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Intradermal vaccination device: VAX-ID  (Euroscicon Biotherapeutics event)
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Intradermal vaccination device: VAX-ID (Euroscicon Biotherapeutics event)

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To date, the vast majority of vaccines are administered into the muscle (intramuscular) using needle and syringe. The past years renewed interest has been shown in intradermal vaccination due to its ...

To date, the vast majority of vaccines are administered into the muscle (intramuscular) using needle and syringe. The past years renewed interest has been shown in intradermal vaccination due to its advantages.

However, devices to accurately deliver vaccines in the dermal layer of the skin are scarce. The project approach with a distinct university-SME collaboration ultimately led to the development of a prototype device, entitled VAX-ID®. Results of a Phase 1 trial will be discussed, in which intramuscular and intradermal vaccination was compared in 102 healthy volunteers.

This presentation was awarded by Euroscicon at the conference on Vaccine Delivery Systems for the Future, in Stevenage, UK.

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Intradermal vaccination device: VAX-ID (Euroscicon Biotherapeutics event) Presentation Transcript

  • 1. Assessment of a newly developed medicaldevice for intradermal vaccination:Results of a Phase 1 study in 102 healthy volunteersVanessa Vankerckhoven, PhDVaccine & Infectious Disease Institute, Univ Antwerp, BelgiumNOVOSANIS NV
  • 2. ID VACCINATIONIntradermal route for vaccination
  • 3. The skin: highlights• Largest organ with surface area of ca 1.5-2 m2• First line of defence against pathogens• Rich in immune cells– Twice the total number of T cellsin circulation– Specialized cells: DCs and macrophages• 3 layers– Epidermis– Dermis– HypodermisDendritic cell
  • 4. Lambert PH, Laurent PE. Vaccine 2008;26:3197-3208Skin anatomy
  • 5. Routes of vaccine administration
  • 6. Dermis: an attractive site for vaccination• Easy accessible (under epidermis)• Allows for mass vaccination campaigns• Highly vascularized, dense network of blood capillaries• High prevalence of immune cells, including specializeddermal DCs• Possible recruitment of other DCs after vaccine injectionVankerckhoven & Van Damme Exp Opin Drug Deliv 2010Nicolas et al Exp Rev Vaccines 2008
  • 7. Intradermal vaccination in clinical practice• Long history• Reduced antigen dose• Rabies vaccination in developing countries & BCG• Influenza & HBV studies– Efficacy• At least comparable to IM or SC• Immune enhancement in populations with poor immunity– Safety compared to IM/SC• Less systemic reactions• More local reactions, but transient (e.g. erythema)Vankerckhoven & Van Damme Exp Opin Drug Deliv 2010; Marra et al Influenza Journal 2012Nicolas et al Exp Rev Vaccines 2008; Michel et al Exp Rev Vaccines 2010; Young and Marra Vaccine 2011
  • 8. Intradermal vaccination: highlights• Easy accessible• Unique immunological properties of the skin– Immune enhancement in e.g. elderly– Immunogenic for several vaccines• Antigen dose saving & cost saving• No need for adjuvants• Few local & systemic reactions• Additional vaccine opportunity in already crowdedschedules
  • 9. DELIVERY SYSTEMSIntradermal vaccine delivery
  • 10. • Not commonly utilized technique• Difficult to perform in clinical settings• Requires training and practice• Variations in skin type can negativelyinfluence the correct placement of theneedle and consequently of dosedelivery incorrect dose leakage incorrect depth … OPPORTUNITIES FOR IMPROVEMENTID injection: Mantoux technique
  • 11. • MicronJet®, Nanopass• Soluvia®, Becton Dickinson• Jet injectorsID injection: alternatives
  • 12. Micronjet, Nanopass
  • 13. • A : Microneedle cap• B : Microneedle pre-attached todepth-limiting syringe tip• C : Window to view vaccinesolution• D : Finger pads for finger grip• E : plunger rodSoluvia, Becton-Dickinson
  • 14. Soluvia, Becton-DickinsonIM needle25 G,16 mm lengthID microneedle30 G,1.5 mm lengthSince 2010:- Soluvia exclusively licensed to Sanofi Pasteur- Intanza® / Fluzone® (= Flu vaccine)
  • 15. Jet injectors
  • 16. VAX-IDDevice for intradermal administration of vaccines
