mulTiplex Immunoassay qualiTy assuRance Panel
ConditionGroup B Strep Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorSt George's, University of London
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Collection of 50mls of blood
Other intervention50mls of blood will be collected from all participants who give consent.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Women not living with HIV, who received the GBS6 vaccine GBS6 Clinical Trial in Kampala, Uganda1 intervention
Trial outcomes
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.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov