Clinical trials: Group B Streptococcal Infections
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 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
Group B Streptococcal Infection
Study of a Group B Streptococcus Vaccine in Pregnant Women Living With HIV and in Pregnant Women Who do Not Have HIV
A randomised, placebo-controlled, double-blind study to evaluate the safety, tolerability and immunogenicity of the GBS-NN/NN2 (Recombinant protein vaccine against Group B Streptococcus) vaccine in women living with HIV and women…
- Trial name
- NCT04596878
- Testing
- GBS-NN/NN2
- Where
- 3 sites in South Africa, Uganda
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
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.
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
Gestational Mother, Streptococcus Agalactiae Infection
Effect of a New Probiotic Strain in the Reduction of Group B Streptococcus Colonization in Pregnant Women
An interventional, randomized, multicenter, double-blind, placebo-controlled, parallel-group study will be conducted to evaluate the effectiveness of the strain Lactobacillus salivarius V4II-90 in the reduction of Group B…
- Trial name
- PROBIGEST (NCT03669094)
- Testing
- Lactobacillus salivarius V4II-90
- Where
- Spain
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- ProbiSearch SL
Group B Streptococcus Infection
A Follow up Study of Group B Streptococcus (GBS)-NN/NN2 Vaccine in Healthy Volunteers
The goal of this follow-up study is to investigate the persistence of the immune response induced by the GBS-NN/NN2 vaccine in women who have participated in study MVX0002, and/or in study MVX0003 with GBS-NN/NN2 vaccine and…
- Trial name
- NCT06280157
- Testing
- GBS-NN/NN2
- Where
- United Kingdom
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
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
Rapid Detection of Group B Streptococcus (Strep)-Labor and Delivery Study
The purpose of this study is to determine whether a rapid bedside diagnosis of group B strep (GBS) growing in the vagina and rectum can be performed with similar success to the routine culture in women who are in labor.
- Trial name
- NCT00330642
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Michigan
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
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, 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
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
Meningococcal Disease, Pneumococcal Disease
Hepatitis B Vaccination in Infants
In the UK, infants currently receive a 5-in-1 vaccine (Pediacel) at 2, 3 and 4 months of age, which protects against diphtheria, tetanus, pertussis (whooping cough), polio and Haemophilus influenzae type b (Hib).
- Conditions
- Meningococcal Disease, Pneumococcal Disease, Haemophilus Influenzae Serotype b Disease, Diphtheria, Tetanus and Pertussis
- Trial name
- Infanrix (NCT01896596)
- Testing
- Menjugate, Menitorix, NeisVac-C
- Where
- United Kingdom
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Public Health England
Infection, Pregnancy
Effects of Oral Probiotic Supplementation on Group B Strep (GBS) Rectovaginal Colonization in Pregnancy
The investigators wish to determine if oral probiotic supplementation during the second half of pregnancy decreases maternal GBS recto-vaginal colonization at 35-37 weeks' gestational age, thereby decreasing need for maternal…
- Trial name
- NCT01479478
- Testing
- Probiotic dietary supplement
- Where
- 3 sites in United States
- Volunteers
- 251 people, healthy volunteers welcome
- Sponsor
- Stanford University
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
Group B Streptococcal Infections
A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS
This study is an extension to the completed first-in-human C1091001 study (NCT03170609) and is to evaluate the safety and immunogenicity of a single booster vaccine dose of GBS6, administered approximately 2 years or more after a…
- Trial name
- NCT04258995
- Testing
- Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6)
- Where
- 4 sites in United States
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
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
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