
Timothi Van Mulder
Novosanis, Belgium
Title: Skin thickness measurements and proof of concept using HepB vaccine as key drivers in the development path of VAX-IDTM, an intradermal injection device platform for both children and adults
Biography
Biography: Timothi Van Mulder
Abstract
Background: Although Intra Muscular (IM) injection is still the most preferred method for vaccination, Intra Dermal (ID) delivery may have several advantages over IM and Sub Cutaneous (SC), including an improved immune response and antigen dose sparing effect. However use is limited due to the difficulty of the standard Mantoux technique. Difficulties encountered could be overcome by the use of alternative ID delivery systems. For the development of an ID device, VAX-IDTM, skin thickness of children and adults was measured through High-Frequency Ultrasound (HF-US) and performance of the device was evaluated in healthy subjects via a hepatitis B booster vaccination.
Method: Skin thickness in Caucasion volunteers aged 0 to 65 years was measured via HF-US at the proximal ventral and dorsal forearm (PVF and PDF), the deltoid region and lastly the medial part of the upper leg in children younger than 1 year. Both left and right body sites were included. Distances were measured from the skin surface to the dermal-hypodermal junction. In healthy adults two routes of administration were compared in four groups IM with HBVAXPRO 10 µg/1 ml or ID in the PDF according to the Mantoux technique with VAX-IDTM or with VAX-IDTM twice. For ID 0.11 cc (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.
Result: Skin measurements showed that a penetration depth of 0.7 mm is ideal for children while this is 1.0 mm for adults. After booster immunization in 48 adults, the ID groups showed a 3 fold higher antibody response at day 14 and 30 compared to IM group.
Conclusion: The investigated ID injection device VAX-IDTM proves to be a good alternative to offer ID vaccination.