drugset / Trial / NCT01261130
Safety and Immunogenicity of a Human Hookworm Candidate Vaccine With or Without Additional Adjuvant in Brazilian Adults
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This two part study will evaluate the safety and immunogenicity of two formulations of Na-GST-1, first in hookworm-naïve individuals using an open-label design, and then in adults living in an area of endemic hookworm infection using a randomized, double-blind design. The two formulations to be evaluated are Na-GST-1 adsorbed to an adjuvant, Alhydrogel®, and Na-GST-1 adsorbed to Alhydrogel® and administered with GLA-AF.
Timeline
- Start
- 2011-11
- Primary completion
- 2014-08
- Completion
- 2014-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Butang® | Vaccine | — | Intramuscular |
| Subject | Na-GST-1 | Protein / enzyme biologic | 10 ug | Intramuscular |
| Subject | Na-GST-1 | Protein / enzyme biologic | 30 ug | Intramuscular |
| Subject | Na-GST-1 | Protein / enzyme biologic | 100 ug | Intramuscular |