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120 results on '"Popmihajlov, Zoran"'

1. Phase 2, Double-Blind, Placebo-controlled Trial of a c-Jun N-Terminal Kinase Inhibitor in Idiopathic Pulmonary Fibrosis.

Author

Mattos, Waldo L. L. D., Khalil, Nasreen, Spencer, Lisa G., Bonella, Francesco, Folz, Rodney J., Rolf, J. Douglass, Mogulkoc, Nesrin, Lancaster, Lisa H., Jenkins, R. Gisli, Lynch, David A., Noble, Paul W., Maher, Toby M., Cottin, Vincent, Senger, Stefanie, Horan, Gerald S., Greenberg, Steven, and Popmihajlov, Zoran

Subjects
KINASE inhibitors, COUGH, THERAPEUTICS, IDIOPATHIC pulmonary fibrosis, DISEASE progression
Abstract

Rationale: Idiopathic pulmonary fibrosis is a fatal and progressive disease with limited treatment options. Objectives: We sought to assess the efficacy and safety of CC-90001, an oral inhibitor of c-Jun N-terminal kinase 1, in patients with idiopathic pulmonary fibrosis. Methods: In a Phase 2, randomized (1:1:1), double-blind, placebo-controlled study ( ID: NCT 03142191), patients received CC-90001 (200 or 400 mg) or placebo once daily for 24 weeks. Background antifibrotic treatment (pirfenidone) was allowed. The primary endpoint was change in the percentage of predicted FVC (ppFVC) from baseline to Week 24; secondary endpoints included safety. Measurements and Main Results: In total, 112 patients received at least one dose of study drug. The study was terminated early because of a strategic decision made by the sponsor. Ninety-one patients (81%) completed the study. The least-squares mean changes from baseline in ppFVC at Week 24 were −3.1% (placebo), −2.1% (200 mg), and −1.0% (400 mg); the differences compared with placebo were 1.1% (200 mg; 95% confidence interval: −2.1, 4.3; P = 0.50) and 2.2% (400 mg; 95% confidence interval: −1.1, 5.4; P = 0.19). Adverse event frequency was similar in patients in the combined CC-90001 arms versus placebo. The most common adverse events were nausea, diarrhea, and vomiting, which were more frequent in patients in CC-90001 arms versus placebo. Fewer patients in the CC-90001 arms than in the placebo arm experienced cough and dyspnea. Conclusions: Treatment with CC-90001 over 24 weeks led to numerical improvements in ppFVC in patients with idiopathic pulmonary fibrosis compared with placebo. CC-90001 was generally well tolerated, which was consistent with previous studies. Clinical trial registered with (NCT 03142191). [ABSTRACT FROM AUTHOR]

Published
2024
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2. Safety and efficacy of inactivated varicella zoster virus vaccine in immunocompromised patients with malignancies: a two-arm, randomised, double-blind, phase 3 trial

