The National Institute of Allergy and Infectious Diseases (NIAID), which is a part of the National Institute of Health, has developed the Collaborative Influenza Vaccine Innovation Centers (CIVICs) program. NIAID will provide up to $51 million in first-year funding for the program, which is designed to support the CIVICs program centers over a course of seven years.

These research centers are intended to have collaborators working together to create more durable, broadly protective, and longer-lasting influenza vaccines. The CIVICs program will create universal influenza vaccines, which could provide longer lasting protection against a wider variety of influenza viruses. Each center will conduct multidisciplinary research that supports the development of vaccine candidates through testing in preclinical studies, clinical trials, and human challenge studies. The network will also explore ways to improve seasonal influenza vaccines, such as testing alternative vaccine platforms or incorporating new adjuvants, which are substances added to vaccines to boost immunity.

The CIVICs program will feature 3 vaccine centers, 1 vaccine manufacturing and toxicology core, 2 clinical cores, and 1 Statistical, Data Management, and Coordination Center (SDMCC).

The vaccine centers will focus on producing novel vaccine candidates and delivery platforms, emphasizing cross-protective vaccine strategies that could be used in healthy adults as well as populations at high risk for the most serious outcomes of influenza (such as children, older adults, and pregnant women). In addition, the vaccine centers will concentrate on new ways to study influenza viruses and the human immune response to them. These studies may use computer modeling, animal models or human challenge trials.

The vaccines with the most potential will advance to clinical trials, which will be conducted by the clinical cores. Vaccine candidates are first evaluated for safety and immunogenicity in small Phase 1 clinical trials conducted among healthy adult participants; if successful, candidates can advance to larger Phase 2 clinical trials in healthy adults, specific age groups, or at-risk populations. Following this, the Vaccine Manufacturing and Toxicology Core will work with the vaccine centers to develop and manufacture the vaccine candidates for clinical testing.

The CIVICs centers will regularly consult the SDMCC for assistance in designing comprehensive preclinical experiments and clinical trials. The SDMCC also will perform data analyses, make results available across the CIVICs program, and ensure that data is available in publicly accessible databases. The SDMCC will be responsible for the network functioning as a collaborative unit, with standardized study protocols and reporting procedures at every step.   


Reference

NIH forms new collaborative influenza vaccine research network [news release]. Bethesday, MD; September 30, 2019: NIH Newsroom. https://www.nih.gov/news-events/news-releases/nih-forms-new-collaborative-influenza-vaccine-research-network. Accessed September 30, 2019.