PROTECT

The challenge

Although child mortality has been in decline, deaths in the neonatal period have not fallen as markedly as previously predicted. As newborns have underdeveloped immune systems, many deaths are due to infections. Vaccination of pregnant women offers a way to protect this vulnerable group, since maternal antibodies can cross the placenta and enter the fetal bloodstream.

A maternal vaccine is already available for respiratory syncytial virus (RSV), a common cause of severe pneumonia in young infants. Another is in development to prevent group B streptococcal (GBS) infections, which can cause deadly bloodstream infections in neonates.

As with all new interventions, it is essential that the safety of new vaccines given to pregnant women is carefully monitored, even after their safety has been demonstrated in clinical trials. However, routine safety monitoring systems are rudimentary in many African settings, and often exclude adolescent girls and pregnant women.

The project

The PROTECT project is supporting maternal vaccine development by creating an international platform for tracking the safety of new vaccines used in African populations. Drawing on newly introduced electronic health record systems, it is helping to establish 12 sentinel safety surveillance sites in Kenya, Malawi, Mozambique and Uganda.

To support the development of this safety monitoring infrastructure, the project is adapting a standard international framework for recording potential safety issues. It is also developing a software tool to automatically extract relevant information from the electronic health records of pregnant women and newborn babies.

Other important project activities include strengthening GBS surveillance to provide additional African data on the burden of GBS disease. This will also enable the effectiveness of a GBS vaccine to be assessed when it is introduced. The project will also evaluate a new GBS diagnostic that could provide additional data on GBS disease burden and could also be introduced into routine clinical practice.

Finally, the project is undertaking an extensive programme of engagement with communities and healthcare workers to explore perceptions of maternal vaccination and participation in research and to identify potential barriers and enablers. These activities will also be used to co-create a communications toolkit to support recruitment into maternal vaccination trials.

Impact

The PROTECT project will establish an international platform for gathering data on the effectiveness and safety of maternal vaccines used in routine care. It will:

• Enable a network of sites to conduct phase III and IV maternal vaccination trials.
• Provide an infrastructure for tracking the safety of vaccines and other medical interventions in pregnant women.
• Generate additional data on the group B streptococcal (GBS) disease burden in Africa to inform national decision-making on vaccine introduction.
• Create materials to support recruitment of women into clinical studies.

Through these impacts, the project will accelerate the development and evaluation of GBS and other maternal vaccines, helping to protect mothers and newborns from severe bacterial infections that currently kill hundreds of thousands of babies a year.