Multiplex immunoassay quality panel for Group B Strep antibodies
Development of Group B Streptococcus Quality Assurance Panel for the GASTON Multiplex Anti-CPS IgG Immunoassay.
St George's, University of London · NCT07562061
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Sex | Female |
| Sponsor | St George's, University of London (other) |
| Locations | 1 site (Kampala) |
| Trial ID | NCT07562061 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Using sera from vaccinated participants to create quality-control and bridging panels is a common and previously successful approach in vaccine laboratory programs.
Eligibility criteria
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 this trial is running
Kampala
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Group B Strep Infection