Trials / Completed
CompletedNCT00730782
Assessment of Three Formulations of the Candidate Vaccine AMA 1 in Healthy Dutch Adult Volunteers
Assessment of the Safety and Immunogenicity of Three Formulations of the Recombinant Pichia Pastoris Apical Membrane Antigen 1 (PfAMA-1-FVO[25-545]), Blood-Stage Malaria Vaccine in Healthy Dutch Adult Volunteers : a Phase 1, Single- Blind, Randomised, Dose-Escalating, Unicentre Trial
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- European Vaccine Initiative · Academic / Other
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study was to evaluate the safety of a candidate malaria vaccine (PfAMA-1) at 3 doses given at monthly intervals of 2 different dosages of AMA-1 (10 μg or 50 μg ) adjuvanted either with alum hydroxide or AS02A or Montanide ISA 720 in healthy adults not previously exposed to the parasite Plasmodium falciparum.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PfAMA-1-FVO[25-545] | Subcutaneous vaccination of 0.5ml of two dosage 10 and 50ug PfAMA1 |
Timeline
- Start date
- 2005-11-01
- Primary completion
- 2007-09-01
- Completion
- 2008-08-01
- First posted
- 2008-08-08
- Last updated
- 2008-08-08
Locations
2 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT00730782. Inclusion in this directory is not an endorsement.