Multiplex immunoassay quality panel for Group B Strep antibodies
Official title: Development of Group B Streptococcus Quality Assurance Panel for the GASTON Multiplex Anti-CPS IgG Immunoassay.
Run by St George's, University of London · NCT07562061 · Data updated 2026-11-12
This project will collect one blood sample from women who received the GBS6 vaccine during pregnancy and are HIV-negative to create quality-control samples for a lab test that measures Group B Strep antibodies.
Quick facts
| Study type | Observational |
|---|---|
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | St George's, University of London Academic / other |
| Locations | 1 site (Kampala) |
| Status | Recruiting |
| Started | March 27, 2026 |
| Main results expected | May 2026 |
| Study ends | January 2027 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT07562061 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women who received the GBS6 vaccine during pregnancy, are confirmed HIV-negative, reachable by phone, and willing to provide informed consent and a single blood sample are ideal candidates.
✕Probably not a fit
Women who received placebo, are living with HIV, are unreachable or unwilling to give blood, or have recent transfusions or immunosuppressive treatment are not eligible and are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-visit follow-up will contact women in Kampala who previously received the GBS6 vaccine during pregnancy and collect a 50 mL blood sample for serum. Samples from consenting, HIV-uninfected participants will be used to create Quality Control Sera and Assay Bridging panels for the GASTON multiplex anti-CPS IgG immunoassay. Collected sera will be shipped to the St George's laboratory for antibody screening, where the GASTON assay will measure IgG concentrations for GBS serotypes (including Ia). The panels are intended to support long-term performance monitoring and quality assurance of the immunoassay.
Why it matters
Potential benefit: If successful, the panels will improve the reliability and comparability of laboratory measurements of GBS antibodies, supporting vaccine evaluation and surveillance.
How similar studies have gone: Using sera from vaccinated participants to create quality-control and bridging panels is a common and previously successful approach in vaccine laboratory programs.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * HIV-uninfected women who received the GBS6 vaccine during pregnancy and completed the whole period of study participation. * Reachable by phone * Willing and able to provide consent. * Willingness to provide a blood sample. Exclusion Criteria: * Receipt of blood/plasma transfusion in the last 3 months * Participants who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids. * Women who will test positive for Syphilis or HIV at screening * Current alcohol abuse or illicit drug use, or with a psychiatric condition * Major illness of the mother that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in the study, including but not limited to the following: I. heart disease II. severe anaemia (Hemoglobin level less than 7.0g/dL)
Where it's running
-
MUJHU Care Ltd, Kampala
Kampala, Uganda Recruiting
Study contacts
- Principal investigator: Kirsty Le Doare — City St George's, University of London
- Study coordinator: Mary Kyohere
- Email: mkyohere@sgul.ac.uk
- Phone: +447490390327
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.