Group B Streptococcal InfectionPhase 2PREPARENCT05832502
Clinical Trial Investigating the Safety and Immunogenicity of GBS6 in Pregnant Women With and Without HIV (PREPARE)
A Phase 2 study testing GBS6 in people with Group B Streptococcal Infection, run by St George's, University of London at 1 site in Uganda.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Group B Streptococcal Infection
- What is being tested?
- GBS6
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteUganda
- Study dates
- 14 Oct 2022to 30 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥ 18 to ≤ 40 years of age, inclusive at day of signing the ICF.
- Pregnant at ≥ 27 0/7 to ≤35 6/7 gestation on the day of planned vaccination, verified by ultrasound scan (U/S).
- Low risk, singleton pregnancy, as assessed by the study physician based on ultra-sound scan and previous obstetric history.
- Documented negative HBV surface antigen, HCV antibody, and syphilis tests at screening.
- Documented HIV test during pregnancy undertaken as per the national guidelines.
- If HIV infected pregnant women, stable on ART for at least 3 months prior to study start
Show all 13Show fewer
- Determined by medical history, physical examination, screening laboratory assessment, and clinical judgment to be appropriate for inclusion in the study.
- Receiving prenatal standard of care including HIV care if applicable at the clin-ics/physician offices/hospital network affiliated with the clinical study site.
- Willing to give birth at Kawempe Specialised National Referral Hospital, or Kisenyi Health center IV, Uganda.
- Willing and able to participate for the duration of the study visits and follow-up until 12-months post-delivery.
- Willing and able to be contacted by telephone for the full duration of the study, and to give informed consent for their infant participant to participate in the study.
- Inclusion criteria for Infants Inclusion criteria for Infants
- 1. Parent(s) willing and able to comply with scheduled visits, investigational plan, laboratory tests, and other study procedures.
Who cannot join
- Any of the following:
- Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are Pfizer employees, including their family members, directly involved in the conduct of the study.
- Participants whose unborn baby have been fathered by investigational site staff members directly involved in the conduct of the study or their family members, site staff members otherwise supervised by the investigator, or Pfizer employees directly involved in the conduct of the study.
- Participation in other studies involving investigational drug(s), vaccines, or medical devices within 28 days prior to study entry and/or during study participation.
- Previous vaccination with any licensed or investigational GBS vaccine.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the investigational product.
Show all 27Show fewer
- History of microbiologically proven invasive disease caused by GBS, or history of an infant with GBS disease.
- Current alcohol abuse or illicit drug use.
- Body mass index (BMI) of ≥40 kg/m2 at the time of the screening visit.
- Clinical history of primary genital herpes simplex virus (HSV) infection during the current pregnancy.
- A prior history of or current pregnancy complications or abnormalities that will increase the risk associated with the participant's participation in, and completion of, the study, including but not limited to the following (refer to the SRM) for further details):
- Gestational hypertension or preeclampsia eclampsia
- Placental abnormality
- Polyhydramnios or oligohydramnios
- Significant bleeding or blood clotting disorder
- Gestational diabetes
- Any signs of premature labour with the current pregnancy
- Prior late stillbirth (defined as loss of pregnancy at any time after 28 weeks gestation) or neonatal death (defined as death of an infant within the first 28 days of life), prior low birth weight baby (defined as infant <2500 g) or premature delivery (defined as delivery before 37 0/7 weeks gestation), prior history of at least 3 miscarriages, prior pregnancies numbering greater than 5, or previous infant with a known or suspected genetic disorder or major congenital anomaly
- Confirmed GBS bacteriuria during the current pregnancy
- Major illness of the mother (outside of HIV serostatus) or conditions of the foetus that, in the investigator's judgment, will substantially increase the risk associated with the participant's participation in, and completion of, the study or could preclude the evaluation of the participant's response, including but not limited to the following (refer to the SRM) for further details):
- hypertension requiring treatment h. heart disease i. lung disease j. neurological disorders including a history of epilepsy or recurrent afebrile seizures k. kidney disease l. liver disease m. haematological disorders (including sickle cell disease) n. severe anaemia (less than 7.0g/dL) o. significant bleeding or blood clotting disorder p. endocrine disorders including known diabetes mellitus
- Participants with known or suspected immunodeficiency (outside of HIV positive sero-status).
- Participants who receive treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids, e.g., for cancer or an autoimmune disease, or planned receipt through the postvaccination blood draw. Inhaled/nebulised, intra articular, intra-bursal, or topical (skin or eyes) corticosteroids are permitted.
- Receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration, or planned receipt through delivery.
