Prophylactic HPV vaccine microarray patch: Target product profile

This document describes minimally acceptable and optimal targets for a prophylactic HPV microarray patch (MAP)—dissolving and solid–coated—which is currently in early–stage preclinical development.

Although the goal of PATH’s MAP Center of Excellence is focused on advancing the MAP technology platform for high–priority needs in low– and middle–income countries (LMICs), a product with a dual market is more sustainable and could reduce costs in LMIC markets.

Therefore, this target product profile describes a global product driven by the needs of LMICs that would also benefit users in high–income countries. Ideally, an HPV MAP product could be suitable for both markets with minimal differences.

Key targets that would differ between LMIC and high–income countries contexts are defined. Parameters that will be critical for the success of using a MAP to deliver a prophylactic HPV vaccine include the intended use case, schedule, breadth of protection, and use of adjuvants.

The target product profile will serve as a living document that will benefit from stakeholder input and evolve over time as new data are generated.

Publication date: October 2023

Prophylactic HPV vaccine microarray patch: Target product profile

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