TechNet-21 - Forum

This forum provides a place for members to ask questions, share experiences, coordinate activities, and discuss recent developments in immunization.

Discussions tagged Intradermal

Implementing low cost solutions to rabid dogbite victims through research.......

Presently the dose of rabies immunoglobulin (RIG) which is an integral part of rabies post exposure prophylaxis (PEP) is calculated based on body weight though the recommendation is to infiltrate the wound(s). This practice demands large quantities of RIG which may be un- affordable to many patients. In this background, we conducted this study to know if the quantity and cost of RIG can be reduced by restricting passive immunization to local infiltration alone and avoiding systemic intramuscular administration based on the available scientific evidence. Two hundred and sixty nine category III patients bitten by suspect or confirmed rabid dogs/ animals were infiltrated with equine rabies immunoglobulin (ERIGs) in and around the wound, the quantity of ERIG used was proportionate to the size and number of wounds irrespective of their body weight. They were followed with a regular course of rabies vaccination by intra-dermal route. As against 363 vials of RIGs required for all these cases as per current recommendation based on body weight, they required only 42 vials of 5ml RIG. Minimum dose of RIGs given was 0.25ml and maximum dose given was 8 ml. On an average 1.26 ml of RIGs was required per patient that costs Rs. 150 ($3). All the patients were followed for 9 months and they were healthy and normal at the end of observation period............here is the link......................

http://www.ncbi.nlm.nih.gov/pubmed/26317441

Dr. Omesh K Bharti, Simla, HP, India
+91-9418120302

http://www.technet-21.org/en/resources/technet-resource-library/

Microarray patches for dermal delivery of vaccines

Hello all, Microarray patches (MAPs) are under development for delivering vaccine into the skin. The technology has exciting potential for application to immunization programs. PATH is looking for input from experts in low- and middle-income country immunization programs about the feasibility of MAPs to facilitate immunization, especially for novel delivery scenarios like self-administration of vaccine at home, as well as more traditional immunization settings in LMICs. We have created an online survey as a forum for collecting your feedback. We value your opinion on this topic. The survey will be open for one week and should take no more than 20 minutes: https://www.surveymonkey.com/r/vaccinepatch The results will inform dialogue with vaccine manufacturers and other stakeholders as we work to advance this exciting new method for vaccine delivery. I encourage you to share your opinion in the survey and to forward the link above to other colleagues, particularly those in LMIC immunization programs. I’m always happy to chat in person as well and have included my contact information below. I hope to hear from you. Best regards, Sarah     Sarah McGray Program Officer, Devices & Tools PATH Tel: 206.285.3500 Skype: smcgray Email: smcgray@path.org www.path.org

First experiences from the ‘FIRST’ IPV vials

Dear viewers
Out of inquisitiveness, we studied the usage of the First IPV vial of 5 facilities and got many things to learn from the service providers of 3 attached planning units, one First Referral Unit and the vaccination clinic of our own College. These lessons are universal and hence can certainly help the policy makers to make necessary revisions / refresh training for the benefit of innocent infants.
Following are the observations:

Average beneficiaries per month for 3 planning units were 11 / 18 & 24; requiring
Actual doses administered were 8; 11; 11 in 3 PHCs; 14 in the tertiary care hospital. 46 doses of 1st vial were administered in the First Referral Unit (FRU) which is centrally located at the Block: total of 90 doses from 5 vials (5×50=250 doses) were administered. Due to accidental touching of the needle/spillage of vaccine due to sudden jerky movement of the child, 6 doses got “wasted”. Remaining 154 doses were “sacrificed” on completing 28 days since the starting day as per MDVP/Open Vial Policy.
Number of times the septum pricked ranged from 8 to 48 per vial.
Number of trips made by the vial ranged from 3 to 14 and the temperature excursions (TEs) ranged from 6 to 28.
On video recording and viewing the intradermal procedure for study purpose to assess the training need, we observed that:
The tense wheal with satisfactory diameter expelled fractions of fractional dose of the vaccine through needle puncture.
Where the diameter was less than 5mm, vaccine comfortably got lodged in thesubcutaneous space and no leakage.

BCG & IPV on "Wheals"

Dear viewers
We wish to share our very short study finding with the TechNet viewers for further input and mutual sharing of experiences for the global benefit of closing the imuunization gap.
Introduction of a newer vaccine or any change in vaccination policy provides an opportunity to train / reorient the service providers to revamp the efficiency for immunizing the vaccinated.
Responses by the TechNet members and global Immunization specialists inspired us to take-up a short study in the vaccination centre in our College. Initially we experienced – intra-dermal administration of just a drop of BCG vaccine=0.05ml especially to a newborn within 24 hrs was really difficult as the skin is too thin and delicate accentuated by the unpredictable movement but now we find it ‘not so difficult’ and administer with confidence.
The skin of 1½ month infant is a little more grown but the quantity of vaccine to be administered is 0.1ml=2 drops, double the 0.05ml.
On satisfactorily administering vaccines intradermally, we ‘dreamt’ of measuring the dimensions of the wheal accurately; enough for operational purpose.
Intra-dermal administration of vaccine raises a tense blanched Peau d’orange ‘bleb/wheal’, stays for a few fractions of a second. We measured the diameter instantly on pushing the vaccine completely by pausing the video and taking print screen, edited for making slides, taking care to maintain the accuracy of measurement. Following are the pictures, 3 each for BCG and IPV.

