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Effect of Plasmodium Falciparum Exposure and Sickle Cell Trait on Infection Rates and Kinetics After IV Administration of PfSPZ Challenge

NCT02237586 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2015-04-23

No results posted yet for this study

Summary

The study is designed to establish infectivity of Plasmodium falciparum sporozoites (PfSPZ) via intravenous (IV) administration in three groups with different malaria immunity-status:

1. Adults with a history of lifelong malaria exposure without sickle cell trait (HbAA)
2. Adults with a history of lifelong malaria exposure with sickle cell trait (HbAS)
3. Adults without previous malaria episodes without sickle cell trait (HbAA)

Initially a dose of 3,200 PfSPZ will be given and the time until thick blood smear positivity after challenge will be assessed. If in any of the groups with a history of lifelong malaria exposure, 50% or less of individuals become thick blood smear positive during the 28 days post injection of PfSPZ Challenge, the dose will be increased 4-fold to 12,800 PfSPZ in this group.

Conditions

  • Plasmodium Falciparum Malaria
  • Malaria

Interventions

BIOLOGICAL

PfSPZ Challenge

live, aseptic, cryopreserved P. falciparum sporozoites

Sponsors & Collaborators

  • Centre de Recherche Médicale de Lambaréné

    collaborator OTHER

  • Institute of Tropical Medicine, University of Tuebingen

    collaborator OTHER

  • Sanaria Inc.

    lead INDUSTRY

Principal Investigators

  • Bertrand Lell, MD · Centre de Recherche Médicale de Lambaréné

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2014-09-30
Completion
2015-02-28

Countries

  • Gabon

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02237586 on ClinicalTrials.gov