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1. No neurocognitive advantage for immediate antiretroviral treatment in adults with greater than 500 CD4+ T-cell counts

Author

Wright, Edwina J, Grund, Birgit, Robertson, Kevin R, Cysique, Lucette, Brew, Bruce J, Collins, Gary L, Poehlman-Roediger, Mollie, Vjecha, Michael J, Penalva de Oliveira, Augusto César, Standridge, Barbara, Carey, Cate, Avihingsanon, Anchalee, Florence, Eric, Lundgren, Jens D, Arenas-Pinto, Alejandro, Mueller, Nicolas J, Winston, Alan, Nsubuga, Moses S, Lal, Luxshimi, and Price, Richard W

Subjects
Infectious Diseases, HIV/AIDS, Clinical Research, Neurosciences, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, AIDS Dementia Complex, Adult, Anti-Retroviral Agents, CD4 Lymphocyte Count, Female, HIV Infections, Humans, Longitudinal Studies, Male, Secondary Prevention, Treatment Outcome, antiretroviral treatment, central nervous system, HAND, HIV, neurocognitive impairment, INSIGHT START Neurology Substudy Group, Biological Sciences, Medical and Health Sciences, Psychology and Cognitive Sciences, Virology
Abstract

ObjectiveTo compare the effect of immediate versus deferred antiretroviral treatment (ART) on neuropsychological test performance in treatment-naive HIV-positive adults with more than 500 CD4 cells/μl.DesignRandomized trial.MethodsThe START parent study randomized participants to commence immediate versus deferred ART until CD4 less than 350 cells/μl. The START Neurology substudy used eight neuropsychological tests, at baseline, months 4, 8, 12 and annually, to compare groups for changes in test performance. Test results were internally standardized to z-scores. The primary outcome was the average of the eight test z-scores (QNPZ-8). Mean changes in QNPZ-8 from baseline were compared by intent-to-treat using longitudinal mixed models. Changes from baseline to specific time points were compared using ANCOVA models.ResultsThe 592 participants had a median age of 34 years; median baseline CD4 count was 629 cells/μl; the mean follow-up was 3.4 years. ART was used for 94 and 32% of accrued person-years in the immediate and deferred groups, respectively. There was no difference between the immediate and deferred ART groups in QNPZ-8 change through follow-up [-0.018 (95% CI -0.062 to 0.027, P = 0.44)], or at any visit. However, QNPZ-8 scores increased in both arms during the first year, by 0.22 and 0.24, respectively (P

Published
2018

3. Long-Term Benefits from Early Antiretroviral Therapy Initiation in HIV Infection.

Author

Lundgren, Jens D., Babiker, Abdel G., Sharma, Shweta, Grund, Birgit, Phillips, Andrew N., Matthews, Gail, Kan, Virginia L., Aagaard, Bitten, Abo, Inka, Alston, Beverly, Arenas-Pinto, Alejandro, Avihingsanon, Anchalee, Badal-Faesen, Sharlaa, Brites, Carlos, Carey, Cate, Casseb, Jorge, Clarke, Amanda, Collins, Simon, Corbelli, Giulio Maria, and Dao, Sounkalo

Subjects
HIV prevention, HIV infections, HIV-positive persons, CONFIDENCE intervals, VIRAL load, ANTIRETROVIRAL agents, HIGHLY active antiretroviral therapy, CD4 lymphocyte count, STATISTICAL sampling, EARLY medical intervention, PROPORTIONAL hazards models, LONGITUDINAL method
Abstract