Close the immunization gap: Intradermal administration of vaccines

For realizing the above, identifying maximum causes of gap and operating good practices for mitigation is essential to meet the global vaccination targets by 2020.
We made video recording and still photos for presenting in the monthly Academic Society Meeting for teaching purpose, to prevent avoidable agony to the infants and to administer antigenic dose of intra-dermal vaccines: BCG/IPV. All professionals including pediatricians have expressed that administering intra-dermal BCG is a skilled process. The movements of the newborn/infants are unpredictable. The skilled de-professionals accomplish intra-dermal administration more satisfactorily. We took the opportunity of administering intra-dermal IPV for reorienting the service providers.

Call for needle-free intradermal delivery devices

The complete announcement is available at http://www.path.org/news/an120416-needlefree-devices.php. Call for needle-free intradermal delivery devices for upcoming clinical trial In collaboration with the Bill & Melinda Gates Foundation, PATH invites letters of interest and applications from technology manufacturers willing to provide eligible needle-free intradermal (ID) delivery devices for use in a clinical trial of reduced-dose inactivated polio vaccine (IPV) scheduled for 2013 in China. Vision Ensuring wide-scale access to IPV is a key goal of polio eradication efforts and post-eradication planning. The Bill & Melinda Gates Foundation plans to support a clinical trial to evaluate the dose-saving potential of IPV when it is delivered intradermally, which could extend vaccine supply and make IPV more affordable for immunization programs in developing countries. Needle-free delivery devices that facilitate safer, easier, and more consistent ID delivery of vaccine could also enable ID delivery of IPV by less-experienced health workers or trained volunteers. Eligibility To be eligible, devices must be needle free with a disposable, autodisabling fluid path and capable of delivering 0.1 ml of IPV intradermally in infants and children. Manually powered devices suitable for use either in a clinic or in a mobile campaign setting are preferred. Multiple devices that meet these requirements may be included in the trial. Final device selections will be made by the Bill & Melinda Gates Foundation. Please also note that the Bill & Melinda Gates Foundation reserves the right to withdraw this request for applications and/or cancel the planned trial at any time. How to apply Letters of interest are requested by April 27, 2012. Full applications and supporting materials are due May 14, 2012. Applications should include: A cover letter with a description of the materials enclosed. Instructions for use for the device. A completed response questionnaire (see Annex 1 [317 KB PDF]). Supporting documentation, where appropriate. Please email the letter of interest and full application to vaccinetech@path.org. Relevant materials can also be mailed to: Emily Griswold PATH PO Box 900922 Seattle, WA 98109 USA For questions and guidance on this opportunity, please contact PATH (primary) at vaccinetech@path.org or Linda Venczel at linda.venczel1@gatesfoundation.org. More information New vaccine tools for polio from PATH (http://sites.path.org/vaccinedevelopment/polio/) Vaccine technologies at PATH (http://www.path.org/our-work/vaccine-delivery.php) http://www.path.org/news/an120416-needlefree-devices.php

