Dr Anna Roca (Epidemiologist) and Professor Beate Kampmann (Theme Leader: Vaccinology) have secured significant funding from Pfizer for a Phase III clinical trial.
The trial will enrol 500 children and aims to lead to the licensing of a new preparation of the highly-successful pneumococcal conjugate vaccine – PCV-13.
Currently this vaccine is given in a single dose preparation which means that the syringe contains only 1 shot at the time and a new pack needs to be opened for every child, creating a lot of waste. In addition, the logistically challenged cold chain arrangements are one of the key limiting factors for the introduction or sustainability of vaccines in Africa.
Pfizer has entered into an agreement with GAVI to improve access to PCV-13. To increase affordability in this programme, Pfizer is developing an equivalent vaccine preparation but will put several doses into the vial, as usually more than one child is vaccinated in clinics in Africa. Storage costs can be reduced and the vaccine becomes more affordable for more countries.
If data generated in this trial show that the immune respojnses to the single-dose and multi-dose are equally good, the new preparation will be licensed rapidly and without the need for additional studies.
The trial is planned to start at the end of May 2013.