Vaccine therapy for cytomegalovirus in the setting of allogeneic hematopoietic cell transplantation

References

• Kharfan-Dabaja MA , Bazarbachi A . Hematopoietic stem cell allografting for chronic lymphocytic leukemia: a focus on reduced-intensity conditioning regimens. Cancer Contr 2012;19(1):68-75
   PubMed Web of Science ®Google Scholar
• Matos-Fernandez NA , Abou Mourad YR , Caceres W , Kharfan-Dabaja MA . Current status of allogeneic hematopoietic stem cell transplantation for paroxysmal nocturnal hemoglobinuria. Biol Blood Marrow Transplant 2009;15(6):656-61
   PubMed Web of Science ®Google Scholar
• Gooley TA , Chien JW , Pergam SA , et al. Reduced mortality after allogeneic hematopoietic-cell transplantation. N Engl J Med 2010;363(22):2091-101
   PubMed Web of Science ®Google Scholar
• Kharfan-Dabaja MA , Labopin M , Bazarbachi A , et al. Comparing i.v. BU dose intensity between two regimens (FB2 vs FB4) for allogeneic HCT for AML in CR1: a report from the Acute Leukemia Working Party of EBMT. Bone Marrow Transplant 2014;49(9):1170-5
   PubMed Web of Science ®Google Scholar
• Nishihori T , Perkins J , Mishra A , et al. Pretransplantation 5-azacitidine in high-risk myelodysplastic syndrome. Biol Bone Marrow Transplant 2014;20(6):776-80
   PubMed Web of Science ®Google Scholar
• Sorror ML , Storb RF , Sandmaier BM , et al. Comorbidity-age index: a clinical measure of biologic age before allogeneic hematopoietic cell transplantation. J Clin Oncol 2014;32(29):3249-56
   PubMed Web of Science ®Google Scholar
• Lee SJ , Klein J , Haagenson M , et al. High-resolution donor-recipient HLA matching contributes to the success of unrelated donor marrow transplantation. Blood 2007;110(13):4576-83
   PubMed Web of Science ®Google Scholar
• Pidala J , Lee SJ , Ahn KW , et al. Non-permissive -DPB1 mismatch among otherwise HLA-matched donor-recipient pairs results in increased overall mortality after myeloablative unrelated allogeneic hematopoietic cell transplantation for hematologic malignancies. Blood 2014. [Epub ahead of print]
   PubMedGoogle Scholar
• Broers AE , van Der Holt R , van Esser JW , et al. Increased transplant-related morbidity and mortality in CMV-seropositive patients despite highly effective prevention of CMV disease after allogeneic T-cell-depleted stem cell transplantation. Blood 2000;95(7):2240-5
   PubMed Web of Science ®Google Scholar
• Meijer E , Dekker AW , Rozenberg-Arska M , et al. Influence of cytomegalovirus seropositivity on outcome after T cell-depleted bone marrow transplantation: contrasting results between recipients of grafts from related and unrelated donors. Clin Infect Dis 2002;35(6):703-12
   PubMed Web of Science ®Google Scholar
• Boeckh M , Nichols WG . The impact of cytomegalovirus serostatus of donor and recipient before hematopoietic stem cell transplantation in the era of antiviral prophylaxis and preemptive therapy. Blood 2004;103(6):2003-8
   PubMed Web of Science ®Google Scholar
• Boeckh M . Complications, diagnosis, management, and prevention of CMV infections: current and future. Hematology Am Soc Hematol Educ Program 2011;2011:305-9
   PubMed Web of Science ®Google Scholar
• Gratwohl A , Brand R , Frassoni F , et al. Cause of death after allogeneic haematopoietic stem cell transplantation (HSCT) in early leukaemias: an EBMT analysis of lethal infectious complications and changes over calendar time. Bone Marrow Transplant 2005;36(9):757-69
   PubMed Web of Science ®Google Scholar
• Fischer SA . Emerging viruses in transplantation: there is more to infection after transplant than CMV and EBV. Transplantation 2008;86(10):1327-39
