MF59®-Adjuvanted H5N1 Vaccine Induces Immunologic Memory and Heterotypic Antibody Responses in Non-Elderly and Elderly Adults
2009

H5N1 Vaccine Induces Immune Memory in Adults

Sample size: 486 publication 10 minutes Evidence: high

Author Information

Author(s): Banzhoff Angelika, Gasparini Roberto, Laghi-Pasini Franco, Staniscia Tommaso, Durando Paolo, Montomoli Emanuele, Capecchi Pamela, di Giovanni Pamela, Sticchi Laura, Gentile Chiara, Hilbert Anke, Brauer Volker, Tilman Sandrine, Podda Audino

Primary Institution: Novartis Vaccines, Marburg, Germany

Hypothesis

Does the MF59-adjuvanted H5N1 vaccine induce immunologic memory and broad antibody responses in both non-elderly and elderly adults?

Conclusion

The MF59-adjuvanted H5N1 vaccine is safe and effective, inducing strong immune responses and cross-reactivity against different strains.

Supporting Evidence

  • Both vaccine formulations were well tolerated with no serious adverse events reported.
  • Seroprotection rates increased significantly after booster vaccination.
  • The vaccine induced cross-reactive antibodies to a heterologous strain.
  • Immunogenicity was comparable between non-elderly and elderly adults.
  • Injection-site pain was the most common mild adverse reaction.
  • Safety was monitored for 6 months post-vaccination.
  • High seroprotection rates were achieved after booster doses.
  • The study met European regulatory criteria for immunogenicity.

Takeaway

This study shows that a vaccine for bird flu can help our bodies remember how to fight it, even in older people.

Methodology

Healthy adults aged 18–60 and >60 years were randomized to receive two primary and one booster injection of 7.5 μg or 15 μg doses of the vaccine, with safety monitored for 6 months.

Potential Biases

Potential bias due to the study being sponsored by Novartis Vaccines.

Limitations

The study was limited by slow recruitment and a small number of participants receiving the booster dose.

Participant Demographics

Participants included 313 non-elderly adults (aged 18–60) and 173 elderly adults (aged >60), with a majority being Caucasian.

Statistical Information

P-Value

p<0.05

Confidence Interval

95% CI

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1371/journal.pone.0004384

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