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Article: Exciting Times for Cytomegalovirus (CMV) Vaccine Development: Navigating the Pathways toward the Goal of Protecting Infants against Congenital CMV Infection.

Schleiss, Mark R / Diamond, Don J

2020 Volume 8, Issue 3

Abstract: The congenital transmission of cytomegalovirus (cCMV) is the most common infectious cause of disability in children in the developed world, and probably globally [ ... ]. ...

Abstract	The congenital transmission of cytomegalovirus (cCMV) is the most common infectious cause of disability in children in the developed world, and probably globally [...].
Language	English
Publishing date	2020-09-14
Publishing country	Switzerland
Document type	Editorial
ZDB-ID	2703319-3
ISSN	2076-393X
ISSN	2076-393X
DOI	10.3390/vaccines8030526
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Article ; Online: Development of CMV-CD19 bi-specific CAR T cells with post-infusion in vivo boost using an anti-CMV vaccine.

Wang, Xiuli / Diamond, Don J / Forman, Stephen J / Nakamura, Ryotaro

International journal of hematology

2021 Volume 114, Issue 5, Page(s) 544–553

Abstract: Adoptive transfer of in vitro expanded, chimeric antigen receptor (CAR)-redirected CD19-specific T cells can induce dramatic disease regression in patients with leukemia and lymphomas. However, the full potential of this emerging modality is hampered in ... ...

Abstract	Adoptive transfer of in vitro expanded, chimeric antigen receptor (CAR)-redirected CD19-specific T cells can induce dramatic disease regression in patients with leukemia and lymphomas. However, the full potential of this emerging modality is hampered in some cancer settings by a significant rate of therapeutic failure arising from the attenuated engraftment and persistence of CAR-redirected T cells, and tumor relapse following adoptive transfer. Here, we discuss an advanced strategy that facilitates post-infusion in vivo boosting of CAR T cells via CMV vaccination, to mediate durable remission of B cell malignancies by engrafting a CAR molecule onto a CMV-specific T cell. We also discuss a feasible and unique platform for the generation of the CMV-CD19CAR T cells for clinical application. This new approach would overcome multiple challenges in current CAR T cell technology including: short T cell persistence, limited duration of response, and inability to re-stimulate T cells after relapse or persistent disease.
MeSH term(s)	Animals ; Antigens, CD19/immunology ; Combined Modality Therapy ; Cytomegalovirus Infections/etiology ; Cytomegalovirus Infections/prevention & control ; Cytomegalovirus Vaccines/administration & dosage ; Cytomegalovirus Vaccines/immunology ; Disease Management ; Disease Susceptibility ; Genetic Engineering ; Humans ; Immunotherapy, Adoptive/adverse effects ; Immunotherapy, Adoptive/methods ; Leukemia/complications ; Leukemia/etiology ; Leukemia/therapy ; Lymphoma/complications ; Lymphoma/etiology ; Lymphoma/therapy ; Prognosis ; Receptors, Antigen, T-Cell/immunology ; T-Lymphocytes/immunology ; T-Lymphocytes/metabolism ; Translational Research, Biomedical ; Treatment Outcome
Chemical Substances	Antigens, CD19 ; CD19-specific chimeric antigen receptor ; Cytomegalovirus Vaccines ; Receptors, Antigen, T-Cell
Language	English
Publishing date	2021-09-24
Publishing country	Japan
Document type	Journal Article ; Review
ZDB-ID	1076875-0
ISSN	1865-3774 ; 0917-1258 ; 0925-5710
ISSN (online)	1865-3774
ISSN	0917-1258 ; 0925-5710
DOI	10.1007/s12185-021-03215-6
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Article ; Online: Synthetic multiantigen MVA vaccine COH04S1 and variant-specific derivatives protect Syrian hamsters from SARS-CoV-2 Omicron subvariants.

