title: Safety and immunogenicity of a modified pox vector-based HIV/AIDS vaccine candidate expressing Env, Gag, Pol and Nef proteins of HIV-1 subtype B (MVA-B) in healthy HIV-1-uninfected volunteers: A phase I clinical trial (RISVAC02).
abstract: BACKGROUND
  To investigate the safety and immunogenicity of a modified vaccinia virus Ankara vector expressing HIV-1 antigens from clade B (MVA-B), a phase-I, doubled-blind placebo-controlled trial was performed.
  
  
  METHODS
  30 HIV-uninfected volunteers at low risk of HIV-1 infection were randomly allocated to receive 3 intramuscular injections (1×10(8)pfu/dose) of MVA-B (n=24) or placebo (n=6) at weeks 0, 4 and 16. All volunteers were followed 48 weeks. Primary end-points were adverse events and immunogenicity.
  
  
  RESULTS
  A total of 169 adverse events were reported, 164 of grade 1-2, and 5 of grade 3 (none related to vaccination). Overall 75% of the volunteers showed positive ELISPOT responses at any time point. The magnitude (median) of the total responses induced was 288SFC/10(6)PBMC at week 18. Antibody responses against Env were observed in 95% and 72% of vaccinees at week 18 and 48, respectively. HIV-1 neutralizing antibodies were detected in 33% of volunteers.
  
  
  CONCLUSIONS
  MVA-B was safe, well tolerated and elicited strong and durable T-cell and antibody responses in 75% and 95% of volunteers, respectively. These data support further exploration of MVA-B as an HIV-1 vaccine candidate. Clinical Trials.gov identifier: NCT00679497.
authors: Hospital Clinic-IDIBAPS, Barcelona, Spain. fgarcia@clinic.ub.es
authors: Felipe
authors: F
authors: García
authors: Juan Carlos López
authors: JC
authors: Bernaldo de Quirós
authors: Carmen E
authors: CE
authors: Gómez
authors: Beatriz
authors: B
authors: Perdiguero
authors: Jose L
authors: JL
authors: Nájera
authors: Victoria
authors: V
authors: Jiménez
authors: Juan
authors: J
authors: García-Arriaza
authors: Alberto C
authors: AC
authors: Guardo
authors: Iñaki
authors: I
authors: Pérez
authors: Vicens
authors: V
authors: Díaz-Brito
authors: Matilde Sánchez
authors: MS
authors: Conde
authors: Nuria
authors: N
authors: González
authors: Amparo
authors: A
authors: Alvarez
authors: José
authors: J
authors: Alcamí
authors: José Luis
authors: JL
authors: Jiménez
authors: Judit
authors: J
authors: Pich
authors: Joan Albert
authors: JA
authors: Arnaiz
authors: María J
authors: MJ
authors: Maleno
authors: Agathe
authors: A
authors: León
authors: María Angeles
authors: MA
authors: Muñoz-Fernández
authors: Peter
authors: P
authors: Liljeström
authors: Jonathan
authors: J
authors: Weber
authors: Giuseppe
authors: G
authors: Pantaleo
authors: José M
authors: JM
authors: Gatell
authors: Montserrat
authors: M
authors: Plana
authors: Mariano
authors: M
authors: Esteban
mesh_terms: D016915:AIDS Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000235:genetics / Q000276:immunology*; D000293:Adolescent; D000328:Adult; D016207:Cytokines / Q000378:metabolism; D004311:Double-Blind Method; D004337:Drug Carriers; D058501:Enzyme-Linked Immunospot Assay; D005260:Female; D005822:Genetic Vectors; D015483:HIV Antibodies / Q000097:blood; D015497:HIV-1 / Q000235:genetics / Q000276:immunology*; D006805:Human Experimentation; D006801:Humans; D007273:Injections, Intramuscular; D007963:Leukocytes, Mononuclear / Q000276:immunology; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000235:genetics / Q000276:immunology; D014616:Vaccinia virus / Q000235:genetics*; D014764:Viral Proteins / Q000235:genetics / Q000276:immunology*; D055815:Young Adult
chemical_list: D016915:AIDS Vaccines; D016207:Cytokines; D004337:Drug Carriers; D015483:HIV Antibodies; D010919:Placebos; D014614:Vaccines, Synthetic; D014764:Viral Proteins