Self-administration of intranasal influenza vaccine

Immunogenicity and volunteer acceptance

Timothy H. Burgess, Clinton K. Murray, Mary F. Bavaro, Michael L. Landrum, Thomas A. O'Bryan, Jessica G. Rosas, Stephanie M. Cammarata, Nicholas J. Martin, Daniel Ewing, Kanakatte Raviprakash, Deepika Mor, Elizabeth R. Zell, Kenneth J. Wilkins, Eugene V. Millar

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)3894-3899
Number of pages6
JournalVaccine
Volume33
Issue number32
DOIs
StatePublished - Jul 31 2015
Externally publishedYes

Fingerprint

intranasal administration
Self Administration
Influenza Vaccines
health care workers
influenza
volunteers
Volunteers
immune response
Attenuated Vaccines
vaccines
Delivery of Health Care
vaccination
Vaccination
Vaccines
military personnel
Mass Vaccination
Military Personnel
Hemagglutinins
hemagglutinins
Vaccine Immunogenicity

Keywords

  • Influenza
  • Military
  • Self-administration
  • Vaccine

ASJC Scopus subject areas

  • Immunology and Microbiology(all)
  • Infectious Diseases
  • Public Health, Environmental and Occupational Health
  • veterinary(all)
  • Molecular Medicine

Cite this

Burgess, T. H., Murray, C. K., Bavaro, M. F., Landrum, M. L., O'Bryan, T. A., Rosas, J. G., ... Millar, E. V. (2015). Self-administration of intranasal influenza vaccine: Immunogenicity and volunteer acceptance. Vaccine, 33(32), 3894-3899. https://doi.org/10.1016/j.vaccine.2015.06.061

Self-administration of intranasal influenza vaccine : Immunogenicity and volunteer acceptance. / Burgess, Timothy H.; Murray, Clinton K.; Bavaro, Mary F.; Landrum, Michael L.; O'Bryan, Thomas A.; Rosas, Jessica G.; Cammarata, Stephanie M.; Martin, Nicholas J.; Ewing, Daniel; Raviprakash, Kanakatte; Mor, Deepika; Zell, Elizabeth R.; Wilkins, Kenneth J.; Millar, Eugene V.

In: Vaccine, Vol. 33, No. 32, 31.07.2015, p. 3894-3899.

Research output: Contribution to journalArticle

Burgess, TH, Murray, CK, Bavaro, MF, Landrum, ML, O'Bryan, TA, Rosas, JG, Cammarata, SM, Martin, NJ, Ewing, D, Raviprakash, K, Mor, D, Zell, ER, Wilkins, KJ & Millar, EV 2015, 'Self-administration of intranasal influenza vaccine: Immunogenicity and volunteer acceptance', Vaccine, vol. 33, no. 32, pp. 3894-3899. https://doi.org/10.1016/j.vaccine.2015.06.061
Burgess TH, Murray CK, Bavaro MF, Landrum ML, O'Bryan TA, Rosas JG et al. Self-administration of intranasal influenza vaccine: Immunogenicity and volunteer acceptance. Vaccine. 2015 Jul 31;33(32):3894-3899. https://doi.org/10.1016/j.vaccine.2015.06.061
Burgess, Timothy H. ; Murray, Clinton K. ; Bavaro, Mary F. ; Landrum, Michael L. ; O'Bryan, Thomas A. ; Rosas, Jessica G. ; Cammarata, Stephanie M. ; Martin, Nicholas J. ; Ewing, Daniel ; Raviprakash, Kanakatte ; Mor, Deepika ; Zell, Elizabeth R. ; Wilkins, Kenneth J. ; Millar, Eugene V. / Self-administration of intranasal influenza vaccine : Immunogenicity and volunteer acceptance. In: Vaccine. 2015 ; Vol. 33, No. 32. pp. 3894-3899.
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