   PubMed Web of Science ®Google Scholar
• Alford CA , Stagno S , Pass RF , Britt WJ . Congenital and perinatal cytomegalovirus infections. Rev Infect Dis 1990;12(Suppl 7):S745-53
   PubMedGoogle Scholar
• Goodrum F , Reeves M , Sinclair J , et al. Human cytomegalovirus sequences expressed in latently infected individuals promote a latent infection in vitro. Blood 2007;110(3):937-45
   PubMed Web of Science ®Google Scholar
• Reeves MB , MacAry PA , Lehner PJ , et al. Latency, chromatin remodeling, and reactivation of human cytomegalovirus in the dendritic cells of healthy carriers. Proc Natl Acad Sci USA 2005;102(11):4140-5
   PubMed Web of Science ®Google Scholar
• Ariza-Heredia EJ , Nesher L , Chemaly RF . Cytomegalovirus diseases after hematopoietic stem cell transplantation: a mini-review. Cancer Lett 2014;342(1):1-8
   PubMed Web of Science ®Google Scholar
• Boeckh M , Ljungman P . How we treat cytomegalovirus in hematopoietic cell transplant recipients. Blood 2009;113(23):5711-19
   PubMed Web of Science ®Google Scholar
• Boeckh M , Leisenring W , Riddell SR , et al. Late cytomegalovirus disease and mortality in recipients of allogeneic hematopoietic stem cell transplants: importance of viral load and T-cell immunity. Blood 2003;101(2):407-14
   PubMed Web of Science ®Google Scholar
• Nichols WG , Price TH , Gooley T , et al. Transfusion-transmitted cytomegalovirus infection after receipt of leukoreduced blood products. Blood 2003;101(10):4195-200
   PubMed Web of Science ®Google Scholar
• Bowden RA , Slichter SJ , Sayers MH , et al. Use of leukocyte-depleted platelets and cytomegalovirus-seronegative red blood cells for prevention of primary cytomegalovirus infection after marrow transplant. Blood 1991;78(1):246-50
   PubMed Web of Science ®Google Scholar
• Bowden RA , Sayers M , Flournoy N , et al. Cytomegalovirus immune globulin and seronegative blood products to prevent primary cytomegalovirus infection after marrow transplantation. N Engl J Med 1986;314(16):1006-10
   PubMed Web of Science ®Google Scholar
• Bowden RA , Slichter SJ , Sayers M , et al. A comparison of filtered leukocyte-reduced and cytomegalovirus (CMV) seronegative blood products for the prevention of transfusion-associated CMV infection after marrow transplant. Blood 1995;86(9):3598-603
   PubMed Web of Science ®Google Scholar
• Kotton CN . CMV: prevention, diagnosis and therapy. Am J Transplant 2013;13(Suppl 3):24-40; quiz 40
   PubMedGoogle Scholar
• Goodrich JM , Bowden RA , Fisher L , et al. Ganciclovir prophylaxis to prevent cytomegalovirus disease after allogeneic marrow transplant. Ann Intern Med 1993;118(3):173-8
   PubMed Web of Science ®Google Scholar
• Boeckh M , Geballe AP . Cytomegalovirus: pathogen, paradigm, and puzzle. J Clin Invest 2011;121(5):1673-80
   PubMed Web of Science ®Google Scholar
• Hodson EM , Jones CA , Strippoli GF , et al. Immunoglobulins, vaccines or interferon for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev 2007;2:CD005129
   Google Scholar
• Alexander BT , Hladnik LM , Augustin KM , et al. Use of cytomegalovirus intravenous immune globulin for the adjunctive treatment of cytomegalovirus in hematopoietic stem cell transplant recipients. Pharmacotherapy 2010;30(6):554-61
   PubMed Web of Science ®Google Scholar
• Chou S , Lurain NS , Thompson KD , et al. Viral DNA polymerase mutations associated with drug resistance in human cytomegalovirus. J Infect Dis 2003;188(1):32-9
   PubMed Web of Science ®Google Scholar
