drugset / Trial / NCT01717950
Safety and Immunogenicity of the Na-APR-1 Hookworm Vaccine in Healthy Adults
Non-randomizedParallel-groupOpen-labelPrevention
Summary
Hookworms digest hemoglobin from erythrocytes for use as an energy source via a proteolytic cascade that begins with the aspartic protease, APR-1. Vaccination with recombinant APR-1 has protected animals from infection in challenge studies. This study will evaluate the safety and immunogenicity of two formulations of Na-APR-1 (M74) in healthy adult volunteers when co-administered with different concentrations of the immunostimulant GLA-AF.
Timeline
- Start
- 2013-09
- Primary completion
- 2015-06
- Completion
- 2015-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GLA-AF | Other / unclassified | 2.5 ug | Intramuscular |
| Subject | GLA-AF | Other / unclassified | 5 ug | Intramuscular |
| Subject | Na-APR-1 (M74) | Vaccine | 30 ug | Intramuscular |
| Subject | Na-APR-1 (M74) | Vaccine | 100 ug | Intramuscular |
| Background | Aluminum hydroxide | Unknown | 240 ug | Intramuscular |
| Background | Aluminum hydroxide | Unknown | 800 ug | Intramuscular |