RecruitingNCT07562061

mulTiplex Immunoassay qualiTy assuRance Panel

Development of Group B Streptococcus Quality Assurance Panel for the GASTON Multiplex Anti-CPS IgG Immunoassay.


Sponsor

St George's, University of London

Enrollment

50 participants

Start Date

Mar 27, 2026

Study Type

OBSERVATIONAL

Conditions

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


Eligibility

Sex: FEMALE

Inclusion Criteria4

  • 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 Criteria6

  • 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)

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Interventions

OTHERCollection of 50mls of blood

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


Locations(1)

MUJHU Care Ltd, Kampala

Kampala, Uganda

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NCT07562061