HHS CDC - Trial Platform for Immunogenicity of Respiratory Viral Vaccines - MRAS

The Department of Health and Human Services (HHS), in collaboration with the General Services Administration (GSA), is conducting market research to establish a comprehensive vaccine trial platform. This initiative aims to address policy-relevant knowledge gaps concerning the immunogenicity of vaccines for respiratory viruses, specifically Respiratory Syncytial Virus (RSV) and Coronavirus Disease 2019 (COVID-19). Despite robust prelicensure trial data supporting these vaccines, there remain significant questions about the durability of immune protection and comparative effectiveness among different vaccine product types. The overarching goal of this contract is to utilize post-licensure randomized trials to fill these gaps, thereby informing future vaccination policies.

The work requested involves creating a randomized trial platform that will assess various vaccine products and vaccination strategies for RSV, COVID-19, and potentially other respiratory viruses among adult populations. These trials will focus on comparing different types of vaccines such as adjuvanted versus non-adjuvanted and their respective impacts on immune responses. By implementing rigorous standard operating procedures, this project aims to optimize sample collection and minimize follow-up loss while allowing for stratified enrollment that ensures a representative sample of the population, including key demographic groups that may have previously been underrepresented in prelicensure trials.

The primary objective is to deliver data and specimens such as serum, plasma, and peripheral blood mononuclear cells to the Centers for Disease Control and Prevention (CDC). This will facilitate comparison of humoral and cell-mediated immune responses at intervals of approximately 1, 3, and 6 months post-vaccination among recommended adult populations. Additionally, secondary objectives include evaluating the durability of immune responses over longer periods such as 12 to 24 months after vaccination; comparing responses between newly licensed vaccines during specific seasons; and characterizing immune responses in individuals who contract respiratory virus infections post-vaccination.

This project targets adults with a special focus on those aged over 60 years for RSV vaccines and over 18 years for COVID-19 vaccines. The initial sample size will be determined based on feasibility but should be sufficient to identify significant differences in humoral immune responses between intervention arms. Through these efforts, HHS seeks not only to enhance understanding of vaccine efficacy but also to ensure informed decision-making regarding public health strategies during early vaccine introduction phases.