Development/production of universal influenza vaccines

National Institute Of Allergy And Infectious Diseases

Investigators

Linked publications & trials

Abstract

Influenza vaccines conferring immunity against multiple strains of virus will be developed at the VPP and manufactured through the VCMP for human clinical trials in compliance with current Good Manufacturing Practices (cGMP) and released for use in human clinical trials in healthy human volunteers. These vaccines may confer broad immunity, a "universal influenza vaccine," over a period of several years against multiple strains in contrast to seasonal products that are only useful for a single season. If these trials demonstrate safety and immunogenicity of these vaccines in human trials, further evaluation may take place in larger (Phase 2) trials which will necessitate production of the clinical trial materials (CTM) at larger scale. Such vaccines would be effective over multiple seasons and would require lengthy clinical study and monitoring for effectiveness across strains that vary from season to season. Vaccines under development include multivalent nanoparticle-based vaccines for supra-seasonal use or universal influenza vaccines.