Periodic Reporting for period 1 - PROTECT (PReparing for Optimal Phase III/IV maTErnal Group B StreptococCal vaccine Trials in Africa (PROTECT))
Période du rapport: 2024-03-01 au 2025-08-31
Recent advances in maternal immunisation have led to the approval of a vaccine targeting respiratory syncytial virus (RSV), whereas a maternal vaccine against Group B Streptococcus (GBS) – a leading cause of newborns infections - is in late-phase development. Implementing these vaccines in low-resource settings requires healthcare systems with robust safety monitoring mechanisms, disease surveillance, delivery capacities, and public trust.
PReparing for Optimal Phase III/IV maTErnal Group B StreptococCal vaccine Trials in Africa (PROTECT) is a multi-country initiative that brings together experts in maternal and infant health, vaccinology, epidemiology, microbiology, clinical trials and implementation science to develop tools and capacities to monitor and evaluate maternal vaccines from late-stage trials to national introduction in sub-Saharan Africa (SSA).
A major challenge in SSA is the lack of robust systems for the identification, reporting and review of adverse effects following immunisation (AEFI) in pregnancy. These systems are essential before introducing new maternal vaccines and for conducting post-licensure (phase IV) studies. PROTECT addresses this gap by integrating pregnancy episodes registries (PERs) into electronic health records (EHR) in Kenya, Mozambique, Malawi and Uganda. This enables the collection of baseline data on maternal and infant outcomes with current vaccines, enabling vaccine safety monitoring once new vaccines are introduced.
In addition, data on the burden of invasive GBS disease (iGBS) in most African countries remains scarce and incomplete. Understanding iGBS burden is crucial to guide vaccine research, development, implementation, coverage, and policy decisions. PROTECT is building laboratory and surveillance capacity at sentinel sites in the four countries to generate incidence data across SSA in preparation for phase III/IV trials.
Recognising the importance of public engagement and trust, PROTECT also integrates social sciences to address vaccine hesitancy and misinformation. Through open dialogue with pregnant women, communities, and the public, and co-creating tailored communication toolkits, we aim to improve willingness to participate in vaccine trials and confidence in maternal vaccines.
PReparing for Optimal Phase III/IV maTErnal Group B StreptococCal vaccine Trials in Africa (PROTECT) is a multi-country initiative that brings together experts in maternal and infant health, vaccinology, epidemiology, microbiology, clinical trials and implementation science to develop tools and capacities to monitor and evaluate maternal vaccines from late-stage trials to national introduction in sub-Saharan Africa (SSA).
A major challenge in SSA is the lack of robust systems for the identification, reporting and review of adverse effects following immunisation (AEFI) in pregnancy. These systems are essential before introducing new maternal vaccines and for conducting post-licensure (phase IV) studies. PROTECT addresses this gap by integrating pregnancy episodes registries (PERs) into electronic health records (EHR) in Kenya, Mozambique, Malawi and Uganda. This enables the collection of baseline data on maternal and infant outcomes with current vaccines, enabling vaccine safety monitoring once new vaccines are introduced.
In addition, data on the burden of invasive GBS disease (iGBS) in most African countries remains scarce and incomplete. Understanding iGBS burden is crucial to guide vaccine research, development, implementation, coverage, and policy decisions. PROTECT is building laboratory and surveillance capacity at sentinel sites in the four countries to generate incidence data across SSA in preparation for phase III/IV trials.
Recognising the importance of public engagement and trust, PROTECT also integrates social sciences to address vaccine hesitancy and misinformation. Through open dialogue with pregnant women, communities, and the public, and co-creating tailored communication toolkits, we aim to improve willingness to participate in vaccine trials and confidence in maternal vaccines.
During its first eighteen months, PROTECT has advanced the establishment of PERs, microbiological surveillance of iGBS, and made strides towards understanding of perceptions toward maternal vaccines and trial participation in Uganda, Malawi, Mozambique, and Kenya.
