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  1. Article ; Online: Prophylactic HIV vaccine: vaccine regimens in clinical trials and potential challenges.

    Pitisuttithum, Punnee / Marovich, Mary Anne

    Expert review of vaccines

    2020  Volume 19, Issue 2, Page(s) 133–142

    Abstract: ... ...

    Abstract Introduction
    MeSH term(s) AIDS Vaccines/administration & dosage ; Adenoviridae/genetics ; Adjuvants, Immunologic/administration & dosage ; Animals ; HIV Infections/immunology ; HIV Infections/prevention & control ; Humans ; Pre-Exposure Prophylaxis/methods ; Research Design
    Chemical Substances AIDS Vaccines ; AIDSVAX ; Adjuvants, Immunologic
    Language English
    Publishing date 2020-02-20
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2181284-6
    ISSN 1744-8395 ; 1476-0584
    ISSN (online) 1744-8395
    ISSN 1476-0584
    DOI 10.1080/14760584.2020.1718497
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  2. Article ; Online: Monoclonal Antibodies for Prevention and Treatment of COVID-19.

    Marovich, Mary / Mascola, John R / Cohen, Myron S

    JAMA

    2020  Volume 324, Issue 2, Page(s) 131–132

    MeSH term(s) Antibodies, Monoclonal/therapeutic use ; Antibodies, Neutralizing/therapeutic use ; Antibodies, Viral/therapeutic use ; Betacoronavirus ; COVID-19 ; Coronavirus Infections/prevention & control ; Coronavirus Infections/therapy ; Humans ; Pandemics/prevention & control ; Pneumonia, Viral/prevention & control ; Pneumonia, Viral/therapy ; SARS-CoV-2 ; Spike Glycoprotein, Coronavirus/immunology
    Chemical Substances Antibodies, Monoclonal ; Antibodies, Neutralizing ; Antibodies, Viral ; Spike Glycoprotein, Coronavirus ; spike protein, SARS-CoV-2
    Keywords covid19
    Language English
    Publishing date 2020-05-30
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2020.10245
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  3. Article ; Online: Forty years of investment in HIV research: progress towards ending the HIV pandemic and preparation for future pandemics.

    Read, Sarah W / Kim, Peter / Marovich, Mary / Dieffenbach, Carl W / Fauci, Anthony S

    Journal of the International AIDS Society

    2022  Volume 25, Issue 12, Page(s) e26039

    MeSH term(s) Humans ; Pandemics/prevention & control ; HIV Infections/drug therapy ; HIV Infections/epidemiology ; HIV Infections/prevention & control
    Language English
    Publishing date 2022-09-08
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2467110-1
    ISSN 1758-2652 ; 1758-2652
    ISSN (online) 1758-2652
    ISSN 1758-2652
    DOI 10.1002/jia2.26039
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  4. Article ; Online: Pox-Protein Public Private Partnership program and upcoming HIV vaccine efficacy trials.

    Russell, Nina D / Marovich, Mary A

    Current opinion in HIV and AIDS

    2016  Volume 11, Issue 6, Page(s) 614–619

    Abstract: Purpose of review: The purpose of review is to provide an overview of the Pox-Protein Public Private Partnership (P5) and highlight the progress of the P5 program, including an upcoming HIV vaccine efficacy trial in South Africa.: Recent findings: ... ...

    Abstract Purpose of review: The purpose of review is to provide an overview of the Pox-Protein Public Private Partnership (P5) and highlight the progress of the P5 program, including an upcoming HIV vaccine efficacy trial in South Africa.
    Recent findings: The RV144 Thai vaccine efficacy trial was the first to demonstrate that an HIV-1 vaccine can prevent HIV acquisition. The P5 vaccine regimen uses an ALVAC prime and protein boost modeled after the RV144 vaccine and adapted for the subtype C virus predominant in the southern African region. This regimen was recently tested in the HIV Vaccine Trials Network 100 phase 1/2a study in South Africa. Based on prospectively defined immunogenicity thresholds, criteria were met to support the launch of an efficacy study in late 2016. The aim of this phase 2b/3 trial will be to improve upon the results of RV144, with increased and more durable vaccine efficacy, to accelerate the potential licensure of a preventive vaccine in southern Africa.
    Summary: The planned P5 efficacy trial, HIV Vaccine Trials Network 702, is designed to test and prospectively define correlates of protection, if efficacious. A vaccine with modest efficacy, vaccine efficacy at least 50%, could have substantial public health impact and significantly decrease the incidence of new infections in heavily burdened areas of the world.
    MeSH term(s) AIDS Vaccines/administration & dosage ; AIDS Vaccines/immunology ; Biomarkers ; Clinical Trials, Phase II as Topic ; Clinical Trials, Phase III as Topic ; HIV Infections/prevention & control ; HIV-1/immunology ; Humans ; Public-Private Sector Partnerships ; South Africa ; Treatment Outcome
    Chemical Substances AIDS Vaccines ; Biomarkers
    Language English
    Publishing date 2016-09-14
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2502511-9
    ISSN 1746-6318 ; 1746-630X
    ISSN (online) 1746-6318
    ISSN 1746-630X
    DOI 10.1097/COH.0000000000000322
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 6812: Show issues Location:
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  6. Article ; Online: Monoclonal Antibodies for Prevention and Treatment of COVID-19