• Chemaly RF , Ullmann AJ , Stoelben S , et al. Letermovir for cytomegalovirus prophylaxis in hematopoietic-cell transplantation. N Engl J Med 2014;370(19):1781-9
   PubMed Web of Science ®Google Scholar
• Marty FM , Winston DJ , Rowley SD , et al. CMX001 to prevent cytomegalovirus disease in hematopoietic-cell transplantation. N Engl J Med 2013;369(13):1227-36
   PubMed Web of Science ®Google Scholar
• Winston DJ , Young JA , Pullarkat V , et al. Maribavir prophylaxis for prevention of cytomegalovirus infection in allogeneic stem cell transplant recipients: a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study. Blood 2008;111(11):5403-10
   PubMed Web of Science ®Google Scholar
• Marty FM , Ljungman P , Papanicolaou GA , et al. Maribavir prophylaxis for prevention of cytomegalovirus disease in recipients of allogeneic stem-cell transplants: a phase 3, double-blind, placebo-controlled, randomised trial. Lancet Infect Dis 2011;11(4):284-92
   PubMed Web of Science ®Google Scholar
• Fujita Y , Rooney CM , Heslop HE . Adoptive cellular immunotherapy for viral diseases. Bone Marrow Transplant 2008;41(2):193-8
   PubMed Web of Science ®Google Scholar
• Walter EA , Greenberg PD , Gilbert MJ , et al. Reconstitution of cellular immunity against cytomegalovirus in recipients of allogeneic bone marrow by transfer of T-cell clones from the donor. N Engl J Med 1995;333(16):1038-44
   PubMed Web of Science ®Google Scholar
• Einsele H , Roosnek E , Rufer N , et al. Infusion of cytomegalovirus (CMV)-specific T cells for the treatment of CMV infection not responding to antiviral chemotherapy. Blood 2002;99(11):3916-22
   PubMed Web of Science ®Google Scholar
• Peggs KS , Verfuerth S , Pizzey A , et al. Adoptive cellular therapy for early cytomegalovirus infection after allogeneic stem-cell transplantation with virus-specific T-cell lines. Lancet 2003;362(9393):1375-7
   PubMed Web of Science ®Google Scholar
• Cobbold M , Khan N , Pourgheysari B , et al. Adoptive transfer of cytomegalovirus-specific CTL to stem cell transplant patients after selection by HLA-peptide tetramers. J Exp Med 2005;202(3):379-86
   PubMed Web of Science ®Google Scholar
• Micklethwaite K , Hansen A , Foster A , et al. Ex vivo expansion and prophylactic infusion of CMV-pp65 peptide-specific cytotoxic T-lymphocytes following allogeneic hematopoietic stem cell transplantation. Biol Blood Marrow Transplant 2007;13(6):707-14
   PubMed Web of Science ®Google Scholar
• Griffiths PD , Stanton A , McCarrell E , et al. Cytomegalovirus glycoprotein-B vaccine with MF59 adjuvant in transplant recipients: a phase 2 randomised placebo-controlled trial. Lancet 2011;377(9773):1256-63
   PubMed Web of Science ®Google Scholar
• Kharfan-Dabaja MA , Boeckh M , Wilck MB , et al. A novel therapeutic cytomegalovirus DNA vaccine in allogeneic haemopoietic stem-cell transplantation: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis 2012;12(4):290-9
   PubMed Web of Science ®Google Scholar
• Plotkin SA , Starr SE , Friedman HM , et al. Effect of Towne live virus vaccine on cytomegalovirus disease after renal transplant. A controlled trial. Ann Internal Med 1991;114(7):525-31
   PubMed Web of Science ®Google Scholar
• Selinsky C , Luke C , Wloch M , et al. A DNA-based vaccine for the prevention of human cytomegalovirus-associated diseases. Hum Vaccin 2005;1(1):16-23
   PubMed Web of Science ®Google Scholar
• Wloch MK , Smith LR , Boutsaboualoy S , et al. Safety and immunogenicity of a bivalent cytomegalovirus DNA vaccine in healthy adult subjects. J Infect Dis 2008;197(12):1634-42
   PubMed Web of Science ®Google Scholar
