Development and Production of Investigational Products for Prevention of Mumps

National Institute Of Allergy And Infectious Diseases

Investigators

Abstract

The current mumps vaccine (MMR) is safe and effective, however, the circulating strain of mumps is now significantly different than the vaccine strain. Additionally, the current mumps vaccine is a weak booster vaccine. Vaccines conferring immunity against the circulating strain of virus and that are stronger booster shots 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 a stronger immune response that may last longer than the boost effect of MMR. These vaccines are likely to be safer in immunocompromised people because they are not “live” vaccines. It is also possible that recipients of the vaccines will have fewer adverse reactions. If the initial Phase 1 trials demonstrate safety and immunogenicity of these vaccines, further evaluation may take place in larger (Phase 2) trials which will necessitate production of the clinical trial materials (CTM) at larger scale.