Author

Cerana, S, Dictar, MO, Bonvehi, P, Tregnaghi, JP, Fein, L, Ashley, D, Singh, M, Hayes, T, Playford, G, Morrissey, O, Thaler, J, Kuehr, T, Greil, R, Pecherstorfer, M, Duck, L, Van Eygen, K, Aoun, M, De Prijck, B, Franke, FA, Barrios, CHE, Mendes, AVA, Serrano, SV, Garcia, RF, Moore, F, Camargo, JFC, Pires, LA, Alves, RS, Radinov, A, Oreshkov, K, Minchev, V, Hubenova, AI, Koynova, T, Ivanov, I, Rabotilova, B, Petrov, PA, Chilingirov, P, Karanikolov, S, Raynov, J, Grimard, D, McNeil, S, Kumar, D, Larratt, LM, Weiss, K, Delage, R, Diaz-Mitoma, FJ, Cano, PO, Couture, F, Carvajal, P, Yepes, A, Torres Ulloa, R, Fardella, P, Caglevic, C, Rojas, C, Orellana, E, Gonzalez, P, Acevedo, A, Galvez, KM, Gonzalez, ME, Franco, S, Restrepo, JG, Rojas, CA, Bonilla, C, Florez, LE, Ospina, AV, Manneh, R, Zorica, R, Vrdoljak, DV, Samarzija, M, Petruzelka, L, Vydra, J, Mayer, J, Cibula, D, Prausova, J, Paulson, G, Ontaneda, M, Palk, K, Vahlberg, A, Rooneem, R, Galtier, F, Postil, D, Lucht, F, Laine, F, Launay, O, Laurichesse, H, Duval, X, Cornely, OA, Camerer, B, Panse, J, Zaiss, M, Derigs, H-G, Menzel, H, Verbeek, M, Georgoulias, V, Mavroudis, D, Anagnostopoulos, A, Terpos, E, Cortes, D, Umanzor, J, Bejarano, S, Galeano, RW, Wong, RSM, Hui, P, Pedrazzoli, P, Ruggeri, L, Aversa, F, Bosi, A, Gentile, G, Rambaldi, A, Contu, A, Marei, L, Abbadi, A, Hayajneh, W, Kattan, J, Farhat, F, Chahine, G, Rutkauskiene, J, Marfil Rivera, LJ, Lopez Chuken, YA, Franco Villarreal, H, Lopez Hernandez, J, Blacklock, H, Lopez, RI, Alvarez, R, Gomez, AM, Quintana, TS, Moreno Larrea, MDC, Zorrilla, SJ, Alarcon, E, Samanez, FCA, Caguioa, PB, Tiangco, BJ, Mora, EM, Betancourt-Garcia, RD, Hallman-Navarro, D, Feliciano-Lopez, LJ, Velez-Cortes, HA, Cabanillas, F, Ganea, DE, Ciuleanu, TE, Ghizdavescu, DG, Miron, L, Cebotaru, CL, Cainap, CI, Anghel, R, Dvorkin, MV, Gladkov, OA, Fadeeva, NV, Kuzmin, AA, Lipatov, ON, Zbarskaya, II, Akhmetzyanov, FS, Litvinov, IV, Afanasyev, BV, Cherenkova, M, Lioznov, D, Lisukov, IA, Smirnova, YA, Kolomietz, S, Halawani, H, Goh, YT, Drgona, L, Chudej, J, Matejkova, M, Reckova, M, Rapoport, BL, Szpak, WM, Malan, DR, Jonas, N, Jung, CW, Lee, DG, Yoon, SS, Lopez Jimenez, J, Duran Martinez, I, Rodriguez Moreno, JF, Solano Vercet, C, de la Camara, R, Batlle Massana, M, Yeh, S-P, Chen, C-Y, Chou, H-H, Tsai, C-M, Chiu, C-H, Siritanaratkul, N, Norasetthada, L, Sriuranpong, V, Seetalarom, K, Akan, H, Dane, F, Ozcan, MA, Ozsan, GH, Kalayoglu Besisik, SF, Cagatay, A, Yalcin, S, Peniket, A, Mullan, SR, Dakhil, KM, Sivarajan, K, Suh, JJ-G, Sehgal, A, Marquez, F, Gomez, EG, Mullane, MR, Skinner, WL, Behrens, RJ, Trevarthe, DR, Mazurczak, MA, Lambiase, EA, Vidal, CA, Anac, SY, Rodrigues, GA, Baltz, B, Boccia, R, Wertheim, MS, Holladay, CS, Zenk, D, Fusselman, W, Wade III, JL, Jaslowsk, AJ, Keegan, J, Robinson, MO, Go, RS, Farnen, J, Amin, B, Jurgens, D, Risi, GF, Jr, Beatty, PG, Naqvi, T, Parshad, S, Hansen, VL, Ahmed, M, Steen, PD, Badarinath, S, Dekker, A, Scouros, MA, Young, DE, Graydon Harker, W, Kendall, SD, Citron, ML, Chedid, S, Posada, JG, Jr, Gupta, MK, Rafiyath, S, Buechler-Price, J, Sreenivasappa, S, Chay, CH, Burke, JM, Young, SE, Mahmood, A, Kugler, JW, Gerstner, G, Fuloria, J, Belman, ND, Geller, R, Nieva, J, Whittenberger, BP, Wong, BMY, Cescon, TP, Abesada-Terk, G, Jr, Guarino, MJ, Zweibach, A, Ibrahim, EN, Takahashi, G, Garrison, MA, Mowat, RB, Choi, BS, Oliff, IA, Singh, J, Guter, KA, Ayrons, K, Rowland, KM, Noga, SJ, Rao, SB, Columbie, A, Nualart, MT, Cecchi, GR, Campos, LT, Mohebtash, M, Flores, MR, Rothstein-Rubin, R, O'Connor, BM, Soori, G, Knapp, M, Miranda, FG, Goodgame, BW, Kassem, M, Belani, R, Sharma, S, Ortiz, T, Sonneborn, HL, Markowitz, AB, Wilbur, D, Meiri, E, Koo, VS, Jhangiani, HS, Wong, L, Sanani, S, Lawrence, SJ, Jones, CM, Murray, C, Papageorgiou, C, Gurtler, JS, Ascensao, JL, Venigalla, ML, D'Andrea, M, De Las Casas, C, Haile, DJ, Qazi, FU, Santander, JL, Thomas, MR, Rao, VP, Craig, M, Garg, RJ, Robles, R, Lyons, RM, Stegemoller, RK, Goel, S, Garg, S, Lowry, P, Lynch, C, Lash, B, Repka, T, Baker, J, Goueli, BS, Campbell, TC, Van Echo, DA, Lee, YJ, Reyes, EA, Senecal, FM, Donnelly, G, Byeff, P, Weiss, R, Reid, T, Roeland, E, Goel, A, Prow, DM, Brandt, DS, Kaplan, HG, Payne, JE, Boeckh, MG, Rosen, PJ, Mena, RR, Khan, R, Betts, RF, Sharp, SA, Morrison, VA, Fitz-Patrick, D, Congdon, J, Erickson, N, Abbasi, R, Henderson, S, Mehdi, A, Wos, EJ, Rehmus, E, Beltzer, L, Tamayo, RA, Mahmood, T, Reboli, AC, Moore, A, Brown, JM, Cruz, J, Quick, DP, Potz, JL, Kotz, KW, Hutchins, M, Chowhan, NM, Devabhaktuni, YD, Braly, P, Berenguer, RA, Shambaugh, SC, O'Rourke, TJ, Conkright, WA, Winkler, CF, Addo, FEK, Duic, JP, High, KP, Kutner, ME, Collins, R, Carrizosa, DR, Perry, DJ, Kailath, E, Rosen, N, Sotolongo, R, Shoham, S, Chen, T, Mullane, Kathleen M, Morrison, Vicki A, Camacho, Luis H, Arvin, Ann, McNeil, Shelly A, Durrand, Jessie, Campbell, Bernadette, Su, Shu-Chih, Chan, Ivan S F, Parrino, Janie, Kaplan, Susan S, Popmihajlov, Zoran, and Annunziato, Paula W

