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Article ; Online: Moving the HIV vaccine field forward: concepts of protective immunity.

Kent, Stephen J / Davenport, Miles P

The lancet. HIV

2019 Volume 6, Issue 6, Page(s) e406–e410

Abstract: Vaccine-induced prevention of HIV infection is widely viewed as requiring both humoral and cellular immunity. Although the evidence for such a multipronged approach is not strong, this strategy increases the possibility that at least one mechanism of ... ...

Abstract	Vaccine-induced prevention of HIV infection is widely viewed as requiring both humoral and cellular immunity. Although the evidence for such a multipronged approach is not strong, this strategy increases the possibility that at least one mechanism of immunity could work to diminish new infections. The concept of broad immunity to HIV is attractive to funding bodies that seek at least some success from expensive trials. However, trying simultaneously to achieve both robust cellular and humoral immunity against HIV might be difficult. Furthermore, a multipronged approach increases the difficulty of later dissecting the immune correlates of protection and thereby iteratively improving HIV vaccines. This Viewpoint briefly discusses different approaches to tackling the challenge of inducing protective immunity to HIV and speculates on how results will move the field forward. We posit that, given the uncertain nature of immunity to HIV at present, focusing on inducing, evaluating, and optimising discrete individual mechanisms of immunity to HIV could provide the most rapid pathway to an effective HIV vaccine.
MeSH term(s)	AIDS Vaccines/administration & dosage ; AIDS Vaccines/immunology ; Animals ; Antibodies, Neutralizing/immunology ; Antibodies, Viral/immunology ; CD8-Positive T-Lymphocytes/immunology ; CD8-Positive T-Lymphocytes/metabolism ; Complement System Proteins/immunology ; HIV Infections/immunology ; HIV Infections/prevention & control ; HIV-1/immunology ; Host-Pathogen Interactions/immunology ; Humans ; Immunity, Cellular ; Immunity, Humoral
Chemical Substances	AIDS Vaccines ; Antibodies, Neutralizing ; Antibodies, Viral ; Complement System Proteins (9007-36-7)
Language	English
Publishing date	2019-05-09
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ISSN	2352-3018
ISSN (online)	2352-3018
DOI	10.1016/S2352-3018(19)30134-1
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Article ; Online: Predicting the efficacy of variant-modified COVID-19 vaccine boosters.

Khoury, David S / Docken, Steffen S / Subbarao, Kanta / Kent, Stephen J / Davenport, Miles P / Cromer, Deborah

Nature medicine

2023 Volume 29, Issue 3, Page(s) 574–578

Abstract: Booster vaccination for the prevention of Coronavirus Disease 2019 (COVID-19) is required to overcome loss of protection due to waning immunity and the spread of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants. Studies have ... ...

Abstract	Booster vaccination for the prevention of Coronavirus Disease 2019 (COVID-19) is required to overcome loss of protection due to waning immunity and the spread of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants. Studies have assessed the ability of existing ancestral-based vaccines as well as novel variant-modified vaccine regimens to boost immunity to different variants, and a crucial question is to assess the relative benefits of these different approaches. Here we aggregate data on neutralization titers from 14 reports (three published papers, eight preprints, two press releases and notes of one advisory committee meeting) comparing booster vaccination with the current ancestral-based vaccines or variant-modified vaccines. Using these data, we compare the immunogenicity of different vaccination regimens and predict the relative protection of booster vaccines under different scenarios. We predict that boosting with ancestral vaccines can markedly enhance protection against both symptomatic and severe disease from SARS-CoV-2 variant viruses, although variant-modified vaccines may provide additional protection, even if not matched to the circulating variants. This work provides an evidence-based framework to inform choices on future SARS-CoV-2 vaccine regimens.
MeSH term(s)	Humans ; COVID-19 Vaccines ; SARS-CoV-2 ; COVID-19/prevention & control ; Antibodies, Viral
Chemical Substances	COVID-19 Vaccines ; Antibodies, Viral
Language	English
Publishing date	2023-03-02
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1220066-9
ISSN	1546-170X ; 1078-8956
ISSN (online)	1546-170X
ISSN	1078-8956
DOI	10.1038/s41591-023-02228-4
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Article ; Online: Nice and slow make the germinal centers go: measured and escalating antigen delivery enhance durability and quality of humoral immune responses against HIV-1.

Tan, Hyon-Xhi / Davenport, Miles P / Kent, Stephen J / Wheatley, Adam K

Immunology and cell biology

2022 Volume 100, Issue 10, Page(s) 750–752

Abstract: A recently published article has confirmed that a novel immunization method of sustained and escalating antigen delivery augments the magnitude, quality and durability of humoral immune responses. ...

