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Controlled Human Malaria Infection (CHMI) After Immunization With Cryopreserved Plasmodium Falciparum Sporozoites Under Chloroquine Prophylaxis

NCT01728701 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-05-15

No results posted yet for this study

Summary

The purpose of the study is to determine the safety and tolerability of ID administration of PfSPZ Challenge to volunteers taking chloroquine chemoprophylaxis (an approach called PfSPZ-CVac).

Conditions

Interventions

BIOLOGICAL

PfSPZ Challenge

PfSPZ Challenge is a suspension of aseptic, purified, cryopreserved PfSPZ that are thawed and formulated in diluent on the day of administration.

BIOLOGICAL

Normal Saline (NS)

Normal saline

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • Sanaria Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Sauerwein, MD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-12-31
Completion
2014-02-28
FDA Drug
Yes

Countries

  • Netherlands

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 NCT01728701 on ClinicalTrials.gov