Published
2019
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13. Safety and efficacy of inactivated varicella zoster virus vaccine in immunocompromised patients with malignancies: a two-arm, randomised, double-blind, phase 3 trial

Author

Mullane, Kathleen M, primary, Morrison, Vicki A, additional, Camacho, Luis H, additional, Arvin, Ann, additional, McNeil, Shelly A, additional, Durrand, Jessie, additional, Campbell, Bernadette, additional, Su, Shu-Chih, additional, Chan, Ivan S F, additional, Parrino, Janie, additional, Kaplan, Susan S, additional, Popmihajlov, Zoran, additional, Annunziato, Paula W, additional, Cerana, S, additional, Dictar, MO, additional, Bonvehi, P, additional, Tregnaghi, JP, additional, Fein, L, additional, Ashley, D, additional, Singh, M, additional, Hayes, T, additional, Playford, G, additional, Morrissey, O, additional, Thaler, J, additional, Kuehr, T, additional, Greil, R, additional, Pecherstorfer, M, additional, Duck, L, additional, Van Eygen, K, additional, Aoun, M, additional, De Prijck, B, additional, Franke, FA, additional, Barrios, CHE, additional, Mendes, AVA, additional, Serrano, SV, additional, Garcia, RF, additional, Moore, F, additional, Camargo, JFC, additional, Pires, LA, additional, Alves, RS, additional, Radinov, A, additional, Oreshkov, K, additional, Minchev, V, additional, Hubenova, AI, additional, Koynova, T, additional, Ivanov, I, additional, Rabotilova, B, additional, Petrov, PA, additional, Chilingirov, P, additional, Karanikolov, S, additional, Raynov, J, additional, Grimard, D, additional, McNeil, S, additional, Kumar, D, additional, Larratt, LM, additional, Weiss, K, additional, Delage, R, additional, Diaz-Mitoma, FJ, additional, Cano, PO, additional, Couture, F, additional, Carvajal, P, additional, Yepes, A, additional, Torres Ulloa, R, additional, Fardella, P, additional, Caglevic, C, additional, Rojas, C, additional, Orellana, E, additional, Gonzalez, P, additional, Acevedo, A, additional, Galvez, KM, additional, Gonzalez, ME, additional, Franco, S, additional, Restrepo, JG, additional, Rojas, CA, additional, Bonilla, C, additional, Florez, LE, additional, Ospina, AV, additional, Manneh, R, additional, Zorica, R, additional, Vrdoljak, DV, additional, Samarzija, M, additional, Petruzelka, L, additional, Vydra, J, additional, Mayer, J, additional, Cibula, D, additional, Prausova, J, additional, Paulson, G, additional, Ontaneda, M, additional, Palk, K, additional, Vahlberg, A, additional, Rooneem, R, additional, Galtier, F, additional, Postil, D, additional, Lucht, F, additional, Laine, F, additional, Launay, O, additional, Laurichesse, H, additional, Duval, X, additional, Cornely, OA, additional, Camerer, B, additional, Panse, J, additional, Zaiss, M, additional, Derigs, H-G, additional, Menzel, H, additional, Verbeek, M, additional, Georgoulias, V, additional, Mavroudis, D, additional, Anagnostopoulos, A, additional, Terpos, E, additional, Cortes, D, additional, Umanzor, J, additional, Bejarano, S, additional, Galeano, RW, additional, Wong, RSM, additional, Hui, P, additional, Pedrazzoli, P, additional, Ruggeri, L, additional, Aversa, F, additional, Bosi, A, additional, Gentile, G, additional, Rambaldi, A, additional, Contu, A, additional, Marei, L, additional, Abbadi, A, additional, Hayajneh, W, additional, Kattan, J, additional, Farhat, F, additional, Chahine, G, additional, Rutkauskiene, J, additional, Marfil Rivera, LJ, additional, Lopez Chuken, YA, additional, Franco Villarreal, H, additional, Lopez Hernandez, J, additional, Blacklock, H, additional, Lopez, RI, additional, Alvarez, R, additional, Gomez, AM, additional, Quintana, TS, additional, Moreno Larrea, MDC, additional, Zorrilla, SJ, additional, Alarcon, E, additional, Samanez, FCA, additional, Caguioa, PB, additional, Tiangco, BJ, additional, Mora, EM, additional, Betancourt-Garcia, RD, additional, Hallman-Navarro, D, additional, Feliciano-Lopez, LJ, additional, Velez-Cortes, HA, additional, Cabanillas, F, additional, Ganea, DE, additional, Ciuleanu, TE, additional, Ghizdavescu, DG, additional, Miron, L, additional, Cebotaru, CL, additional, Cainap, CI, additional, Anghel, R, additional, Dvorkin, MV, additional, Gladkov, OA, additional, Fadeeva, NV, additional, Kuzmin, AA, additional, Lipatov, ON, additional, Zbarskaya, II, additional, Akhmetzyanov, FS, additional, Litvinov, IV, additional, Afanasyev, BV, additional, Cherenkova, M, additional, Lioznov, D, additional, Lisukov, IA, additional, Smirnova, YA, additional, Kolomietz, S, additional, Halawani, H, additional, Goh, YT, additional, Drgona, L, additional, Chudej, J, additional, Matejkova, M, additional, Reckova, M, additional, Rapoport, BL, additional, Szpak, WM, additional, Malan, DR, additional, Jonas, N, additional, Jung, CW, additional, Lee, DG, additional, Yoon, SS, additional, Lopez Jimenez, J, additional, Duran Martinez, I, additional, Rodriguez Moreno, JF, additional, Solano Vercet, C, additional, de la Camara, R, additional, Batlle