Abstract	A recently published article has confirmed that a novel immunization method of sustained and escalating antigen delivery augments the magnitude, quality and durability of humoral immune responses.
MeSH term(s)	Immunity, Humoral ; HIV-1 ; Germinal Center ; Antigens ; Immunization
Chemical Substances	Antigens
Language	English
Publishing date	2022-10-31
Publishing country	United States
Document type	Journal Article
ZDB-ID	284057-1
ISSN	1440-1711 ; 0818-9641
ISSN (online)	1440-1711
ISSN	0818-9641
DOI	10.1111/imcb.12596
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Article ; Online: Building a T cell compartment: how immune cell development shapes function.

Davenport, Miles P / Smith, Norah L / Rudd, Brian D

Nature reviews. Immunology

2020 Volume 20, Issue 8, Page(s) 499–506

Abstract: We are just beginning to understand the diversity of the peripheral T cell compartment, which arises from the specialization of different T cell subsets and the plasticity of individual naive T cells to adopt different fates. Although the progeny of a ... ...

Abstract	We are just beginning to understand the diversity of the peripheral T cell compartment, which arises from the specialization of different T cell subsets and the plasticity of individual naive T cells to adopt different fates. Although the progeny of a single T cell can differentiate into many phenotypes following infection, individual T cells are biased towards particular phenotypes. These biases are typically ascribed to random factors that occur during and after antigenic stimulation. However, the T cell compartment does not remain static with age, and shifting immune challenges during ontogeny give rise to T cells with distinct functional properties. Here, we argue that the developmental history of naive T cells creates a 'hidden layer' of diversity that persists into adulthood. Insight into this diversity can provide a new perspective on immunity and immunotherapy across the lifespan.
MeSH term(s)	Animals ; Cell Differentiation/immunology ; Humans ; Immunity, Cellular/immunology ; Immunologic Memory/immunology ; Mice ; Receptors, Antigen, T-Cell/immunology ; T-Lymphocyte Subsets/cytology ; T-Lymphocyte Subsets/immunology
Chemical Substances	Receptors, Antigen, T-Cell
Language	English
Publishing date	2020-06-03
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2062776-2
ISSN	1474-1741 ; 1474-1733
ISSN (online)	1474-1741
ISSN	1474-1733
DOI	10.1038/s41577-020-0332-3
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Article ; Online: Relating In Vitro Neutralization Level and Protection in the CVnCoV (CUREVAC) Trial.

Cromer, Deborah / Reynaldi, Arnold / Steain, Megan / Triccas, James A / Davenport, Miles P / Khoury, David S

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2022 Volume 75, Issue 1, Page(s) e878–e879

Abstract: The vaccine candidate CVnCoV (CUREVAC) showed surprisingly low efficacy in a recent phase 3 trial compared with other messenger RNA (mRNA) vaccines. Here we show that the low efficacy follows from the dose used and the presence of severe acute ... ...

Abstract	The vaccine candidate CVnCoV (CUREVAC) showed surprisingly low efficacy in a recent phase 3 trial compared with other messenger RNA (mRNA) vaccines. Here we show that the low efficacy follows from the dose used and the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants and is predicted by the neutralizing antibody response induced by the vaccine.
MeSH term(s)	Antibodies, Neutralizing ; Antibodies, Viral ; COVID-19/prevention & control ; COVID-19 Vaccines ; Humans ; SARS-CoV-2 ; Viral Vaccines
Chemical Substances	Antibodies, Neutralizing ; Antibodies, Viral ; COVID-19 Vaccines ; Viral Vaccines
Language	English
Publishing date	2022-08-03
Publishing country	United States
Document type	Clinical Trial ; Journal Article
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciac075
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Article ; Online: Viral clearance as a surrogate of clinical efficacy for COVID-19 therapies in outpatients: a systematic review and meta-analysis.

Elias, Karen M / Khan, Shanchita R / Stadler, Eva / Schlub, Timothy E / Cromer, Deborah / Polizzotto, Mark N / Kent, Stephen J / Turner, Tari / Davenport, Miles P / Khoury, David S

The Lancet. Microbe

2024

Abstract: Background: Surrogates of antiviral efficacy are needed for COVID-19. We aimed to investigate the relationship between the virological effect of treatment and clinical efficacy as measured by progression to severe disease in outpatients treated for mild- ...

