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Article ; Online: Cytomegalovirus Triplex vaccine in pediatric hematopoietic stem cell transplant patients at high risk for cytomegalovirus complications: evaluation of vaccine safety, immunogenicity and impact on viremia requiring antivirals.

La Rosa, Corinna / Park, Yoonsuh / Yang, Dongyun / Zhou, Qiao / Kaltcheva, Teodora / Karras, Nicole / Cheng, Jerry / Sun, Weili / Diamond, Don J / Pawlowska, Anna

Haematologica

2024

Abstract: Not available. ...

Abstract	Not available.
Language	English
Publishing date	2024-02-29
Publishing country	Italy
Document type	Journal Article
ZDB-ID	2333-4
ISSN	1592-8721 ; 0017-6567 ; 0390-6078
ISSN (online)	1592-8721
ISSN	0017-6567 ; 0390-6078
DOI	10.3324/haematol.2023.284256
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Article ; Online: Highly stable and immunogenic CMV T cell vaccine candidate developed using a synthetic MVA platform.

Yll-Pico, Marcal / Park, Yoonsuh / Martinez, Joy / Iniguez, Angelina / Kha, Mindy / Kim, Taehyun / Medrano, Leonard / Nguyen, Vu H / Kaltcheva, Teodora / Dempsey, Shannon / Chiuppesi, Flavia / Wussow, Felix / Diamond, Don J

NPJ vaccines

2024 Volume 9, Issue 1, Page(s) 68

Abstract: Human cytomegalovirus (CMV) is the most common infectious cause of complications post-transplantation, while a CMV vaccine for transplant recipients has yet to be licensed. Triplex, a multiantigen Modified Vaccinia Ankara (MVA)-vectored CMV vaccine ... ...

Abstract	Human cytomegalovirus (CMV) is the most common infectious cause of complications post-transplantation, while a CMV vaccine for transplant recipients has yet to be licensed. Triplex, a multiantigen Modified Vaccinia Ankara (MVA)-vectored CMV vaccine candidate based on the immunodominant antigens phosphoprotein 65 (pp65) and immediate-early 1 and 2 (IE1/2), is in an advanced stage of clinical development. However, its limited genetic and expression stability restricts its potential for large-scale production. Using a recently developed fully synthetic MVA (sMVA) platform, we developed a new generation Triplex vaccine candidate, T10-F10, with different sequence modifications for enhanced vaccine stability. T10-F10 demonstrated genetic and expression stability during extensive virus passaging. In addition, we show that T10-F10 confers comparable immunogenicity to the original Triplex vaccine to elicit antigen-specific T cell responses in HLA-transgenic mice. These results demonstrate improvements in translational vaccine properties of an sMVA-based CMV vaccine candidate designed as a therapeutic treatment for transplant recipients.
Language	English
Publishing date	2024-03-30
Publishing country	England
Document type	Journal Article
ISSN	2059-0105
ISSN (online)	2059-0105
DOI	10.1038/s41541-024-00859-3
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Article ; Online: A phase II randomized, placebo-controlled, multicenter trial to evaluate the efficacy of cytomegalovirus PepVax vaccine in preventing cytomegalovirus reactivation and disease after allogeneic hematopoietic stem cell transplant.

Haematologica

2024

Abstract: Not available. ...

Abstract	Not available.
Language	English
Publishing date	2024-02-08
Publishing country	Italy
Document type	Journal Article
ZDB-ID	2333-4
ISSN	1592-8721 ; 0017-6567 ; 0390-6078
ISSN (online)	1592-8721
ISSN	0017-6567 ; 0390-6078
DOI	10.3324/haematol.2023.284544
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Article ; Online: Hematopoietic stem cell donor vaccination with cytomegalovirus triplex augments frequencies of functional and durable cytomegalovirus-specific T cells in the recipient: A novel strategy to limit antiviral prophylaxis.

La Rosa, Corinna / Aldoss, Ibrahim / Park, Yoonsuh / Yang, Dongyun / Zhou, Qiao / Gendzekhadze, Ketevan / Kaltcheva, Teodora / Rida, Wasima / Dempsey, Shannon / Arslan, Shukaib / Artz, Andrew / Ball, Brian / Nikolaenko, Liana / Pullarkat, Vinod A / Nakamura, Ryotaro / Diamond, Don J

American journal of hematology

2023 Volume 98, Issue 4, Page(s) 588–597

Abstract: To enhance protective cytomegalovirus (CMV)-specific T cells in immunosuppressed recipients of an allogeneic hematopoietic cell transplant (HCT), we evaluated post-HCT impact of vaccinating healthy HCT donors with Triplex. Triplex is a viral vectored ... ...

