In adults who had previously received a full regimen of any of three COVID-19 vaccines granted Emergency Use Authorization (EUA) or approved by the Food and Drug Administration (FDA), an additional booster dose of any of these vaccines was safe and prompted an immune response, according to preliminary clinical trial results reported in The New England Journal of Medicine. The findings served as the basis for recommendations by the FDA and the Centers for Disease Control and Prevention in late fall 2021 to permit mix-and-match COVID-19 booster vaccinations in the United States.

A new observational study has begun to evaluate the immune responses generated by COVID-19 vaccines administered to pregnant or postpartum people. Researchers will measure the development and durability of antibodies against SARS-CoV-2, the virus that causes COVID-19, in people vaccinated during pregnancy or the first two postpartum months. Researchers also will assess vaccine safety and evaluate the transfer of vaccine-induced antibodies to infants across the placenta and through breast milk.

The National Institutes of Health has started a Phase 1/2 clinical trial in which adult volunteers who have been fully vaccinated against COVID-19 will receive booster doses of different COVID-19 vaccines to determine the safety and immunogenicity of mixed boosted regimens. The National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, is leading and funding the study through the Infectious Diseases Clinical Research Consortium, a clinical trials network that encompasses the Institute’s long-standing Vaccine and Treatment Evaluation Units (VTEUs).

An investigational vaccine designed to protect against the B.1.351 SARS-CoV-2 variant has been administered as part of a new Phase 1 clinical trial evaluating the vaccine candidate’s safety and immunogenicity in adult volunteers. The vaccine, known as mRNA-1273.351, was developed by the biotechnology company ModernaTX, Inc., based in Cambridge, Massachusetts. The trial is led and funded by NIAID. The trial will enroll approximately 210 healthy adult volunteers at four clinical research sites in the United States that are part of the NIAID-funded Infectious Diseases Clinical Research Consortium (IDCRC).

The NIAID TB Portals Program is a multi-national collaboration for tuberculosis (TB) data sharing and analysis to advance TB research.

TB Portals is a web-based, open-access repository of multi-domain TB data and tools for its analysis. It offers linked socioeconomic/geographic, clinical, laboratory, radiological, and genomic data from over 3,400 international TB patient cases.

Researchers can explore and analyze these data through any of the tools. TB Portals data are also available for download to support your own research.

NIAID Clinical Trials Data Repository, AccessClinicalData@NIAID, is an NIAID cloud-based, secure data platform that enables sharing of and access to anonymized individual, patient level clinical data sets from NIAID sponsored clinical trials to harness the power of data to generate new knowledge to understand, treat, and prevent infectious diseases such as COVID-19.

Steps to access clinical data can be found at Accessing Clinical Data.

An investigational mRNA vaccine to prevent SARS-CoV-2 infection generates a strong immune response in a NIAID-supported Phase 1 trial.

The virology team focuses on gaining a deeper understanding of viral pathogenesis and advancing clinical approaches to assist in managing diseases. The team works with a range of high-consequence viral pathogens.

The team leverages fundamental methodologies, such as: 

The pathology and histology teams work together to conduct morphologic assessments and molecular assays using in-life and postmortem samples attained during research studies that develop and use established animal models of high-consequence emerging human viruses. The clinical pathologic and histopathologic data are interpreted by the pathologists using historical controls, or within-study controls, to generate reports that address specific pathology-associated aims of each study.

The immunology team interrogates immune responses against pathogens requiring maximum containment by use of a variety of capabilities. These include but are not limited to cytometry (e.g., immunophenotyping), Luminex multiplex protein/cytokine arrays, cartridge-based cell- sorting (MACSQuant Tyto), ELISAs, serology, in vitro functional assays, intracellular cytokine staining (ICS) enzyme-linked immune absorbent spot (ELISPOT; e.g., T cell and B cell).