drugset / Trial / NCT00400101
Phase Ia Malaria Vaccine Trial of Two Virosome-Formulated Peptides
RandomizedParallel-groupSingle-blindPrevention
Summary
Influenza virosomes represent an innovative human-compatible antigen delivery system that has already proven its suitability for subunit vaccine design. The aim of the study was to proof the concept that virosomes can also be used to elicit high titers of antibodies against synthetic peptides derived from the circumsporozoite protein and from the apical-membrane-antigen 1 and that the formulations are safe in humans.
Timeline
- Start
- 2003-11
- Primary completion
- —
- Completion
- 2005-10
Publications
- Okitsu SL, Silvie O, Westerfeld N, Curcic M, Kammer AR, Mueller MS, Sauerwein RW, Robinson JA, Genton B, Mazier D, Zurbriggen R, Pluschke G. A virosomal malaria peptide vaccine elicits a long-lasting sporozoite-inhibitory antibody response in a phase 1a clinical trial. PLoS One. 2007 Dec 5;2(12):e1278. doi: 10.1371/journal.pone.0001278.
- Genton B, Pluschke G, Degen L, Kammer AR, Westerfeld N, Okitsu SL, Schroller S, Vounatsou P, Mueller MM, Tanner M, Zurbriggen R. A randomized placebo-controlled phase Ia malaria vaccine trial of two virosome-formulated synthetic peptides in healthy adult volunteers. PLoS One. 2007 Oct 10;2(10):e1018. doi: 10.1371/journal.pone.0001018.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PEV301 | Vaccine | 10 ug | Intramuscular |
| Subject | PEV301 | Vaccine | 50 ug | Intramuscular |
| Subject | PEV302 | Vaccine | 10 ug | Intramuscular |
| Subject | PEV302 | Vaccine | 50 ug | Intramuscular |