Abstract	To enhance protective cytomegalovirus (CMV)-specific T cells in immunosuppressed recipients of an allogeneic hematopoietic cell transplant (HCT), we evaluated post-HCT impact of vaccinating healthy HCT donors with Triplex. Triplex is a viral vectored recombinant vaccine expressing three immunodominant CMV antigens. The vector is modified vaccinia Ankara (MVA), an attenuated, non-replicating poxvirus derived from the vaccinia virus strain Ankara. It demonstrated tolerability and immunogenicity in healthy adults and HCT recipients, in whom it also reduced CMV reactivation. Here, we report feasibility, safety, and immunological outcomes of a pilot phase 1 trial (NCT03560752 at ClinicalTrials.gov) including 17 CMV-seropositive recipients who received an HCT from a matched related donor (MRD) vaccinated with 5.1 × 10
MeSH term(s)	Adult ; Humans ; Cytomegalovirus ; Hematopoietic Stem Cell Transplantation/adverse effects ; CD8-Positive T-Lymphocytes ; Vaccinia/drug therapy ; Vaccinia/etiology ; Cytomegalovirus Infections/prevention & control ; Antiviral Agents/therapeutic use ; Vaccination
Chemical Substances	Antiviral Agents
Language	English
Publishing date	2023-01-11
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	196767-8
ISSN	1096-8652 ; 0361-8609
ISSN (online)	1096-8652
ISSN	0361-8609
DOI	10.1002/ajh.26824
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Article ; Online: Identification of a Continuous Neutralizing Epitope within UL128 of Human Cytomegalovirus.

Chiuppesi, Flavia / Kaltcheva, Teodora / Meng, Zhuo / Barry, Peter A / Diamond, Don J / Wussow, Felix

Journal of virology

2017 Volume 91, Issue 6

Abstract: As human cytomegalovirus (HCMV) is the most common infectious cause of fetal anomalies during pregnancy, development of a vaccine that prevents HCMV infection is considered a global health priority. Although HCMV immune correlates of protection are only ... ...

Abstract	As human cytomegalovirus (HCMV) is the most common infectious cause of fetal anomalies during pregnancy, development of a vaccine that prevents HCMV infection is considered a global health priority. Although HCMV immune correlates of protection are only poorly defined, neutralizing antibodies (NAb) targeting the envelope pentamer complex (PC) composed of the subunits gH, gL, UL128, UL130, and UL131A are thought to contribute to the prevention of HCMV infection. Here, we describe a continuous target sequence within UL128 that is recognized by a previously isolated potent PC-specific NAb termed 13B5. By using peptide-based scanning procedures, we identified a 13-amino-acid-long target sequence at the UL128 C terminus that binds the 13B5 antibody with an affinity similar to that of the purified PC. In addition, the 13B5 binding site is universally conserved in HCMV, contains a previously described UL128/gL interaction site, and interferes with the 13B5 neutralizing function, indicating that the 13B5 epitope sequence is located within the PC at a site of critical importance for HCMV neutralization. Vaccination of mice with peptides containing the 13B5 target sequence resulted in the robust stimulation of binding antibodies and, in a subset of immunized animals, in the induction of detectable NAb, supporting that the identified 13B5 target sequence constitutes a PC-specific neutralizing epitope. These findings provide evidence for the discovery of a continuous neutralizing epitope within the UL128 subunit of the PC that could be an important target of humoral immune responses that are involved in protection against congenital HCMV infection.
MeSH term(s)	Animals ; Antibodies, Neutralizing/blood ; Antibodies, Viral/blood ; Binding Sites ; Conserved Sequence ; Epitope Mapping ; Epitopes, B-Lymphocyte/immunology ; Membrane Glycoproteins/immunology ; Mice ; Viral Envelope Proteins/immunology
Chemical Substances	Antibodies, Neutralizing ; Antibodies, Viral ; Epitopes, B-Lymphocyte ; Membrane Glycoproteins ; UL128 protein, human cytomegalovirus ; Viral Envelope Proteins
Language	English
Publishing date	2017--15
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	80174-4
ISSN	1098-5514 ; 0022-538X
ISSN (online)	1098-5514
ISSN	0022-538X
DOI	10.1128/JVI.01857-16
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Zs.A 609: Show issues

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Article ; Online: Adoptive transfer of functional SARS-COV-2-specific immunity from donor graft to hematopoietic stem cell transplant recipients.

