% confidence interval 14.4%–25.8%). Two (1.0%) PCR, 10 (5%) ELISA, and 28 (14%) IGRA samples were positive. Travel to Ninewa governorate increased risk for AVL (P =.01). Conclusion AVL was identified in 19.5% of OIF deployers; travel to northwest Iraq correlated with infection. Further studies are needed to inform risk for reactivation VL in US veterans and to target additional blood safety and surveillance measures. [ABSTRACT FROM AUTHOR]

Published
2019
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16. Immunity to Visceral Leishmaniasis Using Genetically Defined Live-Attenuated Parasites

Author

Selvapandiyan, Angamuthu, Dey, Ranadhir, Gannavaram, Sreenivas, Lakhal-Naouar, Ines, Duncan, Robert, Salotra, Poonam, and Nakhasi, Hira L.

Subjects
Article Subject
Abstract

Leishmaniasis is a protozoan parasitic disease endemic to the tropical and subtropical regions of the world, with three major clinical forms, self-healing cutaneous leishmaniasis (CL), mucocutaneous leishmaniasis (MCL), and visceral leishmaniasis (VL). Drug treatments are expensive and often result in the development of drug resistance. No vaccine is available against leishmaniasis. Subunit Leishmania vaccine immunization in animal models has shown some efficacy but little or none in humans. However, individuals who recover from natural infection are protected from reinfection and develop life-long protection, suggesting that infection may be a prerequisite for immunological memory. Thus, genetically altered live-attenuated parasites with controlled infectivity could achieve such memory. In this paper, we discuss development and characteristics of genetically altered, live-attenuated Leishmania donovani parasites and their possible use as vaccine candidates against VL. In addition, we discuss the challenges and other considerations in the use of live-attenuated parasites.

Published
2012
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17. Identification and Characterization of Genes Involved in Leishmania Pathogenesis: The Potential for Drug Target Selection

Author

Duncan, Robert, Gannavaram, Sreenivas, Dey, Ranadhir, Debrabant, Alain, Lakhal-Naouar, Ines, and Nakhasi, Hira L.

Subjects
Article Subject
Abstract

Identifying and characterizing Leishmania donovani genes and the proteins they encode for their role in pathogenesis can reveal the value of this approach for finding new drug targets. Effective drug targets are likely to be proteins differentially expressed or required in the amastigote life cycle stage found in the patient. Several examples and their potential for chemotherapeutic disruption are presented. A pathway nearly ubiquitous in living cells targeted by anticancer drugs, the ubiquitin system, is examined. New findings in ubiquitin and ubiquitin-like modifiers in Leishmania show how disruption of those pathways could point to additional drug targets. The programmed cell death pathway, now recognized among protozoan parasites, is reviewed for some of its components and evidence that suggests they could be targeted for antiparasitic drug therapy. Finally, the endoplasmic reticulum quality control system is involved in secretion of many virulence factors. How disruptions in this pathway reduce virulence as evidence for potential drug targets is presented.

Published
2011
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21. Deletion of Ubiquitin Fold Modifier Protein Ufm1 Processing Peptidase Ufsp in L. donovani Abolishes Ufm1 Processing and Alters Pathogenesis.

Author

Gannavaram, Sreenivas, Davey, Sonya, Lakhal-Naouar, Ines, Duncan, Robert, and Nakhasi, Hira L.

Subjects
UBIQUITIN, PEPTIDASE, PARASITES, AMINO acids, ORGANIC acids
Abstract

Previously, we showed Leishmania donovani Ufm1 has a Gly residue conserved at the C-terminal region with a unique 17 amino acid residue extension that must be processed prior to conjugation to target proteins. In this report, we describe for the first time the isolation and characterization of the Leishmania Ufm1-specific protease Ufsp. Biochemical analysis of L. donovani Ufsp showed that this protein possesses the Ufm1 processing activity using sensitive FRET based activity probes. The Ufm1 cleavage activity was absent in a mutant Ufsp in which the active site cysteine is altered to a serine. To examine the effects of abolition of Ufm1 processing activity, we generated a L. donovani null mutant of Ufsp (LdUfsp−/−). Ufm1 processing activity was abolished in LdUfsp−/− mutant, and the processing defect was reversed by re-expression of wild type but not the cys>ser mutant in the LdUfsp−/− parasites. Further LdUfsp−/− mutants showed reduced survival as amastigotes in infected human macrophages but not as promastigotes. This growth defect in the amastigotes was reversed by re-expression of wild type but not the cys>ser mutant in the Ufsp−/− indicating the essential nature of this protease for Leishmania pathogenesis. Further, mouse infection experiments showed deletion of Ufsp results in reduced virulence of the parasites. Additionally, Ufsp activity was inhibited by an anti-leishmanial drug Amphotericin B. These studies provide an opportunity to test LdUfsp−/− parasites as drug and vaccine targets. [ABSTRACT FROM AUTHOR]

Published
2014
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22. A SARS-CoV-2 spike ferritin nanoparticle vaccine protects against heterologous challenge with B.1.1.7 and B.1.351 virus variants in Syrian golden hamsters.

Author

Wuertz KM, Barkei EK, Chen WH, Martinez EJ, Lakhal-Naouar I, Jagodzinski LL, Paquin-Proulx D, Gromowski GD, Swafford I, Ganesh A, Dong M, Zeng X, Thomas PV, Sankhala RS, Hajduczki A, Peterson CE, Kuklis C, Soman S, Wieczorek L, Zemil M, Anderson A, Darden J, Hernandez H, Grove H, Dussupt V, Hack H, de la Barrera R, Zarling S, Wood JF, Froude JW, Gagne M, Henry AR, Mokhtari EB, Mudvari P, Krebs SJ, Pekosz AS, Currier JR, Kar S, Porto M, Winn A, Radzyminski K, Lewis MG, Vasan S, Suthar M, Polonis VR, Matyas GR, Boritz EA, Douek DC, Seder RA, Daye SP, Rao M, Peel SA, Joyce MG, Bolton DL, Michael NL, and Modjarrad K

Abstract

The emergence of SARS-CoV-2 variants of concern (VOC) requires adequate coverage of vaccine protection. We evaluated whether a spike ferritin nanoparticle vaccine (SpFN), adjuvanted with the Army Liposomal Formulation QS21 (ALFQ), conferred protection against the B.1.1.7 and B.1.351 VOCs in Syrian golden hamsters. SpFN-ALFQ was administered as either single or double-vaccination (0 and 4 week) regimens, using a high (10 μg) or low (0.2 μg) immunogen dose. Animals were intranasally challenged at week 11. Binding antibody responses were comparable between high- and low-dose groups. Neutralizing antibody titers were equivalent against WA1, B.1.1.7, and B.1.351 variants following two high dose two vaccinations. SpFN-ALFQ vaccination protected against SARS-CoV-2-induced disease and viral replication following intranasal B.1.1.7 or B.1.351 challenge, as evidenced by reduced weight loss, lung pathology, and lung and nasal turbinate viral burden. These data support the development of SpFN-ALFQ as a broadly protective, next-generation SARS-CoV-2 vaccine.

Published
2021
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