drugset / Trial / NCT01949909
Safety And Immunogenicity Of Novel Candidate Blood-Stage Malaria Vaccine P27A : Phase Ia/Ib
Phase 1
Completed
56 enrolled
Centre Hospitalier Universitaire Vaudois
European Vaccine Initiative · collabEuropean and Developing Countries Clinical Trials Partnership (EDCTP) · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
P27A study is designed as a randomized phase Ia/Ib trial to evaluate the safety and immunogenicity of the blood stage candidate vaccine P27A against P. falciparum - P27A antigen and associated adjuvant (Alhydrogel or GLA-SE) - in malaria non exposed European volunteers(Switzerland; phase Ia) and malaria exposed African volunteers (Tanzania; phase Ib).
Timeline
- Start
- 2014-03
- Primary completion
- 2015-07
- Completion
- 2015-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aluminum hydroxide | Unknown | — | Intramuscular |
| Subject | GLA-SE | Other / unclassified | 2.5 ug | Intramuscular |
| Subject | GLA-SE | Other / unclassified | 5 ug | Intramuscular |
| Subject | P27A | Peptide | 10 ug | — |
| Subject | P27A | Peptide | 50 ug | — |
| Comparator | Verorub TM | Unknown | — | Intramuscular |