drugset / Trial / NCT02476773
Study of Na-APR-1 (M74)/Alhydrogel® Co-administered With Na-GST-1/Alhydrogel in Brazilian Adults
Phase 1
Completed
60 enrolled
Baylor College of Medicine
Centro de Pesquisas René Rachou · collabGeorge Washington University · collabJohns Hopkins University · collabUniversity of California, San Francisco · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
Na-GST-1 and Na-APR-1 are proteins expressed during the adult stage of the Necator americanus hookworm life cycle that are thought to play a role in the parasite's degradation of host hemoglobin for use as an energy source. Vaccination wtih recombinant GST-1 or APR-1 has protected dogs and hamsters from infection in challenge studies. This study will evaluate the safety and immunogenicity of co-administering Na-GST-1 and Na-APR-1 to healthy Brazilian adults living in an area of endemic hookworm infection.
Timeline
- Start
- 2016-01
- Primary completion
- 2017-06
- Completion
- 2017-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GLA-AF | Other / unclassified | — | Intramuscular |
| Subject | Na-APR-1 | Protein / enzyme biologic | 10 ug | Intramuscular |
| Subject | Na-APR-1 | Protein / enzyme biologic | 30 ug | Intramuscular |
| Subject | Na-APR-1 | Protein / enzyme biologic | 100 ug | Intramuscular |
| Subject | Na-GST-1 | Protein / enzyme biologic | 100 ug | Intramuscular |
| Background | Aluminum hydroxide | Unknown | — | Intramuscular |