Massana, M, additional, Yeh, S-P, additional, Chen, C-Y, additional, Chou, H-H, additional, Tsai, C-M, additional, Chiu, C-H, additional, Siritanaratkul, N, additional, Norasetthada, L, additional, Sriuranpong, V, additional, Seetalarom, K, additional, Akan, H, additional, Dane, F, additional, Ozcan, MA, additional, Ozsan, GH, additional, Kalayoglu Besisik, SF, additional, Cagatay, A, additional, Yalcin, S, additional, Peniket, A, additional, Mullan, SR, additional, Dakhil, KM, additional, Sivarajan, K, additional, Suh, JJ-G, additional, Sehgal, A, additional, Marquez, F, additional, Gomez, EG, additional, Mullane, MR, additional, Skinner, WL, additional, Behrens, RJ, additional, Trevarthe, DR, additional, Mazurczak, MA, additional, Lambiase, EA, additional, Vidal, CA, additional, Anac, SY, additional, Rodrigues, GA, additional, Baltz, B, additional, Boccia, R, additional, Wertheim, MS, additional, Holladay, CS, additional, Zenk, D, additional, Fusselman, W, additional, Wade III, JL, additional, Jaslowsk, AJ, additional, Keegan, J, additional, Robinson, MO, additional, Go, RS, additional, Farnen, J, additional, Amin, B, additional, Jurgens, D, additional, Risi, GF, additional, Beatty, PG, additional, Naqvi, T, additional, Parshad, S, additional, Hansen, VL, additional, Ahmed, M, additional, Steen, PD, additional, Badarinath, S, additional, Dekker, A, additional, Scouros, MA, additional, Young, DE, additional, Graydon Harker, W, additional, Kendall, SD, additional, Citron, ML, additional, Chedid, S, additional, Posada, JG, additional, Gupta, MK, additional, Rafiyath, S, additional, Buechler-Price, J, additional, Sreenivasappa, S, additional, Chay, CH, additional, Burke, JM, additional, Young, SE, additional, Mahmood, A, additional, Kugler, JW, additional, Gerstner, G, additional, Fuloria, J, additional, Belman, ND, additional, Geller, R, additional, Nieva, J, additional, Whittenberger, BP, additional, Wong, BMY, additional, Cescon, TP, additional, Abesada-Terk, G, additional, Guarino, MJ, additional, Zweibach, A, additional, Ibrahim, EN, additional, Takahashi, G, additional, Garrison, MA, additional, Mowat, RB, additional, Choi, BS, additional, Oliff, IA, additional, Singh, J, additional, Guter, KA, additional, Ayrons, K, additional, Rowland, KM, additional, Noga, SJ, additional, Rao, SB, additional, Columbie, A, additional, Nualart, MT, additional, Cecchi, GR, additional, Campos, LT, additional, Mohebtash, M, additional, Flores, MR, additional, Rothstein-Rubin, R, additional, O'Connor, BM, additional, Soori, G, additional, Knapp, M, additional, Miranda, FG, additional, Goodgame, BW, additional, Kassem, M, additional, Belani, R, additional, Sharma, S, additional, Ortiz, T, additional, Sonneborn, HL, additional, Markowitz, AB, additional, Wilbur, D, additional, Meiri, E, additional, Koo, VS, additional, Jhangiani, HS, additional, Wong, L, additional, Sanani, S, additional, Lawrence, SJ, additional, Jones, CM, additional, Murray, C, additional, Papageorgiou, C, additional, Gurtler, JS, additional, Ascensao, JL, additional, Venigalla, ML, additional, D'Andrea, M, additional, De Las Casas, C, additional, Haile, DJ, additional, Qazi, FU, additional, Santander, JL, additional, Thomas, MR, additional, Rao, VP, additional, Craig, M, additional, Garg, RJ, additional, Robles, R, additional, Lyons, RM, additional, Stegemoller, RK, additional, Goel, S, additional, Garg, S, additional, Lowry, P, additional, Lynch, C, additional, Lash, B, additional, Repka, T, additional, Baker, J, additional, Goueli, BS, additional, Campbell, TC, additional, Van Echo, DA, additional, Lee, YJ, additional, Reyes, EA, additional, Senecal, FM, additional, Donnelly, G, additional, Byeff, P, additional, Weiss, R, additional, Reid, T, additional, Roeland, E, additional, Goel, A, additional, Prow, DM, additional, Brandt, DS, additional, Kaplan, HG, additional, Payne, JE, additional, Boeckh, MG, additional, Rosen, PJ, additional, Mena, RR, additional, Khan, R, additional, Betts, RF, additional, Sharp, SA, additional, Morrison, VA, additional, Fitz-Patrick, D, additional, Congdon, J, additional, Erickson, N, additional, Abbasi, R, additional, Henderson, S, additional, Mehdi, A, additional, Wos, EJ, additional, Rehmus, E, additional, Beltzer, L, additional, Tamayo, RA, additional, Mahmood, T, additional, Reboli, AC, additional, Moore, A, additional, Brown, JM, additional, Cruz, J, additional, Quick, DP, additional, Potz, JL, additional, Kotz, KW, additional, Hutchins, M, additional, Chowhan, NM, additional, Devabhaktuni, YD, additional, Braly, P, additional, Berenguer, RA, additional, Shambaugh, SC, additional, O'Rourke, TJ, additional, Conkright, WA, additional, Winkler, CF, additional, Addo, FEK, additional, Duic, JP, additional, High, KP, additional, Kutner, ME, additional, Collins, R, additional, Carrizosa, DR, additional, Perry, DJ, additional, Kailath, E, additional, Rosen, N, additional, Sotolongo, R, additional, Shoham, S, additional, and Chen, T, additional

