title: Safety, immunogenicity and shedding of LAIV4 in HIV-infected and uninfected children.
abstract: OBJECTIVE
  HIV-infected children have poor responses to inactivated influenza vaccines. Live vaccines (LAIVs) are highly efficacious in children, but they are not used in HIV-infected children du e to limited information. We investigated the safety, immunogenicity and viral shedding of LAIV4 in HIV-infected compared with uninfected children.
  
  
  METHODS
  Forty-six HIV-infected and 56 uninfected children 2 to 25 years old, who had been previously vaccinated against influenza, consented to receive a single dose of LAIV4. All grade adverse events (AEs) were recorded in the first month post-vaccination and serious AEs (SAEs) throughout the influenza season. Nasopharyngeal swabs for influenza PCR and IgA ELISA and blood for hemagglutination inhibition antibody (HAI) measurements were collected at entry, 2-5, 7-10 and 21-28 days post-vaccination.
  
  
  RESULTS
  The HIV-infected subjects had median CD4+ cells of 649 cells/μL and plasma HIV RNA of 20 copies/mL. AEs were similar in the two groups. There were no vaccine-related SAEs. Shedding of ≥1 vaccine virus was detected in 67% HIV-infected and 50% uninfected participants (p=0.14). HAI titers did not appreciably change, but mucosal IgA antibodies significantly increased post-vaccination in both groups. High baseline HAI and IgA antibody concentrations were associated with decreased viral shedding in controls, but not in HIV-infected subjects. Similar proportions of HIV-infected vaccinees and controls reported influenza-like illnesses (12% and 6%) throughout the season.
  
  
  CONCLUSIONS
  LAIV4 was equally safe and immunogenic and caused similar viral shedding in HIV-infected and uninfected children. A correlate of protection against vaccine viral shedding was not identified in HIV-infected participants, although both circulating and mucosal antibodies correlated with protection in controls.
authors.affiliation: University of Colorado Denver, 12700 E 19th Avenue, Room 11126, Aurora, CO 80045, USA.
authors.forename: Donna
authors.initials: D
authors.lastname: Curtis
authors.affiliation: University of Colorado Denver, 12700 E 19th Avenue, Room 11126, Aurora, CO 80045, USA.
authors.forename: Mariangeli F
authors.initials: MF
authors.lastname: Ning
authors.affiliation: Children's Hospital Colorado, 13123 E 16th Avenue, B055, Aurora, CO 80045, USA.
authors.forename: Carl
authors.initials: C
authors.lastname: Armon
authors.affiliation: University of Colorado Denver, 12700 E 19th Avenue, Room 11126, Aurora, CO 80045, USA.
authors.forename: Shaobing
authors.initials: S
authors.lastname: Li
authors.affiliation: University of Colorado Denver, 12700 E 19th Avenue, Room 11126, Aurora, CO 80045, USA. Electronic address: Adriana.Weinberg@ucdenver.edu.
authors.forename: Adriana
authors.initials: A
authors.lastname: Weinberg
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D015658:HIV Infections / Q000150:complications / Q000276:immunology*; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007070:Immunoglobulin A / Q000032:analysis; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D009305:Nasopharynx / Q000821:virology; D009975:Orthomyxoviridae / Q000302:isolation & purification*; D016133:Polymerase Chain Reaction; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D017201:Virus Shedding; D055815:Young Adult
chemical_list: D007070:Immunoglobulin A; D007252:Influenza Vaccines; D014613:Vaccines, Attenuated
keywords: Children; HIV; Immunogenicity; Influenza infection; Influenza vaccine; LAIV4; Safety