A Phase I Clinical Trial to Assess the Safety and Immunogenicity of DX-104
brief summary
A randomized, double-blinded, positive-controlled clinical trial will be conducted to observe the safety and immunogenicity of DX-104 in adults 18 to 50 years of age.
detailed description
A total of 30 healthy participants will be enrolled and randomized (2:1) to receive DX-104 or Bexsero® (multicomponent meningococcal group B vaccine). Participants in both the DX-104 and Bexsero® groups will receive three doses of intramuscular vaccination at Months 0, 1, and 6.
After all participants have completed the 6-month safety and immunogenicity observations following full vaccination, the trial will be concluded.
official title
A Phase I, Randomized, Double-blinded, Positive-Controlled Clinical Trial to Assess the Safety and Immunogenicity of the Group B Meningococcal OMV Vaccine (DX-104) in Adults Aged 18 to 50 Years