Clinical trials: GBS Positive
Group B Streptococcal Infection
Effect of Probiotics on GBS Colonization Status During Pregnancy: A Pilot Randomized Controlled Trial
Group B Streptococcus (GBS) is the leading cause of neonatal morbidity and mortality in Canada. It may be passed from a study participant colonized in the genital tract by GBS to their baby during vaginal birth.
- Trial name
- NCT02528981
- Testing
- Probiotic
- Where
- Canada
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Toronto Metropolitan University
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
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.
Group B Strep Infection
Group B Streptococcus Vaccine in Healthy Females
A Phase I, randomised, single centre, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of two doses of Group B Streptococcus vaccine.
- Trial name
- MVX0002 (NCT03807245)
- Testing
- GBS-NN/NN2 with Alhydrogel® 25, GBS-NN/NN2 with Alhydrogel® 50
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
Streptococcus Agalactiae Infection, Neonatal Sepsis
A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
The main objective of the study is to evaluate the persistence of the immunoglobulin G (IgG) antibody responses, specific to Alpha-like protein CN (AlpCN), Ribosomal Protein N (RibN), Alpha-like protein 1N (Alp1N), and Alpha-like…
- Conditions
- Streptococcus Agalactiae Infection, Neonatal Sepsis, Pneumonia, Meningitis
- Trial name
- NCT06592586
- Testing
- GBS-NN/NN2 vaccine
- Where
- 6 sites in Denmark, South Africa
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
Group B Streptococcal Infections
Study to Evaluate the Safety, Tolerability and Immunogenicity of Three Doses of GBS Vaccine in Elderly Participants
The study is a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of three doses of GBS NN/NN2 with Alhydrogel® (Recombinant protein vaccine against Group B…
- Trial name
- NCT05782179
- Testing
- GBS-NN/NN2
- Where
- Belgium
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
Streptococcus Infection, Pregnancy
Rapid Diagnostic Test for Detection of Group B Streptococcus in Pregnancy
This study evaluates the use of a new method of growing and detecting Group B streptococcus in pregnant women. This new method utilizes sandwiched-membrane petri technology and has the advantage of detecting GBS in less than 6…
- Trial name
- GBS (NCT01445717)
- Where
- United States
- Volunteers
- 358 people, healthy volunteers welcome
- Sponsor
- The University of Texas Health Science Center, Houston
Group B Streptococcal Infection
Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women
This is a phase II, multicentre, multinational, randomized, parallel group, placebo-controlled study of four vaccination regimens in healthy pregnant women.
- Trial name
- NCT05154578
- Testing
- GBS-NN/NN2 Vaccine
- Where
- 10 sites in Denmark, South Africa and 1 more
- Volunteers
- 269 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset
Serosurveillance Study of Maternally Derived Anti-GBS Antibody
Globally, neonatal mortality remains unacceptably high, with little change in the death rate in the first 28 days of life since 1990, despite reductions in under-5 mortality of up to 50% over the same period.
- Conditions
- Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset, Group B Streptococcal Infection, Early-Onset, Group B Streptococcus Neonatal Sepsis
- Trial name
- ProGreSs (NCT04549220)
- Where
- Uganda
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
GBS, Group B Streptococcal Infection
Time Frame for GBS Screening
All pregnant women prenatally being followed up or admitted at Rambam HealthCare Campus, Haifa, Israel are potential participants in the study.
- Trial name
- NCT04116645
- Testing
- genital and rectal swab
- Sponsor
- Rambam Health Care Campus
Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset
Maternal, Neonatal and Infant Outcomes at Kawempe National Referral Hospital
Maternal immunisation is an evolving field that deserves special attention given its potential to have a significant positive impact on the health of women and children globally, and the potential safety and risk considerations…
- Conditions
- Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset, Group B Streptococcal Infection, Early-Onset, Group B Streptococcus Neonatal Sepsis
- Trial name
- PREPARE (NCT04653948)
- Where
- Uganda
- Volunteers
- 3,423 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
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
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
Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset
Serocorrelate of Protection Against GBS (PREPARE WP3)
A multicentre, international case-control study to develop a biobank of sera from 150 cases of serotype III GBS disease and associated clinical information from seven countries (Malawi, Uganda, UK, the Netherlands, Italy and…
- Conditions
- Group B Streptococcus Carrier in Childbirth, Group B Streptococcal Infection, Late-Onset, Group B Streptococcal Infection, Early-Onset, Group B Streptococcus Neonatal Sepsis
- Trial name
- NCT04732026
- Where
- 6 sites in France, Italy and 4 more
- Volunteers
- 600 people
- Sponsor
- St George's, University of London
Streptococcus Agalactiae Infection
GBS-NN/NN2 (50 µg of Each Fusion Protein [GBS-NN and GBS-NN2] in Combination With 500 µg Aluminum as Alhydrogel®) Given With and Without the Tdap Vaccine in Healthy Non-pregnant Women 18 to 49 Years of Age
The main objectives of the study are to demonstrate the non-inferiority of the immune response induced by co administered GBS-NN/NN2 and tetanus, diphtheria, and acellular pertussis (Tdap) compared to the separate administration…
- Trial name
- NCT06494475
- Testing
- GBS-NN/NN2 vaccine, Tdap vaccine
- Volunteers
- healthy volunteers welcome
- Sponsor
- Minervax ApS
GBS Positive, Women in Labor Given Vancomycin for Prophylaxis
Intrapartum Vancomycin for Group B Streptococcus (GBS) Prophylaxis
While it is clear that intrapartum antibiotics reduce neonatal GBS infection rates, the mechanism by which these drugs prevent neonatal GBS is not well established.
- Trial name
- NCT02143154
- Where
- United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Women and Infants Hospital of Rhode Island
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.
Group B Streptococcal Infection
Intrapartum Effect of Vancomycin on Rectovaginal GBS Colonization
The aim of this project is to identify the duration of vancomycin administration at which group B streptococcus (GBS) colonization is eradicated from the vaginal and recto-vaginal mucosa.
- Trial name
- NCT02814318
- Testing
- Vaginal and rectovaginal swab cultures
- Where
- 2 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- TriHealth Inc.
Group B Strep Infection
Group B Streptococcus Response After Probiotic Exposure
This is an open-label randomized control trial and feasibility study designed to determine the feasibility of a larger RCT in our setting that would examine prenatal probiotic use in Group B Strep (GBS) positive pregnant women at…
- Trial name
- GRAPE (NCT04721912)
- Testing
- Probiotic dietary supplement
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- University of New Mexico
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