mulTiplex Immunoassay qualiTy assuRance Panel (TITRE)
Development of Group B Streptococcus Quality Assurance Panel for the GASTON Multiplex Anti-CPS IgG Immunoassay.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a single-visit study designed to collect serum samples from women who previously participated in the GBS6 clinical trial, "A placebo-controlled clinical trial investigating the safety and immunogenicity of GBS6 in pregnant women with and without human immunodeficiency virus (HIV) infection and their infants" (GBS6 trial). The purpose of this follow-up study is to obtain serum samples for the development of Quality Control Sera (QCS) and Assay Bridging (AB) panels to support long-term quality control and performance monitoring of the GASTON immunoassay.
The GBS6 trial enrolled 300 pregnant women between October 2022 and July 2023 at Kawempe National Referral Hospital and Kisenyi Health Centre IV. The last participant completed follow-up on 23 October 2024. Of these, 150 participants (75 living with HIV and 75 not living with HIV) were randomized to receive either the GBS6 vaccine or placebo (normal saline). The GBS6 vaccine is a capsular polysaccharide conjugate vaccine targeting the six most common disease-causing GBS serotypes.
For this follow-up study, only participants who received the GBS6 vaccine and are not living with HIV (n=75) will be contacted via telephone using the contact details provided in the GBS6 trial records. Each consenting participant will attend a single study visit for serum collection. Collected samples will be shipped to the City, St George's laboratory for antibody screening. The GASTON assay will measure IgG concentrations for serotypes Ia, Ib, II, III, IV, and V. Based on these results, samples will be ranked by IgG values, and an appropriate pooling strategy will be developed to generate the QCS and AB panels.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Madeleine Cochet
- Número de teléfono: +442087255214
- Correo electrónico: mcochet@sgul.ac.uk
Copia de seguridad de contactos de estudio
- Nombre: Mary Kyohere
- Número de teléfono: +447490390327
- Correo electrónico: mkyohere@sgul.ac.uk
Ubicaciones de estudio
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Kampala, Uganda
- Reclutamiento
- MUJHU Care Ltd, Kampala
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Contacto:
- Zakaria Mukasa, Dr
- Número de teléfono: +256 782 201308
- Correo electrónico: zmukasa@mujhu.org
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Investigador principal:
- Robert Mboizi
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Women not living with HIV, who received the GBS6 vaccine GBS6 Clinical Trial in Kampala, Uganda
Women not living with HIV, who received the GBS6 vaccine in the "a placebo-controlled clinical trial investigating the safety and immunogenicity of GBS6 in pregnant women with and without human immunodeficiency virus (HIV) infection and their infants" (GBS6) Clinical Trial in Kampala, Uganda. The GBS6 trial enrolled 300 pregnant women between October 2022 and July 2023. Of these, 150 participants (75 living with HIV and 75 not living with HIV) were randomized to receive either the GBS6 vaccine (a capsular polysaccharide conjugate vaccine targeting the six most common disease-causing GBS serotypes) or placebo (normal saline). For this follow-up study, only participants who received the GBS6 vaccine and are not living with HIV (n=75) will be contacted via telephone using the contact details provided in the GBS6 trial records. Each consenting participant will attend a single study visit for serum collection. |
50mls of blood will be collected from all participants who give consent.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Creation of a quality control and bridging panels for the GBS multiplex immunoassay (GASTON assay)
Periodo de tiempo: 1 year
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Approx 50mL of blood will be collected from each study participant and will be used only for the development of QCS and AB panels.
Blood samples will be processed and serum stored at -20C in Kampala, Uganda.
The serum will be transferred to the City St George's, University of London laboratory, in the United Kingdom (UK), where the serum will be assayed for GBS6 serotype-specific anti-capsular antibodies using the GASTON multiplex anti-CPS IgG immunoassay.
Concentrations of anti-capsular IgG for the 6 serotypes (Ia, Ib, II, III, IV, and V) will be determined and a serum pooling strategy developed to produce a QCS panel consisting of three samples that span high, medium and low IgG values for each serotype and a 22- member bridging panel that will span the range of the assay for all serotypes.
The QC panels will be distributed to members of the GASTON consortium for the purpose of assay performance monitoring until they are depleted.
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1 year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Kirsty Le Doare, City St George's, University of London
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SE0306
- INV-087236 (Otro número de subvención/financiamiento: Gates Foundation)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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