Wussow, Felix / Kha, Mindy / Kim, Taehyun / Ly, Minh / Yll-Pico, Marcal / Kar, Swagata / Lewis, Mark G / Chiuppesi, Flavia / Diamond, Don J

NPJ vaccines

2023 Volume 8, Issue 1, Page(s) 41

Abstract: Emerging SARS-CoV-2 Omicron subvariants continue to disrupt COVID-19 vaccine efficacy through multiple immune mechanisms including neutralizing antibody evasion. We developed COH04S1, a synthetic modified vaccinia Ankara vector that co-expresses Wuhan-Hu- ...

Abstract	Emerging SARS-CoV-2 Omicron subvariants continue to disrupt COVID-19 vaccine efficacy through multiple immune mechanisms including neutralizing antibody evasion. We developed COH04S1, a synthetic modified vaccinia Ankara vector that co-expresses Wuhan-Hu-1-based spike and nucleocapsid antigens. COH04S1 demonstrated efficacy against ancestral virus and Beta and Delta variants in animal models and was safe and immunogenic in a Phase 1 clinical trial. Here, we report efficacy of COH04S1 and analogous Omicron BA.1- and Beta-specific vaccines to protect Syrian hamsters from Omicron subvariants. Despite eliciting strain-specific antibody responses, all three vaccines protect hamsters from weight loss, lower respiratory tract infection, and lung pathology following challenge with Omicron BA.1 or BA.2.12.1. While the BA.1-specifc vaccine affords consistently improved efficacy compared to COH04S1 to protect against homologous challenge with BA.1, all three vaccines confer similar protection against heterologous challenge with BA.2.12.1. These results demonstrate efficacy of COH04S1 and variant-specific derivatives to confer cross-protective immunity against SARS-CoV-2 Omicron subvariants.
Language	English
Publishing date	2023-03-16
Publishing country	England
Document type	Journal Article
ISSN	2059-0105
ISSN (online)	2059-0105
DOI	10.1038/s41541-023-00640-y
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Article ; Online: Synthetic modified vaccinia Ankara vaccines confer cross-reactive and protective immunity against mpox virus.

Chiuppesi, Flavia / Zaia, John A / Gutierrez-Franco, Miguel-Angel / Ortega-Francisco, Sandra / Ly, Minh / Kha, Mindy / Kim, Taehyun / Dempsey, Shannon / Kar, Swagata / Grifoni, Alba / Sette, Alessandro / Wussow, Felix / Diamond, Don J

Communications medicine

2024 Volume 4, Issue 1, Page(s) 19

Abstract: Background: Although the mpox global health emergency caused by mpox virus (MPXV) clade IIb.1 has ended, mpox cases are still reported due to low vaccination coverage and waning immunity. COH04S1 is a clinically evaluated, multiantigen COVID-19 vaccine ... ...

Abstract	Background: Although the mpox global health emergency caused by mpox virus (MPXV) clade IIb.1 has ended, mpox cases are still reported due to low vaccination coverage and waning immunity. COH04S1 is a clinically evaluated, multiantigen COVID-19 vaccine candidate built on a fully synthetic platform of the highly attenuated modified vaccinia Ankara (MVA) vector, representing the only FDA-approved smallpox/mpox vaccine JYNNEOS. Given the potential threat of MPXV resurgence and need for vaccine alternatives, we aimed to assess the capacity COH04S1 and its synthetic MVA (sMVA) backbone to confer MPXV-specific immunity. Methods: We evaluated orthopoxvirus-specific and MPXV cross-reactive immune responses in samples collected during a Phase 1 clinical trial of COH04S1 and in non-human primates (NHP) vaccinated with COH04S1 or its sMVA backbone. MPXV cross-reactive immune responses in COH04S1-vaccinated healthy adults were compared to responses measured in healthy subjects vaccinated with JYNNEOS. Additionally, we evaluated the protective efficacy of COH04S1 and sMVA against mpox in mpox-susceptible CAST/EiJ mice. Results: COH04S1-vaccinated individuals develop robust orthopoxvirus-specific humoral and cellular responses, including cross-reactive antibodies to MPXV-specific virion proteins as well as MPXV cross-neutralizing antibodies in 45% of the subjects. In addition, NHP vaccinated with COH04S1 or sMVA show similar MPXV cross-reactive antibody responses. Moreover, MPXV cross-reactive humoral responses elicited by COH04S1 are comparable to those measured in JYNNEOS-vaccinated subjects. Finally, we show that mice vaccinated with COH04S1 or sMVA are protected from lung infection following challenge with MPXV clade IIb.1. Conclusions: These results demonstrate the capacity of sMVA vaccines to elicit cross-reactive and protective orthopox-specific immunity against MPXV, suggesting that COH04S1 and sMVA could be developed as bivalent or monovalent mpox vaccine alternatives against MPXV.
Language	English
Publishing date	2024-02-16
Publishing country	England
Document type	Journal Article
ISSN	2730-664X
ISSN (online)	2730-664X
DOI	10.1038/s43856-024-00443-9
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Article ; Online: Immunologic Signatures of Peripheral Blood T Cells Reveal the Outcome of p53MVA Vaccine and Pembrolizumab Treatment in Patients with Advanced Ovarian Cancer.