• Hartikka J , Geall A , Bozoukova V , et al. Physical characterization and in vivo evaluation of poloxamer-based DNA vaccine formulations. J Gene Med 2008;10(7):770-82
   PubMed Web of Science ®Google Scholar
• Kharfan-Dabaja MA , Boeckh M , Wilck MB , et al. Reanalysis of TransVax immunogenicity. Lancet 2013;13(1):18
   PubMed Web of Science ®Google Scholar
• A study to evaluate a therapeutic vaccine, ASP0113, in cytomegalovirus (CMV)-seropositive recipients undergoing allogeneic, hematopoietic cell transplant (HCT) (HELIOS). Available from: http://clinicaltrials.gov/ct2/show/NCT01877655?term=NCT01877655&rank=1
   Google Scholar
• Plotkin SA , Higgins R , Kurtz JB , et al. Multicenter trial of Towne strain attenuated virus vaccine in seronegative renal transplant recipients. Transplantation 1994;58(11):1176-8
   PubMed Web of Science ®Google Scholar
• A study to evaluate the efficacy and safety of a vaccine, ASP0113, in cytomegalovirus (CMV)-seronegative kidney transplant recipients receiving an organ from a cmv-seropositive donor. Available from: http://clinicaltrials.gov/ct2/show/NCT01974206?term=NCT01974206&rank=1
   Google Scholar
• Pergam SA , Xie H , Sandhu R , et al. Efficiency and risk factors for CMV transmission in seronegative hematopoietic stem cell recipients. Biol Blood Marrow Transplant 2012;18(9):1391-400
   PubMed Web of Science ®Google Scholar
• Schmidt-Hieber M , Labopin M , Beelen D , et al. CMV serostatus still has an important prognostic impact in de novo acute leukemia patients after allogeneic stem cell transplantation: a report from the Acute Leukemia Working Party of EBMT. Blood 2013;122(19):3359-64
   PubMed Web of Science ®Google Scholar
• Lönnqvist B , Ringdèn O , Ljungman P , et al. Reduced risk of recurrent leukaemia in bone marrow transplant recipients after cytomegalovirus infection. Br J Haematol 1986;63(4):671-9
   PubMed Web of Science ®Google Scholar
• Nachbaur D , Clausen J , Kircher B . Donor cytomegalovirus seropositivity and the risk of leukemic relapse after reduced-intensity transplants. Eur J Haematol 2006;76(5):414-19
   PubMed Web of Science ®Google Scholar
• Behrendt CE , Rosenthal J , Bolotin E , et al. Donor and recipient CMV serostatus and outcome of pediatric allogeneic HSCT for acute leukemia in the era of CMV-preemptive therapy. Biol Blood Marrow Transplant 2009;15(1):54-60
   PubMed Web of Science ®Google Scholar
• Elmaagacli AH , Steckel NK , Koldehoff M , et al. Early human cytomegalovirus replication after transplantation is associated with a decreased relapse risk: evidence for a putative virus-versus-leukemia effect in acute myeloid leukemia patients. Blood 2011;118(5):1402-12
   PubMed Web of Science ®Google Scholar
• Green ML , Leisenring WM , Xie H , et al. CMV reactivation after allogeneic HCT and relapse risk: evidence for early protection in acute myeloid leukemia. Blood 2013;122(7):1316-24
   PubMed Web of Science ®Google Scholar
• Manjappa S , Bhamidipati PK , Stokerl-Goldstein KE , et al. Protective effect of cytomegalovirus reactivation on relapse after allogeneic hematopoietic cell transplantation in acute myeloid leukemia patients is influenced by conditioning regimen. Biol Blood Marrow Transplant 2014;20(1):46-52
   PubMed Web of Science ®Google Scholar
• Ljungman P . CMV: a warrior against leukemia? Blood 2013;122(7):1101-2
   PubMed Web of Science ®Google Scholar
• Scheper W , van Dorp S , Kersting S , et al. γδT cells elicited by CMV reactivation after allo-SCT cross-recognize CMV and leukemia. Leukemia 2013;27(6):1328-38
   PubMed Web of Science ®Google Scholar
