Study of the Safety and Immunogenicity of Pfs230D1M-EPA/Alhydrogel and Pfs25M-EPA/Alhydrogel , a Transmission Blocking Vaccine Against Plasmodium Falciparum Malaria, in Adults in the U.S. and Mali

• Status: Completed
• Trial end date: 2018-10-22

Summary

Background:

• Malaria is a severe infection caused by a parasite. People can get malaria if a mosquito that carries the parasite bites them. Malaria infection does not happen in the United States, but many people in Africa, Asia, and South America are at risk for it. Researchers want to test two vaccines that may help decrease malaria infection.

Objective:

• To see if two vaccines (Pfs25M-EPA/Alhydrogel and Pfs230DIM-EPA/Alhydrogel ) are safe in humans and cause an immune response that will prevent malaria parasites from correctly growing in the mosquito.

Eligibility:

• Healthy adults ages 18 50.

Design:

• There are several groups in this study. Each group will receive a different dose of the vaccine and some groups will received both vaccines.

• Vaccinations will be given on two days about 4 weeks apart.

• Participants will receive each vaccine as an injection into the arm. Blood will be drawn on the day of vaccination.

• In the 4 weeks after receiving a vaccination, participants will have at least 3 clinic visits and 1 phone contact. They will have at least 3 more visits and 3 phone contacts over the next 6 months.

• At each visit, participants will be evaluated for side effects to the vaccine and any new health changes or problems. They will be asked how they are feeling and if they have taken any medicine. Blood and urine samples may be taken at the visit. More follow-up visits may be needed to follow up on changes or problems.

• Phase: Phase 1

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Rodolphe Merieux Laboratory@@@Bamako, Mali
• Treatments: Aluminum Hydroxide