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Abstract: As aluminium in vaccines has been associated with the incidence of local side effects occurring after vaccination, this observer-blind randomised clinical trial was designed to evaluate the effect of lowering the aluminium content of a combined reduced-antigen-content dTpa vaccine on immunogenicity and safety when administered to healthy adolescents aged 10–18 years. A total of 647 subjects were enrolled, 224 (35%) received a dTpa formulation with 0.5mg aluminium, 209 (32%) a formulation with 0.3mg aluminium and 214 (33%) a formulation with 0.133mg aluminium. One month after boostering, all subjects were seroprotected against diphtheria and tetanus toxoids. All subjects were seropositive for anti-FHA and anti-PRN but 4% of the initially seronegatives in both reduced aluminium groups did not seroconvert for anti-PT. Booster responses did not differ significantly between groups for any antibody, but post booster vaccination anti-PT GMC''s differed significantly between groups and decreased when vaccine aluminium content decreased. No clear difference between study groups in local or general side effects was demonstrated. The most frequently reported symptoms after vaccination were injection site pain (89.5–90.7%), fatigue (42.1–47.4%) and headache (41.1–45.1%). This study showed that the aluminium content has a specific influence on the immunogenicity of this dTpa vaccine. [Copyright &y& Elsevier]

Abstract: Vaccination schedules for under-five children in the EU member states differ markedly, mainly as a consequence of differences in programme organization, decision making and history, and to a limited extent by epidemiological differences. There is little willingness towards unification since little evidence exists to prefer one schedule over the others, but the differences might impact on public confidence. Monitoring key determinants influencing individual decision making on immunization (‘soft impacts’) is thus as important as other existing monitoring systems of the ‘hard’ impacts of immunization programmes, and both should focus on the impact of these schedule differences. Harmonization of vaccination schedules is not the main issue, but the reasons behind the differences should be explained in an understandable and coherent way to the public. Scientists and advisory bodies should look over the country borders and communicate any crucial information, in order to improve scientific consensus on immunization schedules and programmes. These were the main conclusions of a members’ experts panel of the European network of independent science advisory bodies on health (EuSANH), at a workshop in November 2012. [Copyright &y& Elsevier]

Background Intradermal immunization is gaining increased attention due to multiple factors: (1) intradermal (ID) vaccination has been shown to induce improved immunogenicity compared to intramuscular (IM) vaccination; (2) ID vaccination has been shown to have a dose-sparing potential over IM leading to a reduced vaccine cost and an increased availability of vaccines worldwide. However, the currently used Mantoux technique for ID injection is difficult to standardize and requires training. The aim of the study was (1) to assess the epidermal and dermal thickness at the proximal ventral and dorsal forearm (PVF & PDF) and deltoid in adults aged 18–65 years (2) to determine the maximum penetration depth and needle characteristics for the development of a platform of medical devices suited for intradermal injection, VAX-ID™. Materials and methods Mean thickness of the PVF, PDF and deltoid were measured using high-frequency ultrasound of healthy adults aged 18–65 years. Correlation with gender, age and BMI was assessed using Mann-Whitney U Test, Spearman correlation and Wilcoxon Signed Ranks Test, respectively. Results Results showed an overall mean skin thickness of 1.19 mm (0.65–1.55 mm) at the PVF, 1.44 mm (0.78–1.84 mm) at the PDF, and 2.12 mm (1,16–3.19 mm) at the deltoid. Thickness of PVF & PDF and deltoid were significantly different for men vs women ( p mean < 0.001, <0.001, <0.001, and p min < 0.001, 0.012, <0.001, respectively). A significant association was found for age at the deltoid region ( p < 0.001). Skin thickness for PVF, PDF & deltoid was significantly associated to BMI ( p < 0.001). Conclusion Significant differences in skin thickness were seen for the PVF, PDF and deltoid region for gender, and BMI. Age only influenced the skin thickness at deltoid region. A needle length of 1.0 mm is best option for intradermal injection at the dorsal forearm (NCT02363465). [ABSTRACT FROM AUTHOR]

In the context of precision medicine and in response to the highly needed capacity of rapid interventions towards new infectious diseases and pandemic outbreaks, intradermal immunization is gaining increased attention. However, the currently used Mantoux technique for ID injection is difficult to standardize and requires training, especially when used in children. To allow determining the maximum penetration depth and needle characteristics for the development of a platform of medical devices suited for intradermal injection, VAX-ID® and to ensure an accurate ID injection in children, the epidermal and dermal thickness at the proximal ventral and dorsal forearm (PVF & PDF) and at the deltoid region in children aged 8 weeks to 18 years were assessed. The lateral part of the upper leg was assessed as well in children aged 8 weeks to 2 years since it is a commonly used injection site in this population. Mean thickness of the PVF, PDF, lateral part of the upper leg and deltoid were measured using high-frequency ultrasound. Association with gender, age and BMI was assessed using Mann-Whitney U Test, Spearman correlation and Wilcoxon Signed Ranks Test, respectively. Results showed an overall mean skin thickness of 0.99 mm (SD: 0.14 mm) at the PVF, 1.20 mm (SD: 0.17) at the PDF, 1.28 mm (SD: 0.16) at the lateral part of the upper leg and increasing to 1.32 mm (0.25) at the deltoid region. Age and BMI correlated significantly (p < 0.001) with skin thickness at all investigated body sites. Gender did not affect skin thickness in the investigated population. Significant differences in skin thickness at the PVF, PDF and deltoid region were seen according to age and BMI. An optimal needle length of 0.7 mm is advised to guarantee intradermal injection in children at all investigated injection sites. (NCT02727114). [ABSTRACT FROM AUTHOR]

Abstract Background Although intramuscular (IM) injection is still the most preferred method for vaccination, intradermal (ID) delivery may have several advantages over intramuscular and subcutaneous (SC), including an improved immune response and antigen dose sparing effect. However it is currently limited due to the difficulty in standardizing the injection technique often based on the Mantoux technique. Difficulties encountered using the Mantoux technique could be overcome by the use of alternative ID delivery systems that confer more uniform and standardized procedures. The aim of this study was to evaluate the performance of a newly developed intradermal injection device, VAX-ID™, via a proof-of-concept to assess the immunogenicity of a commercially available hepatitis B booster vaccination in healthy hepatitis B pre-immunised subjects. Additionally, device safety and tolerability was evaluated. Materials and methods Three different routes of administration 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. Results A total of 48 subjects were included. 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. Conclusions The investigated ID injection device VAX-ID™ proves to be a good alternative to offer ID vaccination. [ABSTRACT FROM AUTHOR]