Clinical Research Studies

The rapid development of highly effective parenterally administered SARS-CoV-2 vaccines and the subsequent mass vaccination campaigns are triumphs of science and public health that have mitigated the pandemic’s toll of morbidity and mortality. The emergence of viral variants and waning of the immune responses have resulted in diminished effectiveness of these vaccines against infection and mild to moderate disease, albeit with sustained effectiveness against the most severe outcomes. Next generation vaccines, including those with enhanced breadth of protection to variants, durability, and ability to block infection/transmission including mucosal vaccines, may further decrease SARS-CoV-2 infections and transmission. NIAID’s NextGen Vaccine Program will facilitate the clinical development of promising next generation vaccines by supporting a series of phase 1 and phase 2 protocols with harmonized safety and immunogenicity endpoints. Murine pneumonia virus (MPV) vector that encodes the prefusion-stabilized version of the SARS-CoV-2 spike (S) protein (MPV/S-2P) has been shown to be a promising vaccine candidate in non-human primates. MPV/S-2P induces a strong mucosal and systemic immunity and provides protection from a homologous SARS-CoV-2 challenge in macaques. It is therefore anticipated that MPV/S-2P will generate robust immune responses to SARS-CoV-2 as a boost in individuals previously vaccinated and may be a next generation vaccine for COVID-19.