La Rosa, Corinna / Chiuppesi, Flavia / Park, Yoonsuh / Gendzekhadze, Ketevan / Zhou, Qiao / Faircloth, Katelyn / Kaltcheva, Teodora / Johnson, Daisy / Ortega Francisco, Sandra / Amanam, Idoroenyi / Otoukesh, Salman / Pullarkat, Vinod A / Nakamura, Ryotaro / Diamond, Don J / Forman, Stephen J / Al Malki, Monzr M

American journal of hematology

2022 Volume 97, Issue 11, Page(s) E404–E407

MeSH term(s)	Adoptive Transfer ; COVID-19 ; Graft vs Host Disease/etiology ; Hematopoietic Stem Cell Transplantation ; Humans ; SARS-CoV-2
Language	English
Publishing date	2022-09-02
Publishing country	United States
Document type	Letter ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	196767-8
ISSN	1096-8652 ; 0361-8609
ISSN (online)	1096-8652
ISSN	0361-8609
DOI	10.1002/ajh.26691
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Article ; Online: Rapid Acquisition of Cytomegalovirus-Specific T Cells with a Differentiated Phenotype, in Nonviremic Hematopoietic Stem Transplant Recipients Vaccinated with CMVPepVax.

La Rosa, Corinna / Longmate, Jeffrey / Lingaraju, Chetan Raj / Zhou, Qiao / Kaltcheva, Teodora / Hardwick, Nicola / Aldoss, Ibrahim / Nakamura, Ryotaro / Diamond, Don J

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation

2018 Volume 25, Issue 4, Page(s) 771–784

Abstract: Early cytomegalovirus (CMV) reactivation remains a significant cause of morbidity and mortality in allogeneic hematopoietic cell transplant (HCT) recipients. CMVPepVax is an investigational peptide vaccine designed to control CMV infection in HCT ... ...

Abstract	Early cytomegalovirus (CMV) reactivation remains a significant cause of morbidity and mortality in allogeneic hematopoietic cell transplant (HCT) recipients. CMVPepVax is an investigational peptide vaccine designed to control CMV infection in HCT recipients seropositive for CMV by stimulating the expansion of T cell subsets that target the CMV tegument protein pp65. In a randomized Phase Ib pilot trial (ClinicalTrials.gov NCT01588015), two injections of CMVPepVax (at days 28 and 56 post-HCT) demonstrated safety, immunogenicity, increased relapse-free survival, and reduced CMV reactivation and use of antivirals. In the present study, we assessed the phenotypes and time courses of the pp65-specific CD8 T cell subsets that expanded in response to CMVPepVax vaccination. The functionality and antiviral role of CMV-specific T cells have been linked to immune reconstitution profiles characterized predominantly by differentiated effector memory T (TEM) subsets that have lost membrane expression of the costimulatory molecule CD28 and often reexpress the RA isoform of CD45 (TEMRA). Major histocompatibility complex class I pp65
MeSH term(s)	Cytomegalovirus/immunology ; Cytomegalovirus Infections/drug therapy ; Female ; Hematopoietic Stem Cell Transplantation/methods ; Humans ; Longitudinal Studies ; Male ; Phenotype ; T-Lymphocyte Subsets/immunology ; Transplantation Conditioning/methods ; Vaccination/methods
Language	English
Publishing date	2018-12-16
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	1474865-4
ISSN	1523-6536 ; 1083-8791
ISSN (online)	1523-6536
ISSN	1083-8791
DOI	10.1016/j.bbmt.2018.12.070
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Zs.A 5082: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 462: Show issues

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Article ; Online: Successful outcome of pre-engraftment COVID-19 in an HCT patient: impact of targeted therapies and cellular immunity.

Pourhassan, Hoda / La Rosa, Corinna / Chiuppesi, Flavia / Puing, Alfredo / Aldoss, Ibrahim / Park, Yoonsuh / Zhou, Qiao / Karpinski, Veronica / Faircloth, Katelyn / Kaltcheva, Teodora / Johnson, Daisy / Francisco, Sandra Ortega / Zaia, John A / Nakamura, Ryotaro / Al Malki, Monzr M / Diamond, Don J / Dadwal, Sanjeet Singh / Forman, Stephen J

Blood advances

2021 Volume 6, Issue 6, Page(s) 1645–1650

Abstract: Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has emerged as a global pandemic that upended existing protocols and practices, including those for allogeneic hematopoietic stem cell ... ...

