title: A randomized, double-blind, controlled trial of the 17D yellow fever virus vaccine given in combination with immune globulin or placebo: comparative viremia and immunogenicity.
abstract: We evaluated whether coadministration of the yellow fever (YF) virus vaccine with human immunoglobulin (Ig) that contained YF virus-neutralizing antibodies would reduce post-vaccination viremia without compromising immunogenicity and thus, potentially mitigate YF vaccine-associated adverse events. We randomized 80 participants to receive either YF vaccine and Ig or YF vaccine and saline placebo. Participants were followed for 91 days for safety and assessments of viremia and immunogenicity. There were no differences found between the two groups in the proportion of vaccinated participants who developed viremia, seroconversion, cluster of differentiation (CD)-8(+) and CD4(+) T-cell responses, and cytokine responses. These results argue against one putative explanation for the increased reporting of YF vaccine side effects in recent years (i.e., a change in travel clinic practice after 1996 when hepatitis A prophylaxis with vaccine replaced routine use of pre-travel Ig, thus potentially removing an incidental YF vaccine-attenuating effect of anti-YF virus antibodies present in Ig).
authors.affiliation: Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA. sedupug@emory.edu
authors.forename: Srilatha
authors.initials: S
authors.lastname: Edupuganti
authors.forename: Rachel B
authors.initials: RB
authors.lastname: Eidex
authors.forename: Harry
authors.initials: H
authors.lastname: Keyserling
authors.forename: Rama S
authors.initials: RS
authors.lastname: Akondy
authors.forename: Robert
authors.initials: R
authors.lastname: Lanciotti
authors.forename: Walter
authors.initials: W
authors.lastname: Orenstein
authors.forename: Carlos
authors.initials: C
authors.lastname: del Rio
authors.forename: Yi
authors.initials: Y
authors.lastname: Pan
authors.forename: Troy
authors.initials: T
authors.lastname: Querec
authors.forename: Harvey
authors.initials: H
authors.lastname: Lipman
authors.forename: Alan
authors.initials: A
authors.lastname: Barrett
authors.forename: Rafi
authors.initials: R
authors.lastname: Ahmed
authors.forename: Dirk
authors.initials: D
authors.lastname: Teuwen
authors.forename: Martin
authors.initials: M
authors.lastname: Cetron
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Mulligan
mesh_terms: D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D007136:Immunoglobulins / Q000008:administration & dosage*; D008213:Lymphocyte Activation; D010919:Placebos; D014766:Viremia / Q000175:diagnosis* / Q000276:immunology; D022341:Yellow Fever Vaccine / Q000008:administration & dosage* / Q000276:immunology / Q000302:isolation & purification
chemical_list: D007136:Immunoglobulins; D010919:Placebos; D022341:Yellow Fever Vaccine