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Active, Not Recruiting

NCT Number: NCT04549220

Serosurveillance Study of Maternally Derived Anti-GBS Antibody

Globally, neonatal mortality remains unacceptably high, with little change in the death rate in the first 28 days of life since 1990, despite reductions in under-5 mortality of up to 50% over the same period. In 2014, neonatal deaths accounted for 44% of all deaths in children under 5 with neonatal infection accounting for over a third of all deaths. Group B Streptococcus (GBS) is a major cause of septicemia and meningitis in infants globally and a cause of severe adverse neurodevelopmental outcomes in up to 50% of meningitis survivors. It can also lead to sepsis in pregnant women. GBS acquisition occurs through vertical transmission in 15%-50% of infants born to a vaginally/rectally colonized mother. Maternal colonization is a prerequisite for early onset (EO) and a risk factor for late onset (LO) disease.

Our proposal will provide these critical data in Uganda (a country with high neonatal disease burden) in a 12 month pilot study to determine: the burden of GBS disease in a cohort of mother/infant pairs and establish an active surveillance platform for monitoring of early and late onset neonatal infection in term and preterm infants in Uganda and compare this to the burden known for other African countries. This provides essential data on GBS disease outcomes from a high-HIV burden African cohort reflecting the usual standard of care in a low income, highly deprived urban environment. This pilot study will establish minimum disease estimates in the Ugandan cohort to determine the feasibility of a cohort study over three years to determine the level of antibody against GBS in cord blood from pregnancies where women are GBS colonized and non-colonized but whose infants do not develop GBS disease in the first three months of life and compare this to the level in the blood of infants who develop GBS disease. We will compare these results with those from other African countries such as South Africa to enable a robust estimate of potential sero-correlates of protection from natural infection against the most common GBS-disease-causing serotypes.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Delivery (Birth) Cohort

Inclusion criteria

  • consecutive mothers greater than or equal (≥) the age of 18 years delivering at Kawempe Hospital (live or stillbirth) and emancipated minors aged between 14-17 years of age,
  • willing to stay in the area for the first three months of life or willing to travel to clinic until their child is 2 years old if their infant has known or presumed GBS infection).

Exclusion criteria

  • Unable to give written informed consent

Active Surveillance Cohort Matching & Adjustment Criteria: (these will be applied at the analysis stage): (i) exposure to intrapartum antibiotic prophylaxis: defined as intravenous penicillin, ampicillin, cefazolin, clindamycin or vancomycin, for ≤2 hours before delivery. (ii) blood transfusion in the 30 days before delivery (iii) HIV status (iv) Maternal age (v) Infant gestational age

Treatment and study plan

Primary outcomes

  1. Maternal anti-GBS antibody concentration in infants with GBS disease compared to healthy controls.

    Time frame: 31 October 2020

    To establish maternal anti-GBS antibody concentration in infants with GBS disease compared to healthy controls.

Secondary outcomes

  1. Health-centre level active surveillance

    Time frame: 31 October 2020

    To establish health-centre level active surveillance for neonatal sepsis and meningitis and GBS-related stillbirths.

  2. Neurodevelopmental outcomes

    Time frame: 31 October 2020

    To establish the neurodevelopmental outcomes of infants with GBS disease in Uganda up to 2 years of age.

  3. GBS colonisation

    Time frame: 31 October 2020

    To determine the GBS colonisation rate and serotypes in Ugandan women at delivery

Sponsors and collaborators

Lead sponsor

St George's, University of London

Other

Collaborators

  • MRC/UVRI and LSHTM Uganda Research Unit
  • MU-JHU CARE

Registry information

Official study title

Seroepidemiology of Maternally-derived Antibody Against Group B Streptococcus (GBS) in Mulago/Kawempe Hospitals Uganda

Acronym: ProGreSs

Important dates

Study start
2019
Primary completion
2021
Study completion
2025
First posted
Sep 16, 2020
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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