SERUM ANTIBODY ASSAY FOR DETERMINING PROTECTION FROM MALARIA, AND PRE-ERYTHROCYTIC SUBUNIT VACCINES

摘要

Disclosed herein are diagnostic assays for identifying individuals that are protected against Plasmodium falciparum caused malaria. Such assays are particularly useful for determining not only the protective efficacy of Pf whole parasite vaccines for individual subjects, but also within populations of vaccinated subjects. The assays comprise the use of proteomes representing at least 50% of Pf, preferably coupled to a solid phase as a fixed array. The arrays are used to probe the sera of human subjects, particularly subjects of human clinical trials of whole parasite malaria vaccines as well as public health vaccination campaigns. Serum samples with antibody profiles most strongly reactive in multiplex to CSP and MSP5 demonstrate a sensitivity of from 92% to 100% and a specificity of from 84% to 89%.

主权项

1. A method for determining a state of protective immunity against P. falciparum-induced malaria in a human subject said method comprising probing a human body fluid sample with Pf immunologic determinants comprising (i) a first Pf immunologic determinant having a sequence that is at least 80% identical to an amino acid sequence encoded by the nucleic acid sequence of SEQ ID NO: 1 or an antigenic fragment thereof; and (ii) a second Pf immunologic determinant having a sequence that is at least 80% identical to the amino acid sequence encoded by the nucleic acid sequence of SEQ ID NO:2 or an antigenic fragment thereof, and determining whether said human body fluid sample comprises antibodies that are specifically immunoreactive to said first and second Pf immunologic determinants, wherein specific immunoreactivity to said first and second Pf immunologic determinants indicates protective immunity in said subject.