The United States of America, as Represented by the Secretary, Department of Health and Human Services

Kathy Hancock

Victor C W Tsang

Patricia P Wilkins

Melinda L Yushak

Fatima Williams Whitfield

Sowmya Pattabhi

Ryan M Greene

Jeffrey L Call

Victor Cw Tsang

Yeuk-mui Lee

The present disclosure relates to T24 nucleic acid sequences, amino acid sequences, and antibodies. Methods for detecting and diagnosinginfection in a subject using the T24 sequences and specific binding agents are also disclosed. The T24 sequences disclosed herein can be formulated into a pharmaceutical composition for administration to a subject. For example, the disclosed T24 polypeptides can also be administered to a subject to stimulate an immune response in the subject, thereby protecting the subject againstinfection.

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Compositions and methods for the detection ofand the diagnosis ofinfection are described. The nucleotide and amino acid sequences of the antigenicpolypeptides gp50, gp50and gp50are provided. The compositions contain synthetic antigenic polypeptides of larval origin prepared using the sequences described herein. Probes and primers for the detection or amplification ofnucleic acid molecules are also described. The polypeptides can be administered to a human or animal to protect againstinfection. In addition, the polypeptides are useful as research tools for studyingand as reagents in assays for the detection ofantibodies in a biological sample. The methods are sensitive and specific assays that utilize the stable recombinant or synthetic antigenic polypeptides or nucleic acid molecules encoding the larval polypeptides.

A reagent and method for the specific and highly sensitive detection ofin which the reagent is an antibody for a solublesporozoite antigen and the method is an immunoassay in which the antibody is used to detect or quantifysporozoite antigen in a sample. The sample is treated to cause excystation ofoocytes, thereby releasing asporozoite antigen, and combined with antibodies specific for the sporozoite antigen under conditions to form an antibody-antigen complex. Detection of the complex indicates the presence ofin the sample. The assay allows recognition and detection ofin turbid samples, and due to a lack of crossreactivity with otherspecies, is specific forcontamination or infection. The assay is highly sensitive, allowing for the detection of less than 100 oocysts per milliliter of sample.

Compositions and methods for the detection ofand the diagnosis ofinfection are described. The nucleotide and amino acid sequences of the antigenicpolypeptides gp50a, gp50b and gp50c are provided. The compositions contain synthetic antigenic polypeptides of larval origin prepared using the sequences described herein. Probes and primers for the detection or amplification ofnucleic acid molecules are also described. The polypeptides can be administered to a human or animal to protect againstinfection. In addition, the polypeptides are useful as research tools for studyingand as reagents in assays for the detection ofantibodies in a biological sample. The methods are sensitive and specific assays that utilize the stable recombinant or synthetic antigenic polypeptides or nucleic acid molecules encoding the larval polypeptides.

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Atlanta, GA, United States of America

Kathy Hancock