Abstract	Background: Surrogates of antiviral efficacy are needed for COVID-19. We aimed to investigate the relationship between the virological effect of treatment and clinical efficacy as measured by progression to severe disease in outpatients treated for mild-to-moderate COVID-19. Methods: In this systematic review and meta-analysis, we searched PubMed, Scopus, and medRxiv from database inception to Aug 16, 2023, for randomised placebo-controlled trials that tested virus-directed treatments (ie, any monoclonal antibodies, convalescent plasma, or antivirals) in non-hospitalised individuals with COVID-19. We only included studies that reported both clinical outcomes (ie, rate of disease progression to hospitalisation or death) and virological outcomes (ie, viral load within the first 7 days of treatment). We extracted summary data from eligible reports, with discrepancies resolved through discussion. We used an established meta-regression model with random effects to assess the association between clinical efficacy and virological treatment effect, and calculated I Findings: We identified 1718 unique studies, of which 22 (with a total of 16 684 participants) met the inclusion criteria, and were in primarily unvaccinated individuals. Risk of bias was assessed as low in 19 of 22 studies for clinical outcomes, whereas for virological outcomes, a high risk of bias was assessed in 11 studies, some risk in ten studies, and a low risk in one study. The unadjusted relative risk of disease progression for each extra log Interpretation: Despite the aggregation of studies with differing designs, and evidence of risk of bias in some virological outcomes, this review provides evidence that treatment-induced acceleration of viral clearance within the first 5 days after treatment is a potential surrogate of clinical efficacy to prevent hospitalisation with COVID-19. This work supports the use of viral clearance as an early phase clinical trial endpoint of therapeutic efficacy. Funding: Australian Government Department of Health, Medical Research Future Fund, and Australian National Health and Medical Research Council.
Language	English
Publishing date	2024-04-04
Publishing country	England
Document type	Journal Article
ISSN	2666-5247
ISSN (online)	2666-5247
DOI	10.1016/S2666-5247(23)00398-1
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Article ; Online: Artemisinin Resistance and the Unique Selection Pressure of a Short-acting Antimalarial.

Khoury, David S / Cao, Pengxing / Zaloumis, Sophie G / Davenport, Miles P

Trends in parasitology

2020 Volume 36, Issue 11, Page(s) 884–887

Abstract: Resistance to the artemisinin derivatives, our most effective antimalarial drugs, has not manifest as a classical resistance phenotype in which parasites can tolerate higher drug concentrations. Instead, resistant parasites have an altered maturation. We ...

Abstract	Resistance to the artemisinin derivatives, our most effective antimalarial drugs, has not manifest as a classical resistance phenotype in which parasites can tolerate higher drug concentrations. Instead, resistant parasites have an altered maturation. We hypothesize that the short half-life of artemisinin concentrations is an unanticipated driver of this novel resistance phenotype.
MeSH term(s)	Animals ; Antimalarials/pharmacology ; Antimalarials/therapeutic use ; Artemisinins/pharmacology ; Artemisinins/therapeutic use ; Drug Resistance ; Humans ; Inhibitory Concentration 50 ; Plasmodium/drug effects ; Selection, Genetic/drug effects
Chemical Substances	Antimalarials ; Artemisinins
Language	English
Publishing date	2020-08-05
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2036227-4
ISSN	1471-5007 ; 1471-4922
ISSN (online)	1471-5007
ISSN	1471-4922
DOI	10.1016/j.pt.2020.07.004
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Article ; Online: Anti-Drug Antibodies in Pigtailed Macaques Receiving HIV Broadly Neutralising Antibody PGT121.

Lee, Wen Shi / Reynaldi, Arnold / Amarasena, Thakshila / Davenport, Miles P / Parsons, Matthew S / Kent, Stephen J

Frontiers in immunology

2021 Volume 12, Page(s) 749891

Abstract: Broadly neutralising antibodies (bNAbs) may play an important role in future strategies for HIV control. The development of anti-drug antibody (ADA) responses can reduce the efficacy of passively transferred bNAbs but the impact of ADA is imperfectly ... ...