Background: For people with HIV and CD4+ counts >500 cells/mm³, early initiation of antiretroviral therapy (ART) reduces serious AIDS and serious non-AIDS (SNA) risk compared with deferral of treatment until CD4+counts are <350 cells/mm³. Whether excess risk of AIDS and SNA persists once ART is initiated for those who defer treatment is uncertain. Methods: The Strategic Timing of AntiRetroviral Treatment (START) trial, as previously reported, randomly assigned 4684 ART-naive HIV-positive adults with CD4+counts >500 cells/mm³ to immediate treatment initiation after random assignment (n=2325) or deferred treatment (n= 2359). In 2015, a 57% lower risk of the primary end point (AIDS, SNA, or death) for the immediate group was reported, and the deferred group was offered ART. This article reports the follow-up that continued to December 31, 2021. Cox proportional-hazards models were used to compare hazard ratios for the primary end point from randomization through December 31, 2015, versus January 1, 2016, through December 31, 2021. Results: Through December 31, 2015, approximately 7 months after the cutoff date from the previous report, the median CD4+ count was 648 and 460 cells/mm³ in the immediate and deferred groups, respectively, at treatment initiation. The percentage of follow-up time spent taking ART was 95% and 36% for the immediate and deferred groups, respectively, and the time-averaged CD4+ difference was 199 cells/mm³. After January 1, 2016, the percentage of follow-up time on treatment was 97.2% and 94.1% for the immediate and deferred groups, respectively, and the CD4+ count difference was 155 cells/mm³. After January 1, 2016, a total of 89 immediate and 113 deferred group participants experienced a primary end point (hazard ratio of 0.79 [95% confidence interval, 0.60 to 1.04] versus hazard ratio of 0.47 [95% confidence interval, 0.34 to 0.65; P<0.001]) before 2016 (P=0.02 for hazard ratio difference). Conclusions: Among adults with CD4+ counts >500 cells/mm³, excess risk of AIDS and SNA associated with delaying treatment initiation was diminished after ART initiation, but persistent excess risk remained. (Funded by the National Institute of Allergy and Infectious Diseases and others.) In people with HIV and CD4+ counts >500 cells/mm³, immediate initiation of ART reduced serious AIDS and SNA risk, the primary end point, compared with deferring ART until CD4+counts were <350 cells/mm³. Beginning in 2016 after the deferred group was advised to initiate ART, 89 immediate and 113 deferred group participants experienced a primary end point. Persistent excess risk of the primary end point remained in the deferred compared to the immediate ART group. [ABSTRACT FROM AUTHOR]

Published
2023
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5. No neurocognitive advantage for immediate antiretroviral treatment in adults with greater than 500 CD4+T-cell counts

Author

Wright, Edwina J., Grund, Birgit, Robertson, Kevin R., Cysique, Lucette, Brew, Bruce J., Collins, Gary L., Poehlman-Roediger, Mollie, Vjecha, Michael J., Penalva de Oliveira, Augusto César, Standridge, Barbara, Carey, Cate, Avihingsanon, Anchalee, Florence, Eric, Lundgren, Jens D., Arenas-Pinto, Alejandro, Mueller, Nicolas J., Winston, Alan, Nsubuga, Moses S., Lal, Luxshimi, and Price, Richard W.

Abstract

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Published
2018
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6. Determination of the underlying cause of death in three multicenter international HIV clinical trials

Author

Lifson, Alan R, Lundgren, Jens, Belloso, Waldo H, Carey, Cate, Davey, Richard T, Duprez, Daniel, El-Sadr, Wafaa M, Gatell, Jose M, Gey, Daniela C, Hoy, Jennifer F, Krum, Eric A, Nelson, Ray, Nixon, Daniel E, Paton, Nick, Pedersen, Court, Perez, George, Price, Richard W, Prineas, Ronald J, Rhame, Frank S, Sampson, James, Worley, John, Lifson, Alan R, Lundgren, Jens, Belloso, Waldo H, Carey, Cate, Davey, Richard T, Duprez, Daniel, El-Sadr, Wafaa M, Gatell, Jose M, Gey, Daniela C, Hoy, Jennifer F, Krum, Eric A, Nelson, Ray, Nixon, Daniel E, Paton, Nick, Pedersen, Court, Perez, George, Price, Richard W, Prineas, Ronald J, Rhame, Frank S, Sampson, James, and Worley, John

Abstract

Udgivelsesdato: null-null, PURPOSE: Describe processes and challenges for an Endpoint Review Committee (ERC) in determining and adjudicating underlying causes of death in HIV clinical trials. METHOD: Three randomized HIV trials (two evaluating interleukin-2 and one treatment interruption) enrolled 11,593 persons from 36 countries during 1999-2008. Three ERC members independently reviewed each death report and supporting source documentation to assign underlying cause of death; differences of opinion were adjudicated. RESULTS: Of 453 deaths reported through January 14, 2008, underlying causes were as follows: 10% AIDS-defining diseases, 21% non-AIDS malignancies, 9% cardiac diseases, 9% liver disease, 8% non-AIDS-defining infections, 5% suicides, 5% other traumatic events/accidents, 4% drug overdoses/acute intoxications, 11% other causes, and 18% unknown. Major reasons for unknown classification were inadequate clinical information or supporting documentation to determine cause of death. Half (51%) of deaths reviewed by the ERC required follow-up adjudication; consensus was eventually always reached. CONCLUSION: ERCs can successfully provide blinded, independent, and systematic determinations of underlying cause of death in HIV clinical trials. Committees should include those familiar with AIDS and non-AIDS-defining diseases and have processes for adjudicating differences of opinion. Training for local investigators and procedure manuals should emphasize obtaining maximum possible documentation and follow-up information on all trial deaths.

Published
2008

7. Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials.

Author

Larson, Gregg S., Carey, Cate, Grarup, Jesper, Hudson, Fleur, Sachi, Karen, Vjecha, Michael J., and Gordin, Fred

Subjects
BUDGET, CLINICAL trials, EXPERIMENTAL design, HIV infections, HEALTH insurance reimbursement, FINANCIAL management, FEE for service (Medical fees)
Abstract

Background/aims: Randomized clinical trials are widely recognized as essential to address worldwide clinical and public health research questions. However, their size and duration can overwhelm available public and private resources. To remain competitive in international research settings, advocates and practitioners of clinical trials must implement practices that reduce their cost. We identify approaches and practices for large, publicly funded, international trials that reduce cost without compromising data integrity and recommend an approach to cost reporting that permits comparison of clinical trials. Methods: We describe the organizational and financial characteristics of The International Network for Strategic Initiatives in Global HIV Trials, an infectious disease research network that conducts multiple, large, long-term, international trials, and examine challenges associated with simple and streamlined governance and an infrastructure and financial management model that is based on performance, transparency, and accountability. Results: It is possible to reduce costs of participants’ follow-up and not compromise clinical trial quality or integrity. The International Network for Strategic Initiatives in Global HIV Trials network has successfully completed three large HIV trials using cost-efficient practices that have not adversely affected investigator enthusiasm, accrual rates, loss-to-follow-up, adherence to the protocol, and completion of data collection. This experience is relevant to the conduct of large, publicly funded trials in other disease areas, particularly trials dependent on international collaborations. Conclusion: New approaches, or creative adaption of traditional clinical trial infrastructure and financial management tools, can render large, international clinical trials more cost-efficient by emphasizing structural simplicity, minimal up-front costs, payments for performance, and uniform algorithms and fees-for-service, irrespective of location. However, challenges remain. They include institutional resistance to financial change, growing trial complexity, and the difficulty of sustaining network infrastructure absent stable research work. There is also a need for more central monitoring, improved and harmonized regulations, and a widely applied metric for measuring and comparing cost efficiency in clinical trials. ClinicalTrials.gov is recommended as a location where standardized trial cost information could be made publicly accessible. [ABSTRACT FROM AUTHOR]

Published
2016
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8. Predictors of CD4 count change over 8 months of follow up in HIV-1-infected patients with a CD4 count >= 300 cells/mu L who were assigned to 7.5 MIU interleukin-2

