Evaluating Ebola therapies--the case for RCTs.

N Engl J Med

From the Center for Drug Evaluation and Research (E.C., R.T.) and the Office of the Commissioner (L.B.), Food and Drug Administration, Silver Spring, MD.

Published: December 2014

Download full-text PDF

Source
http://dx.doi.org/10.1056/NEJMp1414145DOI Listing

Publication Analysis

Top Keywords

evaluating ebola
4
ebola therapies--the
4
therapies--the case
4
case rcts
4
evaluating
1
therapies--the
1
case
1
rcts
1

Similar Publications

Ebola virus (EBOV) causes severe disease in humans, with mortality as high as 90%. The small-molecule antiviral drug remdesivir (RDV) has demonstrated a survival benefit in EBOV-exposed rhesus macaques. Here, we characterize the efficacy of multiple intravenous RDV dosing regimens on survival of rhesus macaques 42 days after intramuscular EBOV exposure.

View Article and Find Full Text PDF

The Ebola virus (EBOV) causes severe disease in humans, and animal models are needed to evaluate the efficacy of vaccines and therapeutics. While non-human primate (NHP) and rodent EBOV infection models have been well characterized, there is a growing need for an intermediate model. Here, we provide the first report of a small-particle aerosol (AE) EBOV ferret model and disease progression compared with the intramuscular (IM) EBOV ferret model.

View Article and Find Full Text PDF

Platform Technology in Global Vaccine Regulation: Development, Applications, and Regulatory Strategies with Insights from China.

Vaccines (Basel)

December 2024

Center for Drug Evaluation, National Medical Products Administration, Zone 2, No. 22 Guangde Street, Beijing Economic and Technological Development Zone, Beijing 100076, China.

The concept of "platform technology" gained prominence after the Ebola outbreak and since then has become essential to international vaccine (prophylactic vaccines against infectious disease) regulatory frameworks. Its significance was further amplified during the COVID-19 pandemic, where platform technology enabled the rapid development and approval of vaccines, optimizing regulatory processes, and enhancing global public health responses. As a transformative tool, platform technology streamlines product development, allowing for the reduction in the number of clinical trials or exemption from certain clinical trials and facilitating cross-referencing in regulatory submissions.

View Article and Find Full Text PDF

: Orthoebolaviruses and orthomarburgviruses are filoviruses that can cause viral hemorrhagic fever and significant morbidity and mortality in humans. The evaluation and deployment of vaccines to prevent and control Ebola and Marburg outbreaks must be informed by an understanding of the transmission and natural history of the causative infections, but little is known about the burden of asymptomatic infection or undiagnosed disease. This systematic review of the published literature examined the seroprevalence of antibodies to orthoebolaviruses and orthomarburgviruses in sub-Saharan Africa.

View Article and Find Full Text PDF

The Democratic Republic of the Congo (DRC) struggles with low full childhood vaccination coverage (around 50 %) and a high children-under-five mortality rate (79 deaths per 1000 live births). This situation is potentially exacerbated by vaccine hesitancy, which was identified by the World Health Organization (WHO) as one of the top 10 global health threats in 2019. To gain deeper insights into levels of vaccine confidence possibly influencing vaccination coverage, we explored perceptions and attitudes towards childhood and adult vaccines in Boende (Tshuapa province, western DRC), which experienced an Ebola outbreak in 2014 and hosted the EBL2007 Ebola vaccine trial (2019-2022).

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!