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Safety and Protective Efficacy of BCG Vaccination Against Controlled Human Malaria Infection

NCT02692963 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-04-20

No results posted yet for this study

Summary

The Bacillus Calmette-Guérin (BCG) vaccine, a live attenuated Mycobacterium bovis vaccine, has been used to prevent tuberculosis for almost a century, and it is still the most used vaccine in the world. There is also circumstantial and indirect evidence that BCG vaccination can protect against malaria. Investigators hypothesize that BCG vaccination can offer protection against malaria in the Controlled Human Malaria Infection (CHMI) model.

A total of 20 healthy male and female volunteers will participate in this randomized, single-blind clinical trial. Volunteers will be randomized to receive either BCG vaccination (BCG vaccine SSI) (group 1, n=10) or no treatment (group 2, n=10). Five weeks after vaccination of group 1 volunteers, all volunteers will undergo a CHMI administered by the bites of five P. falciparum infected Anopheles mosquitoes.

Conditions

Interventions

BIOLOGICAL

BCG vaccination

BCG vaccine InterVax

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Robert Sauerwein, Prof. · Radboud University Medical Center

  • Mihai Netea, Prof. · Radboud University Medical Center

  • Jona Walk, MD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-10-31
Completion
2017-02-28

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 NCT02692963 on ClinicalTrials.gov