Kos, Ferdynand J / Frankel, Paul / Cristea, Mihaela / Eng, Melissa / Tinsley, Raechelle / Dempsey, Shannon / Ruel, Nora / Stewart, Daphne / Dellinger, Thanh H / Diamond, Don J

Cancer research communications

2024 Volume 3, Issue 12, Page(s) 2585–2595

Abstract: Purpose: Our previous studies indicated that p53-reactive T cells were associated with clinical benefit in patients with advanced ovarian cancer who were treated with p53-expressing modified vaccinia Ankara (p53MVA) vaccine and gemcitabine chemotherapy. ...

Abstract	Purpose: Our previous studies indicated that p53-reactive T cells were associated with clinical benefit in patients with advanced ovarian cancer who were treated with p53-expressing modified vaccinia Ankara (p53MVA) vaccine and gemcitabine chemotherapy. To replace chemotherapy with an approach that will enhance vaccine efficacy and antitumor immunity, we treated patients with p53MVA in combination with PD-1 checkpoint blocker, pembrolizumab. We also attempted to further characterize the activation status of T cells prior to vaccination and during treatment. Experimental design: Patients received up to three triweekly vaccinations concurrent with pembrolizumab, followed by pembrolizumab monotherapy at 3-week intervals. Correlative studies analyzed peripheral blood T-cell phenotypes and profiles of immune function gene expression. Results: We observed 6/28 (21%) patients with a clinical benefit to therapy, including 3 partial responses (PR) and 3 patients with stable disease (SD) for 6+ months. The median progression-free survival was 1.8 months (95% confidence interval: 1.7-3.8) and median overall survival was 15.1 months (9.4-30.4). Two patients remain progression-free at 28 and 33 months. Of the 18 patients evaluable in correlative studies, 6 were immunologic responders of whom 5 had clinical benefit (3 PR, 2 SD). Immunologic non-responders expressed in pretreatment peripheral blood mononuclear cell samples high levels of mRNA for multiple molecules associated with terminally differentiated T cells. Conclusions: p53MVA/pembrolizumab immunotherapy showed promising antitumor activity in patients who demonstrated functionally competent peripheral blood T cells. Detection of markers of terminally differentiated T cells before treatment may identify patients unlikely to respond to p53MVA/pembrolizumab. Significance: The activity of a combination immunotherapy of p53 vaccine and PD-1 checkpoint blockade in patients with platinum-resistant ovarian cancer was evaluated in a phase II trial. Clinical benefit was correlated with the responsive immune status of patients before and during the treatment, defining potential predictive markers for immune therapy.
MeSH term(s)	Female ; Humans ; Carcinoma, Ovarian Epithelial/drug therapy ; Leukocytes, Mononuclear ; Ovarian Neoplasms/drug therapy ; Programmed Cell Death 1 Receptor ; T-Lymphocytes ; Tumor Suppressor Protein p53/genetics ; Vaccinia
Chemical Substances	pembrolizumab (DPT0O3T46P) ; Programmed Cell Death 1 Receptor ; Tumor Suppressor Protein p53
Language	English
Publishing date	2024-01-26
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ISSN	2767-9764
ISSN (online)	2767-9764
DOI	10.1158/2767-9764.CRC-23-0394
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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: Protection against Congenital CMV Infection Conferred by MVA-Vectored Subunit Vaccines Extends to a Second Pregnancy after Maternal Challenge with a Heterologous, Novel Strain Variant

