Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults

Edson D. Moreira, Joel M. Palefsky, Anna R. Giuliano, Stephen Goldstone, Carlos Aranda, Heiko Jessen, Richard J. Hillman, Daron Gale Ferris, Francois Coutlee, Eftyhia Vardas, J. Brooke Marshall, Scott Vuocolo, Richard M. Haupt, Dalya Guris, Elizabeth I.O. Garner

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

Background: Prophylactic vaccination with a quadrivalent HPV (types 6, 11, 16, 18) vaccine (qHPV) has been shown to prevent infection with HPV 6/11/16/18 and associated disease in women and more recently, in men. Here we report on the safety and reactogenicity of the qHPV vaccine in males. A total of 4,065 healthy males aged 16-26 years were enrolled into a randomized, placebo-controlled, double-blind trial. Subjects were randomized 1:1 to receive qHPV vaccine or placebo at day 1, month 2 and month 6. Safety and tolerability were assessed via the collection of reported adverse experiences (AEs). All serious AEs (vaccine- or procedure-related or not) and all deaths occurring during the study were recorded. Safety analyses were conducted in all subjects who received at least one dose of vaccine or placebo. The proportion of subjects who reported at least one injection-site AE was higher in the qHPV vaccine group versus the placebo group (60.1% vs. 53.7%, respectively), however most of these AEs were mild/moderate in intensity. The incidence of at least one systemic AE was comparable between the vaccine and placebo groups (31.7% vs. 31.4%, respectively). There were no vaccine-related serious AEs or deaths. The occurrence of AEs did not increase with each successive injection, and among trial participants who were seropositive for at least one vaccine HPV type at enrollment, the profile of adverse events was similar to that of the entire study cohort. The qHPV vaccine was generally well tolerated in males aged 16-26 years and had a favorable safety profile.

Original languageEnglish (US)
Pages (from-to)768-775
Number of pages8
JournalHuman Vaccines
Volume7
Issue number7
DOIs
StatePublished - Jul 1 2011

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Human papillomavirus 11
Human papillomavirus 6
Virion
Young Adult
Vaccines
Safety
Placebos
Papillomavirus Vaccines
Injections
Vaccination
Cohort Studies

Keywords

  • Adolescent
  • Adult
  • Human papillomavirus (HPV)
  • Male
  • Safety
  • Vaccine

ASJC Scopus subject areas

  • Immunology
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

Moreira, E. D., Palefsky, J. M., Giuliano, A. R., Goldstone, S., Aranda, C., Jessen, H., ... Garner, E. I. O. (2011). Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults. Human Vaccines, 7(7), 768-775. https://doi.org/10.4161/hv.7.7.15579

Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults. / Moreira, Edson D.; Palefsky, Joel M.; Giuliano, Anna R.; Goldstone, Stephen; Aranda, Carlos; Jessen, Heiko; Hillman, Richard J.; Ferris, Daron Gale; Coutlee, Francois; Vardas, Eftyhia; Brooke Marshall, J.; Vuocolo, Scott; Haupt, Richard M.; Guris, Dalya; Garner, Elizabeth I.O.

In: Human Vaccines, Vol. 7, No. 7, 01.07.2011, p. 768-775.

Research output: Contribution to journalArticle

Moreira, ED, Palefsky, JM, Giuliano, AR, Goldstone, S, Aranda, C, Jessen, H, Hillman, RJ, Ferris, DG, Coutlee, F, Vardas, E, Brooke Marshall, J, Vuocolo, S, Haupt, RM, Guris, D & Garner, EIO 2011, 'Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults', Human Vaccines, vol. 7, no. 7, pp. 768-775. https://doi.org/10.4161/hv.7.7.15579
Moreira, Edson D. ; Palefsky, Joel M. ; Giuliano, Anna R. ; Goldstone, Stephen ; Aranda, Carlos ; Jessen, Heiko ; Hillman, Richard J. ; Ferris, Daron Gale ; Coutlee, Francois ; Vardas, Eftyhia ; Brooke Marshall, J. ; Vuocolo, Scott ; Haupt, Richard M. ; Guris, Dalya ; Garner, Elizabeth I.O. / Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults. In: Human Vaccines. 2011 ; Vol. 7, No. 7. pp. 768-775.
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