Author

Fox, Zoe, Antunes, Francisco, Davey, Rick, Gazzard, Brian, Klimas, Nancy, Labriola, Ann, Losso, Marcelo, Neaton, James D., Phillips, Andrew N., Ruxrungtham, Kiat, Staszewski, Schlomo, Weiss, Laurence, Lundgren, Jens D., Abrams, Donald I., Cooper, David A., Darbyshire, Janet H., Duncan, William R., Emery, Sean, Lane, H. Clifford, Lehrman, Sandra, Aguilar, Liliana, Betina Angel, Eleonora, Aquilia, Silvia, Belloso, Waldo, Benetucci, Jorge, Bittar, Victor, Cahn, Pedro, Casiro, Arnaldo, Contarelli, Jorge, Corral, Jorge, Daciuk, Lucia, David, Daniel, Ferrari, Ines, Fridman, Diego, Galache, Viviana, Guaragna, Graciela, Ivalo, Silvina, Laplume, Hector, Lanusse, Isabel, Lasala, Maria B., Lattes, Roberta, Lasovsky, Jaime, Lopardo, Gustavo, Lourtau, Leonardo, Lupo, Sergio, Maranzana, Aldo, Marson, Cristina, Massera, Lucila, Del Lujan Sanchez, Marisa, Somenzini, Carla, Tocci, Mariel, Algar, Sally, Anderson, Jonathan, Baker, David, Blavius, Kathy, Bloch, Mark, Boyle, Michael, Bradford, David, Britton, Phillip, Carrall, Leah, Carr, Andrew, Chuah, John, Curry, Michael, D Arcy-Evans, Clive, Dobson, Pauline, Doong, Nicholas, Egan, Cari, Ferguson, Wendy, Finlayson, Robert, French, Martyn, Frater, Anthony, Gold, Julian, Habel, Philip, Haig, Kay, Holland, Rohan, Hyland, Natalie, Hoy, Jennifer, Hudson, Jeff, James, Robyn, Leung, Jenny, Lowe, Kaye, Macrae, Karen, Mcmurchie, Marilyn, Medland, Nicholas, Miller, Samantha, Murray, Jo, Newman, Rosie, Orth, David, Patching, Julie, Primrose, Ruth, Ree, Hugo, Richardson, Robyn, Rogers, Gary, Roney, Janine, Roth, Norman, Sarangapany, Jeganathan, Shaw, David, Silberberg, Carol, Skett, Jenny, Williams, Leah, Soo, Tuck Meng, Sowden, David, Street, Alan, Vale, Robyn, Villella, Claudio, Walker, Alan, Watson, Ashley, Wendt, Ngaire, Wood, Helen, Youds, David, Aichelburg, Alexander, Rieger, Armin, Vetter, Norbert, Clumeck, Nathan, Wit, Stephane, Kabeya, Kabamba, O Doherty, Elizabeth, Amorim, Cristiane Sales, Basso, Caritas Relva, Lewi, David Salamao, Pereira, Luiz Carlos, Da Silva, Mariliza, Lobato Souza, Tamara Newman, Angel, Jonathan, Bouchard, Pierrette-Rolande, Clark, Fran, Cohen, Jeff, Dambreville, Mimose, Ellis, Michele, Fiset, Stephan, Foster, Andrea, Fraser, Christopher, Gagnon, Susan, Gilmour, Janet, Guenette, Richard, Haldane, Heather, Hawley-Foss, Nanci, Hyndman, Susan, Johnston, Lynn, Jubinville, Nathalie, Juneau, Francoise, Kelleher, Lynn, Lapointe, Lyne, Latendre-Paquette, Judy, Lindemulder, Adeline, Mashinter, Laura, Lefebvre, Eric, Mcfarland, Nancy, Morisseau, Chantal, O