Aim

Immunogenicity and safety of VAX-ID was assessed in a non-inferiority study using a Hepatitis B vaccine.

Methods

Van Mulder et al. investigated the immunogenicity and safety of intradermal delivery of a hepatitis B booster vaccine using this novel drug delivery device, VAX-ID®.

A total of 48 healthy adults were enrolled for the study and divided over 4 groups: (1) standard Intramuscular (IM) injection in the deltoid region (HBVAXPRO® 10 µg, 1 mL), (2) Intradermal (ID) injection in the proximal posterior area of the forearm using the Mantoux technique, (3) ID injection with VAX-ID® in one forearm, or (4) ID injection with VAX-ID® in both forearms. The ID groups received a fractional dose of the HBVAXPRO (1/4th, HBVAXPRO 4µg, 0.1mL) compared to full dose in the intramuscular group.

HepB study design

Results

The results of the study demonstrated promising immunogenicity of the intradermal Hepatitis B booster vaccine using VAX-ID®. Importantly, the vaccine delivered through the intradermal route produced robust antibody responses. This indicates its ability to stimulate the immune system effectively. Indeed, the immunogenicity of the intradermal vaccine was non-inferior to the standard intramuscular vaccination.

Furthermore, the study reported a favourable safety profile for the intradermal delivery method. Also, the incidence of local and systemic adverse reactions was minimal and comparable to those observed with the Mantoux.

Hepatitis B fractional dose boxplot results

Conclusion

The findings of this study highlight the potential of the intradermal route using VAX-ID® as a viable option for Hepatitis B vaccination.

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