TechNet-21 - Forum

This forum provides a place for members to ask questions, share experiences, coordinate activities, and discuss recent developments in immunization.
  1. Mateusz Hasso-Agopsowicz
  2. Vaccines and delivery technologies
  3. Wednesday, 04 November 2020

Many thanks for attending the session on measles and rubella microarray patches. Follow the URL below to see the session in case you have missed it: 

https://www.youtube.com/watch?v=wAcQx5SI6c8

Below I summarise key discussion points from the session: 

• The few remaining countries that use measles (M) vaccine alone expressed an intent to switch to measles-rubella (MR) vaccine by 2030;
• Studies in rhesus-macaques suggest that the immunogenicity of a measles vaccine, when delivered by a MAP, is at least equivalent to the needle and syringe delivery. Currently, there is no clinical data in humans to inform seroconversion for MR-MAPs. The Target product profile clarifies that the seroconversion rates should be non-inferior to a currently prequalified needle and syringe (NS) MR vaccination when given at 9 or 10 months of age;
• Most vaccine candidates for MAPs look at non-adjuvanted vaccines - there is a concern about potential reactogenicity - but there are efforts ongoing to investigate if/how adjuvanted vaccines could be delivered with MAPs, first clinical studies to address reactogenicity will be conducted in 2021;
• The ideal wear time should be under one minute, and expected wear time is somewhere between seconds or few minutes, sufficiently short that children receiving a vaccine do not need to be monitored by a healthcare worker to ensure that the patch remains in situ, a maximum acceptable wear time is five minutes. The recent paper on HD-MAPs for influenza indicate wear time of two minutes (https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003024);
• House-to-house delivery as part of supplementary immunization activities is currently expressed under use case 3;
• The two MR-MAP products that are entering phase one trials either do not have an applicator or have an integrated applicator as a single device. The target product profile specifies the minimum and optimum requirements for the applicator (https://apps.who.int/iris/bitstream/handle/10665/330394/9789240000209-eng.pdf?sequence=1&isAllowed=y). If the additional applicator is needed then its usability should be assessed in acceptability studies;
• There've been some phase I studies published with influenza vaccine that suggest consistent dose delivery, and in one recently published, dose sparing for influenza was demonstrated. but we need more clinical data. flu is moving into larger phase II studies and 2 MR-MAP studies are expected to start in early 2021;
• The amount of antigen that is delivered from the patch into the skin varies between different vaccines because the formulations are different - but for a given vaccine, the antigen administration is consistent - but may also depend on the type of MAP (coated vs dissolvable).


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