Group B Strep InfectionTITRENCT07562061
mulTiplex Immunoassay qualiTy assuRance Panel
An observational study of Group B Strep Infection, run by St George's, University of London at 1 site in Uganda.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Group B Strep Infection
- What is being tested?
- Collection of 50mls of blood
- Type of treatment
- Vaccines
- How many people
- 50 participants
- Where
- 1 siteUganda
- Study dates
- 27 Mar 2026to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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:
- heart disease II. severe anaemia (Hemoglobin level less than 7.0g/dL)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda1 site, 1 recruiting
- Recruiting
MUJHU Care Ltd, Kampala
Kampala
Zakaria Mukasa, Dr, +256 782 201308, zmukasa@mujhu.org
Robert Mboizi
About this study
Official title: Development of Group B Streptococcus Quality Assurance Panel for the GASTON Multiplex Anti-CPS IgG Immunoassay.
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
Read the detailed description
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.
- Conditions
- Group B Strep Infection
- Being tested
- Collection of 50mls of blood
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of 50mls of bloodOther
50mls of blood will be collected from all participants who give consent.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Collection of 50mls of blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start27 Mar 2026
- Primary completionMay 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Group B Strep InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirsty Le Doare, Principal investigator, City St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562061
- Sponsor's protocol ID
- SE0306
- Other IDs
- INV-087236
- Acronym
- TITRE
- Status last verified
- Mar 2026
- First submitted
- 16 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Group B Streptococcus Quality Assurance Panel for the GASTON Multiplex Anti-CPS IgG Immunoassay.
- ClinicalTrials.gov ID
- NCT07562061
- Acronym / sponsor ID
- TITRE / SE0306
- Conditions
- Group B Strep Infection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women not living with HIV, who received the GBS6 vaccine GBS6 Clinical Trial in Kampala, Uganda | – | Other: Collection of 50mls of bloodWomen 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of 50mls of blood50mls of blood will be collected from all participants who give consent. | Other | Women not living with HIV, who received the GBS6 vaccine GBS6 Clinical Trial in Kampala, Uganda |
Primary outcome
Creation of a quality control and bridging panels for the GBS multiplex immunoassay (GASTON assay)
Time frame: 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kirsty Le Doare principal investigator
City St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Group B Strep Infection, run by St George's, University of London at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Kyohere (+447490390327, mkyohere@sgul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation of a quality control and bridging panels for the GBS multiplex immunoassay (GASTON assay) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.