An observational study in Group B Streptococcus, Invasive Bacterial Diseases (IBD) and Maternal Immunization, sponsored by Barcelona Institute for Global Health. Recruiting at 10 sites in 4 countries. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by Barcelona Institute for Global Health · Observational
Infections are one of the key causes of newborn deaths. Among them, Group B Streptococcus (GBS) is the leading cause of sepsis and bacterial meningitis in the first 90 days of life.
Fortunately, GBS vaccines for pregnant women, a powerful tool for fighting infections, are currently in development. Once vaccine trials are completed, these vaccines can stop preventable newborn deaths.
The PReparing for Optimal Phase III/IV maTErnal Group B StreptococCal vaccine Trials in Africa (PROTECT) project, funded by the European \& Developing Countries Clinical Trials Partnership (EDCTP) and European Commission, is supporting medical sites in Kenya, Malawi, Mozambique, and Uganda to establish uniform pregnancy and infant health data collection processes. It is also establishing surveillance of GBS in newborns to determine incidence rates and measure the burden of disease. With better reporting systems, medical sites can participate in vaccine trials and monitor vaccine safety. At the same time, the consortium is working to understand the drivers of vaccine hesitancy and to develop culturally appropriate communication tools to facilitate engagement with vaccines.
The end goal is to set up a network of sites that can monitor vaccine safety for current and future vaccines.
Two vaccines designed for pregnant women, to protect their unborn infant, are entering late phase development and will prevent infections from GBS and respiratory syncytial virus, respectively. For these vaccines to be approved, the vaccine must work effectively without causing any unwanted responses. To implement these vaccines in countries with low resources, healthcare systems must be strengthened by improving vaccine safety monitoring and surveillance of infection, and advancing vaccine delivery, vaccine confidence, and patient participation.
The PROTECT study, funded by the EU Commission EDCTP, is three-fold:
Establishment of pregnancy exposure registries:
The rapid rollout of electronic health records (EHR) in some East African countries offers an opportunity to use routine data to strengthen reporting of rates of adverse pregnancy, neonatal and infant outcomes, and any adverse events following immunisation; this will be imperative in informing and preparing for future large scale vaccination rollout campaigns. The approach will develop pregnancy registries embedded within national reporting systems to establish this data, including baseline rates of pregnancy and infancy outcomes for Tetanus and COVID19 vaccines currently in use. These reporting systems will allow monitoring of potential safety signals once new vaccines are introduced.
Developing sentinel site GBS microbiological surveillance:
The investigators will conduct a prospective observational GBS surveillance study among infants less than 90 days old who are admitted with laboratory confirmed GBS. The investigators will develop and strengthen invasive bacterial disease (IBD) surveillance, with a focus on GBS in Kenya, Malawi, Mozambique and Uganda. Each of the proposed lead sites has access to microbiological capacity that will be leveraged to monitor microbiologically confirmed neonatal sepsis burden. In doing so, the investigators will improve the nations' ability to participate in late phase clinical trials and post-licensure effectiveness studies.
The aim of this study is evaluating the knowledge and practices of pregnant women and other key stakeholders around vaccination and factors influencing vaccine confidence during pregnancy. The investigators will also create tools and communication strategies to improve willingness of pregnant women to participate in vaccine trials and consequently increase confidence in vaccines and vaccine trials during pregnancy in Mozambique, Uganda, Malawi and Kenya.
The investigators will work closely with the World Health Organization (WHO), African Medicines Agency and Country Stakeholders. This programme of work culminates in a network of maternal vaccine trial sites that can rapidly evaluate vaccines in pregnancy from late-stage trials through to introduction on a national level.
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This study's planned enrollment of 18,100 is above the median of 200 across 228 observational studies indexed under Communicable Diseases.
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WP2 Pregnancy Exposure Registries study population:
Pregnant women and their infants up to hospital discharge at the chosen health facilities in Uganda, Malawi, Mozambique, and Kenya.
WP3 GBS surveillance study population:
All infants less than 90 days old admitted with GBS infection detected in blood or CSF by culture, or GBS detected in CSF by qPCR, at referral health facilities in the four countries during a period of at least 12 months.
WP4 study population:
All pregnant women attending the identified health facilities at the time of fieldwork and the health care workers who provide services to these women. It will also consist of stakeholders including, but not limited to, health workers from each country's Ministry of Health, head of facilities, community leaders (community gatekeepers and influencers), older women who give support in the community, male leaders, religious, political, administrative or cultural leaders.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All women and their infants attending for antenatal and/or delivery and postpartum services at the study sites in Uganda, Malawi, Mozambique, and Kenya.
WP3 GBS Surveillance inclusion criteria:
WP4 Vaccine Confidence inclusion criteria:
Exclusion Criteria:
WP4 Vaccine Confidence exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This work package (WP2) will develop systems to determine background pregnancy and infancy outcomes, as defined by Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA), in preparation for maternal vaccine clinical trials and post-implementation studies. WP2 will assess the utility of existing medical records data to accurately determine pregnancy events following immunisation and, using patient data related to atleast 4000 pregnancies in each country, to establish an easy to use pregnancy episodes registry (PER) that can be used for future Phase III/IV trials. The PER will be developed using freely available code developed under EDCTP2 so that it can be used in other African settings in the future. The WP2 group consists of pregnant women and their infants up to hospital discharge at the chosen health facilities in Uganda, Malawi, Mozambique, and Kenya.