Published
2019
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14. The Effect of Age on the Immunogenicity of the Live Attenuated Zoster Vaccine Is Predicted by Baseline Regulatory T Cells and Varicella-Zoster Virus-Specific T Cell Immunity

Author

Weinberg, Adriana, primary, Pang, Lei, additional, Johnson, Michael J., additional, Caldas, Yupanqui, additional, Cho, Alice, additional, Tovar-Salazar, Adriana, additional, Canniff, Jennifer, additional, Schmader, Kenneth E., additional, Popmihajlov, Zoran, additional, and Levin, Myron J., additional

Published
2019
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15. Inactivated varicella zoster vaccine in autologous haemopoietic stem-cell transplant recipients: an international, multicentre, randomised, double-blind, placebo-controlled trial

Author

Winston, Drew J., Mullane, Kathleen M., Cornely, Oliver A., Boeckh, Michael J., Brown, Janice Wes, Pergam, Steven A., Trociukas, Igoris, Zak, Pavel, Craig, Michael D., Papanicolaou, Genovefa A., Velez, Juan D., Panse, Jens, Hurtado, Kimberly, Fernsler, Doreen A., Stek, Jon E., Pang, Lei, Su, Shu-Chih, Zhao, Yanli, Chan, Ivan S. F., Kaplan, Susan S., Parrino, Janie, Lee, Ingi, Popmihajlov, Zoran, Annunziato, Paula W., Arvin, Ann, Winston, Drew J., Mullane, Kathleen M., Cornely, Oliver A., Boeckh, Michael J., Brown, Janice Wes, Pergam, Steven A., Trociukas, Igoris, Zak, Pavel, Craig, Michael D., Papanicolaou, Genovefa A., Velez, Juan D., Panse, Jens, Hurtado, Kimberly, Fernsler, Doreen A., Stek, Jon E., Pang, Lei, Su, Shu-Chih, Zhao, Yanli, Chan, Ivan S. F., Kaplan, Susan S., Parrino, Janie, Lee, Ingi, Popmihajlov, Zoran, Annunziato, Paula W., and Arvin, Ann

Abstract

Background Recipients of autologous haemopoietic stem-cell transplants (auto-HSCT) have an increased risk of herpes zoster and herpes zoster-related complications. The aim of this study was to establish the efficacy and safety of an inactivated varicella zoster vaccine for the prevention of herpes zoster after auto-HSCT. Methods In this randomised, double-blind, placebo-controlled phase 3 trial, participants were recruited from 135 medical centres (ie, stem-cell transplant centres and hospitals) in North America, South America, Europe, and Asia. Patients were eligible if they were aged 18 years or older, scheduled to receive an auto-HSCT within 60 days of enrolment, and had a history of varicella infection or were seropositive for antibodies to varicella zoster virus, or both. Exclusion criteria included a history of herpes zoster within the previous year of enrolment, and intended antiviral prophylaxis for longer than 6 months after transplantation. Participants were randomly assigned according to a central randomisation schedule generated by the trial statistician, to receive either the inactivated-virus vaccine from one of three consistency lots, a high-antigen lot, or placebo, stratified by age (< 50 vs >= 50 years) and intended duration of antiviral prophylaxis after transplantation (<= 3 months vs > 3 to <= 6 months). Participants, investigators, trial staff, and the funder's clinical and laboratory personnel were masked to group assignment. Participants were given four doses of inactivated vaccine or placebo, with the first dose 5-60 days before auto-HSCT, and the second, third, and fourth doses at about 30, 60, and 90 days after transplantation. The primary efficacy endpoint was the incidence of herpes zoster, confirmed by PCR or adjudication by a masked clinical committee, or both, assessed in all participants randomly assigned to the vaccine consistency lot group or placebo group who received at least one dose of vaccine and had auto-HSCT. Safety was asses

Published
2018

16. Cost and utility in immunocompromised subjects who developed herpes zoster during the randomized V212 inactivated varicella-zoster vaccine (ZVIN) trial.

