Initial Study of Malaria Vaccine Pfs25-EPA/Alhydrogel(Registered Trademark)

Summary

Background: \- The malaria vaccine Pfs25-EPA/Alhydrogel may help block malaria parasites from developing in mosquitoes. When a mosquito bites a vaccinated person, the vaccine should prevent parasites from developing in the mosquito. As a result, the mosquito will not spread malaria to the next person it bites. However, the vaccine will not directly prevent people from getting sick with malaria. Researchers want to test the safety of and response to this vaccine. Objectives: \- To test the safety of the malaria vaccine Pfs25-EPA/Alhydrogel. Eligibility: \- Healthy volunteers between 18 and 50 years of age. Design: * Participants will be screened with a medical history, physical exam, and blood tests. * They will be assigned to a study group to have either two or three doses of the vaccine. Participants will have checkups after each dose of vaccine, * The additional doses will be given 2 months or 2 and 4 months after the first vaccine. * Participants will have regular blood tests to check the level of the response to the vaccine. * They will be followed for up to 1 year after the last vaccine to have any additional tests as needed.

Timeline

Start

2011-08

Primary completion

2013-08

Completion

2013-08

Publications

• Background Birkett AJ. PATH Malaria Vaccine Initiative (MVI): perspectives on the status of malaria vaccine development. Hum Vaccin. 2010 Jan;6(1):139-45. doi: 10.4161/hv.6.1.10462. Epub 2010 Jan 29. No abstract available.
• Background Cheru L, Wu Y, Diouf A, Moretz SE, Muratova OV, Song G, Fay MP, Miller LH, Long CA, Miura K. The IC(50) of anti-Pfs25 antibody in membrane-feeding assay varies among species. Vaccine. 2010 Jun 17;28(27):4423-9. doi: 10.1016/j.vaccine.2010.04.036. Epub 2010 Apr 29.
• Background Coler RN, Baldwin SL, Shaverdian N, Bertholet S, Reed SJ, Raman VS, Lu X, DeVos J, Hancock K, Katz JM, Vedvick TS, Duthie MS, Clegg CH, Van Hoeven N, Reed SG. A synthetic adjuvant to enhance and expand immune responses to influenza vaccines. PLoS One. 2010 Oct 27;5(10):e13677. doi: 10.1371/journal.pone.0013677.

Drugs

Indications