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Clinical Trial of the PfSPZ Vaccine

NCT01001650 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-09-10

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and tolerability of a non-replicating, metabolically active Plasmodium falciparum sporozoite (PfSPZ) vaccine in malaria-naïve healthy volunteers following multiple-dose subcutaneous (SC) or intradermal (ID) administration.

In addition, the investigators wish to evaluate PfSPZ vaccine-mediated protection against P. falciparum challenge in the following 4 groups (see below) and compare protective efficacy of the PfSPZ vaccine when given by SC v ID administration in all these groups:

* Group 1: 4 doses of 7,500 PfSPZ/immunization,
* Group 2: 4 doses of 30,000 PfSPZ/immunization,
* Group 3: 4 doses of 135,000 PfSPZ/immunization
* Group 4: 4 or 6 doses of 135,000 PfSPZ/immunization.

If \> 80% protective efficacy is not achieved in Groups 1, 2, or 3, volunteers in Group 4 will receive a fifth and sixth dose.

Conditions

  • Plasmodium Falciparum

Interventions

BIOLOGICAL

Plasmodium falciparum Sporozoite (strain NF-54; Anopheles stephensi mosquitoes) Vaccine, Live, Inactivated (gamma irradiation)

Group 1: 4 doses of 7,500 PfSPZ/immunization, Group 2: 4 doses of 30,000 PfSPZ/immunization, Group 3: 4 doses of 135,000 PfSPZ/immunization, and Group 4: 4 or 6 doses of 135,000 PfSPZ/immunization. If \> 80% protective efficacy is not achieved in Groups 1, 2, or 3, volunteers in Group 4 will receive a fifth and sixth dose.

Sponsors & Collaborators

  • The PATH Malaria Vaccine Initiative (MVI)

    collaborator OTHER

  • Sanaria Inc.

    lead INDUSTRY

Principal Investigators

  • Judith E Epstein, M.D. · Naval Medical Research Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-07-31
Completion
2010-09-30

Countries

  • United States

Study Locations

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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 NCT01001650 on ClinicalTrials.gov