Investigating a new Vaccine Against Meningitis B in Oxford (VAMBOX)
Research type
Research Study
Full title
A phase I/IIa, single centre, dose-escalation study to assess the safety and immunogenicity of the recombinant adenovirus Meningitis B vaccine candidate ChAdOx1 MenB.1
IRAS ID
227641
Contact name
Andrew Pollard
Contact email
Sponsor organisation
University of Oxford
Eudract number
2017-000965-61
Duration of Study in the UK
1 years, 3 months, 31 days
Research summary
Meningococcus Group B causes significant morbidity and mortality by causing meningococcal meningitis or sepsis. A vaccine against the bacteria, Bexsero, does exist, but it has a significant rate of side effects, requires up to 4 doses to be efficacious and is expensive.\n\nThere has recently been development in vaccine technology using an adenovirus as a vector. Using this, we have created a non-replicating adenovirus expressing a modified protein from meningococcus group B (fHbp). Administration of this vaccine will lead to the virus entering human cells and producing the protein, but not replicating itself. The production of this protein produces an immune response to meningococcus group B in mice that is as good as Bexsero and potentially longer lasting. \n\nThis vaccine candidate is expected to be safe, with previously trials using a similar adenovirus vector proving safe for equivalents vectors for vaccines for malaria, TB, Ebola etc. It is also relatively inexpensive and produces little side-effects. Therefore, we believe this vaccine can improve on the current available vaccine for meningococcus B.\n\nWe would therefore like to test this vaccine candidate in a Phase 1 trial, primarily to assess the safety of the vaccine in humans. \n\nWe are also aiming to gauge the immunogenicity as a secondary outcome to inform further potential efficacy trials. In this regard we are testing combinations of low single dose, high single dose, high single dose with later high booster dose and high booster dose following a primary Bexsero dose. These will be compared to Bexsero as a control.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0470
Date of REC Opinion
21 Dec 2017
REC opinion
Further Information Favourable Opinion