- Known to be Rhesus Negative
- Psychiatric condition including recent (within the last year) or active suicidal ideation or behaviour or laboratory abnormalities that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalised involuntarily.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
Read the detailed description
This Phase 2, randomised, placebo controlled, double blinded study will be the first evaluation of the investigational GBS6 in HIV-infected pregnant women. This study will enroll pregnant women with and without HIV to receive GBS6 or Placebo in order to provide an expanded safety and immunogenicity data set (for both pregnant women and their infants) and to support progression of the development of this vaccine.
- Conditions
- Group B Streptococcal Infection
- Being tested
- GBS6, Placebo
- Medical subject headings
- Streptococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBS6Drug
Also called Hexavalent anti capsular polysaccharide (CPS) / cross reactive material 197 glycoconjugate
The investigational products are GBS6 and placebo (saline control). The GBS6 dose will be GBS6 20mcg without AlPO4 (equivalent to 240 mcg/mL) 0.5mL dose or 20 mcg CPS/serotype).
PlaceboDrug
Placebo (saline control) administered intramuscularly by injecting 0.5 mL into the deltoid muscle
| Study group | Role | What they receive |
|---|---|---|
| Placebo (saline) in HIV-uninfected pregnant woman | Placebo comparator | Placebo (saline control) administered intramuscularly by injecting 0.5 mL into the deltoid muscle Receives: Drug: Placebo |
| GBS6 in HIV-uninfected pregnant woman | Active comparator | GBS6 administered intramuscularly by injecting 0.5 mL into the deltoid muscle Receives: Drug: GBS6 |
| Placebo (saline) in HIV-infected pregnant woman | Placebo comparator | Placebo (saline control) administered intramuscularly by injecting 0.5 mL into the deltoid muscle Receives: Drug: Placebo |
| GBS6 in HIV-infected pregnant woman | Active comparator | GBS6 administered intramuscularly by injecting 0.5 mL into the deltoid muscle Receives: Drug: GBS6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary mother outcome 1
- Percentage Occurrence of solicited local reactions within 7 days following administration of investigational product (pain at the injection site, redness, and swelling).
Measured: 7 days following administration of IMP
Primary mother outcome 2
- Percentage Occurrence of solicited systemic events within 7 days following administration of investigational product (fever, nausea/vomiting, diarrhoea, headache, fatigue/tiredness, muscle pain, and joint pain).
Measured: 7 days following administration of IMP
Primary mother outcome 3
- Percentage Occurrence of solicited and unsolicited adverse events through 1 month after administration of investigational product.
Measured: Through 1 month following administration of IMP
Primary mother outcome 4
- Number Occurrence of SAEs, MAEs, and obstetric complications (peripartum, intrapartum, and postpartum) throughout the study (Visit 1 through the 12 month postdelivery study visit) and any unsolicited events leading to study withdrawal.
Measured: Visit 1 through 12 months post-delivery
Primary Infant outcome 1
- Number Occurrence of unsolicited adverse events from birth to 6 weeks of age
Measured: Birth to 6 weeks of age
Primary Infant outcome 2
- Number Occurrence of SAEs, AEs of special interest (major congenital anomalies, developmental delay, and suspected or confirmed GBS infection), and MAEs through 12 months of age and any unsolicited events leading to study withdrawal.
Measured: Through 12 months of age
Secondary outcomes (12)
Secondary mother Outcome 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV positive and HIV negative women
- Geometric mean concentration GBS serotype specific IgG antibody titres measured at baseline in HIV positive and HIV negative women.
Measured: Baseline
Secondary mother Outcome 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV positive and HIV negative women
- Geometric mean concentration GBS serotype specific IgG antibody titres measured at 2 weeks after vaccination in HIV positive and HIV negative women.
Measured: 2 weeks after vaccination
Secondary mother Outcome 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV positive and HIV negative women
- Geometric mean concentration GBS serotype specific IgG antibody titres measured at 1 month after vaccination in HIV positive and HIV negative women.
Measured: 1 month after vaccination
Secondary mother Outcome 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV positive and HIV negative women
- Geometric mean concentration GBS serotype specific IgG antibody titres measured at delivery in HIV positive and HIV negative women.
Measured: Delivery
Secondary mother Outcome 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV positive and HIV negative women
- Geometric mean concentration GBS serotype specific IgG antibody titres measured at 6 weeks after delivery in HIV positive and HIV negative women.
Measured: 6 weeks after delivery
Secondary Mother Objective 2 - Geometric mean concentration GBS serotype specific IgG titres in HIV positive and HIV negative women
- Geometric mean concentration GBS serotype specific IgG titres measured at baseline in HIV positive and HIV negative women.
Measured: Baseline
Secondary Mother Objective 2 - Geometric mean concentration GBS serotype specific IgG titres in HIV positive and HIV negative wome
- Geometric mean concentration GBS serotype specific IgG titres measured at delivery in HIV positive and HIV negative women.
Measured: Delivery
Secondary infant Objective 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV-exposed and unexposed infant participants
- Geometric mean concentration GBS serotype specific IgG antibody titres in HIV-exposed and unexposed infant participants measured at birth
Measured: Birth
Secondary infant Objective 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV-exposed and unexposed infant participants
- Geometric mean concentration GBS serotype specific IgG antibody titres in HIV-exposed and unexposed infant participants measured at 18 weeks of life.
Measured: 18 weeks
Secondary infant Objective 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV-exposed and unexposed infant participants
- Geometric mean concentration GBS serotype specific IgG antibody titres in HIV-exposed and unexposed infant participants measured at 12 months of life.
Measured: 12 months of life
Secondary infant Objective 2 - Geometric mean concentration GBS serotype specific IgG titres in HIV-exposed and unexposed infant participants
- Geometric mean concentration GBS serotype specific IgG titres in HIV-exposed and unexposed infant participants measured at 18 weeks of life.
Measured: 18 weeks of life
Secondary infant Objective 3 - Ratio Placental transfer ratio of GBS-specific antibodies in HIV-exposed and unexposed pregnancies.
- Ratio Placental transfer ratio of GBS-specific antibodies in HIV-exposed and unexposed pregnancies.
Measured: Delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start14 Oct 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Group B Streptococcal 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- MU-JHU CARE, Pfizer
- Responsible party
- Sponsor
- Investigators
- Musa sekikubo, Prof, Principal investigator, Makerere University - John Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832502
- Sponsor's protocol ID
- 2020.0317
- Acronym
- PREPARE
- Status last verified
- Nov 2023
- First submitted
- 20 Feb 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Mboizi R, Sekikubo M, Businge GB, Mukasa Z, Musoke P, Rukundo G, Amone A, Hall T, Daniel O, Bentley E, Kocana CC, Kakai I, Gaylord M, Munjal I, Voysey M, Heath PT, Le Doaret K. Safety and immunogenicity of GBS6 in pregnant women living with and without HIV and their infants in Uganda (PREPARE WP4): a double-blind, randomised, placebo-controlled, phase 2 clinical trial. Lancet Infect Dis. 2026 Aug 25:S1473-3099(26)00318-X. doi: 10.1016/S1473-3099(26)00318-X. Online ahead of print.
PubMed 42641635
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05832502
- Acronym / sponsor ID
- PREPARE / 2020.0317
- Conditions
- Group B Streptococcal Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- MU-JHU CARE, Pfizer
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 27 Apr 2023 (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.
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
Detailed description
This Phase 2, randomised, placebo controlled, double blinded study will be the first evaluation of the investigational GBS6 in HIV-infected pregnant women. This study will enroll pregnant women with and without HIV to receive GBS6 or Placebo in order to provide an expanded safety and immunogenicity data set (for both pregnant women and their infants) and to support progression of the development of this vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo (saline) in HIV-uninfected pregnant woman | Placebo comparator | Drug: PlaceboPlacebo (saline control) administered intramuscularly by injecting 0.5 mL into the deltoid muscle |
| GBS6 in HIV-uninfected pregnant woman | Active comparator | Drug: GBS6GBS6 administered intramuscularly by injecting 0.5 mL into the deltoid muscle |
| Placebo (saline) in HIV-infected pregnant woman | Placebo comparator | Drug: PlaceboPlacebo (saline control) administered intramuscularly by injecting 0.5 mL into the deltoid muscle |
| GBS6 in HIV-infected pregnant woman | Active comparator | Drug: GBS6GBS6 administered intramuscularly by injecting 0.5 mL into the deltoid muscle |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Age ≥ 18 to ≤ 40 years of age, inclusive at day of signing the ICF.
- Pregnant at ≥ 27 0/7 to ≤35 6/7 gestation on the day of planned vaccination, verified by ultrasound scan (U/S).
- Low risk, singleton pregnancy, as assessed by the study physician based on ultra-sound scan and previous obstetric history.
- Documented negative HBV surface antigen, HCV antibody, and syphilis tests at screening.
- Documented HIV test during pregnancy undertaken as per the national guidelines.
Key exclusion criteria (27 listed)
- Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are Pfizer employees, including their family members, directly involved in the conduct of the study.
- Participants whose unborn baby have been fathered by investigational site staff members directly involved in the conduct of the study or their family members, site staff members otherwise supervised by the investigator, or Pfizer employees directly involved in the conduct of the study.
- Participation in other studies involving investigational drug(s), vaccines, or medical devices within 28 days prior to study entry and/or during study participation.
- Previous vaccination with any licensed or investigational GBS vaccine.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the investigational product.