Neill, Robert, Piche, Alain, Ralph, Edward, Rouleau, Danielle, Routy, Jean-Pierre, Sandre, Roger, Schmidt, Shelley, Shafran, Stephen, Smaill, Fiona, Stromberg, Dale, Trepanier, Jean-Marc, Trottier, Sylvie, Veal, Susanne, Walmsley, Sharon, Weiss, Karl, Williams, Kurt, Young, Mavis, Zaleschuk, Barbara, Zarowny, Don, Baadegaard, Bente, Black, Finn, Boedker, Kirsten, Gerstoft, Jan, Jensen, Lene, Mathiesen, Lars, Nielsen, Henrik, Pedersen, Court, Petersen, Dorthe, Aboulker, Jean-Pierre, Baakili, Adyb, Bengrait, Nafissa, Bensalem, Maryse, Berthe, Huguette, Bloche, Martin, Bazin, Claude, Boue, Francois, Bouvet, Elisabeth, Brancon, Christiane, Capitant, Catherine, Ceppi, Carole, Cheneau, Christine, Coutellier, Anne, Chennebault, Jean Marie, Coquet, Fabienne, Truchis, Pierre, Delavalle, Anne-Marie, Frixon-Marin, Veronique, Gastaut, Jean-Albert, Delfraissy, Francois, Eliaszeicz, Muriel, Gallais, Herve, Gataut, Jean-Albert, Gilquin, Jacques, Gonzalez-Canali, Gustavo, Gaudebout, Chrisiane, Goujard, Cecile, Hoen, Bruno, Honore, Patricia, Jarousse, Bernard, Lang, Jean-Marie, Lefebvre, Benedict, Levy, Yves, Loison, Jocelyne, Maignan, Aline, Meynard, Jean-Luc, Michon, Christophe, Mole, Martin, Marsal, Laurence, Matheron, Sophie, Mortier, Emmanuel, Oksenhendler, Eric, Poirier, Sandrine, Picard-Dahan, Catherine, Ravaux, Isabelle, Raffi, Francois, Raguin, Gilles, Reynes, Jacque, Rozenbaum, Willy, Salmon, Dominique, Simon, Anne, Spiridon, Gabriella, Viard, Jean-Paul, Vidal, Michele, Zucman, David, Bergmann, Frank, Brockmeyer, Norbert, Faetkenheuer, Gerd, Fenske, Stefan, Gey, Daniela, Goebel, Frank-Detlef, Goetsch, Martina, Hartmann, Martin, Klinker, Hartwig, Kremer, Gisela, Mantzsch, Kathleen, Mauss, Stefan, Rockstroh, Juergen, Rotty, Jessica, Rund, Ellen, Schneider, Katrin, Schuermann, Dirk, Staszweski, Schlomo, Tilmann, Klaus, Vogel, Martin, Bentwich, Zvi, Drora, Goldstain, Kedem, Eynat, Lang, Ruth, Levi, Itzic, Maayan, Shlomo, Magen, Eli, Mamorsky, Merav, Pilpul, Anat, Pollack, Shimon, Sthoeger, Zev, Vered, Hadas, Yust, Israel, Lyons, Fiona, Mulcahy, Fiona, Rochford, Annette, Auiti, Fernando, Angarano, Gioacchino, Bertelli, Davide, Bini, Teresa, Bruno, Raffaele, Cadeo, Gian Pietro, Carosi, Giampietro, D Arminio Monforte, Antonella, Del Giacco, Sergio, Di Pietro, Massimo, Esposito, Roberto, Filice, Gaetano, Gavazzeni, Gabriella, Guaraldi, Giovanni, Indiveri, Francesco, Lazzarin, Adriano, Mazzotta, Francesco, Minolli, Lorenzo, Montroni, Maria, Moroni, Mauro, Nozza, Silvia, Pastor, Guiseppe, Poli, Guido, Raise, Enzo, Romagnani, Sergio, Rusconi, Vega, Sacchi, Paolo, Suter, Fredy, Tambussi, Giuseppe, Tirelli, Umberto, Fraser, Helen, Iwamoto, Aikichi, Kikuchi, Yoshida, Mori, Masahiko, Nakamura, Tetsuya, Odawara, Takashi, Oka, Shinichi, Shirasaka, Takuma, Takano, Misao, To, Junichiro, Ueta, Chisato, El