title: Safety and immunogenicity of an intranasal Sendai virus-based human parainfluenza virus type 1 vaccine in 3- to 6-year-old children.
abstract: Human parainfluenza virus type 1 (hPIV-1) is the most common cause of laryngotracheobronchitis (croup), resulting in tens of thousands of hospitalizations each year in the United States alone. No licensed vaccine is yet available. We have developed murine PIV-1 (Sendai virus [SeV]) as a live Jennerian vaccine for hPIV-1. Here, we describe vaccine testing in healthy 3- to 6-year-old hPIV-1-seropositive children in a dose escalation study. One dose of the vaccine (5 × 10(5), 5 × 10(6), or 5 × 10(7) 50% egg infectious doses) was delivered by the intranasal route to each study participant. The vaccine was well tolerated by all the study participants. There was no sign of vaccine virus replication in the airway in any participant. Most children exhibited an increase in antibody binding and neutralizing responses toward hPIV-1 within 4 weeks from the time of vaccination. In several children, antibody responses remained above incoming levels for at least 6 months after vaccination. Data suggest that SeV may provide a benefit to 3- to 6-year-old children, even when vaccine recipients have preexisting cross-reactive antibodies due to previous exposures to hPIV-1. Results encourage the testing of SeV administration in young seronegative children to protect against the serious respiratory tract diseases caused by hPIV-1 infections.
authors.affiliation: Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA Department of Pediatrics, University of Tennessee Health Science Center, Memphis, Tennessee, USA.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Adderson
authors.affiliation: Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: Kristen
authors.initials: K
authors.lastname: Branum
authors.affiliation: Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: Robert E
authors.initials: RE
authors.lastname: Sealy
authors.affiliation: Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: Bart G
authors.initials: BG
authors.lastname: Jones
authors.affiliation: Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: Sherri L
authors.initials: SL
authors.lastname: Surman
authors.affiliation: Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: Rhiannon
authors.initials: R
authors.lastname: Penkert
authors.affiliation: Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: Pamela
authors.initials: P
authors.lastname: Freiden
authors.affiliation: Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: Karen S
authors.initials: KS
authors.lastname: Slobod
authors.affiliation: Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: Aditya H
authors.initials: AH
authors.lastname: Gaur
authors.affiliation: Department of Pathology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: Randall T
authors.initials: RT
authors.lastname: Hayden
authors.affiliation: Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: Kim
authors.initials: K
authors.lastname: Allison
authors.affiliation: Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: Nanna
authors.initials: N
authors.lastname: Howlett
authors.affiliation: Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: Jill
authors.initials: J
authors.lastname: Utech
authors.affiliation: Children's GMP, LLC, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: Jim
authors.initials: J
authors.lastname: Allay
authors.affiliation: Children's GMP, LLC, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: James
authors.initials: J
authors.lastname: Knight
authors.affiliation: Children's GMP, LLC, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: Susan
authors.initials: S
authors.lastname: Sleep
authors.affiliation: Children's GMP, LLC, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: Michael M
authors.initials: MM
authors.lastname: Meagher
authors.affiliation: Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA Department of Microbiology, Immunology and Biochemistry, University of Tennessee Health Science Center, Memphis, Tennessee, USA.
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Russell
authors.affiliation: Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: Allen
authors.initials: A
authors.lastname: Portner
authors.affiliation: Department of Infectious Diseases, St. Jude Children's Research Hospital, Memphis, Tennessee, USA Department of Microbiology, Immunology and Biochemistry, University of Tennessee Health Science Center, Memphis, Tennessee, USA julia.hurwitz@stjude.org.
authors.forename: Julia L
authors.initials: JL
authors.lastname: Hurwitz
mesh_terms: D000281:Administration, Intranasal; D000818:Animals; D057134:Antibodies, Neutralizing / Q000097:blood / Q000276:immunology; D000914:Antibodies, Viral / Q000097:blood* / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D003429:Cross Reactions; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D051379:Mice; D010222:Parainfluenza Virus 1, Human / Q000276:immunology*; D010253:Respirovirus Infections / Q000517:prevention & control*; D029082:Sendai virus / Q000254:growth & development / Q000276:immunology*; D014481:United States; D019444:Vaccines, DNA / Q000008:administration & dosage / Q000276:immunology; D062690:Vaccines, Live, Unattenuated / Q000008:administration & dosage* / Q000276:immunology*; D014765:Viral Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology
chemical_list: D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D019444:Vaccines, DNA; D062690:Vaccines, Live, Unattenuated; D014765:Viral Vaccines