Clinical trials: Group B Streptococcus
Group B Streptococcus
Developing a Controlled Human Infection Model for Group B Streptococcus (CHIM_GBS)
Group B Streptococcus (GBS) is the leading cause of neonatal sepsis and meningitis. In 2015, it was estimated that worldwide there were at least 320,000 infants with invasive GBS disease, 90,000 infant deaths and 10,000 cases of…
- Trial name
- TIMING (NCT04059510)
- Testing
- rectovaginal swab, pregnancy test, Menstrual cup
- Where
- United Kingdom
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
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
Streptococcus Agalactiae (Streptococcus Group B)
The Clinical and Molecular Epidemiology of Streptococcus Agalactiae Colonisation on the Kenyan Coast
Sub-Saharan Africa (sSA) has the highest regional rates of perinatal mortality worldwide. Group B Streptococcus (GBS) has been identified as a leading cause of early onset neonatal sepsis (EOS, in <7 days of life) in sSA.
- Trial name
- GBS (NCT01757041)
- Where
- 4 sites in Kenya
- Volunteers
- 7,967 people
- Sponsor
- University of Oxford
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
Group B Streptococcus
Oral Penicillin and Penicillin Levels in Venous Umbilical Cord Blood
Pregnant,laboring women will receive 2 grams of oral penicillin V before delivery. At the time of delivery of the infant, umbilical vein cord blood will be obtained from the umbilical cord.
- Trial name
- NCT00823433
- Testing
- oral penicillin V
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Corewell Health East
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.
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
Bacterial Infection Due to Streptococcus, Group B, Streptococcus Agalactiae
Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects.
The objective of this extension study is the initial assessment of safety and immunogenicity of the second dose of GBS Trivalent Vaccine following the time interval that is close to the inter-pregnancy interval observed in the…
- Trial name
- NCT02690181
- Testing
- GBS Trivalent Vaccine
- Where
- Belgium
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Pregnancy
Probiotics Capsule as Supplemental Therapy for Group B Streptococci Infection and Vaginitis During Pregnancy
B streptococcal infection and the major cause of death before and after the baby is born. B streptococcus infection the way of the newborn, usually infection from the mother in childbirth, if the pregnant women during pregnancy…
- Trial name
- NCT01779193
- Testing
- lactic acid bacteria, cranberry
- Where
- Taiwan
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Meng-Hsing Wu
Pregnancy Related
Carriage of Beta Haemolytic Streptococci During Pregnancy
This is a prospective clinical study that aims to investigate asymptomatic carriage of beta haemolytic streptococci (especially group A streptococci, GAS and group B streptococci, GBS) during pregnancy.
- Trial name
- NCT05365711
- Where
- Finland
- Volunteers
- 1,040 people, healthy volunteers welcome
- Sponsor
- Turku University Hospital
Streptococcus Pyogenes Pharyngitis, Streptococcus Pharyngitis
Controlled Human Infection for Vaccination Against Streptococcus Pyogenes
Group A Streptococcus (GAS) infection is a major cause of death and disability globally with a disproportionately high burden in settings of disadvantage worldwide.
- Conditions
- Streptococcus Pyogenes Pharyngitis, Streptococcus Pharyngitis, Strep Throat, Streptococcus Pyogenes Infection
- Trial name
- CHIVAS (NCT03361163)
- Testing
- emm75 Streptococcus pyogenes (GAS M75, strain 611024)
- Where
- Australia
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Andrew Steer
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 Streptococcus Infection
Study to Assess a Booster Dose of GBS-NN/NN2 Vaccine
This is an open label booster vaccine follow-up study. Participants who had received a primary course of GBS-NN/NN2 or placebo in Study MVX0002 will be invited to return to receive a booster dose (or first dose in the case of…
- Trial name
- NCT05005247
- Testing
- GBS-NN/NN2
- Where
- United Kingdom
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
Maternal Health, Child Health
Group B Strep Correlates of Protection Study
Streptococcus agalactiae or Group B Streptococcus (GBS) is a leading cause of neonatal sepsis in developed and developing countries.
- Conditions
- Maternal Health, Child Health, Infectious Diseases
- Trial name
- GBSCoP (NCT06431217)
- Where
- South Africa
- Volunteers
- 17,842 people, healthy volunteers welcome
- Sponsor
- University of Witwatersrand, South Africa
Streptococcus B Carrier State Complicating Pregnancy
Group B Streptococcal Carrier State Prevalence Among Arab Pregnant Women in Northern Israel District
The incidence of early neonatal GBS (group B Streptococcus) infection in the Nazareth Hospital through the years 2006-2013 has been higher compared to the national average.
- Trial name
- GBS (NCT02528890)
- Testing
- vaginal/anal swab for GBS from all participants
- Where
- Israel
- Volunteers
- 196 people
- Sponsor
- The Nazareth Hospital, Israel
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
Group B Streptococcus Carrier in Childbirth
Oral Probiotic Supplementation in Pregnancy to Reduce Group B Streptococcus Colonization
This is a double-blind randomized placebo controlled trial that will investigate whether the use of three specific species of probiotics taken orally in pregnancy from 25 weeks gestation will reduce the incidence of Group B…
- Trial name
- OPSiP (NCT03407157)
- Testing
- Probiotic supplementation
- Where
- 2 sites in Canada
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Streptococcus Agalactiae
Evaluation of the Consumption of a Probiotic on the Load of S. Agalactiae.
The objective of this study is to evaluate the effects of oral administration of Lactobacillus BSL_PS71 on the presence of S. agalactiae in vaginal microbiota of healthy women.
- Trial name
- NCT04165551
- Testing
- Probiotic
- Where
- Spain
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Biosearch S.A.
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