    Marovich, Mary / Mascola, John R. / Cohen, Myron S.

    JAMA

    2020  Volume 324, Issue 2, Page(s) 131

    Keywords General Medicine ; covid19
    Language English
    Publisher American Medical Association (AMA)
    Publishing country us
    Document type Article ; Online
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2020.10245
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  7. Article ; Online: Optimizing the Immunogenicity of HIV Vaccines by Adjuvants - NIAID Workshop Report.

    Singh, Anjali / Boggiano, César / Eller, Michael A / Maciel, Milton / Marovich, Mary A / Mehra, Vijay L / Mo, Annie X / Singleton, Kentner L / Leitner, Wolfgang W

    Vaccine

    2023  Volume 41, Issue 31, Page(s) 4439–4446

    Abstract: This report summarizes the highlights of a workshop convened by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), on April 4-5, 2022, to provide a discussion forum for sharing insights on the current ... ...

    Abstract This report summarizes the highlights of a workshop convened by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), on April 4-5, 2022, to provide a discussion forum for sharing insights on the current status, key challenges, and next steps to advance the current landscape of promising adjuvants in preclinical and clinical human immunodeficiency virus (HIV) vaccine studies. A key goal was to solicit and share recommendations on scientific, regulatory, and operational guidelines for bridging the gaps in rational selection, access, and formulation of clinically relevant adjuvants for HIV vaccine candidates. The NIAID Vaccine Adjuvant Program working group remains committed to accentuate promising adjuvants and nurturing collaborations between adjuvant and HIV vaccine developers.
    MeSH term(s) United States ; Humans ; National Institute of Allergy and Infectious Diseases (U.S.) ; HIV Infections/prevention & control ; AIDS Vaccines ; Adjuvants, Immunologic ; National Institutes of Health (U.S.)
    Chemical Substances AIDS Vaccines ; Adjuvants, Immunologic
    Language English
    Publishing date 2023-06-16
    Publishing country Netherlands
    Document type Clinical Conference
    ZDB-ID 605674-x
    ISSN 1873-2518 ; 0264-410X
    ISSN (online) 1873-2518
    ISSN 0264-410X
    DOI 10.1016/j.vaccine.2023.06.029
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    Zs.MO 458: Show issues

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  8. Article: Nasopharyngeal Viral Load Is the Major Driver of Incident Antibody Immune Response to SARS-CoV-2 Infection.

    Xu, Meng / O'Brien, Meagan P / Hooper, Andrea T / Forleo-Neto, Eduardo / Isa, Flonza / Hou, Peijie / Chan, Kuo-Chen / Cohen, Myron S / Marovich, Mary A / Hamilton, Jennifer D / Hirshberg, Boaz / Herman, Gary A / Musser, Bret J

    Open forum infectious diseases

    2023  Volume 10, Issue 12, Page(s) ofad598

    Abstract: Background: Virologic determinants of seroconversion to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection were defined in a post hoc analysis of prospectively studied vaccine- and infection-naïve individuals at high risk for ... ...

