A phase I safety and immunogenicity dose escalation trial of plague vaccine, Flagellin/F1/V, in healthy adult volunteers (DMID 08-0066)

• Published in: Vaccine Vol. 35; no. 48; pp. 6759 - 6765
• Main Authors: Frey, Sharon E., Lottenbach, Kathleen, Graham, Irene, Anderson, Edwin, Bajwa, Kanwaldeep, May, Ryan C., Mizel, Steven B., Graff, Aaron, Belshe, Robert B.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 04.12.2017; Elsevier Limited
• Subjects: Adolescent; Adult; Adults; Allergy and Immunology; antibodies; Antibodies, Bacterial - blood; Antigens; Antigens, Bacterial - administration & dosage; Antigens, Bacterial - immunology; Bacterial Proteins - administration & dosage; Bacterial Proteins - immunology; Bioterrorism; blood serum; Child; Cytokines; Cytokines - biosynthesis; Cytokines - immunology; dose response; Dose-response effects; Dose-Response Relationship, Immunologic; Drug-Related Side Effects and Adverse Reactions; Enzyme-Linked Immunosorbent Assay; F1/V antigen; Female; Flagellin; Flagellin - administration & dosage; Flagellin - immunology; Healthy Volunteers - statistics & numerical data; Humans; IgG antibody; immune response; Immunogenicity; Immunoglobulin E; Immunoglobulin G; Injections, Intramuscular; Male; males; Middle Aged; placebos; Plague; Plague - microbiology; Plague - prevention & control; Plague Vaccine - administration & dosage; Plague Vaccine - adverse effects; Plague Vaccine - immunology; Pore Forming Cytotoxic Proteins - administration & dosage; Pore Forming Cytotoxic Proteins - immunology; Proteins; Salmonella; TLR5; Vaccination; Vaccine; Vaccines; Yersinia pestis; Yersinia pestis - immunology; Young Adult; Plague; Flagellin; Vaccine; TLR5; Bioterrorism; F1/V antigen; Yersinia pestis

Intentional aerosolization of Yersinia pestis may result in pneumonic plague which is highly fatal if not treated early. We conducted a phase 1 randomized, double blind (within each group), placebo controlled, dose escalation trial to evaluate a plague vaccine, Flagellin/F1/V, in healthy adults aged...