Long-term immunogenicity and safety of a non-typeable - vaccine: 4-year follow-up of a phase 1 multicentre trial.

A multicomponent vaccine has been developed to reduce the frequency of acute exacerbations of COPD associated with non-typeable (NTHi) and (Mcat) infections, containing NTHi (PD and PE-PilA) and Mcat (UspA2) surface proteins. In a randomised, observer-blind, placebo-controlled study with two steps (NCT02547974), the investigational vaccine had good immunogenicity and no safety concerns were identified. In step 2, 90 adults aged 50-71 years with smoking history received two doses 60 days apart of one of two AS01-adjuvanted formulations containing 10 µg of each antigen (10-10-AS01) or 10 µg NTHi antigens and 3.

A Phase 2a Randomized Study to Evaluate the Safety and Immunogenicity of the 1790GAHB Generalized Modules for Membrane Antigen Vaccine against Administered Intramuscularly to Adults from a Shigellosis-Endemic Country.

Shigellosis is a mild-to-severe diarrheal infection, caused by the genus , and is responsible for significant morbidity and mortality worldwide. We evaluated the safety and immunogenicity of an investigational vaccine (1790GAHB) based on generalized modules for membrane antigens (GMMA) in Kenya, a -endemic country. This phase 2a, observer-blind, controlled randomized study (NCT02676895) enrolled 74 healthy adults aged 18-45 years, of whom 72 were vaccinated.