IMI2-2014-02-04 - Deployment and compliance of vaccination regimens
To control the epidemic, ensuring vaccination coverage is of critical importance. In addition, to ensure lasting protection, a booster dose with a heterologous vaccine may potentially be required. This creates additional challenges for compliance i.e. guaranteeing that the right vaccine dose is given at the right time. Furthermore, the countries mostly affected by the current epidemic experience a climate of distrust in vaccines. Lack of community acceptance represents a significant challenge that could potentially derail both vaccine trials and vaccine distribution.
The project will develop i) technologies and tools that augment the adherence to the vaccination regimen at individual level. It will also ii) look into environmental factors that impact compliance and look at how to favourably influence these at community level.
The project will be rolled out and operationalised during conduct of the large scale phase II and III vaccination trials conducted under Topic 1 of this Call to assess the safety and efficacy of a candidate vaccine. Those trials offer an opportunity to test and validate any new tools and technologies. One option can be to exploit the high penetration of mobile telecommunication and use of mobile apps in West Africa. Proposals that will use mobile communication strategies to increase awareness, acceptance and subject recruitment in the vaccination campaigns or will create specific apps to remind participants of their appointments and keep track of their response or side effects are encouraged. In this type of project it is essential to guarantee privacy of subjects. To that end the operation as such of the telecommunication infrastructure within the study needs to be clearly separated from the scientific work, for example by having different legal entities responsible for the different aspects.
Ethical considerations must also figure in the assessment, taking into account the health-systems context.
The project will develop specific tailor made communication programmes that should help with the overall acceptance of the vaccination programme, and increase the willingness of the community to fully comply with the vaccination regimen.
The scope of the project includes research on community vaccine acceptance and attitude towards vaccines.
Welcome are also considerations on how monitoring of adverse events could be put in place, and how vaccinees who get a fever should be handled.
It is considered that an IMI2 JU financial contribution of approximately 25 million and an EFPIA in-kind contribution of approximately EUR 25 million would allow this specific challenge to be addressed appropriately. Nevertheless, this does not preclude submission and selection of proposals requesting other amounts.
The proposed project is expected to provide a fully validated tool or system that captures critical information for each vaccinee (date, dose, batch no.), allows for automated recalls to the vaccinee for subsequent doses, central tracking of overall vaccination coverage and compliance, all in a user friendly, cost economic way.
Improved overall acceptance and a positive attitude towards vaccination programmes will facilitate the conduct of clinical trials in endemic regions, and will increase compliance and help to combat both the current epidemic and prevent outbreaks in the future.