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Article ; Online: HIV-1 therapeutic vaccines in clinical development to intensify or replace antiretroviral therapy: the promising results of the Tat vaccine.

Cafaro, Aurelio / Ensoli, Barbara

2022 Volume 21, Issue 9, Page(s) 1243–1253

Abstract: Introduction: Upon the introduction of the combination antiretroviral therapy (cART), HIV infection has become a chronic disease. However, cART is unable to eradicate the virus and fails to restore the CD4 counts in about 30% of the treated individuals. ...

Abstract	Introduction: Upon the introduction of the combination antiretroviral therapy (cART), HIV infection has become a chronic disease. However, cART is unable to eradicate the virus and fails to restore the CD4 counts in about 30% of the treated individuals. Furthermore, treatment is life-long, and it does not protect from morbidities typically observed in the elderly. Therapeutic vaccines represent the most cost-effective intervention to intensify or replace cART. Areas covered: Here, we briefly discuss the obstacles to the development and evaluation of the efficacy of therapeutic vaccines and review recent approaches evaluated in clinical trials. Expert opinion: Although vaccines were generally safe and immunogenic, evidence of efficacy was negligible or marginal in most trials. A notable exception is the therapeutic Tat vaccine approach showing promising results of cART intensification, with CD4 T-cell increase and proviral load reduction beyond those afforded by cART alone. Rationale and evidence in support of choosing Tat as the vaccine target are thoroughly discussed.
MeSH term(s)	AIDS Vaccines ; Aged ; HIV Infections/drug therapy ; HIV Infections/prevention & control ; HIV-1 ; Humans ; Viral Load
Chemical Substances	AIDS Vaccines
Language	English
Publishing date	2022-06-17
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2181284-6
ISSN	1744-8395 ; 1476-0584
ISSN (online)	1744-8395
ISSN	1476-0584
DOI	10.1080/14760584.2022.2089119
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Article ; Online: Kaposi's Sarcoma Lesion Progression in BKV-Tat Transgenic Mice Is Increased by Inflammatory Cytokines and Blocked by Treatment with Anti-Tat Antibodies.

Brocca-Cofano, Egidio / Sgadari, Cecilia / Picconi, Orietta / Palladino, Clelia / Caputo, Antonella / Ensoli, Barbara

International journal of molecular sciences

2022 Volume 23, Issue 4

Abstract: Kaposi's sarcoma (KS) is an angioproliferative tumor showing an increased frequency and aggressiveness in HIV-infected subjects (AIDS-KS), due to the combined effects of inflammatory cytokines (IC), angiogenic factors, and the HIV-1 Tat protein. While ... ...

Abstract	Kaposi's sarcoma (KS) is an angioproliferative tumor showing an increased frequency and aggressiveness in HIV-infected subjects (AIDS-KS), due to the combined effects of inflammatory cytokines (IC), angiogenic factors, and the HIV-1 Tat protein. While the introduction of effective combined antiretroviral regimens greatly improved AIDS-KS incidence and course, it continues to be an incurable disease and the development of new rational targeted therapies is warranted. We used the BKV/Tat transgenic mouse model to evaluate the effects of IC and anti-Tat antibodies (Abs) treatment on KS-like lesions arising in BKV/Tat mice. We demonstrated here that IC-treatment increases the severity and delays the regression of KS-like lesions. Further, anti-Tat Abs reduced KS-like lesion severity developing in IC-treated mice when anti-Tat Abs were administered at an early-stage of lesion development as compared to more advanced lesions. Early anti-Tat Abs treatment also accelerated KS-like lesion regression and reduced the rate of severe-grade lesions. This effect was more evident in the first weeks after Ab treatment, suggesting that a longer treatment with anti-Tat Abs might be even more effective, particularly if administered just after lesion development. Although preliminary, these results are encouraging, and the approach deserves further studies for the development of anti-Tat Ab-based therapies for AIDS-KS. Clinical studies specifically addressing the effect of anti-Tat antibodies in treating AIDS-KS are not yet available. Nevertheless, the effectiveness of anti-Tat antibodies in controlling HIV/AIDS progression, likely due to the neutralization of extracellular Tat activities, is suggested by several cross-sectional and longitudinal clinical studies, indicating that anti-Tat Ab treatment or Tat-based vaccines may be effective to treat AIDS-KS patients or prevent the tumor in individuals at risk.
MeSH term(s)	Angiogenesis Inducing Agents/metabolism ; Animals ; Anti-Retroviral Agents/pharmacology ; Antibodies/pharmacology ; Cytokines/metabolism ; Disease Models, Animal ; HIV-1/drug effects ; Male ; Mice ; Mice, Transgenic ; Sarcoma, Kaposi/drug therapy ; Sarcoma, Kaposi/metabolism ; Sarcoma, Kaposi/pathology ; tat Gene Products, Human Immunodeficiency Virus/metabolism
Chemical Substances	Angiogenesis Inducing Agents ; Anti-Retroviral Agents ; Antibodies ; Cytokines ; tat Gene Products, Human Immunodeficiency Virus
Language	English
Publishing date	2022-02-14
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2019364-6
ISSN	1422-0067 ; 1422-0067 ; 1661-6596
ISSN (online)	1422-0067
ISSN	1422-0067 ; 1661-6596
DOI	10.3390/ijms23042081
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Article ; Online: Role of HIV-1 Tat Protein Interactions with Host Receptors in HIV Infection and Pathogenesis.