• Mori T , Mori S , Kanda Y , et al. Clinical significance of cytomegalovirus (CMV) antigenemia in the prediction and diagnosis of CMV gastrointestinal disease after allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant 2004;33(4):431-4
   PubMed Web of Science ®Google Scholar
• Sylwester AW , Mitchell BL , Edgar JB , et al. Broadly targeted human cytomegalovirus-specific CD4+ and CD8+ T cells dominate the memory compartments of exposed subjects. J Exp Med 2005;202(5):673-85
   PubMed Web of Science ®Google Scholar
• Fouts AE , Chan P , Stephan JP , et al. Antibodies against the gH/gL/UL128/UL130/UL131 complex comprise the majority of the anti-cytomegalovirus (anti-CMV) neutralizing antibody response in CMV hyperimmune globulin. J Virol 2012;86(13):7444-7
   PubMed Web of Science ®Google Scholar
• Lilleri D , Kabanova A , Revello MG , et al. Fetal human cytomegalovirus transmission correlates with delayed maternal antibodies to gH/gL/pUL128-130-131 complex during primary infection. PLoS One 2013;8(3):e59863
   PubMed Web of Science ®Google Scholar
• Pötzsch S , Spindler N , Wiegers AK , et al. B cell repertoire analysis identifies new antigenic domains on glycoprotein B of human cytomegalovirus which are target of neutralizing antibodies. PLoS Pathog 2011;7(8):e1002172
   PubMed Web of Science ®Google Scholar
• Huang C , Wang H , Wu S , et al. Comparison of multiple DNA vaccines for protection against cytomegalovirus infection in BALB/c mice. Virol J 2014;11:104
   PubMed Web of Science ®Google Scholar
• Arvin AM , Fast P , Myers M , et al. Vaccine development to prevent cytomegalovirus disease: report from the National Vaccine Advisory Committee. Clin Infect Dis 2004;39(2):233-9
   PubMed Web of Science ®Google Scholar
• La Rosa C , Longmate J , Lacey SF , et al. Clinical evaluation of safety and immunogenicity of PADRE-cytomegalovirus (CMV) and tetanus-CMV fusion peptide vaccines with or without PF03512676 adjuvant. J Infect Dis 2012;205(8):1294-304
   PubMed Web of Science ®Google Scholar
• Horn B , Bao L , Dunham K , et al. Infusion of cytomegalovirus specific cytotoxic T lymphocytes from a sero-negative donor can facilitate resolution of infection and immune reconstitution. Pediatr Infect Dis J 2009;28(1):65-7
   PubMed Web of Science ®Google Scholar
• Zhou W , Longmate J , Lacey SF , et al. Impact of donor CMV status on viral infection and reconstitution of multifunction CMV-specific T cells in CMV-positive transplant recipients. Blood 2009;113(25):6465-76
   PubMed Web of Science ®Google Scholar
• Storek J , Dawson MA , Lim LC , et al. Efficacy of donor vaccination before hematopoietic cell transplantation and recipient vaccination both before and early after transplantation. Bone Marrow Transplant 2004;33(3):337-46
   PubMed Web of Science ®Google Scholar
• Wald A , Selke S , Magaret A , Boeckh M . Impact of human cytomegalovirus (CMV) infection on immune response to pandemic 2009 H1N1 influenza vaccine in healthy adults. J Med Virol 2013;85(9):1557-60
   PubMed Web of Science ®Google Scholar
• MK-8228 (Letermovir) Versus Placebo in the Prevention of Clinically-Significant Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients (MK-8228-001). Available from: http://clinicaltrials.gov/show/NCT02137772 [Last accessed 25 September 2014]
   Google Scholar
• A study of the safety and efficacy of CMX001 for the prevention of cytomegalovirus (CMV) infection in CMV-seropositive (R+) hematopoietic stem cell transplant recipients. Available from: http://clinicaltrials.gov/show/NCT01769170 [Last accessed 25 September] [2014]
   Google Scholar
