drugset / Trial / NCT02335164
A Phase 1 Study to Evaluate the Immunogenicity and Safety of a Pandemic Avian Influenza Vaccine in Adults
Phase 1
Completed
270 enrolled
Vaxine Pty Ltd
Australian Respiratory and Sleep Medicine Institute · collabFlinders University · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
Recombinant hemagglutinin has been shown to induce protective neutralising antibodies against avian influenza virus but is relatively non-immunogenic. An ideal pandemic avian influenza influenza vaccine would combine hemagglutinin antigen with an appropriate adjuvant to increase its immunogenicity. This Phase 1 study will collect preliminary human safety and efficacy data on combined formulations of recombinant hemagglutinin with Advax adjuvant formulations administered by intramuscular injection
Timeline
- Start
- 2015-07
- Primary completion
- 2017-12-01
- Completion
- 2019-05-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Advax1 | Other / unclassified | 20 mg | Intramuscular |
| Subject | Advax2 | Other / unclassified | 20 mg | Intramuscular |
| Subject | Panblok H7 | Vaccine | 2.5 ug | Intramuscular |
| Subject | Panblok H7 | Vaccine | 5 ug | Intramuscular |
| Subject | Panblok H7 | Vaccine | 15 ug | Intramuscular |
| Subject | Panblok H7 | Vaccine | 45 ug | Intramuscular |