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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.
| IOSBIO LTD | LEAD_ORG |
| IOSBIO LTD | PARTICIPANT_ORG |
| Andrew BACON | PM_PER |
Subjects by relevance
- Viruses
- Vaccines
- Antibodies
- Immune system
- Virus diseases
- Zika virus
- Immunology
- Communicable diseases
- Capsules
- Optimisation
Extracted key phrases
- Oral Zika Vaccine
- Novel Zika virus vaccine
- Zika virus antigen
- Programme Stabilitech
- Oral capsule
- Development phase Stabilitech
- Viral vector
- Live virus challenge
- Innovate UK
- Viral challenge
- Phase
- Viral yield
- Small scale human clinical trial
- CTA ready package
- Protective efficacy indication