Abstract	Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has emerged as a global pandemic that upended existing protocols and practices, including those for allogeneic hematopoietic stem cell transplantation (HCT). Here, we describe the successful clinical course and multiple key interventions administered to an acute lymphoblastic leukemia patient, who tested SARS-CoV-2 positive by reverse transcriptase polymerase chain reaction on day -1 of matched unrelated donor (SARS-CoV-2 immunoglobulin G negative) T-cell-replete HCT. This experience allowed for implementing a virologic and immunomonitoring panel to characterize the impact of SARS-CoV-2 on the recipient's nascent humoral and cellular immune response. The finding of robust, functional, and persistent levels of SARS-CoV-2-specific T cells, starting early after transplant was unexpected, and in combination with the clinical strategy, may have contributed to the favorable outcome. Additionally, it is plausible that preexisting cross-reactive endemic coronavirus immunity in the allogeneic graft reduced recipient susceptibility to COVID-19 disease. This case supports the critical role that T-cell responses may play in mitigating SARS-CoV-2 infection, even in the context of transplant immunosuppression, in which reconstitution of humoral response is commonly delayed. Interventional approaches to transfer SARS-CoV-2-specific cellular immunity such as HCT donor vaccination and adaptive cellular therapy could be of benefit.
MeSH term(s)	COVID-19 ; Hematopoietic Stem Cell Transplantation ; Humans ; Immunity, Cellular ; Pandemics ; SARS-CoV-2
Language	English
Publishing date	2021-12-06
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2915908-8
ISSN	2473-9537 ; 2473-9529
ISSN (online)	2473-9537
ISSN	2473-9529
DOI	10.1182/bloodadvances.2021006282
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Zs.A 7153: Show issues

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Article ; Online: Vaccine-induced spike- and nucleocapsid-specific cellular responses maintain potent cross-reactivity to SARS-CoV-2 Delta and Omicron variants.

iScience

2022 Volume 25, Issue 8, Page(s) 104745

Abstract: Cell-mediated immunity may contribute to providing protection against SARS-CoV-2 and its variants of concern (VOC). We developed COH04S1, a synthetic multiantigen modified vaccinia Ankara (MVA)-based COVID-19 vaccine that stimulated potent spike (S) and ... ...

Abstract	Cell-mediated immunity may contribute to providing protection against SARS-CoV-2 and its variants of concern (VOC). We developed COH04S1, a synthetic multiantigen modified vaccinia Ankara (MVA)-based COVID-19 vaccine that stimulated potent spike (S) and nucleocapsid (N) antigen-specific humoral and cellular immunity in a phase 1 clinical trial in healthy adults. Here, we show that individuals vaccinated with COH04S1 or mRNA vaccine BNT162b2 maintain robust cross-reactive cellular immunity for six or more months post-vaccination. Although neutralizing antibodies induced in COH04S1- and BNT162b2-vaccinees showed reduced activity against Delta and Omicron variants compared to ancestral SARS-CoV-2, S-specific T cells elicited in both COH04S1- and BNT162b2-vaccinees and N-specific T cells elicited in COH04S1-vaccinees demonstrated potent and equivalent cross-reactivity against ancestral SARS-CoV-2 and the major VOC. These results suggest that vaccine-induced T cells to S and N antigens may constitute a critical second line of defense to provide long-term protection against SARS-CoV-2 VOC.
Language	English
Publishing date	2022-07-11
Publishing country	United States
Document type	Journal Article
ISSN	2589-0042
ISSN (online)	2589-0042
DOI	10.1016/j.isci.2022.104745
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Article ; Online: Synthetic multiantigen MVA vaccine COH04S1 protects against SARS-CoV-2 in Syrian hamsters and non-human primates.

NPJ vaccines

2022 Volume 7, Issue 1, Page(s) 7

Abstract: Second-generation COVID-19 vaccines could contribute to establish protective immunity against SARS-CoV-2 and its emerging variants. We developed COH04S1, a synthetic multiantigen modified vaccinia Ankara-based SARS-CoV-2 vaccine that co-expresses spike ... ...

Abstract	Second-generation COVID-19 vaccines could contribute to establish protective immunity against SARS-CoV-2 and its emerging variants. We developed COH04S1, a synthetic multiantigen modified vaccinia Ankara-based SARS-CoV-2 vaccine that co-expresses spike and nucleocapsid antigens. Here, we report COH04S1 vaccine efficacy in animal models. We demonstrate that intramuscular or intranasal vaccination of Syrian hamsters with COH04S1 induces robust Th1-biased antigen-specific humoral immunity and cross-neutralizing antibodies (NAb) and protects against weight loss, lower respiratory tract infection, and lung injury following intranasal SARS-CoV-2 challenge. Moreover, we demonstrate that single-dose or two-dose vaccination of non-human primates with COH04S1 induces robust antigen-specific binding antibodies, NAb, and Th1-biased T cells, protects against both upper and lower respiratory tract infection following intranasal/intratracheal SARS-CoV-2 challenge, and triggers potent post-challenge anamnestic antiviral responses. These results demonstrate COH04S1-mediated vaccine protection in animal models through different vaccination routes and dose regimens, complementing ongoing investigation of this multiantigen SARS-CoV-2 vaccine in clinical trials.
Language	English
Publishing date	2022-01-21
Publishing country	England
Document type	Journal Article
ISSN	2059-0105
ISSN (online)	2059-0105
DOI	10.1038/s41541-022-00436-6
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