    Abstract Background: Virologic determinants of seroconversion to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection were defined in a post hoc analysis of prospectively studied vaccine- and infection-naïve individuals at high risk for coronavirus disease 2019 (COVID-19).
    Methods: This phase 3 COVID-19 prevention trial (NCT04452318) with casirivimab and imdevimab was conducted in July 2020-February 2021, before widespread vaccine availability. Placebo-treated participants who were uninfected (SARS-CoV-2 quantitative reverse transcription polymerase chain reaction [RT-qPCR] negative) and seronegative were assessed weekly for 28 days (efficacy assessment period [EAP]) for COVID-19 symptoms and SARS-CoV-2 infection by RT-qPCR of nasopharyngeal swab samples and for serostatus by antinucleocapsid immunoglobulin (Ig) G. Regression-based modeling, including causal mediation analysis, estimated the effects of viral load on seroconversion.
    Results: Of 157/1069 (14.7%) uninfected and seronegative (for antispike IgG, antispike IgA, and antinucleocapsid IgG) participants who became infected during the EAP, 105 (65%) seroconverted. The mean (SD) maximum viral load of seroconverters was 7.23 (1.68) log
    Conclusions: Maximum SARS-CoV-2 viral load is a major driver of seroconversion and symptomatic COVID-19, with high viral loads (∼6.0 log
    Language English
    Publishing date 2023-12-02
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2757767-3
    ISSN 2328-8957
    ISSN 2328-8957
    DOI 10.1093/ofid/ofad598
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  9. Article ; Online: AIDS Vaccine Research Subcommittee (AVRS) Consultation: Early-Life Immunization Strategies against HIV Acquisition.

    Singh, Anjali / Permar, Sallie / Kollmann, Tobias R / Levy, Ofer / Marovich, Mary / De Paris, Kristina

    mSphere

    2019  Volume 4, Issue 4

    Abstract: This report summarizes a consultation meeting convened by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), on 12 September 2017 to discuss the scientific rationale for selectively testing relevant ... ...

    Abstract This report summarizes a consultation meeting convened by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), on 12 September 2017 to discuss the scientific rationale for selectively testing relevant HIV vaccine candidates in early life that are designed to initiate immune responses for lifelong protective immunity. The urgent need to develop interventions providing durable protective immunity to HIV before sexual debut coupled with the practicality of infant vaccine schedules supports optimizing infant HIV vaccines as a high priority. The panelists discussed the unique opportunities and challenges of testing candidate HIV vaccines in the context of distinct early-life immunity. Key developments providing rationale and grounds for cautious optimism regarding evaluation of early-life HIV vaccines include recent studies of early-life immune ontogeny, studies of HIV-infected infants demonstrating relatively rapid generation of broadly neutralizing antibodies (bNAbs), discovery of novel adjuvants active in early life, and cutting-edge sample-sparing systems biology and immunologic assays promising deep insight into vaccine action in infants. Multidisciplinary efforts toward the goal of an infant HIV vaccine are under way and should be nurtured and amplified.
    MeSH term(s) AIDS Vaccines ; Adjuvants, Immunologic ; Adolescent ; Child ; Clinical Trials as Topic ; Congresses as Topic ; Female ; HIV Infections/immunology ; HIV Infections/prevention & control ; HIV-1/immunology ; Humans ; Immunization Schedule ; Infant ; Referral and Consultation ; United States
    Chemical Substances AIDS Vaccines ; Adjuvants, Immunologic
    Language English
    Publishing date 2019-07-17
    Publishing country United States
    Document type Journal Article
    ISSN 2379-5042
    ISSN (online) 2379-5042
    DOI 10.1128/mSphere.00320-19
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Leveraging lessons learned from the COVID-19 pandemic for HIV.

    Calder, Thomas / Tong, Tina / Hu, Dale J / Kim, Jerome H / Kotloff, Karen L / Koup, Richard A / Marovich, Mary A / McElrath, M Juliana / Read, Sarah W / Robb, Merlin L / Renzullo, Philip O / D'Souza, M Patricia

    Communications medicine

    2022  Volume 2, Page(s) 110

    Abstract: The rapid development of COVID-19 vaccines and their deployment in less than a year is an unprecedented scientific, medical, and public health achievement. This rapid development leveraged knowledge from decades of HIV/AIDS research and advances. However, ...

    Abstract The rapid development of COVID-19 vaccines and their deployment in less than a year is an unprecedented scientific, medical, and public health achievement. This rapid development leveraged knowledge from decades of HIV/AIDS research and advances. However, the search for an HIV vaccine that would contribute to a durable end to the HIV pandemic remains elusive. Here, we draw from the US government experience and highlight lessons learned from COVID-19 vaccine development, which include the importance of public-private partnerships, equitable inclusion of populations impacted by the infectious pathogen, and continued investment in basic research. We summarize key considerations for an accelerated and re-energized framework for developing a safe and efficacious HIV vaccine.
    Language English
    Publishing date 2022-08-29
    Publishing country England
    Document type Journal Article ; Review
    ISSN 2730-664X
    ISSN (online) 2730-664X
    DOI 10.1038/s43856-022-00175-8
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