To tackle the human health challenges that face the world today, the FNIH develops collaborations with top experts from government, industry, academia and the not-for-profit sector and provides a neutral environment where we can work productively toward a common goal.

Centralized Envelope Comparative Immunogenicity Study

The Centralized Envelope Comparative Immunogenicity Study is an HIV/AIDS vaccine development project that seeks to answer a central question that has blocked the development of a successful HIV vaccine: how can we design vaccine immunogens that address the broad genetic diversity of HIV?

Eliminate Dengue

This program is field testing a new self-sustaining biocontrol technology to prevent transmission of dengue, zika and chikungunya viruses by vector mosquitoes.

Support of Ebola Research by NIAID

In response to the critical Ebola Virus Disease (EVD) outbreak in 2014, the FNIH has established a fund that supports the Division of Clinical Research of the National Institute of Allergy and Infectious Diseases (NIAID) in its efforts to prevent, treat and research the EVD in West Africa.

Biomarkers Consortium - PROGRESS OA: Clinical Evaluation and Qualification of Osteoarthritis Biomarkers

The goal of this three-year project is to validate the novel radiographic measures, MRI measures and biochemical markers from the Phase I OA Biomarkers Consortium Project, and to qualify those biomarkers via the formal regulatory qualification process with both the FDA and EMA.

Biomarkers Consortium - The Performance of Novel Cardiac Biomarkers in the General U.S. Population

The Biomarkers Consortium’s Novel Cardiac Biomarkers in the General US Population (the Cardiac Troponin Project) seeks to define the reference ranges and to generate the epidemiologic basis for the use of several significant novel cardiac and related biomarkers for cardiovascular risk stratification in the general U.S. population. The program will measure a panel of biomarkers in almost 30,000 individuals in a national study. The project will provide key reference data regarding novel biomarkers for cardiovascular risk stratification and inform U.S. clinical and laboratory guidelines.

Biomarkers Consortium - Treatments Against RA and Effect on FDG PET-CT (TARGET Biomarker Study)

The Biomarkers Consortium’s TARGET Biomarker Study seeks to utilize validated proteomic biomarkers of rheumatoid arthritis (RA) disease activity and inflammation to categorize baseline and disease-modifying antirheumatic drug (DMARD)-associated changes in vascular inflammation in RA patients.

Biomarkers Consortium - Osteoarthritis Biomarkers Project

The Biomarkers Consortium - Osteoarthritis Biomarkers Project is a $3.4 million study aimed at determining which biomarkers have greater prognostic ability to measure early progression of structural and symptomatic changes in the joint over time and which are likely to predict treatment response better than the radiographic measurement of narrowing of joint space in knee OA patients. These new biomarkers are candidates for follow-on studies for evaluation and use in regulatory decision-making.

Biomarkers Consortium - Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia Clinical Endpoint Development (HABP/VABP)

The Biomarkers Consortium’s Hospital-Acquired Bacterial Pneumonia (HABP) and Ventilator-Associated Bacterial Pneumonia (VABP) Project aims to develop clinically relevant endpoints in clinical trials to improve antibacterial trial feasibility.

Biomarkers Consortium - Developing Endpoints for Clinical Trials in Community Acquired Bacterial Pneumonia (CABP) and Acute Skin and Skin Infections (ABSSSI)

The Biomarkers Consortium’s Developing Endpoints for Clinical Trials in CABP and Skin Infections aims to develop approaches that will help the U.S. Food and Drug Administration develop efficacy outcome measures (endpoints) for modern-day clinical trials of investigational agents for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

Biomarkers Consortium - Diabetes Drug Development: Identification and Validation of Markers That Predict Long-Term Beta Cell Function and Mass

This is the first project in a two-stage strategy that seeks to characterize beta cell function for predicting long-term beta cell response to an intervention based on short-term measures. The first stage’s goal is to characterize key methodological issues in the assessment of beta cell function by evaluating Mixed Meal Tolerance (MTT) and Arginine Stimulation Tests against the standard Frequently Sampled Intravenous Glucose Tolerance (FSIGT) Test in a series of clinical studies.