title: A bovine parainfluenza virus type 3 vaccine is safe and immunogenic in early infancy.
abstract: BACKGROUND
  A phase 2 trial was conducted to assess in young infants the safety, tolerability, infectivity, and immunogenicity of multiple doses of an intranasal vaccine using bovine parainfluenza virus type 3 (bPIV3).
  
  
  METHODS
  One hundred ninety-two healthy 2-month-old infants were randomized 1 : 1 : 1 to receive 1x10(5) median tissue culture infective dose (TCID(50)) bPIV3 vaccine, 1x10(6) TCID(50) bPIV3 vaccine, or placebo at 2, 4, 6, and 12-15 months of age. Safety information was collected by use of diary sheets and telephone interviews. Nasal wash and serum specimens were collected for assessment of infectivity and immunogenicity.
  
  
  RESULTS
  The safety profiles of both dosages of bPIV3 were similar to that of placebo, with the exception of fever with temperature of >/=38.1 degrees C after dose 2 only, occurring in 34% of the 1x10(5) TCID(50) group, 35% of the 1x10(6) TCID(50) group, and 12% of the placebo group (P<.01). No vaccine-related serious adverse events were reported. The cumulative vaccine infectivity (isolation of bPIV3 and/or bPIV3 seroconversion) after dose 3 was similar in the 2 vaccine groups (87% in the 1x10(5) TCID(50) group and 77% in the 1x10(6) TCID(50) group) (P=.46). Seroconversion rates after dose 3, assessed by means of hemagglutination inhibition assay, after adjustment for decrease in maternal antibody titers, were 67% in the 1x10(5) TCID(50) group, 57% in the 1x10(6) TCID(50) group, and 12% in the placebo group (P<.01). Isolation of bPIV3 was common after dose 1, dose 2, or dose 3, but only 1 of 51 participants in the vaccine groups had bPIV3 isolated after dose 4.
  
  
  CONCLUSIONS
  Multiple doses of bPIV3 vaccine were well tolerated and immunogenic in young infants.
authors.affiliation: University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA.
authors.forename: David P
authors.initials: DP
authors.lastname: Greenberg
authors.forename: Robert E
authors.initials: RE
authors.lastname: Walker
authors.forename: Min-Shi
authors.initials: MS
authors.lastname: Lee
authors.forename: Keith S
authors.initials: KS
authors.lastname: Reisinger
authors.forename: Joel I
authors.initials: JI
authors.lastname: Ward
authors.forename: Ram
authors.initials: R
authors.lastname: Yogev
authors.forename: Mark M
authors.initials: MM
authors.lastname: Blatter
authors.forename: Sylvia H
authors.initials: SH
authors.lastname: Yeh
authors.forename: Ruth A
authors.initials: RA
authors.lastname: Karron
authors.forename: Chithra
authors.initials: C
authors.lastname: Sangli
authors.forename: Lane
authors.initials: L
authors.lastname: Eubank
authors.forename: Kathleen L
authors.initials: KL
authors.lastname: Coelingh
authors.forename: Julie M
authors.initials: JM
authors.lastname: Cordova
authors.forename: Marilyn J
authors.initials: MJ
authors.lastname: August
authors.forename: Harshvardhan B
authors.initials: HB
authors.lastname: Mehta
authors.forename: Wendy
authors.initials: W
authors.lastname: Chen
authors.forename: Paul M
authors.initials: PM
authors.lastname: Mendelman
mesh_terms: D000281:Administration, Intranasal; D000914:Antibodies, Viral / Q000097:blood*; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007223:Infant; D017817:Nasal Lavage Fluid / Q000276:immunology / Q000821:virology; D022241:Parainfluenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D029101:Parainfluenza Virus 3, Bovine / Q000276:immunology*; D010224:Parainfluenza Virus 3, Human / Q000276:immunology*; D010253:Respirovirus Infections / Q000517:prevention & control*; D014481:United States
chemical_list: D000914:Antibodies, Viral; D022241:Parainfluenza Vaccines