Fernández-Alarcón, Claudia / Buchholz, Grace / Contreras, Heidi / Wussow, Felix / Nguyen, Jenny / Diamond, Don J. / Schleiss, Mark R.

Viruses. 2021 Dec. 20, v. 13, no. 12

2021

Abstract: Maternal reinfection of immune women with novel human cytomegalovirus (HCMV) strains acquired during pregnancy can result in symptomatic congenital CMV (cCMV) infection. Novel animal model strategies are needed to explore vaccine-mediated protections ... ...

Abstract	Maternal reinfection of immune women with novel human cytomegalovirus (HCMV) strains acquired during pregnancy can result in symptomatic congenital CMV (cCMV) infection. Novel animal model strategies are needed to explore vaccine-mediated protections against maternal reinfection. To investigate this in the guinea pig cytomegalovirus (GPCMV) model, a strictly in vivo-passaged workpool of a novel strain, the CIDMTR strain (dose, 1 × 10⁷ pfu) was used to infect dams that had been challenged in a previous pregnancy with the 22122 strain, following either sham-immunization (vector only) or vaccination with MVA-vectored gB, gH/gL, or pentameric complex (PC) vaccines. Maternal DNAemia cleared by day 21 in the glycoprotein-vaccinated dams, but not in the sham-immunized dams. Mean pup birth weights were 72.85 ± 10.2, 80.0 ± 6.9, 81.4 ± 14.1, and 89.38 ± 8.4 g in sham-immunized, gB, gH/gL, and PC groups, respectively (p < 0.01 for control v. PC). Pup mortality in the sham-immunized group was 6/12 (50%), but reduced to 3/35 (8.6%) in combined vaccine groups (p = 0.0048). Vertical CIDMTR transmission occurred in 6/12 pups (50%) in the sham-vaccinated group, compared to 2/34 pups (6%) in the vaccine groups (p = 0.002). We conclude that guinea pigs immunized with vectored vaccines expressing 22122 strain-specific glycoproteins are protected after a reinfection with a novel, heterologous clinical isolate (CIDMTR) in a second pregnancy.
Keywords	Caviid betaherpesvirus 2 ; Human betaherpesvirus 5 ; animal models ; glycoproteins ; mortality ; pregnancy ; vaccination
Language	English
Dates of publication	2021-1220
Publishing place	Multidisciplinary Digital Publishing Institute
Document type	Article
ZDB-ID	2516098-9
ISSN	1999-4915
ISSN	1999-4915
DOI	10.3390/v13122551
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Induction of poxviral immunity by synthetic MVA-based dual-antigen COVID-19 vaccine COH04S1

Chiuppesi, Flavia / Zaia, John A / Francisco, Sandra Ortega / Ly, Michael / Wussow, Felix / Diamond, Don J

medRxiv

Abstract: The recent outbreak of monkeypox outside its endemic boundaries has attracted global attention and prompted world leaders to reserve thousands of doses of the only approved third-generation smallpox/monkeypox vaccine Jynneos, which is based on the highly ...