PATH Study on Intradermal IPV- needs implementation

Dear Sir,Based on the PATH report, we must immediately demand from DCGI office or GOI for use of IPV through Intradermal Route as well, otherwise people would be cheated as they have been with Rabies vaccine. Though I disagree with the report on one point that is a device is required for effective delivery of vaccine as this can be done with needle and syringe as well in India as we are doing with BCG/ ARV. also I disagree with the report that the needle syringe method would cost more, especially the costs calculated for disposal of waste are not appropriate. What, important is the delivery of vaccine through intradermal method. Read the report... In this report, results are presented from an economic model that calculates the costs involved in delivering IPV vaccine in Indian immunization clinics according to the first three strategies listed above. The model analyzed the costs associated with four delivery devices: disposable needle and syringe, disposable-syringe jet injectors (DSJI), an ID adapter (which controls the depth and angle of the ID injection), or a syringe-mounted hollow microneedle (MN). Clinical trials have shown that IDD of reduced doses (delivering 20% of the volume of a standard dose) can be sufficiently immunogenic. The results of the economic analysis suggest that IDD of IPV using needle and syringe, DSJI, or ID adapter could result in cost savings of up to 71%–73% per immunized infant compared with delivery of the standard dose via the usual intramuscular (IM) route using needle and syringe. Combining IPV with adjuvant so that only 10% of the original antigen content was needed, whilst still using the IM route, had the potential to save 82% to 83% of the immunization costs, depending upon the delivery device used. An aim of this strategy is to reduce the amount of vaccine antigen required to induce a protective immune response by intradermal (ID) delivery of fractional or reduced doses, i.e., administering a smaller volume of the existing formulation. If this could be achieved for IPV, it would have the potential to stretch the manufacturing capacity of existing IPV facilities and also to reduce the manufacturing cost per dose. Some logistics costs might also be reduced as it is possible that a lower-volume dose would require less space in the cold chain during distribution and storage.Intradermal delivery (IDD) of fractional doses has been investigated for a number of vaccines, most notably rabies, influenza, and hepatitis B.* Three studies of IDD of fractional doses of IPV have been published: * Reviewed in Intradermal Delivery of Vaccines. A review of the literature and the potential for development for use in low- and middle-income countries. PATH, August 2009. http://www.path.org/files/TS_opt_idd_review.pdf.IDD of reduced doses (20% of the standard volume and therefore 20% of the standard antigen content) induced striking antibody responses in adults and children who had previously been immunized.[14] No IM comparator arm was included in this trial. A schedule of two ID doses (20% of the standard dose) in nonimmune subjects resulted in a seroconversion index of 82% which was described as being comparable to an index of 91% seen in a previous study following two IM doses.[15] Nirmal et al.[16] reported that two or three 0.1 ml doses ID were equivalent in terms of seroconversion to two 0.5 ml doses of IPV delivered IM in a previous study. The overall seroconversion rates to all three poliovirus types were 85.5% and 89.0% following two or three ID doses, respectively. Seroconversion was seen in all infants (following either two or three ID doses) who did not have maternal antibodies present in prevaccination sera.[16] More recently, two GPEI-sponsored trials used the Biojector 2000® disposable syringe jet injector (DSJI) device to deliver a 20% dose ID compared with full-dose IM.5 Two different immunization schedules were tested, one in each of the two countries (Oman and Cuba) selected to run the study, and vaccines from two different suppliers were used. Thanks, Dr. Omesh Kumar BhartiM.B.B.S.,D.H.M.,M.A.E.(Epidemiology)Directorate of Health Safety and Regulation, SHIMLA, Himachal Pradesh, India.+91-9418120302[email=bhartiomesh@yahoo.com]bhartiomesh@yahoo.com[/email]; [email]bhartiomesh@gmail.com[/email]

10 Vaccines can be given Intradermally to spare costs as well as doses

Dear Friends, Here is more on intradermal delivery of vaccines. As many as 10 vaccines can be given intradermally to spare costs as well as doses, but unfortunately this is not promoted by vested interests. Please see the link on the WHO website: http://www.who.int/immunization_delivery/systems_policy/Intradermal-delivery-vaccines_report_2009-Sept.pdf Happy Diwali,Regards,Dr. Omesh BhartiM.B.B.S.,D.H.M.,M.A.E.(Epidemiology)Directorate of Health Safety and Regulation, Himachal Pradesh+91-9418120302[email=bhartiomesh@yahoo.com]bhartiomesh@yahoo.com[/email]; [email]bhartiomesh@gmail.com[/email]

Intradermal Influenza vaccination superior than IM

Dear Friends, Here is more on intradermal Influenza vaccine: http://www.ncbi.nlm.nih.gov/pubmed/18652550                http://content.nejm.org/cgi/content/full/351/22/2286 The government of India is importing 2.8 million doses of H1N1 vaccine, but it can come down to 0.7-0.8 million doses if they try for the intradermal route for this influenza vaccine. Five times the saving! Is there anyone listening? Regards, Dr. Omesh BhartiM.B.B.S.,D.H.M.,M.A.E.(Epidemiology)Directorate of Health Safety and Regulation, Himachal Pradesh+91-9418120302[email=bhartiomesh@yahoo.com]bhartiomesh@yahoo.com[/email]; [email]bhartiomesh@gmail.com[/email]

After the antirabies vaccine Virorab, Sanofi Pasteur comes out with an intradermal Influenza vaccine

Dear Friends, After Virorab, Sanofi-Pasteur has come out with a low-cost Intradermal Influenza vaccine Intanza® / IDflu® vaccine*, see the link below, http://198.73.159.214/sanofi-pasteur2/ImageServlet?imageCode=24890&siteCode=SP_CORP Dr. Omesh BhartiM.B.B.S.,D.H.M.,M.A.E.(Epidemiology)Directorate of Health Safety and Regulation, Himachal Pradesh+91-9418120302[email=bhartiomesh@yahoo.com]bhartiomesh@yahoo.com[/email]; [email]bhartiomesh@gmail.com[/email]

Report on Intradermal Delivery of Vaccines

We would like to share a report on intradermal delivery of vaccines that was commissioned by PATH's Disposable Jet Injector Project and Project Optimize (a collaborative project between WHO and PATH). The report was authored by Julian Hickling and Rebecca Jones from Working in Tandem Ltd. The purpose of the report is three-fold: 1) To summarize the clinical evidence supporting the intradermal route for vaccine administration and the devices being developed for this purpose; 2) to determine whether intradermal delivery broadly holds promise for vaccine applications for low- and middle-income countries in the future; and 3) to begin to prioritize vaccine targets and device strategies that best fit the public health needs in these countries and likely merit further investigation. We hope the document is useful to others and welcome comments from Technet members. All the best, Debbie Kristensen, Group Leader Vaccine Technologies, PATH and Darin Zehrung, Technical Officer, PATH ##text##
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