Clinical trials: GBS
Group B Streptococcal Infections
Phase I/II Study to a Assess the GBS-06 Vaccine Manufactured by Inventprise, Inc., in Healthy, Non-Pregnant, Adult Women of Childbearing Age.
To assess the safety and tolerability of IVT GBS-06 vaccine administered as a single-dose regimen, at three dosage levels in healthy, non-pregnant, adult women of childbearing age (WOCBA).
- Trial name
- NCT06611371
- Testing
- IVT GBS-06
- Where
- 2 sites in United States, South Africa
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Inventprise Inc.
Infections, Streptococcal, Streptococcal Infections
Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine
The purpose of the present study is to assess and compare in healthy non-pregnant women 18 to 40 years of age the safety and immunogenicity of a liquid formulation of Group B Streptococcus (GBS) Trivalent Vaccine (not requiring…
- Trial name
- NCT02270944
- Testing
- GBS Vaccine
- Where
- 9 sites in United States, Belgium and 1 more
- Volunteers
- 1,053 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Invasive Group B Streptococcus (GBS) Disease
A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18- 40 Years of Age
The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect humans from infection.
- Trial name
- NCT00645346
- Testing
- GBS glycoconjugate vaccine
- Where
- Switzerland
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Group B Streptococcus (GBS) Disease
A Study to Assess the Persistence of a GBS Antibody in Women Previously Immunized With a GBS Vaccine
This study looks at the body's immune responses to a GBS vaccine 2 years after the orginal vaccine(s) were given in the V98P1 study. Blood will be drawn and evaluated for GBS antibody levels.
- Trial name
- NCT01052935
- Testing
- Group B streptococcus (GBS) vaccine
- Where
- Switzerland
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Novartis
Streptococcus Agalactiae
Feasibility Study for Identifying Anti Capsular Antibody Protection Against Invasive Group B Streptococcus (GBS) Disease in Newborns of 0-6 Days Age (Early Onset Disease [EOD]) as Well as Among Infants of 7-90 Days Age (Late Onset Disease [LOD])
The purpose of this study is to evaluate antibody levels against Group B streptococcus in mothers and the risk of developing invasive Group B streptococcus disease in newborns of less than 6 days age as well as infants of age…
- Trial name
- NCT01888471
- Testing
- Blood sample, Vaginal swab sample
- Where
- South Africa
- Volunteers
- 3,033 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Guillain-Barré Syndrome
A Clinical Study of ANX005 and IVIG in Subjects With Guillain Barré Syndrome (GBS)
This study is a multi center, open-label, study of ANX005 in combination with IVIg in subjects diagnosed with GBS.
- Trial name
- NCT04035135
- Testing
- ANX005, Intravenous immunoglobulin
- Where
- 2 sites in Bangladesh, Denmark
- Volunteers
- 14 people
- Sponsor
- Annexon, Inc.
Streptococcus Agalactiae Infection
Validation of the GenePOC GBS Assay for the Detection of the Cfb Gene From Streptococcus Agalactiae Strains
The primary purpose of this clinical investigation is to verify the performance of the GenePOC GBS Assay on the GenePOC Instrument.
- Trial name
- NCT02718157
- Testing
- Comparison between GenePOC PCR and Reference Method
- Where
- 4 sites in United States, Canada
- Volunteers
- 771 people
- Sponsor
- Meridian Bioscience, Inc.
Guillain-Barre Syndrome
A Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barré Syndrome
This is a Phase 3, prospective, multicenter, placebo controlled, double blind, randomized study to investigate the efficacy and safety of eculizumab in participants with severe GBS, defined using the Hughes Functional Grade (FG)…
- Trial name
- NCT04752566
- Testing
- Eculizumab
- Where
- 22 sites in Japan
- Volunteers
- 57 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Invasive Group B Streptococcus (GBS) Disease
A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of a Monovalent Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18-40 Years of Age
The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect humans from infection.
- Trial name
- NCT00657683
- Testing
- Monovalent GBS-CRM glycoconjugate vaccine
- Where
- Switzerland
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
GBS Disease, Streptococcus Agalactiae
Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women
Evaluate the safety and immunogenicity of the trivalent group B streptococcus vaccine in healthy pregnant women. The study will also evaluate the levels of GBS serotype-specific antibodies in infants, placental transfer from the…
- Trial name
- NCT02046148
- Testing
- GBS trivalent vaccine
- Where
- 6 sites in United States
- Volunteers
- 75 people
- Sponsor
- GlaxoSmithKline
Streptococcal Infections, Gram-Positive Bacterial Infections
Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
The study compared the magnitude of the antibody response and safety of a GBS Trivalent Vaccine in HIV positive and HIV negative pregnant women and their offspring.
