Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001779268
Ethics application status
Approved
Date submitted
18/10/2018
Date registered
30/10/2018
Date last updated
30/10/2018
Date data sharing statement initially provided
30/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Burden of Diseases Potentially Preventable by Maternal Immunization in Sub-Saharan Africa
Scientific title
Burden of Diseases Potentially Preventable by Maternal Immunization in Sub-Saharan Africa
Secondary ID [1] 296365 0
EC N° 2017/RTD/E.5/OP/PP-05761-2017
Universal Trial Number (UTN)
Trial acronym
GRIP Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Tract Infections 310100 0
Preterm birth 310101 0
Stillbirth 310102 0
Neonatal Sepsis 310103 0
Condition category
Condition code
Public Health 308842 308842 0 0
Epidemiology
Reproductive Health and Childbirth 308888 308888 0 0
Complications of newborn
Reproductive Health and Childbirth 308889 308889 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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
Intervention code [1] 312697 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307819 0
Prevalence of Group B streptococcus infection rate. This outcome will be measured using blood of infants with signs of sepsis and women with signs of metritis after birth for culture.
Timepoint [1] 307819 0
Pregnant woman: Weekly after 28 weeks of pregnancy and days 1, 7, 42 and 60 after birth.

Infant: On days 1, 3 and 7 in the early neonatal period; day 29, 41, 60, 90, 180 and 365 in infancy for the child and
Primary outcome [2] 307900 0
Prevalence rate of Respiratory Syncytial and Influenza Virus Infection in infants as a composite outcome. This outcome will be measured using multiplex Reverse transcriptase polymerase chain reaction assays on nasopharyngeal swabs. Additional assays will also identify the individual pathogens.
Timepoint [2] 307900 0
Infant: On days 1, 3 and 7 in the early neonatal period; day 29, 41, 60, 90, 180 and 365 in infancy for the child
Primary outcome [3] 307901 0
Prevalence of Pertussis among infants. This outcome will be measured using multiplex Reverse transcriptase polymerase chain reaction assays on nasopharyngeal swabs
Timepoint [3] 307901 0
Infant: On days 1, 3 and 7 in the early neonatal period; day 29, 41, 60, 90, 180 and 365 in infancy for the child and
Secondary outcome [1] 353051 0
Group B streptococcus carriage rates in pregnant women, irrespective of their HIV status. this will be assessed from blood samples of pregnant women with sepsis and neonates with sepsis.
Timepoint [1] 353051 0
After 28 weeks of pregnancy in the woman and in the first month of life of the baby.
Secondary outcome [2] 353052 0
Preterm birth rate attributable to GBS through estimation of the gestational age at birth from pregnancy ultrasound or reported last normal menstrual period of the woman.
Timepoint [2] 353052 0
at birth
Secondary outcome [3] 353364 0
Recto-vaginal GBS colonisation rate estimated from recto-vaginal swabs taken for all women for culture and sensitivity. there will also be grouping and serotyping.
Timepoint [3] 353364 0
During pregnancy after 28 weeks of gestation.

Eligibility
Key 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
Minimum age
15 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-consent

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Simple tabulations; Incidence and prevalence rate estimation and regression modelling

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/10/2018
Date of last participant enrolment
Anticipated
28/02/2019
Actual
Date of last data collection
Anticipated
31/10/2020
Actual
Sample size
Target
1000
Accrual to date
20
Final
Recruitment outside Australia
Country [1] 20941 0
Ghana
State/province [1] 20941 0
Kintampo, Brong-Ahafo Region
Country [2] 20942 0
Zimbabwe
State/province [2] 20942 0
Mabvuku, Harare

Funding & Sponsors
Funding source category [1] 300968 0
Government body
Name [1] 300968 0
European Commission
Country [1] 300968 0
Belgium
Primary sponsor type
University
Name
Liverpool School of Tropical Medicine
Address
Centre for Maternal and Newborn Health
Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L3 5QA
Country
United Kingdom
Secondary sponsor category [1] 300546 0
None
Name [1] 300546 0
Address [1] 300546 0
Country [1] 300546 0
Other collaborator category [1] 280395 0
Other Collaborative groups
Name [1] 280395 0
Kintampo Health Research Centre (Ghana Health Service)
Address [1] 280395 0
Kintampo Health Research Centre
P. O. Box 200
Kintampo, Brong Ahafo Region
Ghana
Country [1] 280395 0
Ghana
Other collaborator category [2] 280396 0
Other Collaborative groups
Name [2] 280396 0
Centre for Sexual Health and HIV Research (CESHHAR)
Address [2] 280396 0
Centre for Sexual Health and HIV Research (CESHHAR)
9 Monmouth Road, Avondale
Harare, Zimbabwe
Country [2] 280396 0
Zimbabwe

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301731 0
Liverpool School of Tropical Medicine Ethics Review Committee
Ethics committee address [1] 301731 0
Liverpool School of Tropical Medicine ERC
Pembroke Place
Liverpool
L3 5QA
Ethics committee country [1] 301731 0
United Kingdom
Date submitted for ethics approval [1] 301731 0
16/04/2018
Approval date [1] 301731 0
26/07/2018
Ethics approval number [1] 301731 0
LSTM REC Research Protocol (18-034RS)

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87922 0
Prof Matthews Mathai
Address 87922 0
Centre for Maternal and Newborn Health
Liverpool School of Tropical Medicine
Pembroke Place, Liverpool
L3 5QA
Country 87922 0
United Kingdom
Phone 87922 0
+441517053396
Fax 87922 0
Email 87922 0
[email protected]
Contact person for public queries
Name 87923 0
Dr Alexander Ansah Manu
Address 87923 0
Centre for Maternal and Newborn Health
Liverpool School of Tropical Medicine
Pembroke Place, Liverpool
L3 5QA
Country 87923 0
United Kingdom
Phone 87923 0
+441517029314
Fax 87923 0
Email 87923 0
[email protected]
Contact person for scientific queries
Name 87924 0
Prof Matthews Mathai
Address 87924 0
Centre for Maternal and Newborn Health
Liverpool School of Tropical Medicine
Pembroke Place, Liverpool
L3 5QA
Country 87924 0
United Kingdom
Phone 87924 0
+441517053396
Fax 87924 0
Email 87924 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
This will be dependent on the data Policy of the European Commission (EC) and the Liverpool School. The School gives a minimum period of 10 years after closure of data and submission and funder report for all the analyses and all data could be made public based on agreement of the EC
When will data be available (start and end dates)?
See discussion above
Available to whom?
Public and interest groups
Available for what types of analyses?
Quantitative
How or where can data be obtained?
Funder-approved mechanisms for data sharing based on request initially and then public


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.