Clinical trials: Group B Streptococcal Infection
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
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 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 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 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 Streptococcal Infection
Clinical Trial Investigating the Safety and Immunogenicity of GBS6 in Pregnant Women With and Without HIV (PREPARE)
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
- Trial name
- PREPARE (NCT05832502)
- Testing
- GBS6
- Where
- Uganda
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- St George's, University of London
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
Premature Rupture of Fetal Membranes, Group B Streptococcal Infection
Group B Streptococcus Infection and PROM Incidince
To investigate incidince of prom with GBS infection and role of prophylaxis against it
- Trial name
- NCT06735703
- Testing
- To provide ampicillin sulbactam to pregnant women with premature rupture of membrane
- Volunteers
- 150 people
- Sponsor
- Assiut University
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
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
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
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
Invasive Streptococcal Infection, Invasive Group A Streptococcal Disease
Genetic Susceptibility to Severe Streptococcal Infections
Invasive bacterial infection is a dangerous but relatively uncommon disease where bacteria spread deep into the body causing diseases like blood poisoning ('bacteraemia'), pneumonia, meningitis and others.
- Conditions
- Invasive Streptococcal Infection, Invasive Group A Streptococcal Disease, Invasive Group B Streptococcal Disease, Necrotising Fasciitis
- Trial name
- NCT01911572
- Where
- United Kingdom
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Group B Streptococcus, Invasive Bacterial Diseases (IBD)
Preparing for Maternal GBS Vaccine Trials in Africa
Infections are one of the key causes of newborn deaths. Among them, Group B Streptococcus (GBS) is the leading cause of sepsis and bacterial meningitis in the first 90 days of life.
- Conditions
- Group B Streptococcus, Invasive Bacterial Diseases (IBD), Maternal Immunization
- Trial name
- PROTECT (NCT06833957)
- Where
- 10 sites in Kenya, Malawi and 2 more
- Volunteers
- 18,100 people, healthy volunteers welcome
- Sponsor
- Barcelona Institute for Global Health
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
Preterm Labor
Group B Streptococcus (GBS) Infection and in Preterm Labor Women Conceived Through IVF
This is a cross - sectional study to determine the prevalence of GBS infection and associated factors in preterm labor women conceived through ART. 221 subjects will be involved.
- Trial name
- NCT03122704
- Testing
- GBS screening
- Where
- Vietnam
- Sponsor
- Manh Tuong Ho
Beta Haemolytic Streptococcal Infection
Prevention of GBS Colonization Via Immunity
The group B streptococcus (GBS) vaccine study is being done to see if a single vaccination with a GBS type III vaccine can stop women from getting GBS type III bacteria in the vagina.
- Trial name
- NCT00128219
- Testing
- GBS III-TT, Tetanus and diptheria toxoids vaccine
- Where
- 3 sites in United States
- Volunteers
- 667 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
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
Vaginal Colonization With GBS
Integrative Approach to Identify Environmental Risk Factors for CC-17 Group B Streptococcal Neonatal Infection
Streptococcus agalactiae (GBS) is the leading cause of neonatal septicaemia, meningitis, and pneumonia in the industrialized world.
- Trial name
- STREPB17 (NCT02471937)
- Testing
- Bacteriological analyses on clinical samples performed with Eswabs
- Where
- France
- Volunteers
- 151 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris