title: Characterization of humoral and cellular immune responses elicited by a recombinant adenovirus serotype 26 HIV-1 Env vaccine in healthy adults (IPCAVD 001).
abstract: BACKGROUND
  Adenovirus serotype 26 (Ad26) has been developed as a novel candidate vaccine vector for human immunodeficiency virus type 1 (HIV-1) and other pathogens. The primary safety and immunogenicity data from the Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) 001 trial, the first-in-human evaluation of a prototype Ad26 vector-based vaccine expressing clade A HIV-1 Env (Ad26.ENVA.01), are reported concurrently with this article. Here, we characterize in greater detail the humoral and cellular immune responses elicited by Ad26.ENVA.01 in humans.
  
  
  METHODS
  Samples from the IPCAVD 001 trial were used for humoral and cellular immunogenicity assays.
  
  
  RESULTS
  We observed a dose-dependent expansion of the magnitude, breadth, and epitopic diversity of Env-specific binding antibody responses elicited by this vaccine. Antibody-dependent cell-mediated phagocytosis, virus inhibition, and degranulation functional activity were also observed. Env-specific cellular immune responses induced by the vaccine included multiple CD8(+) and CD4(+) T-lymphocyte memory subpopulations and cytokine secretion phenotypes, although cellular immune breadth was limited. Baseline vector-specific T-lymphocyte responses were common but did not impair Env-specific immune responses in this study.
  
  
  CONCLUSIONS
  Ad26.ENVA.01 elicited a broad diversity of humoral and cellular immune responses in humans. These data support the further clinical development of Ad26 as a candidate vaccine vector.
  
  
  BACKGROUND
  NCT00618605.
authors.affiliation: Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA. dbarouch@bidmc.harvard.edu
authors.forename: Dan H
authors.initials: DH
authors.lastname: Barouch
authors.forename: Jinyan
authors.initials: J
authors.lastname: Liu
authors.forename: Lauren
authors.initials: L
authors.lastname: Peter
authors.forename: Peter
authors.initials: P
authors.lastname: Abbink
authors.forename: M Justin
authors.initials: MJ
authors.lastname: Iampietro
authors.forename: Ann
authors.initials: A
authors.lastname: Cheung
authors.forename: Galit
authors.initials: G
authors.lastname: Alter
authors.forename: Amy
authors.initials: A
authors.lastname: Chung
authors.forename: Anne-Sophie
authors.initials: AS
authors.lastname: Dugast
authors.forename: Nicole
authors.initials: N
authors.lastname: Frahm
authors.forename: M Juliana
authors.initials: MJ
authors.lastname: McElrath
authors.forename: Holger
authors.initials: H
authors.lastname: Wenschuh
authors.forename: Ulf
authors.initials: U
authors.lastname: Reimer
authors.forename: Michael S
authors.initials: MS
authors.lastname: Seaman
authors.forename: Maria G
authors.initials: MG
authors.lastname: Pau
authors.forename: Mo
authors.initials: M
authors.lastname: Weijtens
authors.forename: Jaap
authors.initials: J
authors.lastname: Goudsmit
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Walsh
authors.forename: Raphael
authors.initials: R
authors.lastname: Dolin
authors.forename: Lindsey R
authors.initials: LR
authors.lastname: Baden
mesh_terms: D016915:AIDS Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D000260:Adenoviruses, Human / Q000145:classification / Q000235:genetics*; D004311:Double-Blind Method; D015686:Gene Products, env / Q000235:genetics / Q000276:immunology*; D015483:HIV Antibodies / Q000097:blood*; D015658:HIV Infections / Q000276:immunology / Q000517:prevention & control; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007111:Immunity, Cellular / Q000276:immunology*; D007963:Leukocytes, Mononuclear / Q000276:immunology; D016896:Treatment Outcome; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D016915:AIDS Vaccines; D015686:Gene Products, env; D015483:HIV Antibodies; D014614:Vaccines, Synthetic