Cafaro, Aurelio / Schietroma, Ivan / Sernicola, Leonardo / Belli, Roberto / Campagna, Massimo / Mancini, Flavia / Farcomeni, Stefania / Pavone-Cossut, Maria Rosaria / Borsetti, Alessandra / Monini, Paolo / Ensoli, Barbara

International journal of molecular sciences

2024 Volume 25, Issue 3

Abstract: Each time the virus starts a new round of expression/replication, even under effective antiretroviral therapy (ART), the transactivator of viral transcription Tat is one of the first HIV-1 protein to be produced, as it is strictly required for HIV ... ...

Abstract	Each time the virus starts a new round of expression/replication, even under effective antiretroviral therapy (ART), the transactivator of viral transcription Tat is one of the first HIV-1 protein to be produced, as it is strictly required for HIV replication and spreading. At this stage, most of the Tat protein exits infected cells, accumulates in the extracellular matrix and exerts profound effects on both the virus and neighbor cells, mostly of the innate and adaptive immune systems. Through these effects, extracellular Tat contributes to the acquisition of infection, spreading and progression to AIDS in untreated patients, or to non-AIDS co-morbidities in ART-treated individuals, who experience inflammation and immune activation despite virus suppression. Here, we review the role of extracellular Tat in both the virus life cycle and on cells of the innate and adaptive immune system, and we provide epidemiological and experimental evidence of the importance of targeting Tat to block residual HIV expression and replication. Finally, we briefly review vaccine studies showing that a therapeutic Tat vaccine intensifies ART, while its inclusion in a preventative vaccine may blunt escape from neutralizing antibodies and block early events in HIV acquisition.
MeSH term(s)	Humans ; HIV Infections ; HIV-1/metabolism ; tat Gene Products, Human Immunodeficiency Virus/metabolism ; Antibodies, Neutralizing ; Vaccines/therapeutic use
Chemical Substances	tat Gene Products, Human Immunodeficiency Virus ; Antibodies, Neutralizing ; Vaccines
Language	English
Publishing date	2024-01-30
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2019364-6
ISSN	1422-0067 ; 1422-0067 ; 1661-6596
ISSN (online)	1422-0067
ISSN	1422-0067 ; 1661-6596
DOI	10.3390/ijms25031704
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Article ; Online: The Impact of Human Papilloma Viruses, Matrix Metallo-Proteinases and HIV Protease Inhibitors on the Onset and Progression of Uterine Cervix Epithelial Tumors: A Review of Preclinical and Clinical Studies.

Barillari, Giovanni / Monini, Paolo / Sgadari, Cecilia / Ensoli, Barbara

International journal of molecular sciences

2018 Volume 19, Issue 5

Abstract: Infection of uterine cervix epithelial cells by the Human Papilloma Viruses (HPV) is associated with the development of dysplastic/hyperplastic lesions, termed cervical intraepithelial neoplasia (CIN). CIN lesions may regress, persist or progress to ... ...

