drugset / Trial / NCT02304185
Safety, Tolerability and Immunogenicity Study of 2 Dose Levels of Trimeric Glycoprotein140 (gp140) in Healthy Adult Volunteers
Phase 1
Completed
50 enrolled
Crucell Holland BV
Beth Israel Deaconess Medical Center · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
The purpose of this study is to assess the safety and tolerability of 2 different dose levels of trimeric glycoprotein140 (gp140) administered as a 2-dosage regimen, intramuscularly (injection of a substance into a muscle), with and without aluminum phosphate as adjuvant in healthy human immunodeficiency virus (HIV)-uninfected participants.
Timeline
- Start
- 2014-12
- Primary completion
- 2016-04
- Completion
- 2016-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aluminum Phosphate | Unknown | 0.425 mg | Intramuscular |
| Subject | gp140 | Vaccine | 50 ug | Intramuscular |
| Subject | gp140 | Vaccine | 250 ug | Intramuscular |
Indications
No indication recorded.