drugset / Trial / NCT03420053
Study to Evaluate Safety, Immunogenicity and Efficacy of PfSPZ Vaccine in HIV Negative and HIV Positive Tanzanian Adults
Phase 1
Completed
21 enrolled
Sanaria Inc.
Ifakara Health Institute · collabMedical Care Development, Inc. · collabSwiss Tropical & Public Health Institute · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This is a randomized, double-blind, placebo-controlled trial to evaluate safety and tolerability of PfSPZ Vaccine administered as five doses of 9.0x10\^5 PfSPZ or normal saline at 0, +2, +4, +6 and +28 days to healthy HIV negative adult volunteers and healthy HIV positive volunteers in Tanzania.
Timeline
- Start
- 2018-02-07
- Primary completion
- 2018-08-25
- Completion
- 2018-08-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PfSPZ Vaccine | Vaccine | 450000 unknown | Intravenous |
| Subject | PfSPZ Vaccine | Vaccine | 900000 unknown | Intravenous |