Journal Article

Chimeric Live, Attenuated Vaccine against Japanese Encephalitis (ChimeriVax-JE): Phase 2 Clinical Trials for Safety and Immunogenicity, Effect of Vaccine Dose and Schedule, and Memory Response to Challenge with Inactivated Japanese Encephalitis Antigen

Monath, Thomas P., Murphy, Chris, Blum, Paul, Schrader, Robert, Nichols, Richard, Mathis, Danell, Bedford, Philip, Woodward, Stephen, Johnson, Casey, Guirakhoo, Farshad, Yoksan, Sutee, McCarthy, Karen

2003

Overview

ChimeriVax-JE is a live, attenuated vaccine against Japanese encephalitis, using yellow fever (YF) 17D vaccine as a vector. In a double-blind phase 2 trial, 99 adults received vaccine, placebo, or YF 17D vaccine (YF-VAX). ChimeriVax-JE was well tolerated, with no differences in adverse events between treatment groups. Viremias resulting from administration of ChimeriVax-JE and YF-VAX were of short duration and low titer; 82 (94%) of 87 subjects administered graded doses (1.8–5.8 log10) of ChimeriVax-JE developed neutralizing antibodies. A second dose, administered 30 days later, had no booster effect. Previous inoculation with YF did not interfere with ChimeriVax-JE, but there was a suggestion (not statistically significant) that ChimeriVax-JE interfered with YF-VAX administered 30 days later. A separate study explored immunological memory both in subjects who had received ChimeriVax-JE 9 months before and in ChimeriVax-JE–naive subjects challenged with inactivated mouse-brain vaccine (JE-VAX). Anamnestic responses were observed in preimmune individuals. ChimeriVax-JE appears to be a safe vaccine that provides protective levels of neutralizing antibody after a single dose

• Publisher: The University of Chicago Press,University of Chicago Press,Oxford University Press
• Subject: Animals / Antibodies / Antibodies, Viral - blood / Antigens, Viral - immunology / Applied microbiology / Arboviral encephalitis / Arboviroses / Biological and medical sciences / Dosage / Dose-Response Relationship, Drug / Double-Blind Method / Encephalitis Virus, Japanese - genetics / Encephalitis Virus, Japanese - immunology / Encephalitis, Japanese - prevention & control / Encephalitis, Japanese - virology / Fundamental and applied biological sciences. Psychology / Genetic Vectors / HIV/AIDS / Human viral diseases / Humans / Immunization Schedule / Immunologic Memory / Infectious diseases / Inoculation / Japanese encephalitis / Japanese Encephalitis Vaccines - administration & dosage / Japanese Encephalitis Vaccines - adverse effects / Japanese Encephalitis Vaccines - immunology / Medical sciences / Mice / Microbiology / Neutralization Tests / Neutralizing antibodies / Placebos / Treatment Outcome / Tropical viral diseases / Vaccination / Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) / Vaccines, Attenuated - administration & dosage / Vaccines, Attenuated - adverse effects / Vaccines, Attenuated - immunology / Vaccines, Inactivated / Viral diseases / Viral Vaccines - administration & dosage / Viral Vaccines - adverse effects / Viral Vaccines - genetics / Viral Vaccines - immunology / Viremia / Viruses / West Nile Virus Vaccines / Yellow fever / Yellow Fever Vaccine - administration & dosage / Yellow Fever Vaccine - adverse effects / Yellow Fever Vaccine - genetics / Yellow Fever Vaccine - immunology / Yellow fever virus - genetics