Streptococcal Group B Infection Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Uganda
MUJHU Care Ltd, Kampala
RECRUITING
Kampala
Contact Information
Primary
Mary Kyohere
mkyohere@sgul.ac.uk
+447490390327
Backup
Madeleine Cochet
mcochet@sgul.ac.uk
+442087255214
Time Frame
Start Date: 2026-03-27
Estimated Completion Date: 2027-01
Participants
Target number of participants: 50
Treatments
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.
Sponsors
Leads: St George's, University of London

This content was sourced from clinicaltrials.gov