title: Self-administration of intranasal influenza vaccine: Immunogenicity and volunteer acceptance.
abstract: BACKGROUND
  In outbreak settings, mass vaccination strategies could maximize health protection of military personnel. Self-administration of live attenuated influenza vaccine (LAIV) may be a means to vaccinate large numbers of people and achieve deployment readiness while sparing the use of human resources.
  
  
  METHODS
  A phase IV, open-label, randomized controlled trial evaluating the immunogenicity and acceptance of self-administered (SA) LAIV was conducted from 2012 to 2014. SA subjects were randomized to either individual self-administration or self-administration in a group setting. Control randomized subjects received healthcare worker-administered (HCWA) LAIV. Anti-hemagglutinin (HAI) antibody concentrations were measured pre- and post-vaccination. The primary endpoint was immunogenicity non-inferiority between SA and HCWA groups. Subjects were surveyed on preferred administration method.
  
  
  RESULTS
  A total of 1077 subjects consented and were randomized (529 SA, 548 HCWA). Subject characteristics were very similar between groups, though SA subjects were younger, more likely to be white and on active duty. The per-protocol analysis included 1024 subjects (501 SA, 523 HCWA). Post-vaccination geometric mean titers by vaccine strain and by study group (HCWA vs. SA) were: A/H1N1 (45.8 vs. 48.7, respectively; p=0.43), A/H3N2 (45.5 vs. 46.4; p=0.80), B/Yamagata (17.2 vs. 17.8; p=0.55). Seroresponses to A components were high (∼67%), while seroresponses to B components were lower (∼25%). Seroresponse did not differ by administration method. Baseline preference for administration method was similar between groups, with the majority in each group expressing no preference. At follow-up, the majority (64%) of SA subjects preferred SA vaccine.
  
  
  CONCLUSIONS
  LAIV immunogenicity was similar for HCWA and SA vaccines. SA was well-tolerated and preferred to HCWA among those who performed SA.
authors.affiliation: Walter Reed National Military Medical Center, 8901 Rockville Pike, Bethesda, MD 20889, USA. Electronic address: timothy.h.burgess.mil@mail.mil.
authors.forename: Timothy H
authors.initials: TH
authors.lastname: Burgess
authors.affiliation: San Antonio Military Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, San Antonio, TX, 78234, USA. Electronic address: clinton.k.murray.mil@mail.mil.
authors.forename: Clinton K
authors.initials: CK
authors.lastname: Murray
authors.affiliation: Naval Medical Center, 34800 Bob Wilson Drive, San Diego, CA 92134, USA. Electronic address: mary.bavaro@med.navy.mil.
authors.forename: Mary F
authors.initials: MF
authors.lastname: Bavaro
authors.affiliation: San Antonio Military Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, San Antonio, TX, 78234, USA; Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University, 11300 Rockville Pike, Suite 1211, Rockville, MD 20852, USA. Electronic address: michael.l.landrum@att.net.
authors.forename: Michael L
authors.initials: ML
authors.lastname: Landrum
authors.affiliation: San Antonio Military Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, San Antonio, TX, 78234, USA; Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University, 11300 Rockville Pike, Suite 1211, Rockville, MD 20852, USA. Electronic address: thomas.a.obryan2.ctr@mail.mil.
authors.forename: Thomas A
authors.initials: TA
authors.lastname: O'Bryan
authors.affiliation: San Antonio Military Medical Center, 3551 Roger Brooke Drive, Fort Sam Houston, San Antonio, TX, 78234, USA; Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University, 11300 Rockville Pike, Suite 1211, Rockville, MD 20852, USA. Electronic address: jessica.geistman@gmail.com.
authors.forename: Jessica G
authors.initials: JG
authors.lastname: Rosas
authors.affiliation: Naval Medical Center, 34800 Bob Wilson Drive, San Diego, CA 92134, USA; Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University, 11300 Rockville Pike, Suite 1211, Rockville, MD 20852, USA. Electronic address: stephanie.cammarata.ctr@med.navy.mil.
authors.forename: Stephanie M
authors.initials: SM
authors.lastname: Cammarata
authors.affiliation: Naval Medical Research Center, 503 Robert Grant Avenue, Silver Spring, MD 20910, USA. Electronic address: nicholas.martin@fe.navy.mil.
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: Martin
authors.affiliation: Naval Medical Research Center, 503 Robert Grant Avenue, Silver Spring, MD 20910, USA. Electronic address: daniel.ewing@med.navy.mil.
authors.forename: Daniel
authors.initials: D
authors.lastname: Ewing
authors.affiliation: Naval Medical Research Center, 503 Robert Grant Avenue, Silver Spring, MD 20910, USA. Electronic address: kanakatte.raviprakash@med.navy.mil.
authors.forename: Kanakatte
authors.initials: K
authors.lastname: Raviprakash
authors.affiliation: Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University, 11300 Rockville Pike, Suite 1211, Rockville, MD 20852, USA. Electronic address: dmor@idcrp.org.
authors.forename: Deepika
authors.initials: D
authors.lastname: Mor
authors.affiliation: Stat-Epi Associates Inc., 13 Sea Winds Lane South, Ponte Vedra Beach, FL 32082, USA. Electronic address: erzell@stat-epi.com.
authors.forename: Elizabeth R
authors.initials: ER
authors.lastname: Zell
authors.affiliation: National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD 20892, USA. Electronic address: kenneth.wilkins@nih.gov.
authors.forename: Kenneth J
authors.initials: KJ
authors.lastname: Wilkins
authors.affiliation: Infectious Disease Clinical Research Program, Department of Preventive Medicine and Biostatistics, Uniformed Services University, 11300 Rockville Pike, Suite 1211, Rockville, MD 20852, USA. Electronic address: emillar@idcrp.org.
authors.forename: Eugene V
authors.initials: EV
authors.lastname: Millar
mesh_terms: D000281:Administration, Intranasal; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D005260:Female; D064368:Healthy Volunteers; D006385:Hemagglutination Inhibition Tests; D019267:Hemagglutinin Glycoproteins, Influenza Virus / Q000276:immunology; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D008297:Male; D010342:Patient Acceptance of Health Care; D012646:Self Administration / Q000523:psychology*; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000276:immunology
chemical_list: D000914:Antibodies, Viral; D019267:Hemagglutinin Glycoproteins, Influenza Virus; D007252:Influenza Vaccines; D014613:Vaccines, Attenuated
keywords: Influenza; Military; Self-administration; Vaccine