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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618001779268
Acronym
GRIP Study
Enrollment
20
Registered
2018-10-30
Start date
2018-10-09
Completion date
2019-02-28
Last updated
2018-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 unti

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

Sponsors

Liverpool School of Tropical Medicine
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
15 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

All pregnant women residing in the study areas in Ghana and Zimbabwe, carrying a viable foetus and who consent to participation and for their infants to be followed-up in the first year of life

Exclusion criteria

Non-consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026