IMP321 (sLAG-3), an immunopotentiator for T cell responses against a HBsAg antigen in healthy adults: a single blind randomised controlled phase I study
2007

Study of IMP321 as a Vaccine Adjuvant for Hepatitis B

Sample size: 50 publication Evidence: moderate

Author Information

Author(s): Brignone Chrystelle, Grygar Caroline, Marcu Manon, Perrin Gaëlle, Triebel Frédéric

Primary Institution: Immutep S.A.

Hypothesis

Can IMP321 enhance T cell responses against HBsAg in healthy adults?

Conclusion

IMP321 as an adjuvant to HBsAg was well-tolerated and enhanced T cell response vaccine immunogenicity.

Supporting Evidence

  • IMP321 was well tolerated with fewer adverse events compared to the Engerix-B group.
  • HBsAg-specific antibody responses were higher in IMP321 recipients at 8 and 12 weeks.
  • Increased numbers of responders to HBsAg were found in IMP321 recipients compared to the control group.
  • CD4 Th1 antigen-specific T cells were induced in some individuals after just one injection of IMP321.

Takeaway

This study tested a new vaccine helper called IMP321 to see if it could make the hepatitis B vaccine work better, and it did!

Methodology

A single blind controlled phase I dose escalation study with 48 healthy volunteers receiving HBsAg with or without IMP321.

Potential Biases

Potential bias due to the single-blind design.

Limitations

The study had a small sample size and was limited to healthy adults aged 18-55.

Participant Demographics

Healthy adults aged 18-55, seronegative for HBV.

Statistical Information

P-Value

p<0.05

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1476-8518-5-5

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