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 |
|---|---|---|
| GBS6Also: Hexavalent anti capsular polysaccharide (CPS) / cross reactive material 197 glycoconjugateThe investigational products are GBS6 and placebo (saline control). The GBS6 dose will be GBS6 20mcg without AlPO4 (equivalent to 240 mcg/mL) 0.5mL dose or 20 mcg CPS/serotype). | Drug | GBS6 in HIV-infected pregnant woman, GBS6 in HIV-uninfected pregnant woman |
| PlaceboPlacebo (saline control) administered intramuscularly by injecting 0.5 mL into the deltoid muscle | Drug | Placebo (saline) in HIV-infected pregnant woman, Placebo (saline) in HIV-uninfected pregnant woman |
Primary outcome
Primary mother outcome 1
Time frame: 7 days following administration of IMP
1. Percentage Occurrence of solicited local reactions within 7 days following administration of investigational product (pain at the injection site, redness, and swelling).
Primary mother outcome 2
Time frame: 7 days following administration of IMP
2. Percentage Occurrence of solicited systemic events within 7 days following administration of investigational product (fever, nausea/vomiting, diarrhoea, headache, fatigue/tiredness, muscle pain, and joint pain).
Primary mother outcome 3
Time frame: Through 1 month following administration of IMP
3. Percentage Occurrence of solicited and unsolicited adverse events through 1 month after administration of investigational product.
Primary mother outcome 4
Time frame: Visit 1 through 12 months post-delivery
4. Number Occurrence of SAEs, MAEs, and obstetric complications (peripartum, intrapartum, and postpartum) throughout the study (Visit 1 through the 12 month postdelivery study visit) and any unsolicited events leading to study withdrawal.
Primary Infant outcome 1
Time frame: Birth to 6 weeks of age
1. Number Occurrence of unsolicited adverse events from birth to 6 weeks of age
Primary Infant outcome 2
Time frame: Through 12 months of age
2. Number Occurrence of SAEs, AEs of special interest (major congenital anomalies, developmental delay, and suspected or confirmed GBS infection), and MAEs through 12 months of age and any unsolicited events leading to study withdrawal.
12 secondary outcomes
Secondary mother Outcome 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV positive and HIV negative women
Time frame: Baseline
Secondary mother Outcome 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV positive and HIV negative women
Time frame: 2 weeks after vaccination
Secondary mother Outcome 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV positive and HIV negative women
Time frame: 1 month after vaccination
Secondary mother Outcome 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV positive and HIV negative women
Time frame: Delivery
Secondary mother Outcome 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV positive and HIV negative women
Time frame: 6 weeks after delivery
Secondary Mother Objective 2 - Geometric mean concentration GBS serotype specific IgG titres in HIV positive and HIV negative women
Time frame: Baseline
Secondary Mother Objective 2 - Geometric mean concentration GBS serotype specific IgG titres in HIV positive and HIV negative wome
Time frame: Delivery
Secondary infant Objective 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV-exposed and unexposed infant participants
Time frame: Birth
Secondary infant Objective 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV-exposed and unexposed infant participants
Time frame: 18 weeks
Secondary infant Objective 1 - Geometric mean concentration GBS serotype specific IgG antibody titres in HIV-exposed and unexposed infant participants
Time frame: 12 months of life
Secondary infant Objective 2 - Geometric mean concentration GBS serotype specific IgG titres in HIV-exposed and unexposed infant participants
Time frame: 18 weeks of life
Secondary infant Objective 3 - Ratio Placental transfer ratio of GBS-specific antibodies in HIV-exposed and unexposed pregnancies.
Time frame: Delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Derived from this study: PubMed 42641635Mboizi R, Sekikubo M, Businge GB, Mukasa Z, Musoke P, Rukundo G, Amone A, Hall T, Daniel O, Bentley E, Kocana CC, Kakai I, Gaylord M, Munjal I, Voysey M, Heath PT, Le Doaret K. Safety and immunogenicity of GBS6 in pregnant women living with and without HIV and their infants in Uganda (PREPARE WP4): a double-blind, randomised, placebo-controlled, phase 2 clinical trial. Lancet Infect Dis. 2026 Aug 25:S1473-3099(26)00318-X. doi: 10.1016/S1473-3099(26)00318-X. Online ahead of print.
Related trials for Group B Streptococcal Infection
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 2/3
A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingObservational study
Preparing for Maternal GBS Vaccine Trials in Africa
Group B Streptococcus, Invasive Bacterial Diseases (IBD)
RecruitingObservational study
mulTiplex Immunoassay qualiTy assuRance Panel
Group B Strep Infection
Active, not recruitingPhase 1/2
Phase I/II Study to a Assess the GBS-06 Vaccine Manufactured by Inventprise, Inc., in Healthy, Non-Pregnant, Adult Women of Childbearing Age.
Group B Streptococcal Infections
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. This study is not recruiting at the moment.
Musa sekikubo, Prof principal investigator
Makerere University - John Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GBS6 in people with Group B Streptococcal 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 13 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 16 Feb 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary mother outcome 1 (time frame: 7 days following administration of IMP). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05832502, which also lists 1 linked publication.
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 16 Feb 2024.