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.

Understanding the Mechanisms of Intravenous BCG-Induced Protection Against TB in NHP (TB Vaccine)

Two billion people worldwide are infected with Mycobacterium tuberculosis (Mtb) resulting in 10 million cases of clinical disease and 1.5 million deaths each year. The hurdles for developing a highly protective and durable vaccine against Mtb require addressing four central tenets of T cell immunology – magnitude, quality, breadth, and location of the response. These specific elements of the problem will be addressed by focusing on how altering the route of vaccination using a whole attenuated organism vaccine substantially increases immune responses and protection in a rigorous non-human primate model of Mtb infection.

Gene Drive Research-Related Activities

Gene drive is a mechanism that can promote the preferential inheritance of a beneficial genetic trait, thereby increasing its prevalence in a population. A variety of gene drive mechanisms occur in nature that can cause specific genetic elements to spread throughout populations in varying degrees. Researchers have long sought to harness these naturally occurring gene drive mechanisms to prevent the transmission of mosquito or other insect-borne diseases that pose some of society's most intractable public health problems.

Support functions for development of new technologies for controlling transmission of mosquito-borne diseases

The project provides the FNIH management and advisory services for research programs seeking to develop new cost-effective and sustainable biologic strategies for controlling mosquito-borne infections like malaria and dengue fever.

Comprehensive Cellular Vaccine Immune Monitoring Consortium

A collaborative program that provides standardized and research level assays for clinical and pre-clinical HIV vaccine trials.

SHORTEN-TB

SHORTEN-TB will build on lessons learned from the HIT-TB program to identify leads that have the greatest potential to comprise drug regimens that will significantly reduce the duration of chemotherapy for tuberculosis.

PredictTB

PredictTB is a five-year clinical trial project that aims to shorten the treatment times of tuberculosis (TB) in drug-sensitive patients through individualized therapy.

Global Health Fund

The Global Health Fund supports FNIH programs that are designed to alleviate widespread suffering in the developing world. Program focus includes research and training on diseases such as malaria and HIV, as well as conditions like malnutrition that afflict hundreds of millions of people globally.

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.

Non-Invasive Biomarkers of Metabolic Liver Disease (NIMBLE)

The NIMBLE Project is a comprehensive, five-year collaborative effort to standardize, compare and appropriately validate imaging and circulating biomarkers for NASH to: 1. Diagnose and stage the disease and; 2. Measure response to therapeutic intervention.

Biomarkers Consortium - Workshop: Defining an Evidentiary Criteria Framework for Surrogate Endpoint Qualification

The FNIH Biomarkers Consortium and FDA hosted a workshop to provide a Framework for Defining the Evidentiary Criteria for Surrogate Endpoint Qualification on July 30-31, 2018. The workshop aimed to create alignment of the biomedical community and regulators on the levels of evidence required to qualify biomarkers for use in drug development, with an emphasis on surrogate endpoints and specific clinical outcome measures.