- Conditions
- Streptococcal Infections, Gram-Positive Bacterial Infections, Bacterial Infections
- Trial name
- NCT01412801
- Testing
- Group B streptococcus vaccine
- Where
- 2 sites in Malawi, South Africa
- Volunteers
- 270 people
- Sponsor
- Novartis Vaccines
Streptococcal Infection, Gram-positive Bacterial Infection
Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings
The study investigated the immune response induced by the Group B streptococcus vaccine in healthy pregnant women. In addition, the study investigated the amount of vaccine induced antibodies which were transferred to the newborn.
- Conditions
- Streptococcal Infection, Gram-positive Bacterial Infection, Bacterial Infection
- Trial name
- NCT01446289
- Testing
- Group B Streptococcus Trivalent Vaccine
- Where
- 5 sites in Belgium, Canada
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Novartis
Guillain-Barré Syndrome (GBS)
A Study of Imlifidase in Patients With Guillain-Barré Syndrome
The study participants are patients which have been diagnosed with Guillain-Barré Syndrome (GBS) and are planned to receive treatment with intravenous immunoglobulin (IVIg). IVIg is a standard of care treatment for GBS patients.
- Trial name
- NCT03943589
- Testing
- Imlifidase
- Where
- 11 sites in France, Netherlands and 1 more
- Volunteers
- 30 people
- Sponsor
- Hansa Biopharma AB
Gestational Mother, Streptococcus Agalactiae Infection
Colonization with Group B Streptococcus During Pregnancy
An observational study to estimate the probability of pregnant women, who were GBS-negative in the first trimester of pregnancy become GBS-positive at the end of pregnancy. It is an observational.
- Trial name
- PROBIGEST (NCT03671486)
- Where
- Spain
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- ProbiSearch SL
Streptococcal Infections
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age
This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at one dose in healthy non pregnant women and then in three different doses in healthy pregnant women.
- Trial name
- NCT01193920
- Testing
- Group B Streptococcus Trivalent Vaccine - 20/20/20 μg, Saline solution, Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg
- Where
- South Africa
- Volunteers
- 380 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Pregnancy, GBS
Clinical Evaluation of the ARIES Group B Streptococcus (GBS) Assay
The ARIES GBS Assay is a real-time PCR based qualitative test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs obtained from pregnant women between 35 - 37 weeks…
- Trial name
- NCT02497430
- Where
- 5 sites in United States
- Volunteers
- 918 people, healthy volunteers welcome
- Sponsor
- Luminex Corporation
Guillain-Barré Syndrome
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Participants With Guillain-Barré Syndrome (GBS)
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of crovalimab compared with placebo as an add-on therapy to intravenous immunoglobulin (IVIg) in participants with severe GBS.
- Trial name
- NCT05494619
- Testing
- Crovalimab, Intravenous immunoglobulin therapy
- Sponsor
- Hoffmann-La Roche
Guillain-Barré Syndrome
A Clinical Trial of CK0801 (a New Drug) In Patients With Treatment-Resistant Guillain-Barré Syndrome (GBS)
The goal of this research study is to determine whether it is safe and practical to give CK0801 (a cord-blood derived T-regulatory cell product) to patients with Guillain-Barré Syndrome (GBS).
- Trial name
- NCT03773328
- Testing
- CK0801
- Sponsor
- Cellenkos, Inc.
Invasive Group B Streptococcus Disease, Group B Streptococcus
Comprehensive Outcomes Monitoring for Peri- and Postnatal Invasive Group B Strep Sequelae (COMPPASS) Registry
The goal of this registry is to collect and store important medical and non-health information on children from 0 to 18 years of age affected by early- (up to 24 hours after birth) and late-onset (up to 90 days after birth)…
- Conditions
- Invasive Group B Streptococcus Disease, Group B Streptococcus, Group B Streptococcal Infection, Group B Streptococcus (GBS) Disease
- Trial name
- COMPPASS (NCT06896526)
- Volunteers
- 10,000 people
- Sponsor
- Precia Group
Guillain-Barré Syndrome (GBS)
A Study of Empasiprubart as Add-On Therapy to IVIg in Adult Participants With Guillain-Barré Syndrome
The main purpose of this study is to learn whether empasiprubart, when given in addition to intravenous immunoglobulin (IVIg), helps adults with Guillain-Barré syndrome (GBS) recover and whether it is safe.
- Trial name
- embridge (NCT07821762)
- Testing
- Empasiprubart IV, Intravenous immunoglobulin (IVIg)
- Volunteers
- 63 people
- Sponsor
- argenx