Author

Eriksson, Jennifer, Hunger, Matthias, Bourhis, François, Thorén, Robyn, Popmihajlov, Zoran, Finelli, Lynn, and Jiang, Yiling

Abstract

Objectives: Immunocompromised subjects are at increased risk for herpes zoster (HZ) and HZ-related complications, such as post-herpetic neuralgia (PHN). We describe health utilities, health care resource utilization (HCRU), productivity loss and health care costs in recipients of autologous hematopoietic stem-cell transplantation (Auto-HSCT) who developed confirmed HZ in the phase 3 clinical trial. Methods: HCRU, costs, and EQ-5D-3L utility were assessed for 155 confirmed HZ cases observed after receiving inactivated varicella-zoster virus (VZV) vaccine (ZVIN) or placebo. In a prospective, longitudinal 6-month follow up, costs and utilities were analyzed for two health states, HZ without PHN and HZ with PHN. Results: There was a clinically relevant difference in utility between HZ without PHN (mean 0.814) and HZ with PHN (0.729). The disutility for HZ without PHN was estimated to -0.117 and to -0.186 for HZ with PHN. Direct costs (2017 USD) associated with a HZ without PHN episode and HZ with PHN episode was estimated at $3,412 and $3,711, respectively, of which hospitalizations accounted for 90% of the costs. Expert opinion: Both HZ and PHN are associated with considerable disutility in recipients of Auto-HSCT. Costs were comparable to published estimates in other immunocompromised subjects. The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT01229267). [ABSTRACT FROM AUTHOR]

Published
2020
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17. Immunogenicity of Inactivated Varicella Zoster Vaccine in Autologous Hematopoietic Stem Cell Transplant Recipients and Patients With Solid or Hematologic Cancer.

Author

Boeckh, Michael J, Arvin, Ann M, Mullane, Kathleen M, Camacho, Luis H, Winston, Drew J, Morrison, Vicki A, Hurtado, Kimberly, Hall, Jessie Durrand, Pang, Lei, Su, Shu-Chih, Kaplan, Susan S, Annunziato, Paula W, Popmihajlov, Zoran, and Group, V212 Protocol 001 Trial Group and V212 Protocol 011 Trial

Subjects
HEMATOPOIETIC stem cells, STEM cell transplantation, HERPES zoster vaccines, VARICELLA-zoster virus diseases, HERPES zoster, CHICKENPOX, CLINICAL trial registries
Abstract

Background In phase 3 trials, inactivated varicella zoster virus (VZV) vaccine (ZVIN) was well tolerated and efficacious against herpes zoster (HZ) in autologous hematopoietic stem cell transplant (auto-HSCT) recipients and patients with solid tumor malignancies receiving chemotherapy (STMc) but did not reduce HZ incidence in patients with hematologic malignancies (HMs). Here, we describe ZVIN immunogenicity from these studies. Methods Patients were randomized to ZVIN or placebo (4 doses). Immunogenicity was assessed by glycoprotein enzyme-linked immunosorbent assay (gpELISA) and VZV interferon (IFN)-γ enzyme-linked immunospot (ELISPOT) assay in patients receiving all 4 doses without developing HZ at the time of blood sampling. Results Estimated geometric mean fold rise ratios (ZVIN/placebo) by gpELISA and IFN-y ELISPOT ~28 days post–dose 4 were 2.02 (95% confidence interval [CI], 1.53–2.67) and 5.41 (95% CI, 3.60–8.12) in auto-HSCT recipients; 1.88 (95% CI, 1.79–1.98) and 2.10 (95% CI, 1.69–2.62) in patients with STMc; and not assessed and 2.35 (95% CI, 1.81–3.05) in patients with HM. Conclusions ZVIN immunogenicity was directionally consistent with clinical efficacy in auto-HSCT recipients and patients with STMc even though HZ protection and VZV immunity were not statistically correlated. Despite a lack of clinical efficacy in patients with HM, ZVIN immunogenicity was observed in this population. Immunological results did not predict vaccine efficacy in these 3 populations. Clinical trial registration NCT01229267, NCT01254630. [ABSTRACT FROM AUTHOR]

Published
2020
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19. Persistence of Varicella-Zoster Virus Cell-Mediated Immunity After the Administration of a Second Dose of Live Herpes Zoster Vaccine

Author

Weinberg, Adriana, primary, Popmihajlov, Zoran, additional, Schmader, Kenneth E, additional, Johnson, Michael J, additional, Caldas, Yupanqui, additional, Salazar, Adriana Tovar, additional, Canniff, Jennifer, additional, McCarson, Barbara J, additional, Martin, Jason, additional, Pang, Lei, additional, and Levin, Myron J, additional

Published
2018
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20. Inactivated varicella zoster vaccine in autologous haemopoietic stem-cell transplant recipients: an international, multicentre, randomised, double-blind, placebo-controlled trial

