Safety and Immunogenicity of a Plasmodium vivax Sporozoite Vaccine

Daniel M. GordonWalter Reed Army Institute of Research, United States Army Medical Institute of Infectious Diseases, SmithKline Beecham Pharmaceuticals, Biomedical Research Institute, Washington, DC

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Thomas M. CosgriffWalter Reed Army Institute of Research, United States Army Medical Institute of Infectious Diseases, SmithKline Beecham Pharmaceuticals, Biomedical Research Institute, Washington, DC

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Imogene SchneiderWalter Reed Army Institute of Research, United States Army Medical Institute of Infectious Diseases, SmithKline Beecham Pharmaceuticals, Biomedical Research Institute, Washington, DC

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Gail F. WassermanWalter Reed Army Institute of Research, United States Army Medical Institute of Infectious Diseases, SmithKline Beecham Pharmaceuticals, Biomedical Research Institute, Washington, DC

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William R. MajarianWalter Reed Army Institute of Research, United States Army Medical Institute of Infectious Diseases, SmithKline Beecham Pharmaceuticals, Biomedical Research Institute, Washington, DC

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Michael R. HollingdaleWalter Reed Army Institute of Research, United States Army Medical Institute of Infectious Diseases, SmithKline Beecham Pharmaceuticals, Biomedical Research Institute, Washington, DC

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Jeffrey D. ChulayWalter Reed Army Institute of Research, United States Army Medical Institute of Infectious Diseases, SmithKline Beecham Pharmaceuticals, Biomedical Research Institute, Washington, DC

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A recombinant DNA Plasmodium vivax sporozoite vaccine containing the repeating region of the Salvador I strain circumsporozoite (CS) protein was produced in Escherichia coli. This vaccine was tested in 13 naive volunteers at doses of 10–1,000 µg. No serious adverse reactions were noted. None of 4 volunteers receiving the 10 µg dose developed antibodies measurable by ELISA. Six of 9 volunteers in the other dose groups developed measurable antibodies: 5 of 5 volunteers receiving 100 µg and 1 of 4 receiving 1,000 µg. Antibody responses measured by immunofluorescence assays paralleled those seen by ELISA. None of the volunteers developed antisera that inhibited sporozoite invasion of human hepatoma cells in vitro. Lack of a classical anamnestic response and lack of a typical dose response to increasing amounts of antigen suggests the possible presence of an immunosuppressive epitope in the repetitive region of the CS protein.

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