NCT02692963

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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

• Malaria
• Plasmodium Falciparum

Interventions

Type	Name	Description
BIOLOGICAL	BCG vaccination	BCG vaccine InterVax

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-10-01
• Completion: 2017-02-01
• First posted: 2016-02-26
• Last updated: 2017-04-20

Locations

1 site across 1 country: Netherlands