Author

Winston, Drew J, primary, Mullane, Kathleen M, additional, Cornely, Oliver A, additional, Boeckh, Michael J, additional, Brown, Janice Wes, additional, Pergam, Steven A, additional, Trociukas, Igoris, additional, Žák, Pavel, additional, Craig, Michael D, additional, Papanicolaou, Genovefa A, additional, Velez, Juan D, additional, Panse, Jens, additional, Hurtado, Kimberly, additional, Fernsler, Doreen A, additional, Stek, Jon E, additional, Pang, Lei, additional, Su, Shu-Chih, additional, Zhao, Yanli, additional, Chan, Ivan S F, additional, Kaplan, Susan S, additional, Parrino, Janie, additional, Lee, Ingi, additional, Popmihajlov, Zoran, additional, Annunziato, Paula W, additional, Arvin, Ann, additional, Basso, AC, additional, Bonvehi, P, additional, Cerana, S, additional, Dictar, MO, additional, Campbell, P, additional, Playford, G, additional, Sasadeusz, J, additional, Maertens, J, additional, Poire, X, additional, Sellesag, D, additional, Schots, R, additional, Theunissen, K, additional, Willems, E, additional, Alves, RS, additional, Camargo, JFC, additional, Castro, NS, additional, Maria Fogliatto, L, additional, Rodrigo, O, additional, Courture, F, additional, McGeer, A, additional, Miller, M, additional, Combariza, JF, additional, Sossa, CL, additional, Velez, JD, additional, Nemet, D, additional, Ostojic Kolonic, S, additional, Jebavy, L, additional, Mayer, J, additional, Novak, J, additional, Pohlreich, D, additional, Maldonado, B, additional, Gastinne, T, additional, Karlin, L, additional, Launay, O, additional, Cornely, OA, additional, Duerk, HA, additional, Haenel, M, additional, Heinz, W, additional, Kaufmann, M, additional, Panse, J, additional, Teschner, D, additional, Verbeek, M, additional, Wulf, G, additional, Aviv, F, additional, Grisariu, S, additional, Nagler, A, additional, Yeshurun, M, additional, Bosi, A, additional, Corradini, P, additional, Martinelli, G, additional, Onida, F, additional, Rambaldi, A, additional, Velardi, A, additional, Trociukas, I, additional, Gomez, AD, additional, Wondergem, MJ, additional, Ypma, PF, additional, Fanilla, E, additional, Moreno Larrea, MDC, additional, Abecasis, MM, additional, Ferreira, RB, additional, Geraldes, C, additional, Castro, J, additional, Afanasyev, BV, additional, Kruchkova, IV, additional, Zaritskiy, AY, additional, Cheong, JW, additional, Kim, SJ, additional, Lee, DG, additional, Yoon, SS, additional, Aguado Bueno, B, additional, Jarque Ramos, I, additional, Solano Vercet, C, additional, Cherif, H, additional, Ljungman, P, additional, Vaht, K, additional, Cook, G, additional, Kanfer, E, additional, Milligan, DW, additional, Parker, A, additional, Akard, L, additional, Bachier, C, additional, Ball, ED, additional, Betts, FR, additional, Braunschweig, I, additional, Brown, JM, additional, Carroll, MP, additional, Chandrasekar, PH, additional, Collins, R, additional, Cooper, B, additional, Craig, M, additional, D'Cunha, N, additional, Donato, ML, additional, Essell, J, additional, Flomenberg, P, additional, Freifeld, A, additional, Freytes, C, additional, Guarino, MJ, additional, Hall, MC, additional, Heimenz, JW, additional, High, KP, additional, Isola, LM, additional, Kaminer, L, additional, Klein, LM, additional, Janakiraman, N, additional, Kane, K, additional, Komanduri, K, additional, Krijanovski, OI, additional, Lawrence, SJ, additional, Leis, JF, additional, Lill, M, additional, Longo, WL, additional, Lynch, JP, additional, Mattar, BI, additional, Mehta, J, additional, Mullane, KM, additional, Nathan, S, additional, Papanicolaou, GA, additional, Pergam, SA, additional, Roy, V, additional, Rybka, W, additional, Safah, H, additional, Saltzman, D, additional, Segal, GM, additional, Selby, GB, additional, Schuster, MW, additional, Shoham, S, additional, Sloan, JM, additional, Strasfeld, LM, additional, Styler, M, additional, Sullivan, K, additional, Tse, W, additional, Vance, EA, additional, Winston, DJ, additional, and Yanovich, S, additional

Published
2018
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21. Safety and Immunogenicity of Zoster Vaccine Live in Human Immunodeficiency Virus–Infected Adults With CD4+ Cell Counts >200 Cells/mL Virologically Suppressed on Antiretroviral Therapy

Author

Benson, Constance A, primary, Andersen, Janet W, additional, Macatangay, Bernard J C, additional, Mailliard, Robbie B, additional, Rinaldo, Charles R, additional, Read, Sarah, additional, Bozzolo, Dawn R, additional, Purdue, Lynette, additional, Jennings, Cheryl, additional, Keefer, Michael C, additional, Glesby, Marshall, additional, Tebas, Pablo, additional, Russell, Amy Falk, additional, Martin, Jason, additional, Annunziato, Paula, additional, Popmihajlov, Zoran, additional, and Lennox, Jeffrey L, additional

Published
2018
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22. A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Study the Safety, Tolerability, Efficacy, and Immunogenicity of Inactivated Vzv Vaccine (ZVIN) in Recipients of Autologous Hematopoietic Cell Transplants (Auto-Hcts)

Author

Winston, Drew J., Mullane, Kathleen M., Boeckh, Michael J., Cornely, Oliver A., Hurtado, Kimberly, Su, Shu-Chih, Pang, Lei, Zhao, Yanli, Chan, Ivan S. F., Stek, Jon E., Kaplan, Susan S., Parrino, Janie, Annunziato, Paula, Popmihajlov, Zoran, Arvin, Ann, Winston, Drew J., Mullane, Kathleen M., Boeckh, Michael J., Cornely, Oliver A., Hurtado, Kimberly, Su, Shu-Chih, Pang, Lei, Zhao, Yanli, Chan, Ivan S. F., Stek, Jon E., Kaplan, Susan S., Parrino, Janie, Annunziato, Paula, Popmihajlov, Zoran, and Arvin, Ann

Published
2017

23. Additional file 2: Table S1. of Evaluation of two doses of etoricoxib, a COX-2 selective non-steroidal anti-inflammatory drug (NSAID), in the treatment of Rheumatoid Arthritis in a double-blind, randomized controlled trial

