Safety and immunogenicity of a monovalent MF59 ®-adjuvanted A/H1N1 vaccine in HIV-infected children and young adults

Paolo Palma, Maria Luisa Romiti, Stefania Bernardi, Giuseppe Pontrelli, Nadia Mora, Veronica Santilli, Hyppolite Kuekou Tchidjou, Angela Aquilani, Nicola Cotugno, Federico Alghisi, Vincenzina Lucidi, Paolo Rossi, Iyadh Douagi

Research output: Contribution to journalArticlepeer-review

Abstract

Background: This Phase IV study evaluated the safety and immunogenicity of a two-dose, MF59 ®-adjuvanted (Novartis Vaccines, Marburg, Germany), monovalent, A/H1N1 pandemic influenza vaccination schedule in Human Immunodeficiency Virus (HIV) positive children and young adults. Methods: A total of 83 children infected with HIV-1, and 37 non-immunocompromised, age-matched controls were enrolled. All participants received two vaccine doses administered three weeks apart. Antibody responses were assessed by haemagglutination assay at baseline, three weeks after each vaccine dose, and six months after immunization. Vaccines were evaluated according to European influenza vaccine licensure criteria. Results: The investigational vaccine was well tolerated. After the first vaccine dose, seroconversion rates were significantly lower in HIV-positive patients (60%) than controls (82%), with GMTs of 419 and 600, respectively. No significant differences in seroconversion rates were observed between the two study groups in response to the second vaccine dose. Persisting antibody titers were similar for both HIV-positive and non-infected controls, six months after immunization. Conclusion: One dose of MF59-adjuvanted vaccine was sufficient to provide adequate levels of seroprotection against A/H1N1 influenza disease in HIV-positive children. However, a two-dose vaccination schedule may be optimal for this population.

Original languageEnglish
Pages (from-to)134-139
Number of pages6
JournalBiologicals
Volume40
Issue number2
DOIs
Publication statusPublished - Mar 2012

Keywords

  • H1N1
  • HIV
  • MF59
  • Pandemic influenza
  • Pediatric

ASJC Scopus subject areas

  • Biotechnology
  • Applied Microbiology and Biotechnology
  • Bioengineering
  • Immunology and Microbiology(all)
  • Pharmacology

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