Immunogenicity and safety of VAX-ID was assessed in a non-inferiority study using a Hepatitis B vaccine.
In a total of 48 subjects three different routes of administration and doses were compared over 4 groups, each receiving hepatitis B vaccine antigen: (1) standard IM injection in the deltoid region (HBVAXPRO® 10 µg/1 ml), (2) ID injection in the proximal posterior area of the forearm according to the Mantoux technique, (3) with VAX-ID™ in one forearm, or (4) with VAX-ID™ in both forearms. For ID injections 0.11 cc, of which 0.01 cc is overfill, was drawn from a vial containing HBVAXPRO® 40 µg/1 ml. Immunogenicity and safety were followed-up at day 0, 14, 30 and 210.
The results demonstrated that all subjects showed an anamnestic response at 14 days post booster vaccination. Elevated titres persisted until end of follow-up at day 210. For the ID groups a 3 fold higher immune response at day 14 and day 30 was recorded compared to IM group. Local adverse events were more reported for ID compared to IM.
The investigated ID injection device VAX-ID® proved to be a good alternative to offer ID vaccination.