Abstract	Infection of uterine cervix epithelial cells by the Human Papilloma Viruses (HPV) is associated with the development of dysplastic/hyperplastic lesions, termed cervical intraepithelial neoplasia (CIN). CIN lesions may regress, persist or progress to invasive cervical carcinoma (CC), a leading cause of death worldwide. CIN is particularly frequent and aggressive in women infected by both HPV and the Human Immunodeficiency Virus (HIV), as compared to the general female population. In these individuals, however, therapeutic regimens employing HIV protease inhibitors (HIV-PI) have reduced CIN incidence and/or clinical progression, shedding light on the mechanism(s) of its development. This article reviews published work concerning: (i) the role of HPV proteins (including HPV-E5, E6 and E7) and of matrix-metalloproteinases (MMPs) in CIN evolution into invasive CC; and (ii) the effect of HIV-PI on events leading to CIN progression such as basement membrane and extracellular matrix invasion by HPV-positive CIN cells and the formation of new blood vessels. Results from the reviewed literature indicate that CIN clinical progression can be monitored by evaluating the expression of MMPs and HPV proteins and they suggest the use of HIV-PI or their derivatives for the block of CIN evolution into CC in both HIV-infected and uninfected women.
MeSH term(s)	Disease Progression ; Epithelial Cells/virology ; Female ; HIV Protease Inhibitors/pharmacology ; HIV Protease Inhibitors/therapeutic use ; Humans ; Matrix Metalloproteinases/metabolism ; Papillomaviridae/physiology ; Uterine Cervical Neoplasms/drug therapy ; Uterine Cervical Neoplasms/virology
Chemical Substances	HIV Protease Inhibitors ; Matrix Metalloproteinases (EC 3.4.24.-)
Language	English
Publishing date	2018-05-09
Publishing country	Switzerland
Document type	Journal Article ; Review
ZDB-ID	2019364-6
ISSN	1422-0067 ; 1422-0067 ; 1661-6596
ISSN (online)	1422-0067
ISSN	1422-0067 ; 1661-6596
DOI	10.3390/ijms19051418
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Article: Rational vaccine strategies against AIDS: background and rationale.

Ensoli, Barbara

Microbes and infection

2005 Volume 7, Issue 14, Page(s) 1445–1452

Abstract: New vaccine candidates exploiting the rational combination of regulatory and structural HIV gene products are being developed within the program of the AIDS Vaccine Integrated Project (AVIP) and will be tested in comparative preclinical and clinical ... ...

Abstract	New vaccine candidates exploiting the rational combination of regulatory and structural HIV gene products are being developed within the program of the AIDS Vaccine Integrated Project (AVIP) and will be tested in comparative preclinical and clinical trials with the ultimate goal of selecting proper candidates for advanced clinical testing in developing countries.
MeSH term(s)	AIDS Vaccines/genetics ; AIDS Vaccines/immunology ; Clinical Trials as Topic ; Drug Evaluation, Preclinical ; HIV Infections/prevention & control ; HIV Infections/therapy ; Humans ; Vaccines, Combined/genetics ; Vaccines, Combined/immunology ; Viral Nonstructural Proteins/genetics ; Viral Nonstructural Proteins/immunology ; Viral Structural Proteins/genetics ; Viral Structural Proteins/immunology
Chemical Substances	AIDS Vaccines ; Vaccines, Combined ; Viral Nonstructural Proteins ; Viral Structural Proteins
Language	English
Publishing date	2005-11
Publishing country	France
Document type	Journal Article
ZDB-ID	1465093-9
ISSN	1769-714X ; 1286-4579
ISSN (online)	1769-714X
ISSN	1286-4579
DOI	10.1016/j.micinf.2005.07.024
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Article: Criteria for selection of HIV vaccine candidates--general principles.

Ensoli, Barbara

Microbes and infection

2005 Volume 7, Issue 14, Page(s) 1433–1435

Abstract: The generation of a vaccine against HIV/AIDS is extremely challenging, as evidenced by more than 20 years of attempts. Here are highlighted the strategies adopted within the AIDS Vaccine Integrated project (AVIP) to speed up the clinical evaluation of ... ...

