Safety and immunogenicity of a parenterally administered rotavirus VP8 subunit vaccine in healthy adults |
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| Institution: | 1. Vaccine Development Global Program, PATH, 455 Massachusetts Ave., Suite 1000, Washington, DC, 20001, USA;2. Center for Immunization Research, Department of International Health, The Johns Hopkins Bloomberg School of Public Health, 624N. Broadway, Suite 117, Hampton House, Baltimore, MD 21205, USA;3. Laboratory for Specialized Clinical Studies, Division of Infectious Diseases, Cincinnati Children''s Hospital Medical Center, 333 Burnet Avenue ML6014, Cincinnati, OH, 45229, USA;4. The EMMES Corporation, 401N. Washington Street, Suite 700, Rockville, MD, 20850, USA |
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| Abstract: | BackgroundThe P2-VP8 subunit vaccine for the prevention of rotavirus gastroenteritis is comprised of a truncated VP8 subunit protein from the rotavirus Wa strain (G1P8]) fused to the tetanus toxin P2 epitope, and adsorbed on aluminum hydroxide for intramuscular administration.MethodsThree groups of 16 adults were randomized to receive three injections of P2-VP8 (12) or placebo (4) at doses of 10, 30 or 60 μg of vaccine. IgG and IgA antibodies to P2-VP8 were assessed by ELISA in serum and lymphocyte supernatant (ALS). Serum samples were tested for neutralizing antibodies to homologous and heterologous strains of rotavirus.ResultsThe vaccine was well-tolerated. All vaccine recipients demonstrated significant IgA responses and all but one demonstrated IgG responses; in the 60 μg cohort, geometric mean titers (GMTs) rose 70- and 80-fold for IgA and IgG, respectively. Homologous neutralizing antibody responses were observed in about half of participants in all three dose cohorts; in the 60 μg cohort, GMTs against Wa rose from 128 to 992. Neutralizing antibody responses were robust to P8] strains, moderate to P4] strains and negligible to P6] strains. ALS IgA responses were dose dependent.ConclusionsThe P2-VP8 subunit vaccine was well tolerated and evoked promising immune responses.Clinical trials registrationNCT01764256 |
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| Keywords: | Rotavirus Vaccine Diarrhea Subunit Parenteral Non-replicating |
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