WP3 will conduct a prospective observational GBS surveillance study among infants less than 90 days old who are admitted with laboratory confirmed GBS at sentinel sites in Kenya, Uganda, Malawi and Mozambique. The WP3 study team will develop and strengthen IBD surveillance, with a focus on GBS in each site. All of the proposed sites have access to microbiological capacity that will be leveraged to monitor microbiologically confirmed neonatal sepsis burden. In doing so, WP3 will improve the nations' ability to participate in late phase clinical trials and post-licensure effectiveness studies in preparation for phase III/IV GBS maternal vaccine clinical trials and vaccine decision making. The WP3 group consists of all infants less than 90 days old admitted with GBS infection detected in blood or cerebrospinal fluid (CSF) by culture, or GBS detected in CSF by quantitative polymerase chain reaction, at the health facilities in the four countries during a period of at least 12 months.
Many low- and middle-income countries face significant challenges regarding vaccine implementation including vaccine confidence and participation in vaccine clinical trials, especially for vaccines targeting pregnant women. Through a mixed-methods study, WP4 will assess the knowledge, attitudes and practices of pregnant women, health care providers, community members and other relevant stakeholders towards maternal vaccines, and assess the understanding and willingness to participate in maternal vaccine trials in Kenya, Malawi, Mozambique and Uganda. WP4 will also co-create a communication/education toolkit to enhance understanding of the importance of maternal vaccines and participation in maternal vaccine trials. The WP4 group therefore consists of pregnant women and health care workers at the identified health facilities at the time of fieldwork. It will also consist of stakeholders such as Ministries of Health, community leaders, religious, political, or cultural leaders.
Pregnancy exposure registries outcome 1.1
To establish pregnancy episode registries at sentinel site locations, at least 1 site per country.
Time frame: 01.03.2026 - 28.02.2027
Pregnancy exposure registries outcome 1.2
To generate longitudinal cohort data on pregnancies, deliveries and infant outcomes for maternal vaccine safety assessment, specifically rates of obstetric and neonatal outcomes as defined by the GAIA project.
Time frame: 01.03.2026 - 28.02.2027
Pregnancy exposure registries outcomes 1.3
To generate comparable essential data across Kenya, Malawi, Mozambique and Uganda on adverse pregnancy, neonatal and infant outcomes using consensus definitions for maternal vaccine safety assessment.
Time frame: 01.03.2026 - 28.02.2027
Sentinel site GBS disease surveillance outcome 2.1
To develop and strengthen capacities for GBS disease surveillance in infants less than 90 days old at sentinel sites in four African countries, using microbiological and molecular detection methods.
Time frame: 01.01.2025 - 01.09.2025
Sentinel site GBS disease surveillance outcome 2.2
To determine the incidence rates of early and late onset iGBS disease among infants less than 90 days old admitted across established sentinel sites (at least 1 site per country).
Time frame: 01.03.2026 - 28.02.2027
Vaccine confidence outcome 3.1
To enhance understanding of the importance of vaccination in pregnancy.
Time frame: 01.03.2025 - 28.02.2027
Vaccine confidence outcome 3.2
To understand contextual facilitators and barriers to maternal vaccination and willingness to participate in maternal vaccine trials in the four countries.
Time frame: 01.03.2025 - 28.02.2027
Vaccine confidence outcome 3.3
To co-develop an educational/communication toolkit with key stakeholders to enhance understanding of the importance of maternal vaccines in pregnancy and to support engagement with maternal vaccine trials in the four countries.
Time frame: 01.11.2025 - 20.08.2026
Sentinel site GBS disease surveillance outcome 2.3
To assess the antimicrobial resistance patterns of GBS isolates among infants less than 90 days old.
Time frame: 01.09.2025 - 28.02.2027
Sentinel site GBS disease surveillance outcome 2.4
To determine the genomic profile of iGBS strains.
Time frame: 01.09.2025 - 28.02.2027
Plan to share: Yes — As soon as possible following study completion, CSG and ISGlobal will deposit the de-identified datasets in access-controlled data repositories. CSG will use Figshare (https://knowledge.figshare.com/about), and ISGlobal will use the Consortium for Catalan Universities (CSUC) and CERCA public repository (https://dataverse.csuc.cat/dataverse/ISGlobal). DOIs will be created for the datasets. Interested scientists will thus be able to see what the metadata are and can contact CSG and ISG to gain access for research purposes. The genome sequences will be held on Genebank, in addition to the sequencing data and associated metadata being made publicly available in research repositories such as the European Nucleotide Archive.
Time frame: Anticipated start date: 01/05/2027 No end date.
Access criteria: Scientists interested in the PROTECT data will be able access the IPD to view the metadata in the public research repositories and Genebank. The data collected in this project will be quantitative data generated from clinical assessments and medical records (entered onto digital clinical report forms -CRF- via the REDCap secure database); microbiological data, molecular data and whole genome sequences. Scientists interested in the PROTECT data will be able to view the metadata in the public research repositories and Genebank. Following an access request they will be able to view the associated data.
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