Microarray patch target product profiles (TPPs)
The MAP Center of Excellence has developed draft target product profiles (TPPs) that outline key characteristics for rabies and HPV vaccine MAPs. The TPPs describe minimally acceptable and optimal targets for features such as thermostability, dosage, and vaccination regimens.
The TPPs were informed by background research and internal and external consultations to refine key attributes and gather input from experts—including MAP developers, manufacturers, vaccinologists, and global health stakeholders. These versions of the TPPs serve as drafts broadly distributed for public consultation. Please send any feedback or comments on the documents to firstname.lastname@example.org. The TPPs will serve as living documents that will evolve over time as new data are generated.
Publication date: June 2020
Rabies vaccine microarray patch: Target product profile665.2 KB PDF
This document describes minimally acceptable and optimal targets for a rabies MAP (dissolving and solid-coated), which is currently in early-stage preclinical development. A rabies MAP is intended for potential use with both pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) vaccine regimens. This TPP outlines the expectations of PATH’s Center of Excellence for Microarray Patch Technology for a product that would be clinically and programmatically suitable for use in low- and middle-income countries (LMICs). Critical parameters for the success of using a MAP to deliver rabies vaccine include efficacy, the intended use case, dosage, and schedule. Additional context related to India is also provided since rabies is a key public health issue in India and several vaccine manufacturers and MAP developers are based there. The TPP will serve as a living document that will benefit from stakeholder input and evolve over time as new data are generated.