A5013688633- HIV Research and Treatment
- Mobile Health and mHealth Applications
- Statistical Methods in Clinical Trials
- Mosquito-borne diseases and control
- vaccines and immunoinformatics approaches
- Viral-associated cancers and disorders
- Virology and Viral Diseases
- Medication Adherence and Compliance
- HIV/AIDS drug development and treatment
- Digital Mental Health Interventions
- HIV/AIDS Research and Interventions
- Immune Cell Function and Interaction
- Lymphoma Diagnosis and Treatment
- Privacy-Preserving Technologies in Data
- Viral Infections and Vectors
- Syphilis Diagnosis and Treatment
- Patient Satisfaction in Healthcare
- Parvovirus B19 Infection Studies
- Biosimilars and Bioanalytical Methods
- Autism Spectrum Disorder Research
- Telemedicine and Telehealth Implementation
- Artificial Intelligence in Healthcare and Education
- Optical Imaging and Spectroscopy Techniques
- Pharmacogenetics and Drug Metabolism
- Healthcare Policy and Management
PRA Health Sciences
2021
National Institutes of Health
2006-2014
National Institute of Dental and Craniofacial Research
2009-2014
National Institute of Allergy and Infectious Diseases
2006-2010
National Cancer Institute
2006-2007
Center for Cancer Research
2006-2007
Office of AIDS Research
2007
AIDS United
2002
University of Delaware
2002
Background. A candidate vaccine consisting of human immunodeficiency virus type 1 (HIV-1) subunit gp120 protein was found previously to be nonprotective in an efficacy trial (Vax004) despite strong antibody responses against the antigens. Here we assessed magnitude and breadth neutralizing Vax004. Methods. Neutralizing antibodies were measured highly sensitive (tier 1) moderately 2) strains HIV-1 subtype B 2 independent assays. Vaccine recipients stratified by sex, race, high versus low...
The COVID-19 pandemic has been a catalyst for the implementation of decentralized clinical trials (DCTs) enabled by digital health technologies (DHTs) in field while curtailing in-person interactions and putting significant demands on care resources. DHTs offer improvements real-time data acquisition remotely maintaining privacy security. Here, we describe implications technologies, including edge computing, zero-trust environments, federated computing DCTs DHTs. Taken together, these...
A clinical trial was conducted to test the activity of cidofovir (CDV), a drug with in vitro against Kaposi sarcoma (KS)-associated herpesvirus (KSHV), KS. Five patients human immunodeficiency virus-associated KS (4 receiving antiretroviral therapy) and 2 classical were administered CDV (5 mg/kg/dose) weekly for weeks then every other week. All 7 had progression their at median 8.1 (range, 5-27 weeks). Skin biopsy specimens lesions showed no change expression latent or early lytic genes,...
Marcella Sarzotti-Kelsoe and colleagues harmonize various approaches to Good Clinical Laboratory Practice for clinical trials into a single set of recommendations.
In vitro and in ovo virus neutralization assays were conducted to assess the role of different host systems infectious bursal disease (IBDV) antigenic immunogenic variation. Four strains, two variant (1084 E GLS) standard (Edgar STC), propagated separately bursa Fabricius embryos, compared with cell culture-adapted preparations homologous strains. Chicken polyclonal antisera prepared against each IBDV neutralizing antibody titres determined. Normalized concentrations used heterologous IBDVs...
ABSTRACT All current human immunodeficiency virus (HIV) vaccine candidates contain multiple viral components and elicit antibodies that react positively in licensed HIV diagnostic tests, which similar products. Thus, trial participants could be falsely diagnosed as infected with HIV. Additionally, uninfected, seropositive vaccinees may encounter long-term social economic harms. Moreover, this also interferes early detection of true infections during preventive trials. An HIV-seropositive...
Vaccine-induced seropositivity (VISP) or seroreactivity (VISR), defined as the reaction of antibodies elicited by HIV vaccines with antigens used in diagnostic immunoassays, can result reactive assay results for vaccinated but uninfected individuals, subsequent misclassification their infection status. The eventual licensure a vaccine will magnify this issue and calls development mitigating solutions advance. An immunoassay that discriminates between those has been developed to address...
HIV-Selectest is a serodiagnostic enzyme immunoassay (EIA), containing p6 and gp41 peptides, designed to differentiate between vaccine-induced antibodies true infections. A rapid test version of the was developed. Both assays detected HIV in men women within 2 4 weeks infection, with sensitivity similar third-generation EIAs.
Differences in the relative pathogenicity of variant (1084 E and GLS) standard (Edgar STC) infectious bursal disease virus (IBDV) strains were observed after propagation bursa Fabricius, embryos, or cell cultures. Bursa-derived IBDV induced most severe lesions Fabricius when compared with propagated embryos Embryo-derived moderate gross lesions, whereas culture-derived did not damage grossly. A high frequency re-isolations was obtained from bursal, spleen, thymic samples collected birds...
Antigenic variation of infectious bursal disease virus (IBDV) due to propagation in different host systems (bursa Fabricius, embryos, or cell cultures) was determined by enzyme-linked immunosorbent assay (indirect and antigen capture) western blot analysis. To conduct this study, we used 27 non-neutralizing anti-VP(2) monoclonal antibodies, a reference panel nine neutralizing 13 anti-IBDV chicken polyclonal antibodies. Changes occurred neutralizing, cross-reactive, conformation-dependent...
<sec> <title>BACKGROUND</title> Pharmacoepidemiologic studies require Anatomic Therapeutic Chemical (ATC) drug classification from real-world data sources. These enable standardized analysis of utilization patterns and safety monitoring, ultimately promoting rational use improving health outcomes. Proprietary tools for this purpose are expensive while free lack generalizability. Large language models (LLMs), like GPT-4o, offer a cost-effective alternative as they can produce explanations...
<sec> <title>UNSTRUCTURED</title> The proliferation and increasing maturity of biometric monitoring technologies allows clinical investigators to measure the health status trial participants in a more holistic manner, especially outside settings. This includes capturing meaningful aspects daily living granular objective manner compared traditional tools Within multidisciplinary teams, statisticians data scientists are increasingly involved trials that incorporate digital measures called upon...