Filali, Kamal, Erradey, Ikbale, Himmich, Hakima, Blok, W., Borleffs, J., Bravenboer, B., Bronveld, W., Claessen, F., Duurvoort, Maurice, Ferwerda, J., Frissen, P., Hulshoff, Nicolette, Juttman, Job, Kauffmann, R., Koopmans, P., Kroon, F., Lowe, Selwyn, Leemhuis, M., Meenhorst, P., Boer, Lieselotte Posthuma, Reiss, Peter, Reinders-Folmer, S., Richter, C., Santegoets, Rick, Schoemaker, Marijke, Schrey, G., Sprenger, Herman, Ten Veen, Jacob, Tessalaar, Judith, Ende, M., Vall, H., Eeden, Arne, Leeuwen, Remko, Vermeulen, Joost, Ten Kate, Reinier W., Boxtel, Renee, Eden, Arne, Ven, Bernadette, Meulen, Piet, Ten Napei, C., Vriesendrop, R., Bruun, Johann, Bakowska, Elzbieta, Beniowski, Marek, Boron-Kaczmarska, Anna, Gasiorowski, Jacek, Gxadysz, Andrzej, Horban, Andrzej, Knysz, Brygida, Mularska, Elzbieta, Pynka, Magdelena, Szymczak, Aleksandra, Aldir, Isabel, Doroana, Manuela, Duque, Luis, Mansinho, Kamal, Pinto, Inez, Valadas, Emilia, Vera, Jose, Foo, Estelle, Panchalingham, Anushia, Lim, Poh Lian, Paton, Nick, Peperstraete, Bernard, Quek, Angela, Alcazar-Caballero, Rosario, Arrizabalaga, Julio, Bouza, Emilio, Cepeda, Concepcion, Barron, Xabier, Cervero Jimenez, Miguel, Clotet, Bonaventura, Cortes, Luis, Domingo, Pere, Fernandez, Pompeyo, Fernandez-Cruz, Eduardo, Fuster, Montserrat, Gatell, Jose, Gijon, Paloma, Gil, Ignacio, Gonzales-Lahoz, Juan, Gonzalez, Alicia, Hernandez, Manuel, Iribarren, Jose, Jimenez, Miguel, Knobel, Hernando, Leon, Agathe, Carlos Lopez, Juan, Lozano, Angeles, Lopez, Paco, Moreno, Jose, Munoz, Rosa, Padilla, Belen, Parras, Angeles, Pastor, Antoni, Pedreira, Jose, Pristo, Julio, Pena, Jose, Roca, Victor, Rubio, Rafael, Sanchez Rivera, Jose, Sanz, Jesus, Tamargo, Lara, Torres, Rafael, Pehrson, Pehr O., Sandstrom, Eric, Bernasconi, Enos, Gurtner, Vanina, Magenta, Lorenzo, Ampunpong, Uangarun, Bowonwatnuwong, Chureeratana, Chanchai, Patimoaporn, Chetchotisakd, Ploenchan, Chuenyam, Thesinee, Duncombe, Chris, Horsakulthai, Mannassinee, Kantipong, Pacharee, Liddy, John, Phanuphak, Praphan, Pongsurachet, Vithaya, Seekaew, Samroeng, Sonjai, Areerat, Subsri, Nuramon, Suwanagool, Surapol, Techasathit, Wichai, Wankoon, Jaturaporn, Adebiyi, Aderonke, Aldam, Diana, Alexander, Ian, Angus, Brian, Barber, Tristan, Bonnington, Sue, Care, Chris, Carroll, Anne, Cornforth, David, Donaldson, Oscar, Druiff, Laurance, Easterbrook, Philippa, Edwards, Beverley, Ellis, Chris, Fisher, Martin, Fox, Ray, Harrison, Allan, Herman, Sandra, Heald, Lisa, Higgs, Christopher, Jendrulek, Isabelle, Johnson, Margaret, Judges, Lucy, Karim, Fatimah, Kinghorn, George, Laurenti, Julie, Lee, Christine, Leen, Clifford, Legg, Ken, Maw, Raymond, Macconachie, Alisdair, Mckernan, Sinead, Mclean, Lorna, Mcmillan, Andrew, Mguni, Sifiso, Morris, Sheila, Mulchay, Fiona, Mullan, Dee, Mullaney, Scott, Murphy, Maurice, Nunn, Andrew, Ong, Edmund, Owen, Maxine, Palfreeman, Adrian, Perry, Nicky, Peters, Barry, Pozniak, Anton, Ronan, Agnes, Skinner, Cecilia, Stroud, Carol, Takawira, Martin, Tamm, Norbert, Thomas, Rachel, Yee, Thynn