• Eiz-Vesper B , Maecker-Kolhoff B , Blasczyk R . Adoptive T-cell immunotherapy from third-party donors: characterization of donors and set up of a T-cell donor registry. Front Immunol 2012;3:410
   PubMed Web of Science ®Google Scholar
• Cytomegalovirus (CMV) vaccine in donors and recipients undergoing allogeneic hematopoietic cell transplant (HCT). Available from: http://clinicaltrials.gov/show/NCT00285259
   Google Scholar
• An evaluation of a cytomegalovirus (CMV) vaccine (ASP0113) in CMV-seropositive and CMV-seronegative healthy subjects and CMV-seronegative dialysis patients. Available from: http://clinicaltrials.gov/ct2/show/NCT02103426?term=NCT02103426&rank=1
   Google Scholar
• A study to evaluate safety and tolerability of a therapeutic vaccine, ASP0113, in subjects undergoing allogeneic hematopoietic cell transplant. Available from: http://clinicaltrials.gov/ct2/show/NCT01903928?term=NCT01903928&rank=1
   Google Scholar
• CMV glycoprotein B vaccine in allograft recipients. Available from: http://clinicaltrials.gov/ct2/show/NCT00299260?term=NCT00299260&rank=1
   Google Scholar
• gB/MF59 vaccine in preventing cytomegalovirus infection in healthy adolescent females. Available from: http://clinicaltrials.gov/show/NCT00133497
   Google Scholar
• Recombinant CMV gB Vaccine in postpartum women. Available from: http://clinicaltrials.gov/ct2/show/NCT00125502?term=NCT00125502&rank=1
   Google Scholar
• Study to evaluate safety and immunogenicity of the GSK bio CMV vaccine in CMV-seronegative healthy male adult subjects. Available from: clinicaltrials.gov/ct2/show/NCT00435396?term=NCT00435396&rank=1
   Google Scholar
• Accelerated immunization to induce cytomegalovirus immunity in stem cell donors. Available from: http://clinicaltrials.gov/ct2/show/NCT00353977?term=NCT00353977&rank=1
   Google Scholar
• Vaccine therapy in healthy volunteers with or without previous exposure to cytomegalovirus. Available from: http://clinicaltrials.gov/show/NCT01941056
   Google Scholar
• Vaccine therapy in preventing cytomegalovirus in healthy participants. Available from: http://clinicaltrials.gov/ct2/show/NCT00722839?term=NCT00722839&rank=1
   Google Scholar
• Vaccine therapy in preventing cytomegalovirus infection in patients with hematological malignancies undergoing donor stem cell transplant. Available from: http://clinicaltrials.gov/ct2/show/NCT01588015?term=NCT01588015&rank=1
   Google Scholar
• A clinical trial of an alphavirus replicon vaccine for cytomegalovirus (CMV). Available from: clinicaltrials.gov/ct2/show/NCT00439803?term=NCT00439803&rank=1
   Google Scholar
• Safety, tolerability, and immunogenicity of the human cytomegalovirus vaccine (V160) in healthy adults (V160-001). Available from: http://clinicaltrials.gov/ct2/show/NCT01986010?term=NCT01986010&rank=1
   Google Scholar
• Trial of pDNA CMV Vaccine (VCL-CT02) Followed by Towne CMV Vaccine (Towne) Challenge. Available from: http://clinicaltrials.gov/ct2/show/NCT00373412?term=NCT00373412&rank=1
   Google Scholar
• Phase 1 trial of CMV towne vaccine in subjects previously received VCL CT02 vaccine ID or IM. Available from: http://clinicaltrials.gov/ct2/show/NCT00370006?term=NCT00370006&rank=1
   Google Scholar
• Evaluation of the immunogenicity and efficacy of the towne strain of CMV in seronegative women. Available from: http://clinicaltrials.gov/ct2/show/NCT00201448?term=NCT00201448&rank=1
   Google Scholar
• Safety study of four chimera cytomegalovirus (CMV) vaccines in healthy adult males 30-50 years of age. Available from: http://clinicaltrials.gov/ct2/show/NCT01195571?term=NCT01195571&rank=1
   Google Scholar