Abstract	The generation of a vaccine against HIV/AIDS is extremely challenging, as evidenced by more than 20 years of attempts. Here are highlighted the strategies adopted within the AIDS Vaccine Integrated project (AVIP) to speed up the clinical evaluation of novel vaccine candidates and to increase the chances to get an effective preventive and/or therapeutic vaccine.
MeSH term(s)	AIDS Vaccines/genetics ; AIDS Vaccines/immunology ; Animals ; Clinical Trials as Topic ; Disease Models, Animal ; Drug Evaluation, Preclinical ; Gene Products, env/genetics ; Gene Products, env/immunology ; Gene Products, nef/genetics ; Gene Products, nef/immunology ; Gene Products, tat/genetics ; Gene Products, tat/immunology ; Genes, Viral ; HIV Antigens/genetics ; HIV Antigens/immunology ; HIV Infections/immunology ; HIV Infections/prevention & control ; HIV-1/genetics ; HIV-1/immunology ; Humans ; Models, Animal ; Vaccines, Combined/genetics ; Vaccines, Combined/immunology ; Vaccines, DNA/immunology ; env Gene Products, Human Immunodeficiency Virus ; nef Gene Products, Human Immunodeficiency Virus ; tat Gene Products, Human Immunodeficiency Virus
Chemical Substances	AIDS Vaccines ; Gene Products, env ; Gene Products, nef ; Gene Products, tat ; HIV Antigens ; Vaccines, Combined ; Vaccines, DNA ; env Gene Products, Human Immunodeficiency Virus ; gp140 envelope protein, Human immunodeficiency virus 1 ; nef Gene Products, Human Immunodeficiency Virus ; tat Gene Products, Human Immunodeficiency Virus
Language	English
Publishing date	2005-11
Publishing country	France
Document type	Journal Article
ZDB-ID	1465093-9
ISSN	1769-714X ; 1286-4579
ISSN (online)	1769-714X
ISSN	1286-4579
DOI	10.1016/j.micinf.2005.07.019
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Article: New insights into pathogenesis point to HIV-1 Tat as a key vaccine target

Ensoli, Barbara / Moretti, Sonia / Borsetti, Alessandra / Maggiorella, Maria Teresa / Buttò, Stefano / Picconi, Orietta / Tripiciano, Antonella / Sgadari, Cecilia / Monini, Paolo / Cafaro, Aurelio

Archives of virology. 2021 Nov., v. 166, no. 11

2021

Abstract: Despite over 30 years of enormous effort and progress in the field, no preventative and/or therapeutic vaccines against human immunodeficiency virus (HIV) are available. Here, we briefly summarize the vaccine strategies and vaccine candidates that in ... ...

Abstract	Despite over 30 years of enormous effort and progress in the field, no preventative and/or therapeutic vaccines against human immunodeficiency virus (HIV) are available. Here, we briefly summarize the vaccine strategies and vaccine candidates that in recent years advanced to efficacy trials with mostly unsatisfactory results. Next, we discuss a novel and somewhat contrarian approach based on biological and epidemiological evidence, which led us to choose the HIV protein Tat for the development of preventive and therapeutic HIV vaccines. Toward this goal, we review here the role of Tat in the virus life cycle as well as experimental and epidemiological evidence supporting its key role in the natural history of HIV infection and comorbidities. We then discuss the preclinical and clinical development of a Tat therapeutic vaccine, which, by improving the functionality and homeostasis of the immune system and by reducing the viral reservoir in virologically suppressed vaccinees, helps to establish key determinants for intensification of combination antiretroviral therapy (cART) and a functional cure. Future developments and potential applications of the Tat therapeutic vaccine are also discussed, as well as the rationale for its use in preventative strategies. We hope this contribution will lead to a reconsideration of the current paradigms for the development of HIV/AIDS vaccines, with a focus on targeting of viral proteins with key roles in HIV pathogenesis.
Keywords	HIV infections ; antiretroviral agents ; homeostasis ; immune system ; natural history ; pathogenesis ; therapeutics ; vaccines ; virology ; viruses
Language	English
Dates of publication	2021-11
Size	p. 2955-2974.
Publishing place	Springer Vienna
Document type	Article
Note	Review
ZDB-ID	7491-3
ISSN	1432-8798 ; 0304-8608
ISSN (online)	1432-8798
ISSN	0304-8608
DOI	10.1007/s00705-021-05158-z
Database	NAL-Catalogue (AGRICOLA)

