Adjuvant-containing subunit vaccines represent a promising approach for protection against tuberculosis (TB), but current candidates require refrigerated storage. Here we present results from a ...randomized, double-blinded Phase 1 clinical trial (NCT03722472) evaluating the safety, tolerability, and immunogenicity of a thermostable lyophilized single-vial presentation of the ID93 + GLA-SE vaccine candidate compared to the non-thermostable two-vial vaccine presentation in healthy adults. Participants were monitored for primary, secondary, and exploratory endpoints following intramuscular administration of two vaccine doses 56 days apart. Primary endpoints included local and systemic reactogenicity and adverse events. Secondary endpoints included antigen-specific antibody (IgG) and cellular immune responses (cytokine-producing peripheral blood mononuclear cells and T cells). Both vaccine presentations are safe and well tolerated and elicit robust antigen-specific serum antibody and Th1-type cellular immune responses. Compared to the non-thermostable presentation, the thermostable vaccine formulation generates greater serum antibody responses (p < 0.05) and more antibody-secreting cells (p < 0.05). In this work, we show the thermostable ID93 + GLA-SE vaccine candidate is safe and immunogenic in healthy adults.
Stable heterosexual HIV-1 serodiscordant couples in Africa have high HIV-1 transmission rates and are a critical population for evaluation of new HIV-1 prevention strategies. The Partners PrEP Study ...is a randomized, double-blind, placebo-controlled trial of tenofovir and emtricitabine-tenofovir pre-exposure prophylaxis to decrease HIV-1 acquisition within heterosexual HIV-1 serodiscordant couples. We describe the trial design and characteristics of the study cohort.
HIV-1 serodiscordant couples, in which the HIV-1 infected partner did not meet national guidelines for initiation of antiretroviral therapy, were enrolled at 9 research sites in Kenya and Uganda. The HIV-1 susceptible partner was randomized to daily oral tenofovir, emtricitabine-tenofovir, or matching placebo with monthly follow-up for 24-36 months.
From July 2008 to November 2010, 7920 HIV-1 serodiscordant couples were screened and 4758 enrolled. For 62% (2966/4758) of enrolled couples, the HIV-1 susceptible partner was male. Median age was 33 years for HIV-1 susceptible and HIV-1 infected partners IQR (28-40) and (26-39) respectively. Most couples (98%) were married, with a median duration of partnership of 7.0 years (IQR 3.0-14.0) and recent knowledge of their serodiscordant status median 0.4 years (IQR 0.1-2.0). During the month prior to enrollment, couples reported a median of 4 sex acts (IQR 2-8); 27% reported unprotected sex and 14% of male and 1% of female HIV-1 susceptible partners reported sex with outside partners. Among HIV-1 infected partners, the median plasma HIV-1 level was 3.94 log(10) copies/mL (IQR 3.31-4.53) and median CD4 count was 496 cells/µL (IQR 375-662); the majority (64%) had WHO stage 1 HIV-1 disease.
Couples at high risk of HIV-1 transmission were rapidly recruited into the Partners PrEP Study, the largest efficacy trial of oral PrEP. (ClinicalTrials.gov NCT00557245).
Extensible Framework for Analysis of Farm Practices and Programs Satheesan, Sandeep Puthanveetil; Bhattarai, Rabin; Bradley, Shannon ...
Proceedings of the Practice and Experience in Advanced Research Computing on Rise of the Machines (learning),
07/2019
Conference Proceeding
We present an open source extensible web framework for the analysis of different farm practices and programs and easy dissemination of their results to the users. Currently, this framework is being ...applied to two use cases --- a web-based decision support system for cover crop management and a web-based farm program analysis tool to assist farmers, academics, and policymakers to understand programs and policies surrounding the Farm Bill. Through the first use case, we address the problem of bridging the gap between the scientific research that happens in labs and experimental plots and the day to day practices and decisions taken by the farmers in the fields. Specifically, this use case focuses on the practice of cover crops, their management, and the impact on reducing nutrient runoff into water bodies. Through the second use case, we address the problem of predicting the expected payment amounts and measured risk or probability of payment for different government insurance programs authorized by the 2018 Farm Bill, namely the Agriculture Risk Coverage (ARC) and Price Loss Coverage (PLC). This helps the farmers compare these programs based on forecasted crop yields and prices. In this paper, we describe the overall architecture of the framework and its major components, the use cases that are currently benefiting from using this framework and share screenshots of the web applications developed using this framework for those use cases. We also share our plans for future work and conclusions about applying this framework to the two use cases.
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