Optimization of Controlled Human Malarial Infection by Injection of P. Falciparum Sporozoites in Non-Immune Adults
NCT01771848 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2016-04-04
Summary
The study is designed to establish the best dose to safely infect healthy individuals with Plasmodium falciparum sporozoites (PfSPZ) by injection.
The goal of this study is to achieve infections in human volunteers with infection rates of 100% and pre-patent periods of less than 12 days.
Conditions
Interventions
- BIOLOGICAL
-
PfSPZ Challenge
Aseptic, purified, vialed, cryopreserved fully infectious NF54 P. falciparum sporozoites
Sponsors & Collaborators
-
Barcelona Centre for International Health Research
collaborator OTHER -
Sanaria Inc.
lead INDUSTRY
Principal Investigators
-
Pedro L Alonso, MD, Ph.D. · Barcelona Centre for International Health Research (CRESIB), Hospital Clínic-Universitat de Barcelona
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-12-31
- Primary Completion
- 2013-05-31
- Completion
- 2013-07-31
Countries
- Spain
Study Locations
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