Pfs230D1M-EPA/AS01 Vaccine, a Transmission Blocking Vaccine Against Plasmodium Falciparum, in an Age De-Escalation Trial of Children and a Family Compound Trial in Mali

• Status: Recruiting
• Trial end date: 2020-08-31

Summary

Background:

Malaria affects many people in Mali and other parts of Africa. It is spread by mosquito bites. Malaria can make people sick or can lead to death. Scientists want to learn if a vaccine can stop it from spreading to other people.

Objective:

To test how well an experimental malaria vaccine works to decrease malaria infections.

Eligibility:

Healthy people ages 5 and older who live in Doneguebougou, Mali, and surrounding areas

Design:

Participants will be screened with:

Medical history

Physical exam

Blood, urine, and heart tests

EKG

Participants will be randomly assigned to get either the experimental vaccine or an approved vaccine. They will not know which they are getting.

Participants will have a visit about a week before their first vaccine. They will take a medicine that kills malaria. They will take it at the clinic the next 2 days. Participants ages 5-8 will take the drug again 2 weeks before their third vaccine.

Participants get the vaccine through a needle in the arm. They will have visits 1, 3, 7, and 14 days after. They will have blood tests or finger pricks.

Participants will get another vaccine 1 and 6 months later.

Participants will have blood tests once a month. At these visits they may also have urines tests or mosquito feeds. For the feeds a cup full of mosquitoes will be placed on arms or legs for 15-20 minutes.

Participants will have visits twice a month for 4 months after their last vaccine.

• Phase: Phase 2

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Artemether; Artemether, Lumefantrine Drug Combination; Lumefantrine; Vaccines