A practical electronic PER using existing hospital data to capture pregnancy outcomes following immunization has been implemented in two of the four country settings. A Delphi process defined core outcome variables, and feasibility assessments confirmed that these data can be collected as part of routine care. The PER is now operational in Malawi and Mozambique using hospital paper records as data sources. In Kenya and Uganda, it will soon be integrated within existing hospital electronic systems.
To monitor iGBS, surveillance capacities have been strengthened at sentinel sites in all four countries. Staff training, development of protocols, case report forms, standard operating procedures, and laboratory manuals were completed. Following a three-month pilot, full surveillance began in September 2025. One year of data will yield updated iGBS burden estimates to inform vaccine trial planning and policy decisions.
Significant efforts have also been made to explore maternal vaccine confidence and hesitancy, recognizing that cultural context and trust strongly influence vaccine uptake. Activities include a scoping review into the existing literature, and a mixed methods study with pregnant women and stakeholders (health workers, authorities, community and religious leaders, and partners). Data analysis will conclude in early 2026, followed by workshops to co-create culturally appropriate information, communication, and education materials to support awareness and understanding of maternal vaccines and trials.
A practical electronic PER using existing hospital data to capture pregnancy outcomes following immunization has been implemented in two of the four country settings. A Delphi process defined core outcome variables, and feasibility assessments confirmed that these data can be collected as part of routine care. The PER is now operational in Malawi and Mozambique using hospital paper records as data sources. In Kenya and Uganda, it will soon be integrated within existing hospital electronic systems.
To monitor iGBS, surveillance capacities have been strengthened at sentinel sites in all four countries. Staff training, development of protocols, case report forms, standard operating procedures, and laboratory manuals were completed. Following a three-month pilot, full surveillance began in September 2025. One year of data will yield updated iGBS burden estimates to inform vaccine trial planning and policy decisions.
Significant efforts have also been made to explore maternal vaccine confidence and hesitancy, recognizing that cultural context and trust strongly influence vaccine uptake. Activities include a scoping review into the existing literature, and a mixed methods study with pregnant women and stakeholders (health workers, authorities, community and religious leaders, and partners). Data analysis will conclude in early 2026, followed by workshops to co-create culturally appropriate information, communication, and education materials to support awareness and understanding of maternal vaccines and trials.
GBS remains a leading cause of newborn infections in Africa, resulting in sepsis, meningitis, stillbirths, and long-term disabilities—making its prevention a global priority. Despite this, data on GBS disease burden and capacity for maternal vaccine trials in SSA are limited. The WHO Full Value of Vaccines Assessment for GBS highlights these gaps and the need for robust epidemiological data, phase III trial infrastructure, and serocorrelates of protection to support licensure.
PROTECT advances the field by addressing these gaps through a multi-dimensional approach. It is generating high-quality, representative data on iGBS incidence in infants under 90 days across four SSA countries. By establishing baseline safety and disease burden data, PROTECT equips national and global stakeholders with tools for informed vaccine policy and regulatory decisions.
The electronic PER enables real-time monitoring of maternal and infant outcomes following immunisation, forming a foundation for safety surveillance and post-licensure studies.
Strengthened laboratory infrastructure, harmonised surveillance protocols, and staff training enhance regional readiness for phase III/IV maternal vaccine trials.
Complementing these efforts, co-designed communication toolkits promote informed participation in vaccine trials and immunisation programmes, reflecting the integration of social sciences within the project.
PROTECT advances the field by addressing these gaps through a multi-dimensional approach. It is generating high-quality, representative data on iGBS incidence in infants under 90 days across four SSA countries. By establishing baseline safety and disease burden data, PROTECT equips national and global stakeholders with tools for informed vaccine policy and regulatory decisions.
The electronic PER enables real-time monitoring of maternal and infant outcomes following immunisation, forming a foundation for safety surveillance and post-licensure studies.
Strengthened laboratory infrastructure, harmonised surveillance protocols, and staff training enhance regional readiness for phase III/IV maternal vaccine trials.
Complementing these efforts, co-designed communication toolkits promote informed participation in vaccine trials and immunisation programmes, reflecting the integration of social sciences within the project.