Immunogenicity of Fractional Doses of Tetravalent A/C/Y/W135 Meningococcal Polysaccharide Vaccine: Results from a Randomized Non-Inferiority Controlled Trial in Uganda
2008

Fractional Doses of Meningococcal Vaccine in Uganda

Sample size: 750 publication 10 minutes Evidence: moderate

Author Information

Author(s): Guerin Philippe J., Næss Lisbeth M., Fogg Carole, Rosenqvist Einar, Pinoges Loretxu, Bajunirwe Francis, Nabasumba Carolyn, Borrow Ray, Frøholm Leif O., Ghabri Salah, Batwala Vincent, Twesigye Rogers, Aaberge Ingeborg S., Røttingen John-Arne, Piola Patrice, Caugant Dominique A.

Primary Institution: Epicentre, Paris, France

Hypothesis

Can fractional doses of a licensed meningococcal polysaccharide vaccine induce a comparable immune response to full doses in healthy volunteers aged 2-19 years?

Conclusion

Fractional doses of the meningococcal vaccine can provide a similar immune response to full doses for some serogroups, making them a viable option during vaccine shortages.

Supporting Evidence

  • 94% of vaccinees in the 1/5-dose arm were responders for serogroup W135.
  • Non-inferiority was demonstrated for serogroups W135 and Y between full and fractional doses.
  • Safety and tolerability data were favorable, similar to other studies.

Takeaway

This study tested smaller doses of a meningitis vaccine to see if they work just as well as the full dose. It found that smaller doses can be just as good, which is helpful when there aren't enough vaccines.

Methodology

A randomized, non-inferiority trial comparing full and fractional doses of a meningococcal vaccine in healthy volunteers aged 2-19 years.

Potential Biases

Potential bias in participant selection and the exclusion of certain demographics.

Limitations

The study may not have captured all adverse events due to the weekly follow-up schedule, and HIV testing was not systematically performed.

Participant Demographics

Healthy volunteers aged 2-19 years from Mbarara, Uganda.

Statistical Information

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1371/journal.pntd.0000342

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