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.
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.
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 email@example.com.
Relevant materials can also be mailed to:
PO Box 900922
Seattle, WA 98109
For questions and guidance on this opportunity, please contact PATH (primary) at firstname.lastname@example.org or Linda Venczel at email@example.com.
Posted April 1, 2012.