mulTiplex Immunoassay qualiTy assuRance Panel

NCT07562061 | Recruiting

• 2 other identifiers: SE0306INV-087236
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Collection of serum from 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, for the Development of Group B Streptococcus quality assurance panel for the GASTON multiplex anti-CPS IgG immunoassay

Conditions

Group B Strep Infection

Outcome Measures

Primary Outcomes (1)

• Creation of a quality control and bridging panels for the GBS multiplex immunoassay (GASTON assay)

  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.

  1 year

Study Arms (1)

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.

Other: Collection of 50mls of blood

Interventions

Collection of 50mls of blood OTHER

50mls of blood will be collected from all participants who give consent.

Women not living with HIV, who received the GBS6 vaccine GBS6 Clinical Trial in Kampala, Uganda

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• St George's, University of London: lead

Study Sites (1)

MUJHU Care Ltd, Kampala

Kampala, Uganda

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Streptococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Kirsty Le Doare

  City St George's, University of London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Kyohere

CONTACT

+447490390327; mkyohere@sgul.ac.uk

Madeleine Cochet

CONTACT

+442087255214; mcochet@sgul.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: May 1, 2026
• Study Start: March 27, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-03

Locations

UG (1)