RecruitingACTRN12618001779268

Burden of Diseases Potentially Preventable by Maternal Immunization in Sub-Saharan Africa

Sponsor

Liverpool School of Tropical Medicine

Enrollment

1,000 participants

Start Date

Oct 9, 2018

Study Type

Observational

Conditions

Neonatal Sepsis Respiratory Tract Infections Stillbirth

Summary

Infections from GBS, RSV, Influenza and Pertussis (GRIP) account for about a third of newborn deaths in sub-Saharan Africa and other low- and middle-income settings. Maternal immunisation may protect their babies (born and unborn) from infections especially in the crucial neonatal period prior to the onset of routine immunisation. If this protection is to be achieved, mothers should be able to pass on antibodies produced when infected with these organisms to their babies and these antibodies should be about to neutralise any new infections in the baby. To invest into maternal vaccines for these organisms, this study wants to first quantify the burden of infections with GRIP organisms in sub-Saharan Africa (Ghana and Zimbabwe) and assess whether antibodies from infected mother provide protection to the infant.

Eligibility

Sex: FemalesMin Age: 15 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

Each year, infections from four bacteria and viruses — Group B Streptococcus (GBS), Respiratory Syncytial Virus (RSV), Influenza, and Pertussis (whooping cough) — cause a significant proportion of newborn deaths in sub-Saharan Africa. Vaccinating mothers during pregnancy may protect newborns by passing maternal antibodies through the placenta before birth, during the critical first weeks of life before routine childhood vaccines begin. This study, conducted in Ghana and Zimbabwe, aims to measure exactly how common these infections are in pregnant women and newborns, and to assess whether antibodies produced by infected mothers actually protect their babies. This data will be crucial for making the case for maternal vaccination programs that could save thousands of newborn lives each year. You may be eligible if you are a pregnant woman living in one of the study areas in Ghana or Zimbabwe, carrying a viable baby, and willing to have your infant followed for the first year of life. The only reason for exclusion is if you decline to participate.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Print for Your Doctor Check Your Eligibility

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

The study is examining whether mothers who are infected with Group B Streptococcus (GBS), Respiratory Syncytial Virus (RSV), Influenza and Pertussis (together referred to as GRIP infections) during pregnancy and generate antibodies pass on these antibodies to their unborn baby and whether these are protective from death and infant infections after birth. Participants will be pregnant women, recruited before 28 weeks of gestation (before the viability cut-off) and followed through pregnancy until birth. Their infants will also be followed for the first year of life to document incidence of GRIP infections through clinical assessment and laboratory confirmation. Participants will be visited in their homes or at health facilities after enrolment and socio-demographic, morbidity and an asset data will be collected from them. When the pregnancy terminates, labour and birth history will be collected and the infant will also be entered into morbidity surveillance together with the mother. Research assistants will administer a morbidity form at monthly intervals from 28 weeks for the pregnant woman and her infant when born. Any participant who is taken ill during the follow-up will be brought by a study vehicle upon notification of the study team, and treated by the study clinicians. Where indicated, blood or urine samples of the mother will be collected for culture or PCR tests and for serology. When the results of these tests are ready, they will inform the management of the participant's illness but treatment will not be delayed for the results of the study. similarly infants with signs and symptoms of Lower respiratory tract infection or severe upper respiratory tract infection will be brought in by the study team for management and sample collection. It will be between carried out 2018 to 2021