Thynn, Vanthuyne, An, Wansborough-Jones, Mark, Weber, Jonathan, White, David, Wilkins, Ed, Wiselka, Martin, Williams, Ian, Waugh, Mike, Wotherspoon, Joyce, Youle, Mike, Doyle, Margaret, Goodwin, Edward, Luskin-Hawk, Roberta, Sullivan, James, Verheggen, Rita, Abrams, Donald, Baxter, John, Besch, C. Lynn, Child, Carroll, Cohn, David, Cooper, Pam, El-Sadr, Wafaa, Farrough, Martha, Fisher, Evelyn, Fuentes, Luis, Gordin, Fred, Graeber, Carol, Kelly, Mary Ellen, Kostman, Jay, Lattanzi, Kelly, Macarthur, Rodger, Makohon, Linda, Markowitz, Norman P., Martinez, Norma, Mastro-Polak, Diane, Mitchell, Vinnie, Mushatt, David, Patterson, Kathryn, Perez, George, Rosmarin, Corey, Rouff, Jack R., Saldanha, Jennifer, Sampson, James, Sawyer, Robert, Standridge, Barbara, Sweeton, Bentley, Tedaldi, Ellen, Thompson, Melanie, Valencia, Patricia, Verlinghieri, Gwen, Walker, Janice, Watson, Vicky, Williams, Bruce, Armstrong, Adam, Banks, Susan, Blazes, David, Barile, Anthony, Coelho, Linda, Dennis, Marilyn, Flaks, Hannah, Gilcrest, Joyce, Gittens, Kathleen, Hopper, Shelia, Humphries, M. J., Spooner, Katherine, Tamminga, Cindy L., Vita, Jean, Wegner, Scott A., Wortmann, Glenn, Bisby, Nicole, Blake, William, Brown, Sheldon, Chilliade, Phillippe, Cole, Teresa, Elliot, Katherine, Geisler, Christiane, Goetz, Matthew, Gomez-Perez, Elizabeth, Helman, Jami, Nahass, Ronald, Leflore, Dirk, Marston, Barbara, Obregon, Maria, Petrolati, Jennifer, Pitrak, David L., Roland, Robert, Rosa, Carol, Rossman, Barbara, Schlueter Wirtz, Susan, Schuck, Suzanne, Scretchings, Tiffany, Simon, Gary, Smith, Mack, Summers, Kimberley, Werhane, Mary Jo, Arduino, Roberto, Bell, Brian, Breaux, Katherine, Cuervo, Hilda, Hale, Carl, Lewis, Stanley, Mall, Mark, Mora, Fransisco, Diez, Martine M., Okhuysen, Pablo, Rodriguez-Barradas, Maria, Schrader, Shannon R., Healy, Lynn, Kaszubski, Chris, Kolber, Michael, Tanner, Tom, Armstrong, Joann, Dahlke, Jennifer, Johnson, Leonard, Kaminski, Patricia, Rhame, Frank, Shoden, Cheryl, Temesgen, Zelalem, Urbanich, Marcy, Valenti, Sharon, Zervos, Marcus, Barrick, Bill, Chaitt, Doreen, Hahn, Barbara, Lane, Cliff, Martell, Dennis, Mcnay, Laura, Metcalf, Julia, Powers, April, Tavel, Jorge A., Loveless, Karen, Peterson, Sue, Sweek, Suzanne, Albrecht, Helmut, Antoine, Nicole, Pell, Paula, Gatell, Jose