MenPF-1 - A New Vaccine Against Meningococcal Disease
Condition: Serogroup B Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study the investigators are testing a new vaccine against Neisseria meningitidis, the
      leading infective cause of childhood death in the UK. This bug (also known as meningococcus)
      can infect the lining of the brain (meningitis) or the blood stream (septicaemia) and can
      affect all ages, but especially children, adolescents and young adults.

      The bug is classified into different groups based on its outer capsule (or shell), and this
      study will test a new vaccine to protect against group B meningococcus (MenB) disease, which
      is the most common type in the UK.

      Vaccines are given to prepare the immune system to fight an infection. Vaccines work by
      stimulating the immune system to produce specialised proteins (called antibodies) and white
      blood cells designed to kill the bug later in life if needed.

      Vaccines against other types of meningococcus have been developed and saved many lives.
      However MenB is different because its outer capsule does not stimulate the immune system very
      effectively. There is therefore no broadly effective vaccine against MenB disease.
    

Detailed description: 
      The vaccine the investigators are testing in this study is known as MenPF-1, and uses two
      bacterial proteins called PorA and FetA. PorA works to move particles across the bacterial
      cell wall, and FetA is needed to bind to iron that the bacteria need in order to grow. These
      proteins are found on almost all meningococcal bugs so they are an excellent target for the
      immune system, and it is thought that they could be the key to developing a new vaccine
      against MenB disease.

      MenPF-1 is a type of vaccine known as an Outer Membrane Vesicle (OMV) vaccine. This means
      that it has been produced from 'blebs' of the meningococcal bug's outer membrane, released by
      the meningococcus both during natural infection and in the laboratory. These outer membrane
      vesicles contain the PorA and FetA proteins, so can be used to make vaccines. The techniques
      used to produce the OMVs to make MenPF-1 are the same as those used in other very similar
      safe and effective vaccines. The MenB strain that the investigators use naturally produces
      PorA protein, and has been genetically modified to produce increased amounts of FetA for the
      OMV vaccine.

      MenPF-1 contains:

        -  Many proteins, but especially PorA and FetA

        -  Aluminium, which is safe and commonly used in many vaccines to better activate the
           immune system

        -  Sugar and water for injection

      It is worth noting that the vaccine product MenPF-1 is designed to work against MenB and,
      even if successful, would not protect against all forms of meningitis. Also, it is not a live
      vaccine and therefore cannot cause a meningitis infection.
    

Intervention name(s): MenPF-1.
Intervention type(s): Biological
Intervention description(s): A new vaccine against meningococcal disease.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other