Title
CoPED ID
Status
Funders
Value
Start Date
End Date
Description
“During the Phase 1 Innovate UK funded programme Stabilitech demonstrated that a thermally stabilised oral capsule delivering a vaccine-inducing viral vector to the gastrointestinal tract can stimulating systemic immunity. In these studies, the viral vector was designed to transduce expression of Zika virus antigens, giving rise to specific antibodies providing protective response from live virus challenge in preclinical models.
During the Phase 2 programme Stabilitech will further develop this novel Zika virus vaccine to First-in-Human ready. Within this development phase Stabilitech will optimise viral yields from culture and in vitro (dissolution) release characteristics of the capsule in the alimentary canal, with protective efficacy indication following viral challenge. Once optimisation has been performed Stabilitech will prepare under CDMO contract GMP (engineering and production) lots of the vaccine, perform non-clinical immunological and safety testing requirements as provided in the guidance provided in CPMP/SWP/465/95. The overall aim by the end of the proposed program of work, is a CTA ready package to facility small scale human clinical trials.
| Stabilitech Biopharma Ltd | LEAD_ORG |
| Stabilitech Biopharma Ltd | PARTICIPANT_ORG |
| Iosbio Ltd | LEAD_ORG |
| Iosbio Ltd | PARTICIPANT_ORG |
| Andrew BACON | PM_PER |
| Andrew BACON | PM_PER |
Subjects by relevance
- Viruses
- Vaccines
- Immune system
- Zika virus
- Antibodies
- Vaccination
- Immunology
- Optimisation
- Virus diseases
- Capsules
Extracted key phrases
- Novel Zika virus vaccine
- Oral Zika vaccine
- Zika virus antigen
- Programme Stabilitech
- Development phase Stabilitech
- Viral vector
- Live virus challenge
- Viral challenge
- Innovate UK
- Phase
- Viral yield
- Facility small scale human clinical trial
- Oral capsule
- CTA ready package
- Protective efficacy indication