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Book: Italian concerted action for the development of a vaccine against HIV/AIDS (ICAV)

Ensoli, Barbara

progress report

(Rapporti ISTISAN, ; 02/6)

2002

Institution	Centro di coordinamento, organizzazione e verifica dei progetti per la lotta all'AIDS
Author's details	scientific coordinator, Barbara Ensoli ; edited by Centro di coordinamento, organizzazione e verifica dei progetti per la lotta all'AIDS
Series title	Rapporti ISTISAN, ; 02/6
MeSH term(s)	AIDS Vaccines ; HIV Infections/prevention & control ; HIV/immunology
Keywords	Italy
Language	English
Size	55 p.
Publisher	Istituto Superiore di Sanità
Publishing place	Roma
Document type	Book
Database	Catalogue of the US National Library of Medicine (NLM)

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Article: The Tat Protein of HIV-1 Prevents the Loss of HSV-Specific Memory Adaptive Responses and Favors the Control of Viral Reactivation.

Nicoli, Francesco / Gallerani, Eleonora / Sicurella, Mariaconcetta / Pacifico, Salvatore / Cafaro, Aurelio / Ensoli, Barbara / Marconi, Peggy / Caputo, Antonella / Gavioli, Riccardo

Vaccines

2020 Volume 8, Issue 2

Abstract: The development of therapeutic strategies to control the reactivation of the Herpes Simplex Virus (HSV) is an unaddressed priority. In this study, we evaluated whether Tat, a HIV-1 protein displaying adjuvant functions, could improve previously ... ...

Abstract	The development of therapeutic strategies to control the reactivation of the Herpes Simplex Virus (HSV) is an unaddressed priority. In this study, we evaluated whether Tat, a HIV-1 protein displaying adjuvant functions, could improve previously established HSV-specific memory responses and prevent viral reactivation. To this aim, mice were infected with non-lethal doses of HSV-1 and, 44 days later, injected or not with Tat. Mice were then monitored to check their health status and measure memory HSV-specific cellular and humoral responses. The appearance of symptoms associated with HSV-reactivation was observed at significantly higher frequencies in the control group than in the Tat-treated mice. In addition, the control animals experienced a time-dependent decrease in HSV-specific Immunoglobulin G (IgG), while the Tat-treated mice maintained antibody titers over time. IgG levels were directly correlated with the number of HSV-specific CD8
Language	English
Publishing date	2020-06-04
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2703319-3
ISSN	2076-393X
ISSN	2076-393X
DOI	10.3390/vaccines8020274
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Article ; Online: HIV therapeutic vaccines aimed at intensifying combination antiretroviral therapy.

Moretti, Sonia / Cafaro, Aurelio / Tripiciano, Antonella / Picconi, Orietta / Buttò, Stefano / Ensoli, Fabrizio / Sgadari, Cecilia / Monini, Paolo / Ensoli, Barbara

Expert review of vaccines

2020 Volume 19, Issue 1, Page(s) 71–84

Abstract: ... ...

Abstract	Introduction
MeSH term(s)	AIDS Vaccines/administration & dosage ; AIDS Vaccines/immunology ; Animals ; Anti-HIV Agents/administration & dosage ; Anti-HIV Agents/pharmacology ; CD4-Positive T-Lymphocytes/immunology ; Drug Therapy, Combination ; HIV Infections/immunology ; HIV Infections/prevention & control ; HIV Infections/virology ; Humans ; Virus Replication/drug effects
Chemical Substances	AIDS Vaccines ; Anti-HIV Agents
Language	English
Publishing date	2020-01-19
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2181284-6
ISSN	1744-8395 ; 1476-0584
ISSN (online)	1744-8395
ISSN	1476-0584
DOI	10.1080/14760584.2020.1712199
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