title: HIV-1 vaccine induced immune responses in newborns of HIV-1 infected mothers.
abstract: OBJECTIVE
  Breast milk transmission continues to account for a large proportion of cases of mother-to-child transmission of HIV-1 worldwide. An effective HIV-1 vaccine coupled with either passive immunization or short-term antiretroviral prophylaxis represents a potential strategy to prevent breast milk transmission. This study evaluated the safety and immunogenicity of ALVAC HIV-1 vaccine with and without a subunit envelope boost in infants born to HIV-1-infected women.
  
  
  METHODS
  : Placebo-controlled, double-blinded study.
  
  
  METHODS
  Infants born to HIV-1-infected mothers in the US were immunized with a prime-boost regimen using a canarypox virus HIV-1 vaccine (vCP1452) and a recombinant glycoprotein subunit vaccine (rgp120). Infants (n = 30) were randomized to receive: vCP1452 alone, vCP1452 + rgp120, or corresponding placebos.
  
  
  RESULTS
  Local reactions were mild or moderate and no significant systemic toxicities occurred. Subjects receiving both vaccines had gp120-specific binding serum antibodies that were distinguishable from maternal antibody. Repeated gp160-specific lymphoproliferative responses were observed in 75%. Neutralizing activity to HIV-1 homologous to the vaccine strain was observed in 50% of the vCP1452 + rgp120 subjects who had lost maternal antibody by week 24. In some infants HIV-1-specific proliferative and antibody responses persisted until week 104. HIV-1-specific cytotoxic T lymphocyte responses were detected in two subjects in each treatment group; the frequency of HIV-1 specific cytotoxic T lymphocyte responses did not differ between vaccine and placebo recipients.
  
  
  CONCLUSIONS
  The demonstration of vaccine-induced immune responses in early infancy supports further study of HIV-1 vaccination as a strategy to reduce breast milk transmission.
authors.affiliation: Department of Pediatric Infectious Diseases, University of Colorado Health Sciences Center, Denver Colorado, USA. betsy.mcfarland@uchsc.edu
authors.forename: Elizabeth J
authors.initials: EJ
authors.lastname: McFarland
authors.forename: Daniel C
authors.initials: DC
authors.lastname: Johnson
authors.forename: Petronella
authors.initials: P
authors.lastname: Muresan
authors.forename: Terence
authors.initials: T
authors.lastname: Fenton
authors.forename: Georgia D
authors.initials: GD
authors.lastname: Tomaras
authors.forename: James
authors.initials: J
authors.lastname: McNamara
authors.forename: Jennifer S
authors.initials: JS
authors.lastname: Read
authors.forename: Steven D
authors.initials: SD
authors.lastname: Douglas
authors.forename: Jaime
authors.initials: J
authors.lastname: Deville
authors.forename: Marc
authors.initials: M
authors.lastname: Gurwith
authors.forename: Sanjay
authors.initials: S
authors.lastname: Gurunathan
authors.forename: John S
authors.initials: JS
authors.lastname: Lambert
mesh_terms: D016915:AIDS Vaccines / Q000009:adverse effects / Q000276:immunology*; D001942:Breast Feeding / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D015483:HIV Antibodies / Q000096:biosynthesis / Q000097:blood; D015699:HIV Envelope Protein gp120 / Q000276:immunology; D015658:HIV Infections / Q000517:prevention & control* / Q000635:transmission; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007111:Immunity, Cellular; D007231:Infant, Newborn / Q000276:immunology*; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008297:Male
chemical_list: D016915:AIDS Vaccines; C468116:ALVAC-HIV vCP1452; D015483:HIV Antibodies; D015699:HIV Envelope Protein gp120