Clinical trials: Group B Strep Infection
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
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
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 Streptococcal Infections
A Phase 1/2, Randomized, Placebo-controlled, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Adults 18 To 49 Years Of Age
This is the Phase 1/2 first-in-human, randomized, placebo-controlled, observer-blinded study evaluating the investigational multivalent group B streptococcus vaccine.
- Trial name
- NCT03170609
- Testing
- Multivalent group B streptococcus vaccine
- Where
- 4 sites in United States
- Volunteers
- 365 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
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
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
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
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 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
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 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
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
Infection by Streptococcus Group B
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non-pregnant Women 18-40 Years of Age.
Part A: The primary objective is to evaluate the safety and tolerability of a potential vaccine against Group B streptococcus. Part B: To evaluate the long term safety profile of the GBS-NN vaccine up to one year following the…
- Trial name
- MVX13211 (NCT02459262)
- Testing
- GBS-NN vaccine
- Where
- United Kingdom
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Minervax ApS
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
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
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
Genitourinary; Infection, Complicating Pregnancy
Probiotic Supplementation as Prophylactic for Group B β-hemolytic Streptococcus (GBS) Infection
Streptococcus agalactiae, a Group B β-hemolytic streptococcus (GBS), is the leading cause of severe neonatal infection in developed countries.
- Trial name
- NCT06231056
- Testing
- Probiotic iNatal®
- Where
- Italy
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Liaquat University of Medical & Health Sciences
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