Abstract	The recent outbreak of monkeypox outside its endemic boundaries has attracted global attention and prompted world leaders to reserve thousands of doses of the only approved third-generation smallpox/monkeypox vaccine Jynneos, which is based on the highly attenuated modified vaccinia Ankara (MVA) vector. Given the potential urgency to vaccinate individuals at risk in both endemic and non-endemic countries to curtail further spread of the outbreak, there is a legitimate need for substantial doses of smallpox/monkeypox vaccines. We previously developed COH04S1, a multiantigen SARS-CoV-2 vaccine candidate built on a synthetic MVA platform. COH04S1 was found to be safe and to induce SARS-CoV-2-specific immune responses in healthy adults participating in a phase 1, blinded, randomized, placebo-controlled clinical trial. Here we perform a retrospective analysis of vaccine-induced orthopoxvirus immunity in a subgroup of volunteers enrolled in the phase 1 clinical trial that were vaccinated with COH04S1 at different doses. At all dose levels, vaccination with COH04S1 resulted in robust MVA-specific binding and neutralizing antibody responses, which were sustained over six months post-vaccination. Similarly, both CD8+ and CD4+ T cells specific for MVA were induced by COH04S1 vaccination and remained durable for at least six months. Given that both arms of the immune response are thought to be involved in protection against orthopoxvirus infections, our results indicate that COH04S1 or other sMVA-based vaccines may represent valuable candidates for smallpox/monkeypox vaccination.
Keywords	covid19
Language	English
Publishing date	2022-07-29
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2022.07.26.22277958
Database	COVID19

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Article: Targeting fat mass and obesity-associated protein mitigates human colorectal cancer growth

Phan, Thuy / Nguyen, Vu H / Su, Rui / Li, Yangchan / Qing, Ying / Qin, Hanjun / Cho, Hyejin / Jiang, Lei / Wu, Xiwei / Chen, Jianjun / Fakih, Marwan / Diamond, Don J / Goel, Ajay / Melstrom, Laleh G

Frontiers in oncology

2023 Volume 13, Page(s) 1087644

Abstract: Introduction: Colorectal cancer (CRC) remains a significant cause of cancer related mortality. Fat mass and obesity-associated protein (FTO) is a m6A mRNA demethylase that plays an oncogenic role in various malignancies. In this study we evaluated the ... ...

Abstract	Introduction: Colorectal cancer (CRC) remains a significant cause of cancer related mortality. Fat mass and obesity-associated protein (FTO) is a m6A mRNA demethylase that plays an oncogenic role in various malignancies. In this study we evaluated the role of FTO in CRC tumorigenesis. Methods: Cell proliferation assays were conducted in 6 CRC cell lines with the FTO inhibitor CS1 (50-3200 nM) (± 5-FU 5-80 mM) and after lentivirus mediated FTO knockdown. Cell cycle and apoptosis assays were conducted in HCT116 cells (24 h and 48 h, 290 nM CS1). Western blot and m6A dot plot assays were performed to assess CS1 inhibition of cell cycle proteins and FTO demethylase activity. Migration and invasion assays of shFTO cells and CS1 treated cells were performed. An in vivo heterotopic model of HCT116 cells treated with CS1 or with FTO knockdown cells was performed. RNA-seq was performed on shFTO cells to assess which molecular and metabolic pathways were impacted. RT-PCR was conducted on select genes down-regulated by FTO knockdown. Results: We found that the FTO inhibitor, CS1 suppressed CRC cell proliferation in 6 colorectal cancer cell lines and in the 5-Fluorouracil resistant cell line (HCT116-5FUR). CS1 induced cell cycle arrest in the G2/M phase by down regulation of CDC25C and promoted apoptosis of HCT116 cells. CS1 suppressed in vivo tumor growth in the HCT116 heterotopic model (p< 0.05). Lentivirus knockdown of FTO in HCT116 cells (shFTO) mitigated in vivo tumor proliferation and in vitro demethylase activity, cell growth, migration and invasion compared to shScr controls (p< 0.01). RNA-seq of shFTO cells compared to shScr demonstrated down-regulation of pathways related to oxidative phosphorylation, MYC and Akt/ mTOR signaling pathways. Discussion: Further work exploring the targeted pathways will elucidate precise downstream mechanisms that can potentially translate these findings to clinical trials.
Language	English
Publishing date	2023-02-17
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2649216-7
ISSN	2234-943X
ISSN	2234-943X
DOI	10.3389/fonc.2023.1087644
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