Author

Bickham, Kara, Kivitz, Alan, Anish Mehta, Frontera, Nancy, Shah, Sandhya, Stryszak, Paul, Popmihajlov, Zoran, and Peloso, Paul

Abstract

Summary of Additional Endpoints during Part I (6 weeks of treatment). Table S2. Summary of Additional Endpoints during Part II Among Inadequate Responders from Part I. (DOCX 21 kb)

Published
2016
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28. A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Study the Safety, Tolerability, Efficacy, and Immunogenicity of Inactivated Vzv Vaccine (ZVIN) in Recipients of Autologous Hematopoietic Cell Transplants (Auto-Hcts)

Author

Winston, Drew J., primary, Mullane, Kathleen M., additional, Boeckh, Michael J., additional, Cornely, Oliver A., additional, Hurtado, Kimberly, additional, Su, Shu-Chih, additional, Pang, Lei, additional, Zhao, Yanli, additional, Chan, Ivan S.F., additional, Stek, Jon E., additional, Kaplan, Susan S., additional, Parrino, Janie, additional, Annunziato, Paula, additional, Popmihajlov, Zoran, additional, and Arvin, Ann, additional

Published
2017
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30. Persistence of Varicella-Zoster Virus Cell-Mediated Immunity After the Administration of a Second Dose of Live Herpes Zoster Vaccine.

Author

Weinberg, Adriana, Popmihajlov, Zoran, Schmader, Kenneth E, Johnson, Michael J, Caldas, Yupanqui, Salazar, Adriana Tovar, Canniff, Jennifer, McCarson, Barbara J, Martin, Jason, Pang, Lei, and Levin, Myron J

Subjects
*HERPES zoster, *HERPES zoster vaccines, *CELLULAR immunity, *VACCINE effectiveness, *DRUG efficacy, *AGE distribution, *COMPARATIVE studies, *HERPESVIRUSES, *IMMUNITY, *IMMUNIZATION, *INTERFERONS, *INTERLEUKIN-2, *RESEARCH methodology, *MEDICAL cooperation, *RESEARCH, *VACCINES, *VIRAL antibodies, *EVALUATION research
Abstract

Protection against zoster conferred by zoster vaccine live (ZVL; Zostavax) wanes over time. We compared varicella-zoster virus cell-mediated immunity (VZV-CMI) of adults ≥70 years who received a second dose of ZVL ≥10 years after the initial dose with de novo-immunized age-matched controls. Before and during the first year after vaccination, VZV-CMI was significantly higher in reimmunized compared with de novo vaccinees. At 3 years, VZV-CMI differences between groups decreased and only memory responses remained marginally higher in reimmunized participants. In conclusion, the increase in VZV-CMI generated by reimmunization with ZVL is at least equally persistent compared with de novo immunization. [ABSTRACT FROM AUTHOR]

Published
2019
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36. Cellular and Humoral Responses to a Second Dose of Herpes Zoster Vaccine Administered 10 Years After the First Dose Among Older Adults

Author

Levin, Myron J., primary, Schmader, Kenneth E., additional, Pang, Lei, additional, Williams-Diaz, Angela, additional, Zerbe, Gary, additional, Canniff, Jennifer, additional, Johnson, Michael J., additional, Caldas, Yupanqui, additional, Cho, Alice, additional, Lang, Nancy, additional, Su, Shu-Chih, additional, Parrino, Janie, additional, Popmihajlov, Zoran, additional, and Weinberg, Adriana, additional

Published
2015
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37. 6 - A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Study the Safety, Tolerability, Efficacy, and Immunogenicity of Inactivated Vzv Vaccine (ZVIN) in Recipients of Autologous Hematopoietic Cell Transplants (Auto-Hcts)

Author

Winston, Drew J., Mullane, Kathleen M., Boeckh, Michael J., Cornely, Oliver A., Hurtado, Kimberly, Su, Shu-Chih, Pang, Lei, Zhao, Yanli, Chan, Ivan S.F., Stek, Jon E., Kaplan, Susan S., Parrino, Janie, Annunziato, Paula, Popmihajlov, Zoran, and Arvin, Ann

Published
2017
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49. Association of β2-microglobulin with the α3 domain of H-2Db heavy chain.

Author

Lilić, Mirjana, Popmihajlov, Zoran, Monaco, John J., and Vukmanovi&caucte;, Stanislav

Subjects
*AMINO acids, *ORGANIC acids, *CYTOPLASM, *DIMERS, *ACIDS, *PROTOPLASM
Abstract

MHC class I molecules are heterotrimeric complexes composed of heavy chain, β2-microglobulin (β2m) and short peptide. This trimeric complex is generated in the endoplasmic reticulum (ER), where a peptide loading complex (PLC) facilitates transport from the cytosol and binding of the peptide to the preassembled ER resident heavy chain/β2m dimers. Association of mouse MHC class I heavy chain with β2m is characterized by allelic differences in the number and/or positions of amino acid interactions. It is unclear, however, whether all alleles follow common binding patterns with minimal contributions by allele-specific contacts, or whether essential contacts with β2m are different for each allele. While searching for the PLC binding site in the α3 domain of the mouse MHC class I molecule H-2Db, we unexpectedly discovered a site critical for binding mouse, but not human, β2m. Interestingly, amino acids in the corresponding region of another MHC class I heavy chain allele do not make contacts with the mouse β2m. Thus, there are allelic differences in the modes of binding of β2m to the heavy chain of MHC class I. [ABSTRACT FROM AUTHOR]

Published
2004
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