Abstract	Broadly neutralising antibodies (bNAbs) may play an important role in future strategies for HIV control. The development of anti-drug antibody (ADA) responses can reduce the efficacy of passively transferred bNAbs but the impact of ADA is imperfectly understood. We previously showed that therapeutic administration of the anti-HIV bNAb PGT121 (either WT or LALA version) controlled viraemia in pigtailed macaques with ongoing SHIV infection. We now report on 23 macaques that had multiple treatments with PGT121. We found that an increasing number of intravenous doses of PGT121 or human IgG1 isotype control antibodies (2-4 doses) results in anti-PGT121 ADA induction and low plasma concentrations of PGT121. ADA was associated with poor or absent suppression of SHIV viremia. Notably, ADA within macaque plasma recognised another human bNAb 10E8 but did not bind to the variable domains of PGT121, suggesting that ADA were primarily directed against the constant regions of the human antibodies. These findings have implications for the development of preclinical studies examining multiple infusions of human bNAbs.
MeSH term(s)	Animals ; Broadly Neutralizing Antibodies/administration & dosage ; Broadly Neutralizing Antibodies/blood ; Broadly Neutralizing Antibodies/immunology ; HIV Antibodies/administration & dosage ; HIV Antibodies/blood ; HIV Antibodies/immunology ; Immunoglobulin G/administration & dosage ; Macaca nemestrina/immunology ; Simian Acquired Immunodeficiency Syndrome/immunology ; Simian Acquired Immunodeficiency Syndrome/prevention & control ; Simian Immunodeficiency Virus/immunology ; Viremia/immunology ; Viremia/prevention & control
Chemical Substances	Broadly Neutralizing Antibodies ; HIV Antibodies ; Immunoglobulin G
Language	English
Publishing date	2021-11-11
Publishing country	Switzerland
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2021.749891
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Article ; Online: Balancing Statistical Power and Risk in HIV Cure Clinical Trial Design.

Lau, Jillian S Y / Cromer, Deborah / Pinkevych, Mykola / Lewin, Sharon R / Rasmussen, Thomas A / McMahon, James H / Davenport, Miles P

The Journal of infectious diseases

2022 Volume 226, Issue 2, Page(s) 236–245

Abstract: Background: Analytical treatment interruptions (ATI) are pauses of antiretroviral therapy (ART) in the context of human immunodeficiency virus (HIV) cure trials. They are the gold standard in determining if interventions being tested can achieve ... ...

Abstract	Background: Analytical treatment interruptions (ATI) are pauses of antiretroviral therapy (ART) in the context of human immunodeficiency virus (HIV) cure trials. They are the gold standard in determining if interventions being tested can achieve sustained virological control in the absence of ART. However, withholding ART comes with risks and discomforts to trial participant. We used mathematical models to explore how ATI study design can be improved to maximize statistical power, while minimizing risks to participants. Methods: Using previously observed dynamics of time to viral rebound (TVR) post-ATI, we modelled estimates for optimal sample size, frequency, and ATI duration required to detect a significant difference in the TVR between control and intervention groups. Groups were compared using a log-rank test, and analytical and stochastic techniques. Results: In placebo-controlled TVR studies, 120 participants are required in each arm to detect 30% difference in frequency of viral reactivation at 80% power. There was little statistical advantage to measuring viral load more frequently than weekly, or interrupting ART beyond 5 weeks in a TVR study. Conclusions: Current TVR HIV cure studies are underpowered to detect statistically significant changes in frequency of viral reactivation. Alternate study designs can improve the statistical power of ATI trials.
MeSH term(s)	Anti-Retroviral Agents/therapeutic use ; Clinical Trials as Topic/methods ; HIV Infections/drug therapy ; Humans ; Research Design ; Risk Assessment ; Viral Load/statistics & numerical data ; Withholding Treatment
Chemical Substances	Anti-Retroviral Agents
Language	English
Publishing date	2022-02-01
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	3019-3
ISSN	1537-6613 ; 0022-1899
ISSN (online)	1537-6613
ISSN	0022-1899
DOI	10.1093/infdis/jiac032
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Article: Artemisinin Resistance and the Unique Selection Pressure of a Short-acting Antimalarial

Khoury, David S / Cao, Pengxing / Zaloumis, Sophie G / Davenport, Miles P

Trends in parasitology. 2020 Nov., v. 36, no. 11

2020

Institution	The Interdisciplinary Approaches to Malaria Consortium
Abstract	Resistance to the artemisinin derivatives, our most effective antimalarial drugs, has not manifest as a classical resistance phenotype in which parasites can tolerate higher drug concentrations. Instead, resistant parasites have an altered maturation. We hypothesize that the short half-life of artemisinin concentrations is an unanticipated driver of this novel resistance phenotype.
Keywords	artemisinin ; half life ; parasites ; parasitology ; phenotype ; selection pressure
Language	English
Dates of publication	2020-11
Size	p. 884-887.
Publishing place	Elsevier Ltd
Document type	Article
Note	NAL-light
ZDB-ID	2036227-4
ISSN	1471-5007 ; 1471-4922
ISSN (online)	1471-5007
ISSN	1471-4922
DOI	10.1016/j.pt.2020.07.004
Database	NAL-Catalogue (AGRICOLA)

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