title: Phase 2 evaluation of parainfluenza type 3 cold passage mutant 45 live attenuated vaccine in healthy children 6-18 months old.
abstract: A phase 2 evaluation of live attenuated parainfluenza type 3 (PIV3)-cold passage mutant 45 (cp45) vaccine was conducted in 380 children 6-18 months old; 226 children (59%) were seronegative for PIV3. Of the 226 seronegative children, 114 received PIV3-cp45 vaccine, and 112 received placebo. No significant difference in the occurrence of adverse events (i.e., runny nose, cough, or temperature > or =38 degrees C) was noted during the 14 days after vaccination. There was no difference between groups in the occurrence of acute otitis media or serous otitis media. Paired serum samples were available for 109 of the seronegative vaccine recipients and for 110 of the seronegative placebo recipients; 84% of seronegative vaccine recipients developed a > or =4-fold increase in antibody titers. The geometric mean antibody titer after vaccination was 1 : 25 in the vaccine group and <1 : 4 in the placebo group. PIV3-cp45 vaccine was safe and immunogenic in seronegative children and should be evaluated for efficacy in a phase 3 field trial.
authors.affiliation: Division of Infectious Diseases and Immunology, Saint Louis University, St. Louis, Missouri, USA. belsherb@slu.edu
authors.forename: Robert B
authors.initials: RB
authors.lastname: Belshe
authors.forename: Frances K
authors.initials: FK
authors.lastname: Newman
authors.forename: Theodore F
authors.initials: TF
authors.lastname: Tsai
authors.forename: Ruth A
authors.initials: RA
authors.lastname: Karron
authors.forename: Keith
authors.initials: K
authors.lastname: Reisinger
authors.forename: Don
authors.initials: D
authors.lastname: Roberton
authors.forename: Helen
authors.initials: H
authors.lastname: Marshall
authors.forename: Richard
authors.initials: R
authors.lastname: Schwartz
authors.forename: James
authors.initials: J
authors.lastname: King
authors.forename: Frederick W
authors.initials: FW
authors.lastname: Henderson
authors.forename: William
authors.initials: W
authors.lastname: Rodriguez
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Severs
authors.forename: Peter F
authors.initials: PF
authors.lastname: Wright
authors.forename: Harry
authors.initials: H
authors.lastname: Keyserling
authors.forename: Geoffrey A
authors.initials: GA
authors.lastname: Weinberg
authors.forename: Kenneth
authors.initials: K
authors.lastname: Bromberg
authors.forename: Richard
authors.initials: R
authors.lastname: Loh
authors.forename: Peter
authors.initials: P
authors.lastname: Sly
authors.forename: Peter
authors.initials: P
authors.lastname: McIntyre
authors.forename: John B
authors.initials: JB
authors.lastname: Ziegler
authors.forename: Jill
authors.initials: J
authors.lastname: Hackell
authors.forename: Anne
authors.initials: A
authors.lastname: Deatly
authors.forename: Alice
authors.initials: A
authors.lastname: Georgiu
authors.forename: Maribel
authors.initials: M
authors.lastname: Paschalis
authors.forename: Shin-Lu
authors.initials: SL
authors.lastname: Wu
authors.forename: Joanne M
authors.initials: JM
authors.lastname: Tatem
authors.forename: Brian
authors.initials: B
authors.lastname: Murphy
authors.forename: Edwin
authors.initials: E
authors.lastname: Anderson
mesh_terms: D000208:Acute Disease; D000281:Administration, Intranasal; D000914:Antibodies, Viral / Q000032:analysis; D001315:Australia; D003080:Cold Temperature; D003371:Cough / Q000209:etiology; D004311:Double-Blind Method; D005334:Fever / Q000209:etiology; D006389:Hemagglutinins, Viral / Q000276:immunology; D006801:Humans; D007223:Infant; D009154:Mutation; D010033:Otitis Media / Q000517:prevention & control; D010224:Parainfluenza Virus 3, Human / Q000235:genetics / Q000276:immunology*; D012141:Respiratory Tract Infections / Q000517:prevention & control; D010253:Respirovirus Infections / Q000097:blood / Q000276:immunology* / Q000517:prevention & control*; D012220:Rhinitis / Q000209:etiology; D012692:Serial Passage; D014481:United States; D014611:Vaccination / Q000379:methods*; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D014765:Viral Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D006389:Hemagglutinins, Viral; D014613:Vaccines, Attenuated; D014765:Viral Vaccines