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Safety and Protective Efficacy of Intravenous Immunization With Cryopreserved Plasmodium Falciparum Sporozoites Under Chemoprophylaxis

NCT02115516 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2017-05-15

No results posted yet for this study

Summary

TÜCHMI-002 is a single center, randomized, placebo-controlled, double-blinded, PfSPZ Challenge dose finding trial with two chemoprophylactic regimens and subsequent controlled human malaria infection (CHMI).

Conditions

  • Malaria
  • Plasmodium Falciparum Malaria

Interventions

BIOLOGICAL

PfSPZ Challenge

Aseptic, purified, vialed, cryopreserved, infectious P. falciparum sporozoites, strain NF54

BIOLOGICAL

0.9% Sodium Chloride (Placebo)

Sponsors & Collaborators

  • Institute of Tropical Medicine, University of Tuebingen

    collaborator OTHER

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • Sanaria Inc.

    lead INDUSTRY

Principal Investigators

  • Benjamin Mordmüller, MD · Institute of Tropical Medicine, University of Tuebingen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-12-31
Completion
2016-04-30

Countries

  • Germany

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 NCT02115516 on ClinicalTrials.gov