title: Phase 1 safety and immunogenicity testing of DNA and recombinant modified vaccinia Ankara vaccines expressing HIV-1 virus-like particles.
abstract: BACKGROUND
  Recombinant DNA and modified vaccinia virus Ankara (rMVA) vaccines represent a promising approach to an HIV/AIDS vaccine. This Phase 1 clinical trial compared the safety and immunogenicity of a rMVA vaccine administered with and without DNA vaccine priming
  
  
  METHODS
  GeoVax pGA2/JS7 DNA (D) and MVA/HIV62 (M) vaccines encode noninfectious virus-like particles. Intramuscular needle injections were used to deliver placebo, 2 doses of DNA followed by 2 doses of rMVA (DDMM), one dose of DNA followed by 2 doses of rMVA (DMM), or 3 doses of rMVA (MMM) to HIV-seronegative participants.
  
  
  RESULTS
  Local and systemic symptoms were mild or moderate. Immune response rates for CD4 + and CD8 + T cells were highest in the DDMM group and lowest in the MMM group (77% vs 43% CD4 + and 42% vs 17% CD8 +). In contrast, response rates for Env binding and neutralizing Ab were highest in the MMM group. The DMM group had intermediate response rates. A 1/10th-dose DDMM regimen induced similar T cell but reduced Ab response rates compared with the full-dose DDMM.
  
  
  CONCLUSIONS
  MVA62 was well tolerated and elicited different patterns of T cell and Ab responses when administered alone or in combination with the JS7 DNA vaccine.
authors.affiliation: Department of Medicine, University of Alabama at Birmingham, AL 35294, USA. paulg@uab.edu
authors.forename: Paul A
authors.initials: PA
authors.lastname: Goepfert
authors.forename: Marnie L
authors.initials: ML
authors.lastname: Elizaga
authors.forename: Alicia
authors.initials: A
authors.lastname: Sato
authors.forename: Li
authors.initials: L
authors.lastname: Qin
authors.forename: Massimo
authors.initials: M
authors.lastname: Cardinali
authors.forename: Christine M
authors.initials: CM
authors.lastname: Hay
authors.forename: John
authors.initials: J
authors.lastname: Hural
authors.forename: Stephen C
authors.initials: SC
authors.lastname: DeRosa
authors.forename: Olivier D
authors.initials: OD
authors.lastname: DeFawe
authors.forename: Georgia D
authors.initials: GD
authors.lastname: Tomaras
authors.forename: David C
authors.initials: DC
authors.lastname: Montefiori
authors.forename: Yongxian
authors.initials: Y
authors.lastname: Xu
authors.forename: Lilin
authors.initials: L
authors.lastname: Lai
authors.forename: Spyros A
authors.initials: SA
authors.lastname: Kalams
authors.forename: Lindsey R
authors.initials: LR
authors.lastname: Baden
authors.forename: Sharon E
authors.initials: SE
authors.lastname: Frey
authors.forename: William A
authors.initials: WA
authors.lastname: Blattner
authors.forename: Linda S
authors.initials: LS
authors.lastname: Wyatt
authors.forename: Bernard
authors.initials: B
authors.lastname: Moss
authors.forename: Harriet L
authors.initials: HL
authors.lastname: Robinson
mesh_terms: D016915:AIDS Vaccines / Q000276:immunology*; D000293:Adolescent; D000328:Adult; D018791:CD4 Lymphocyte Count; D015496:CD4-Positive T-Lymphocytes / Q000276:immunology; D018414:CD8-Positive T-Lymphocytes / Q000276:immunology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005822:Genetic Vectors; D015483:HIV Antibodies / Q000096:biosynthesis / Q000097:blood; D015658:HIV Infections / Q000517:prevention & control*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D014481:United States; D019444:Vaccines, DNA / Q000276:immunology* / Q000592:standards; D014616:Vaccinia virus / Q000235:genetics / Q000276:immunology*; D055815:Young Adult
chemical_list: D016915:AIDS Vaccines; D015483:HIV Antibodies; D010919:Placebos; D019444:Vaccines, DNA