Maria, Hoy, Jenny, Lifson, Alan, Pederson, Court, Borup, Liselotte, Dragsted, Ulrik Bak, Greve, Anne Fau, Jensen, Karoline, Jens Lundgren, Mollerup, David, Pearson, Mary, Phillips, Andrew, Aboulhab, Jamila, Babiker, Abdel, Cordwell, Brooke, Darbyshire, Janet, Hack, Lisa, Hooker, Malcolm, Moraes, Yolanda, Newberry, Douglas, Nuwagaba-Biribonwoha, Harriet, Hooff, Fionna, Denning, Eileen, Holland Klemme, Leslie, Carey, Cate, Chan, Fonnie, Cooper, David, Courtney-Rodgers, David, Drummond, Fraser, Jacoby, Simone, Law, Matthew, Stewart, Morgan, Pett, Sarah, Alloo, Zarina, Bebchuk, Judy, Bollenbeck, Patty, Duchene, Alain G., Fosdick, Lisa, Harrison, Merrie, Krum, Eric, Larson, Gregg, Meger, Sue, Neaton, James, Nelson, Ray, Quan, Siu-Fun L., Schultz, Terri, Telke, Susan, Thackeray, Lisa, Thompson, Greg, Wentworth, Deborah, Wyman, Nicole, Duncan, William, Ferguson, Elaine, Fox, Lawrence, Gettinger, Nikki, Herrera, Janet, Luzar, Mary Anne, Maeshiro, Mieko, Martinez, Ana, Oseekey, Karen, Baigent, Greg, Capra, William, Duliege, Anne-Marie, Fitzgerald, Linda, Kwakkelstein, Marthin, Maral, Jean, O Hara, Mary, Sahner, David, Weber, Claire, Adam-Perchec, Christine, Barron, Nigel, Bell, Mary Louise, Dolan, Sandra, Eckstrand, Julie, Hicks, Steven, Mcauley, George, Beck, Sharon, Brown, Shawn, and Rupert, Adam

9. Early expansion of CD38+ICOS+ GC Tfh in draining lymph nodes during influenza vaccination immune response.

Author

Law H, Mach M, Howe A, Obeid S, Milner B, Carey C, Elfis M, Fsadni B, Ognenovska K, Phan TG, Carey D, Xu Y, Venturi V, Zaunders J, Kelleher AD, and Munier CML

Abstract

T follicular helper (Tfh) cells provide critical help to B cells during the germinal center (GC) reaction to facilitate generation of protective humoral immunity. Accessing the human lymph node (LN) to study the commitment of CD4 T cells to GC Tfh cell differentiation during in vivo vaccine responses is difficult. We used ultrasound guided fine needle biopsy to monitor recall responses in axillary LNs to seasonal influenza vaccination in healthy volunteers. Specific expansion of GC cell subsets occurred exclusively within draining LNs five days postvaccination. Draining LN GC Tfh and precursor-Tfh cells express higher levels of CD38, ICOS, and Ki67, indicating they were significantly more activated, motile, and proliferating, compared to contralateral LN cells. These observations provide insight into the early expansion phase of the human Tfh lineage within LNs during a vaccine induced memory response and highlights early LN immune responses may not be reflected in the periphery., (© 2021 The Author(s).)

Published
2021
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