Hepatitis B Vaccine Study: Immunogenicity and Safety of VAX-ID® Intradermal Delivery

Overview

This clinical study evaluated the immunogenicity and safety of VAX-ID® for intradermal delivery of a Hepatitis B booster vaccine. The research aimed to determine whether intradermal vaccination with a fractional vaccine dose could provide immune protection comparable to standard intramuscular injection while maintaining a favourable safety profile.

Study Aim

The objective of the study was to assess the immunogenicity and safety of VAX-ID® in a non-inferiority trial using a Hepatitis B vaccine booster.

Researchers investigated whether intradermal (ID) administration with VAX-ID® could generate an immune response comparable to conventional intramuscular (IM) vaccination, despite using a lower vaccine dose.

Study Methods

Van Mulder et al. conducted the study on 48 healthy adult participants who were divided into four vaccination groups:

  1. Standard Intramuscular Injection (IM)
    Participants received HBVAXPRO® 10 µg (1 mL) via intramuscular injection in the deltoid region.
  2. Mantoux Intradermal Injection (ID)
    Participants received intradermal vaccination in the proximal posterior forearm using the traditional Mantoux technique.
  3. VAX-ID® Single Forearm Injection
    Participants received intradermal vaccination using VAX-ID® in one forearm.
  4. VAX-ID® Bilateral Forearm Injection
    Participants received intradermal vaccination using VAX-ID® in both forearms.

The intradermal groups received a fractional dose of HBVAXPRO® vaccine (4 µg, 0.1 mL), representing one-quarter of the standard intramuscular dose.

HepB study design

Hepatitis B Study Design

  • Participants: 48 healthy adults
  • Study Type: Non-inferiority clinical study
  • Vaccine: HBVAXPRO® Hepatitis B booster vaccine
  • Delivery Routes: Intramuscular vs intradermal
  • Device Evaluated: VAX-ID® intradermal delivery device
  • Dose Comparison: Full-dose IM vs fractional-dose ID vaccination

Study Results

The study demonstrated promising results for intradermal delivery of the Hepatitis B booster vaccine using VAX-ID®.

Strong Immune Response with Fractional Dosing

Participants who received the vaccine intradermally showed robust antibody responses, demonstrating effective stimulation of the immune system despite the lower vaccine dose.

Importantly, the immunogenicity achieved through intradermal vaccination with VAX-ID® was shown to be non-inferior to standard intramuscular vaccination.

Safety and Tolerability

The study also reported a favourable safety profile for the intradermal delivery method using VAX-ID®.

Key safety findings included:

  • Minimal local adverse reactions
  • Minimal systemic adverse reactions
  • Comparable tolerability to the Mantoux intradermal technique
  • Well-tolerated administration across all intradermal groups

Hepatitis B fractional dose boxplot results

Conclusion

The findings of this study support the potential of VAX-ID® as an effective intradermal vaccine delivery solution for Hepatitis B booster vaccination.

By achieving non-inferior immunogenicity with a fractional vaccine dose, intradermal delivery using VAX-ID® may offer advantages in vaccine dose-sparing, patient tolerability, and efficient immunization strategies.