  • 17. Need for VAX-ID• Increased knowledge skin immunology• Advantages intradermal injection of vaccines• Limited availability of ID delivery systems
  • 18. Product idea• Device suitable for ID injections of vaccines• Ease of use• Safety considerations: needle-stick & re-use/abuse• Injections by non-medical staff (and self-admin?)• Technical specifications: needle length & thickness– Injections in children– Injections at different anatomic sites(time saving & near therapeutic indication)
  • 19. Multi-Disciplinary Approach• Prof Dr Monique Elseviers• Timothi Van Mulder• Prof Dr Pierre Van Damme• Dr Vanessa Vankerckhoven• Dr Stijn Verwulgen• Linda Scheelen• Ruben CamerlynckVaxinfectio Nursery & MidwiferyProduct DevelopmentIndustrial Partner, SME• Koen BeyersBiR&D• Dr Ludo Lauwers• Dr Guido PetitApplied Economics• Prof Dr Annouk Lievens• Charlotte Reypens
  • 20. VAX-ID – assembled device3D render
  • 21. VAX-ID – exploded view3D render
  • 22. Technical specificationsNeedle thickness Ranges from 29G to 31GNeedle length 1 mm injection depthReservoir Adjustability volume: 0.1cc to 0.3ccAdministration Self-administration  developing countries?
  • 23. BenefitsUsability Easy to useSafety Avoid needle stick injuries & re-useAnatomic sites Multiple: deltoid, fore arm, abdominal wall…Age groups Multiple: children, adults, elderlyAdministration By medical & non-medical staffSelf-administration
  • 24. PHASE 1 STUDYClinical assessment of VAX-ID in 102 healthy volunteers
  • 25. Clinical assessment: study design• Vaccinees (n=102): evaluation device• Evaluation usability device• Evaluation by vaccinees & vaccinators (n=9)
  • 26. Clinical assessment: injections• Saline solution (0.9% NaCl)• IM:• 0.5cc• 1 mm syringe• 23G needle• ID:• 0.1cc• 1 mm penetration depth• 31G needle
  • 27. Clinical assessment: questionnaires• Healthy volunteers– Demographic data– Assessment injections(VAS score)– 5-day e-diary• Vaccinators– Assessment of usability(VAS score)Use of pulse oximeter
  • 28. Demographics healthy volunteersDemografics participantsTotal groupN: 102ID groupn: 51IM groupn: 51p*Gender % man 53.9 54.5 45.5 .427woman 46.1 44.7 55.3 .427Age mean (range) 31.9 (19 – 63) 30.8 (19 – 58) 33.0 (19 – 63) .326Education oriented at healthcare % 16.7 12.0 22.0 .287Number of vaccinations last 5 years mean(range)2.3 (0 – 7) 2.3 (0 – 7) 2.3 (0 – 7) .929Number of blood collections last 5 yearsmean (range)3.3 (0 – 40) 3.0 (0 – 20) 3.4 (0 – 40) .653Chi-Square: comparison of gender and educationIndependent Samples T-Test: comparison of age, vaccination and blood collections*p-value of <0.05 is considered statistically significantNO SIGNIFICANT DIFFERENCES BETWEEN GROUPS
  • 29. Clinical assessment: results (1)
  • 30. Clinical assessment: results (2)
  • 31. Clinical assessment: results (3)
  • 32. Clinical assessment: results (4)NO SIGNIFICANT DIFFERENCES BETWEEN ID AND IMSystemic side effects ID vs IM N: 96ID group (n: 49) IM group (n: 47)Mean Mean p*Headache 1.6 1.2 .167Malaise 1.2 1.0 .269Chills 1.0 1.0 .330Myalgia 1.6 1.3 .235Arthralgia 1.1 1.1 .971Weakness / fatigue 1.7 1.2 .066Temperature 36.5 36.5 .708* Independent Samples T-TestThe presence of systemic reactions has been questioned by a Visual Analogue Scale where 1 indicates no presence and 10 astrong presence.
  • 33. • Successful trial in 102 vaccinees using saline• Evaluated as non-painful & few anxiety reported• Few local reactions (only redness)• No systemic reactions• High degree of acceptability by vaccinatorsClinical assessment: conclusions
  • 34. • Imaging study• HBV (Engerix®)Clinical assessment: future studies 2013
  • 35. www.novosanis.com
  • 36. Our company• We design, develop and manufacture medical devicesranging from injection appliances to in vitrodiagnostics• Spin-off company of the University of Antwerp• Privately funded, founded 2013
  • 37. Mission statementTo improve health and patient care and offer abetter quality of life through sustainabletechnologies
  • 38. Our portfolioDevice for intradermalvaccination*Device for capturing first voidor midstream urine** Patent pending
  • 39. AckowledgementsTEAMWORKcoming together is a beginningkeeping together is progressworking together is success- Henry Ford
  • 40. THANK YOU!All rights reserved © 2013 Novosanis NV – reproduction or unauthorised use for commercial purposes without prior consent prohibited